WorldWideScience

Sample records for drug application nda

  1. 21 CFR 330.11 - NDA deviations from applicable monograph.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false NDA deviations from applicable monograph. 330.11... EFFECTIVE AND NOT MISBRANDED Administrative Procedures § 330.11 NDA deviations from applicable monograph. A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that...

  2. 77 FR 50121 - Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70

    Science.gov (United States)

    2012-08-20

    ...] Hospira, Inc.; Withdrawal of Approval of a New Drug Application for DEXTRAN 70 AGENCY: Food and Drug... new drug application (NDA) for DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL Glass... that FDA withdraw approval of NDA 080-819, DEXTRAN 70 (6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 m...

  3. Elements of nondestructive assay (NDA) technology

    International Nuclear Information System (INIS)

    Anon.

    1981-01-01

    This session provides an introduction to nondestructive assay methods and instruments as they are applied to nuclear safeguards. The purpose of the sessions is to enable participants to: (1) discuss the general principles and major applications of NDA; (2) describe situations in which NDA is particularly useful for nuclear safeguards purposes; (3) distinguish between various passive and active gamma-ray and neutron NDA methods; (4) describe several NDA instruments that measure gamma rays, and identify assay situations particularly suited to gamma-ray techniques; (5) describe several NDA instruments that measure neutrons, and identify assay situations particularly suited to neutron techniques; (6) discuss the role of calorimetry in the NDA of plutonium-bearing materials; and (7) compare the advantages and disadvantages of various NDA methods for different types of nuclear materials

  4. 78 FR 33426 - Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX

    Science.gov (United States)

    2013-06-04

    ...] Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX AGENCY: Food and Drug... new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, Indianapolis, IN 46285. Lilly has voluntarily requested that approval of this...

  5. 77 FR 16039 - Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated...

    Science.gov (United States)

    2012-03-19

    ...] Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New... Tablets... Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157. NDA... (diphenhydramine Healthcare. HCl)) Injection Preservative Free. NDA 010021 Placidyl Abbott Laboratories...

  6. Elements of nondestructive assay (NDA) technology

    International Nuclear Information System (INIS)

    Hatcher, C.R.; Smith, H.

    1984-01-01

    A thorough introduction to nondestructive assay methods and instruments as they are applied to nuclear safeguards is presented. The general principles and major applications of NDA are discussed and situations in which NDA is particularly useful for nuclear safeguards purposes are described. Various passive and active γ-ray and neutron methods are examined and assay situations particularly suited to γ-ray techniques, or to neutron techniques are identified. The role of calorimetry in the NDA of plutonium-bearing materials is also discussed. The advantages and disadvantages of various NDA methods for different types of nuclear materials are mentioned

  7. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Science.gov (United States)

    2011-03-03

    ... subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than... 23, 1983, notice, the manufacturer had submitted supplemental applications proposing to reformulate... Laboratories, a subsidiary of Elan Corp., PLC, 800 Gateway Blvd., South San Francisco, CA 94080; Copley...

  8. 78 FR 66748 - Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications...

    Science.gov (United States)

    2013-11-06

    ... Ave., Glendale, CA 91201. NDA 017861 Acthar Gel Synthetic Armour (seractide acetate) Pharmaceutical Co... the Center for Drug Evaluation and Research proposes to issue an order under section 505(e) of the..., all issues relating to the legal status of the drug products covered by these applications. An...

  9. 75 FR 80061 - Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA

    Science.gov (United States)

    2010-12-21

    ... withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral... requested that Abbott voluntarily withdraw MERIDIA (sibutramine HCl) oral capsules from the market, based on FDA's recent analysis of clinical trial data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT...

  10. Review and Ranking of NDA Techniques to Determine Plutonium Content in Spent Fuel

    International Nuclear Information System (INIS)

    Cheatham, Jesse R.; Wagner, John C.

    2010-01-01

    A number of efforts are under way to improve nondestructive assay (NDA) techniques for spent nuclear fuel (SNF) safeguard applications. These efforts have largely focused on advancing individual NDA approaches to assay plutonium content. Although significant improvements have been made in NDA techniques, relatively little work has been done to thoroughly and systematically compare the methods. A comparative review of the relative strengths and weaknesses of current NDA techniques brings a new perspective to guide future research. To gauge the practicality and effectiveness of the various relevant NDA approaches, criteria have been developed from two broad categories: functionality and operability. The functionality category includes accuracy estimates, measurement time, plutonium verification capabilities, and assembly or fuel rod assay. Since SNF composition changes with operational history and cooling times, the viability of certain NDA approaches will also change over time. While active interrogation approaches will benefit from reduced background radiation, passive assays will lose the information contained in short-lived isotopes. Therefore, the expected assay accuracy as a function of time is considered. The operability category attempts to gauge the challenges associated with the application of different NDA techniques. This category examines the NDA deploy-ability, measurement capabilities and constraints in spent fuel pools, required on-site facilities, NDA technique synergies, and the extent to which the measurements are obtrusive to the facility. Each topic listed in the categories will be given a numerical score used to rank the different NDA approaches. While the combined numerical score of each technique is informative, the individual-topic scoring will allow for a more-tailored ranking approach. Since the needs and tools of the International Atomic Energy Agency differ from those of a recycling facility, the best assay technique may change with users

  11. NDA National Graduate Programme 'nucleargraduates'

    International Nuclear Information System (INIS)

    Dawson, Carl

    2010-01-01

    , Environmental Sciences, Finance, Procurement and Project Controls. These disciplines were expanded for the later cohorts to include areas such as materials, electrical engineering, health physics, safety case writing and chemistry. The graduates have gone through a series of four secondments. Throughout the programme four periods of training have been conducted. All secondments are in a specific work discipline and have had defined projects. Training has been structured and aligned with relevant 'Institute' competencies to ensure a route through to chartered status for any graduates wishing to follow this line. There is also an emphasis on behavioural and technical training to ensure a broad experience for those going through the programme. Attraction and recruitment was formed from two areas: Recruitment of second jobbers and traditional 'milk-round' recruitment. An online Applicant Tracking System has been used to streamline much of the application and assessment phases of the recruitment phase and capture graduates not suitable for the NDA programme that may be of interest to stakeholders. A bespoke Socio-Economic Programme, named Footprints, has delivered: '10% Time' - a voluntary work in the community programme, which compliments other training areas, focussing on 'the skills agenda' and bringing the NDA into the heart of the community; Society 'programme days' introducing the graduates to the role of the industry in society through bespoke away days. These have included visits to facilities such as the UK Government, coal mines, schools, meat markets, churches etc. The 'Footprints' programme is themed around specific strands such as education, innovation, community and governance and is targeted at geographical areas aligned to NDA's socio economic plan. (authors)

  12. Fabricating defensible reference standards for the NDA lab

    Energy Technology Data Exchange (ETDEWEB)

    Ceo, R.N.; May, P.K. [Oak Ridge Y-12 Plant, TN (United States)

    1997-11-01

    Nondestructive analysis (NDA) is performed at the Oak Ridge Y-12 Plant in support of the enriched uranium operations. Process materials are analyzed using gamma ray- and neutron-based instruments including segmented gamma scanners, solution assay systems, and an active well coincidence counter. Process wastes are also discarded based on results of these measurements. Good analytical practice, as well as applicable regulations, mandates that these analytical methods be calibrated using reference materials traceable to the national standards base. Reference standards for NDA instruments are not commercially available owing to the large quantities of special nuclear materials involved. Instead, representative materials are selected from each process stream, then thoroughly characterized by methods that are traceable to the national standards base. This paper discusses the process materials to be analyzed, reference materials selected for calibrating each NDA instrument, and details of their characterization and fabrication into working calibrations standards. Example calibration curves are also presented. 4 figs.

  13. Fabricating defensible reference standards for the NDA lab

    International Nuclear Information System (INIS)

    Ceo, R.N.; May, P.K.

    1997-01-01

    Nondestructive analysis (NDA) is performed at the Oak Ridge Y-12 Plant in support of the enriched uranium operations. Process materials are analyzed using gamma ray- and neutron-based instruments including segmented gamma scanners, solution assay systems, and an active well coincidence counter. Process wastes are also discarded based on results of these measurements. Good analytical practice, as well as applicable regulations, mandates that these analytical methods be calibrated using reference materials traceable to the national standards base. Reference standards for NDA instruments are not commercially available owing to the large quantities of special nuclear materials involved. Instead, representative materials are selected from each process stream, then thoroughly characterized by methods that are traceable to the national standards base. This paper discusses the process materials to be analyzed, reference materials selected for calibrating each NDA instrument, and details of their characterization and fabrication into working calibrations standards. Example calibration curves are also presented. 4 figs

  14. FDA's requirements for radiation dosimetry of radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Abel, N.M.

    1986-01-01

    The primary concern of the Office of Drug Research and Review of the Food and Drug Administration in the field of radiation dosimetry is to ensure that radiopharmaceutical drug products are safe when used as investigational drugs (INDs) and are both safe and effective when a new drug application (NDA) is approved. In order to accomplish this, the sponsor of either an IND or applicant in the case of NDA must provide information that clearly describes the radiation dose that a patient will receive from the administration of the drug. The submitted numerical estimates of the radiation dose should be based on an absorbed fraction method of radiation dose calculation, such as the system set forth by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine or the system set forth by the International Commission on Radiological Protection (ICRP). This presentation will describe in detail the data that a sponsor of an IND needs to submit to satisfy the regulatory requirements. Examples will be given of common mistakes and omissions by sponsors in their presentation of data

  15. Evalution of NDA techniques and instruments for assay of nuclear waste at a waste terminal storage facility

    International Nuclear Information System (INIS)

    Blakeman, E.D.; Allen, E.J.; Jenkins, J.D.

    1978-05-01

    The use of Nondestructive Assay (NDA) instrumentation at a nuclear waste terminal storage facility for purposes of Special Nuclear Material (SNM) accountability is evaluated. Background information is given concerning general NDA techniques and the relative advantages and disadvantages of active and passive NDA methods are discussed. The projected characteristics and amounts of nuclear wastes that will be delivered to a waste terminal storage facility are presented. Wastes are divided into four categories: High Level Waste, Cladding Waste, Intermediate Level Waste, and Low Level Waste. Applications of NDA methods to the assay of these waste types is discussed. Several existing active and passive NDA instruments are described and, where applicable, results of assays performed on wastes in large containers (e.g., 55-gal drums) are given. It is concluded that it will be difficult to routinely achieve accuracies better than approximately 10--30% with ''simple'' NDA devices or 5--20% with more sohpisticated NDA instruments for compacted wastes. It is recommended that NDA instruments not be used for safeguards accountability at a waste storage facility. It is concluded that item accountability methods be implemented. These conclusions and recommendations are detailed in a concurrent report entitled ''Recommendations on the Safeguards Requirements Related to the Accountability of Special Nuclear Material at Waste Terminal Storage Facilities'' by J.D. Jenkins, E.J. Allen and E.D. Blakeman

  16. 75 FR 47821 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-09

    ... the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01- 392), for new drug application (NDA) 20-632, MERIDIA (sibutramine hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, for...

  17. 77 FR 17487 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-26

    ... line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug application (NDA) 203- 100, for a fixed-dose combination tablet of...

  18. ARIES NDA Robot operators' manual

    International Nuclear Information System (INIS)

    Scheer, N.L.; Nelson, D.C.

    1998-05-01

    The ARIES NDA Robot is an automation device for servicing the material movements for a suite of Non-destructive assay (NDA) instruments. This suite of instruments includes a calorimeter, a gamma isotopic system, a segmented gamma scanner (SGS), and a neutron coincidence counter (NCC). Objects moved by the robot include sample cans, standard cans, and instrument plugs. The robot computer has an RS-232 connection with the NDA Host computer, which coordinates robot movements and instrument measurements. The instruments are expected to perform measurements under the direction of the Host without operator intervention. This user's manual describes system startup, using the main menu, manual operation, and error recovery

  19. Automatic identification of NDA measured items: Use of E-tags

    International Nuclear Information System (INIS)

    Chitumbo, K.; Olsen, R.; Hatcher, C.R.; Kadner, S.P.

    1995-01-01

    This paper describes how electronic identification devices or E-tags could reduce the time spent by LAEA inspectors making nondestructive assay (NDA) measurements. As one example, the use of E-tags with a high-level neutron coincidence counter (HLNC) is discussed in detail. Sections of the paper include inspection procedures, system description, software, and future plans. Mounting of E-tabs, modifications to the HLNC, and the use of tamper indicating devices are also discussed. The technology appears to have wide application to different types of nuclear facilities and inspections and could significantly change NDA inspection procedures

  20. Radiopharmaceutical drug review process

    International Nuclear Information System (INIS)

    Frankel, R.

    1985-01-01

    To ensure proper radioactive drug use (such as quality, diagnostic improvement, and minimal radioactive exposure), the Food and Drug Administration evaluates new drugs with respect to safety, effectiveness, and accuracy and adequacy of the labeling. The IND or NDA process is used for this purpose. A brief description of the process, including the Chemical Classification System and the therapeutic potential classification, is presented as it applies to radiopharmaceuticals. Also, the status of the IND or NDA review of radiopharmaceuticals is given

  1. NDA National Graduate Programme 'nucleargraduates'

    Energy Technology Data Exchange (ETDEWEB)

    Dawson, Carl

    2010-07-01

    of partners. The first cohort targeted graduates from the following disciplines areas: Civil and Mechanical Engineering, Environmental Sciences, Finance, Procurement and Project Controls. These disciplines were expanded for the later cohorts to include areas such as materials, electrical engineering, health physics, safety case writing and chemistry. The graduates have gone through a series of four secondments. Throughout the programme four periods of training have been conducted. All secondments are in a specific work discipline and have had defined projects. Training has been structured and aligned with relevant 'Institute' competencies to ensure a route through to chartered status for any graduates wishing to follow this line. There is also an emphasis on behavioural and technical training to ensure a broad experience for those going through the programme. Attraction and recruitment was formed from two areas: Recruitment of second jobbers and traditional 'milk-round' recruitment. An online Applicant Tracking System has been used to streamline much of the application and assessment phases of the recruitment phase and capture graduates not suitable for the NDA programme that may be of interest to stakeholders. A bespoke Socio-Economic Programme, named Footprints, has delivered: '10% Time' - a voluntary work in the community programme, which compliments other training areas, focussing on 'the skills agenda' and bringing the NDA into the heart of the community; Society 'programme days' introducing the graduates to the role of the industry in society through bespoke away days. These have included visits to facilities such as the UK Government, coal mines, schools, meat markets, churches etc. The 'Footprints' programme is themed around specific strands such as education, innovation, community and governance and is targeted at geographical areas aligned to NDA's socio economic plan. (authors)

  2. Neutron method for NDA in the Sapphire Project

    International Nuclear Information System (INIS)

    Lewis, K.D.

    1995-01-01

    The implementation of Project Sapphire, the top-secret mission to the Republic of Kazakhstan to recover weapons-grade nuclear materials, consisted of four major elements: (1) repacking of fissile material from Kazakh containers into suitable U.S. containers; (2) nondestructive analyses (NDA) to quantify the 235 U content of each container for nuclear criticality safety and compliance purposes; (3) packaging of the fissile material containers into 6M/2R drums, which are internationally approved for shipping fissile material; and (4) shipping or transport of the recovered fissile material to the United States. This paper discusses the development and application of a passive neutron counting technique used in the NDA phase of the Sapphire operations to analyze uranium/beryllium (U/Be) alloys and compounds for 235 U content

  3. Regulatory considerations concerning IND radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Nissel, M.

    1985-01-01

    The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

  4. Creating NDA working standards through high-fidelity spent fuel modeling

    International Nuclear Information System (INIS)

    Skutnik, Steven E.; Gauld, Ian C.; Romano, Catherine E.; Trellue, Holly

    2012-01-01

    The Next Generation Safeguards Initiative (NGSI) is developing advanced non-destructive assay (NDA) techniques for spent nuclear fuel assemblies to advance the state-of-the-art in safeguards measurements. These measurements aim beyond the capabilities of existing methods to include the evaluation of plutonium and fissile material inventory, independent of operator declarations. Testing and evaluation of advanced NDA performance will require reference assemblies with well-characterized compositions to serve as working standards against which the NDA methods can be benchmarked and for uncertainty quantification. To support the development of standards for the NGSI spent fuel NDA project, high-fidelity modeling of irradiated fuel assemblies is being performed to characterize fuel compositions and radiation emission data. The assembly depletion simulations apply detailed operating history information and core simulation data as it is available to perform high fidelity axial and pin-by-pin fuel characterization for more than 1600 nuclides. The resulting pin-by-pin isotopic inventories are used to optimize the NDA measurements and provide information necessary to unfold and interpret the measurement data, e.g., passive gamma emitters, neutron emitters, neutron absorbers, and fissile content. A key requirement of this study is the analysis of uncertainties associated with the calculated compositions and signatures for the standard assemblies; uncertainties introduced by the calculation methods, nuclear data, and operating information. An integral part of this assessment involves the application of experimental data from destructive radiochemical assay to assess the uncertainty and bias in computed inventories, the impact of parameters such as assembly burnup gradients and burnable poisons, and the influence of neighboring assemblies on periphery rods. This paper will present the results of high fidelity assembly depletion modeling and uncertainty analysis from independent

  5. Design and fabrication of NDA standards

    International Nuclear Information System (INIS)

    Long, S.M.; Hsue, S.T.

    1996-01-01

    The Plutonium Facility, TA-55, at Los Alamos National Laboratory is currently producing NDA calibration standards used by various laboratories in the DOE complex. These NIST traceable standards have been produced to calibrate NDA instruments for accountability measurements used for resolving shipper/receiver differences, and for accountability in process residues and process waste. Standards are needed to calibrate various NDA (Non-destructive Assay) instruments such as neutron coincidence counters, gamma-ray counters, and calorimeters. These instruments measure various ranges of nuclear material being produced in the DOE nuclear community. Los Alamos National Laboratory has taken a lead role in fabrication of uranium and plutonium standards, along with other actinides such as neptunium and americium. These standards have been fabricated for several laboratories within the complex. This paper will summarize previous publications detailing the careful planning encompassing components such as precise weighing, destructive analysis, and the use of post fabrication NDA measurements to confirm that the standards meet all preliminary expectations before use in instrument calibration. The paper will also describe the specialized containers, diluents, and the various amount of nuclear materials needed to accommodate the calibration ranges of the instruments

  6. Los Alamos safeguards program overview and NDA in safeguards

    International Nuclear Information System (INIS)

    Keepin, G.R.

    1988-01-01

    Over the years the Los Alamos safeguards program has developed, tested, and implemented a broad range of passive and active nondestructive analysis (NDA) instruments (based on gamma and x-ray detection and neutron counting) that are now widely employed in safeguarding nuclear materials of all forms. Here very briefly, the major categories of gamma ray and neutron based NDA techniques, give some representative examples of NDA instruments currently in use, and cite a few notable instances of state-of-the-art NDA technique development. Historical aspects and a broad overview of the safeguards program are also presented

  7. 75 FR 48352 - Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn...

    Science.gov (United States)

    2010-08-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0391] Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn From Sale for... Applicant NDA 17-463 MOTRIN (ibuprofen) Tablets, 300 milligrams (mg), McNeil Consumer Healthcare, 7050 Camp...

  8. A neutron method for NDA analysis in the SAPPHIRE Project

    International Nuclear Information System (INIS)

    Lewis, K.D.

    1995-01-01

    The implementation of Project SAPPHIRE, the top secret mission to the Republic of Kazakhstan to recover weapons grade nuclear materials, consisted of four major elements: (1) the re-packing of fissile material from Kazakh containers into suitable US containers; (2) nondestructive analyses (NDA) to quantify the U-235 content of each container for Nuclear Criticality Safety and compliance purposes; (3) the packaging of the fissile material containers into 6M/2R drums, which are internationally approved for shipping fissile material; and (4) the shipping or transport of the recovered fissile material to the United States. This paper discusses the development and application of a passive neutron counting technique used in the NDA phase of SAPPHIRE operations to analyze uranium/beryllium (U/Be) alloys and compounds for U-235 content

  9. Evaluation of radiation doses from radioactive drugs

    International Nuclear Information System (INIS)

    Halperin, J.A.; Grove, G.R.

    1977-01-01

    Radioactive new drugs are regulated by the Food and Drug Administration (FDA) in the United States. Before a new drug can be marketed it must have an approved New Drug Application (NDA). Clinical investigations of a radioactive new drug are carried out under a Notice of Claimed Investigational Exemption for a New Drug (IND), submitted to the FDA. In the review of the IND, radiation doses are projected on the basis of experimental data from animal models and from calculations based upon radiation characteristics, predicted biodistribution of the drug in humans, and activity to be administered. FDA physicians review anticipated doses and prevent clinical investigations in humans when the potential risk of the use of a radioactive substance outweighs the prospect of achieving beneficial results from the administration of the drug. In the evaluation of an NDA, FDA staff attempt to assure that the intended diagnostic or therapeutic effect is achievable with the lowest practicable radiation dose. Radiation doses from radioactive new drugs are evaluated by physicians within the FDA. Important radioactive new drugs are also evaluated by the Radiopharmaceuticals Advisory Committee. FDA also supports the Center for Internal Radiation Dosimetry at Oak Ridge, to provide information regarding in vivo distribution and dosimetry to critical organs and the whole body from radioactive new drugs. The process for evaluation of radiation doses from radioactive new drugs for protection against use of unnecessary radiation exposure by patients in nuclear medicine procedures, a

  10. 77 FR 6804 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2012-02-09

    ... symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3- adrenoceptor (AR) agonist and is a new molecular entity. The benefit/ risk discussion will focus on the adequacy of... benefits and risks of mirabegron (YM178), under new drug application (NDA) 202611, submitted by Astellas...

  11. 77 FR 12310 - Drugs for Human Use; Drug Efficacy Study Implementation; Prescription Drugs That Contained...

    Science.gov (United States)

    2012-02-29

    ...) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice. DATES: Effective Date: This notice is effective February 29, 2012. ADDRESSES: All communications... evidence of effectiveness for various indications for Atarax Tablets (NDA 10-392), Atarax Syrup (NDA 10-485...

  12. Non destructive assay (NDA) techniques

    International Nuclear Information System (INIS)

    Mafra Guidicini, Olga; Llacer, Carlos D.; Rojo, Marcelo

    2001-01-01

    In the IAEA Safeguards System the basic verification method used is nuclear material accountancy, with containment and surveillance as important complementary measures. If nuclear material accountancy is to be effective, IAEA inspectors have to make independent measurements to verify declared material quantities. Most of the equipment available to the inspectors is designed to measure gamma rays and/or neutrons emitted by various nuclear materials. Equipment is also available to measure the gross weight of an item containing nuclear material. These types of measurement techniques are generally grouped under the title of nondestructive assay (NDA). The paper describes the NDA techniques and instruments used to verify the total amount of nuclear material held at a nuclear facility. (author)

  13. NDA [nondestructive assay] training for new IAEA inspectors at Los Alamos

    International Nuclear Information System (INIS)

    Stewart, J.E.; Reilly, T.D.; Belew, W.; Woelfl, E.; Fager, J.

    1987-01-01

    The history of the evolution of nondestructive assay (NDA) training for international inspectors at Los Alamos is described. The current NDA training course for International Atomic Energy Agency inspectors is presented in terms of structure, content, and rationale. Results of inspector measurement exercises are given along with projections for future developments in NDA inspector training. 3 refs

  14. Genel Anestezi Altında Çocukta Diş Tedavisi

    OpenAIRE

    Gülhan, A.; Sandallı, N.

    2013-01-01

    ÖZETBu makalede çocuklarda genel anestezi altında diş tedavisinin koşulları anlatıldı ve normal tedavi koşulları sağlanamadığı takdirde, genel anesteziye başvurmanın yararlarına ve sakıncalarına değinildi. Genel anestezi indikasyonları sıralanarak, bunlar arasında en sık rastladığımız «Güç çocuklarım" genci anesteziye başvurmadan Önce hangi yollara başvurularak normal tedavinin deneneceğinden bahsedildi.Bir hastane ortamında genel anestezi altında çalışmaya karar verildikten sonra, bir a...

  15. R and D activities of the ESARDA NDA working group

    International Nuclear Information System (INIS)

    Guardini, S.; Bignan, G.

    1999-01-01

    The aim of this paper is to report the R and D activities of the ESARDA Working Group on Techniques and Standards for Non-Destructive Analysis (NDA), as well as to discuss the role and possibilities of the group in the modern R and D scenario in safeguards and non-proliferation. The main tasks of the ESARDA NDA Working have been identified as being to: Define needs for procedural standards and reference materials; Design and manage the production and characterisation of reference materials; Assess and contribute to improving the performances of NDA techniques; Set up and maintain a list of NDA instruments and methods currently used for Safeguards purposes; and, through the above activities, assist Operators and Safeguards Authorities in their duty of Safeguards implementation. Members and observers appointed to the working group represent plant operators, the nuclear industry, R and D laboratories, NDA instrument developers and both safeguards control authorities. The participation of major European plant operators and of the EURATOM Safeguards Directorate and IAEA has always been assured and contributes to the good outcome of the WG activities. The ongoing R and D activities of the NDA Working Group are: Monte Carlo performance intercomparisons; 242 Pu accuracy assessment and improvement; NDA Sampling errors; General NDA performance evaluations. Some milestones have recently been reached: The 242 Pu uncertainty improvement project is coming to an end with the issuing of a new isotopic correlation; The NCC 'reals' evaluation and the Monte Carlo round robin is producing its first results; The Uranium Enrichment Round Robin Exercise has been completed; The waste drum standards are being characterised and constructed: they will be available by spring 1998. The round robin amongst laboratories will then start: summer 1998. Future activities comprise, beside the above issues, technical problems linked with the new challenges posed by new regimes of safeguards and non

  16. Modern NDA needs at Savannah River Site

    International Nuclear Information System (INIS)

    Holt, S.H.

    1995-01-01

    As the missions within the nuclear weapons complex change, so do the accountability measurement needs. Non-Destructive Assay (NDA) measurements have played a key role in accounting for special nuclear materials (SNM), and as time goes on, more and more reliance is made on this type of measurement. Key questions NDA instrument designers ask are: Which isotopes are of interest? What matrix are they in? What other isotopes are present? What container configuration will it be measured through? What precision and accuracy is required? What level of resolution is required? At the Savannah River Site (SRS) the desire to make direct measurements of SNM isotopes has prompted the evaluation to these and other questions. This paper will outline the current NDA needs at SRS. The discussion includes the types of materials that require measurement ,including the very difficult waste measurements. The special challenges associated with these measurement efforts will also be discussed

  17. Session 31B - Panel: Opportunities in the UK with the Nuclear Decommissioning Authority (NDA)

    International Nuclear Information System (INIS)

    Benda, Gary; Hayes, David; Gorham, Ron; Wareing, Mark; Simper, Adrian; Selby, Terry

    2006-01-01

    The NDA participated in a panel session 31B on Wednesday afternoon starting at 3:15. The NDA is a non-departmental public body, set up in April 2005 under the Energy Act 2004 to take strategic responsibility for the UK's nuclear legacy. Details of their organization and history are located on their web site at www.nda.gov.uk. Also copies of their Power Point presentations made at WM'06 are available on their web site. Their core objective is to ensure that the 20 civil public sector nuclear sites under our ownership are decommissioned and cleaned up safely, securely, cost effectively and in ways that protect the environment for this and future generations. They lead the development of a unified and coherent decommissioning strategy, working in partnership with regulators and site licensees to achieve best value, optimum impact on local communities, and the highest environmental standards. The NDA's main task is the decommissioning and clean up of civil nuclear sites. If the Government decides it is necessary, however, the Energy Act 2004 allows the NDA to take responsibility for sites currently operated by, or on behalf of, the Ministry of Defence (MoD). Resources will then be transferred from the MoD to meet the costs of clean up. The NDA made a number of presentations to allow conference delegates the opportunity to understand some of the major aspects of their work and to interact with NDA staff. These included the following topics and gave opportunity for audience discussion: - A brief presentation to update on progress by the NDA; - Outline of low level waste management and the prioritisation process; - Discussion of the competition schedule related to low level waste management and the Drigg site. The following presentations and handout were delivered in various sessions of the conference as noted below and are available on their web page including the WM'06 Plenary Session presentation by Sir Anthony Cleaver, Chairman of the NDA. During Session 31B, the

  18. EMR Measurements on NDA Equipment

    Energy Technology Data Exchange (ETDEWEB)

    Macdonell, Alexander Thomas [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Meierbachtol, Krista Cruse [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Evans, James Walter Jr. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Mayo, Douglas R. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-07-10

    Electromagnetic radiation (EMR) emission strength measurements were performed on a suite of passive non-destructive assay (NDA) radiation detection equipment. Data were collected from 9 kHz up to 6 GHz on each of the assembled systems.

  19. A brief history of NDA at the IAEA

    International Nuclear Information System (INIS)

    Sprinkle, J.K.; Sinkule, B.J.; Hsue, S.-T.; Abhold, M.E.

    2001-01-01

    Nearly 30 years ago, the first portable nondestructive assay instrument, a SAM-II, was brought to Vienna for IAEA consideration. This initial foray into the usage of nondestructive assay (NDA) as an independent assessment tool has materialized into one of the important tools for IAEA inspections. NDA instruments have several inherent advantages for inspectors; their measurements generate no radioactive waste, provide immediate answers, do not require specialized operators, and can be either taken to the items to be measured (portable instruments), or the items for measurement can be brought to the instruments, such as can be applied in on-site IAEA laboratories or off-site IAEA lab at Siebersdorf. The SAM-II was a small, lightweight, battery-powered, gamma-ray instrument used for uranium enrichment measurements. It was also found to be usehl for locating nuclear material, distinguishing between uranium and plutonium, and determining the active length of items like fuel pins. However it was not well suited for determining the amount of bulk material present, except for small containers of low-density materials. A 6-sided neutron coincidence counter, easily disassembled so it could be shipped and carried by airplane, was developed for bulk measurements of plutonium. The HLNCC (High Level Neutron Coincidence Counter) was immediately useful for quantitative measurements of pure plutonium oxide. However, the IAEA had to make a trade-off between the ease of use of NDA instruments on-site, and the problems of obtaining small samples for shipment to an independent lab for more accurate analysis. NDA does not create radioactive waste, so as waste handling has become more cautious and more regulated, NDA looks better and better. After acceptance of NDA by the IAEA for routine use, the follow-up question was naturally, 'How much better can this measurement be made?' The Program for Technical Assistance to IAEA Safeguards (POTAS) supported multiple and varied efforts in this

  20. NDA 2000 -- A modern, networked laboratory

    International Nuclear Information System (INIS)

    Thompson, K.A.; Ceo, R.N.

    1996-01-01

    As part of the modernization process, the Nondestructive Analysis (NDA) laboratory at Oak Ridge is undergoing changes to increase reliability, incorporate new analytical techniques, and improve quality assurance. The data system has been decentralized into a network, allowing any instrument to be controlled from any client, even remotely for trouble shooting purposes. By making the computers interchangeable, reliability increases. The software has been redesigned to function on a network, and incorporates several improvements to enhance accuracy and include quality assurance. The emphasis of this paper is directed at the actual hardware and software to integrate NDA 2000. Another paper (Reference 1) by the same authors presented at this symposium gives more details concerning new analytical and QA techniques

  1. NDA generic research programme for higher activity waste management issues - 16390

    International Nuclear Information System (INIS)

    McKinney, James; Brownridge, Melanie

    2009-01-01

    NDA has a responsibility to ensure decommissioning activities are sufficiently technically underpinned and appropriate Research and Development (Rand D) is carried out. The NDA funds research and development (R and D) indirectly via the Site Licence Companies (SLCs) or directly. The main component of directly funded R and D is the NDA Direct Research Portfolio (DRP). The DRP is split into four framework areas: - University Interactions; - Waste Processing; - Material Characterisation; - Actinide and Strategic Nuclear Materials. These four framework areas were competed through an Official Journal of European Union (OJEU) process in 2008. Although all four areas involve waste management, Waste Processing and Material Characterisation specifically deal with Higher Activity Waste (HAW) waste management issues. The Waste Processing area was awarded to three groups: (i) National Nuclear Laboratory (NNL), (ii) Consortium led by Hyder Consulting Ltd, and (iii) Consortium led by UKAEA Ltd. The Material Characterisation area was awarded to three groups: (i) NNL, (ii) Serco, and (iii) Consortium led by UKAEA Ltd. The initial work in Waste Processing and Material Characterisation was centered on establishing a forward research programme to address the generic needs of the UK civil nuclear industry and the NDA strategic drivers for waste management and land quality. This has been achieved by the four main framework contractors from the Waste Processing and Materials Characterisation areas working together with the NDA to identify the key research themes and begin the development of the NDA's HAW Management Research Programme. The process also involves active engagement with both industry and regulators via the Nuclear Waste Research Forum (NWRF). The NDA's HAW Management Research Programme includes a number of themes: - Optimisation of Interim Store Operation and Design; - Alternative Waste Encapsulants; - Waste Package Integrity; - Alternative Waste treatment methods

  2. Enflasyon Ortamında Mamul Fiyatlandırması

    OpenAIRE

    GÜNEŞ, Recep

    2013-01-01

    Fiyatlandırma konusu farklı bilim dallarında farklı varsayımlaradayandırılarak açıklanmaya çalışılırken, uygulama alanındamaliyet artı metodunun önemli bir yer tuttuğu yapılan saha çalışmalarındaortaya konulmuştur. Maliyet artı kar metodunun genelolarak enflasyonun olmadığı ortamlarda kolayca uygulanabilirken,maliyetlerin sürekli değiştiği enflasyon ortamında fiyatlandırmadaha da karmaşık bir görünüm arz etmektedir. Bu çalışmada,enflasyon ortamında maliyet artı kar metodunun uygulanabilirliği...

  3. Setup and organisation of a NDA-system procurement project

    International Nuclear Information System (INIS)

    Botte, John; Gielen, Paul

    2007-01-01

    Belgoprocess is momentarily in the process of purchasing its fifth NDA-system. Measurement systems are, although based on general designs, not from the shelf items but tailor-made sophisticated and highly automated devices. It is obvious that such a project cannot be carried out by solely a NDA team, but needs a multifunctional team. This team combines NDA expertise with experts in civil works, electrical and mechanical engineering, procurement, IT, safety and legal administration. From less positive experiences in the past, Belgoprocess learned a lot and has now a systematic in place. This systematic structures the project from definition of requirements to operation, a two to three year process. This paper defines the phases of a NDA project and gives for each phase some do's and don'ts. A second subject is the writing and handling of the vast but needed and required documentation. It gives a brief overview of the over thirty documents and files needed. The described, integrated and formal approach reduces the risk of failing projects, systems not meeting the expectations or denied qualification. It puts clear agreements in place, smoothening the relationship between company, supplier and authorities. (authors)

  4. Performance values for non destructive assay (NDA) techniques applied to safeguards: the 2002 evaluation by the ESARDA NDA Working Group

    International Nuclear Information System (INIS)

    Guardini, S.

    2003-01-01

    The first evaluation of NDA performance values undertaken by the ESARDA Working Group for Standards and Non Destructive Assay Techniques (WGNDA) was published in 1993. Almost 10 years later the Working Group decided to review those values, to report about improvements and to issue new performance values for techniques which were not applied in the early nineties, or were at that time only emerging. Non-Destructive Assay techniques have become more and more important in recent years, and they are used to a large extent in nuclear material accountancy and control both by operators and control authorities. As a consequence, the performance evaluation for NDA techniques is of particular relevance to safeguards authorities in optimising Safeguards operations and reducing costs. Performance values are important also for NMAC regulators, to define detection levels, limits for anomalies, goal quantities and to negotiate basic audit rules. This paper presents the latest evaluation of ESARDA Performance Values (EPVs) for the most common NDA techniques currently used for the assay of nuclear materials for Safeguards purposes. The main topics covered by the document are: techniques for plutonium bearing materials: PuO 2 and MOX; techniques for U-bearing materials; techniques for U and Pu in liquid form; techniques for spent fuel assay. This issue of the performance values is the result of specific international round robin exercises, field measurements and ad hoc experiments, evaluated and discussed in the ESARDA NDA Working Group. (author)

  5. Kazak Mitleri ve Mitik Efsaneleri Hakkında

    OpenAIRE

    İBRAYEV, Şakir; ARIKAN, Metin

    2006-01-01

    Kazak halkının geleneksel dünya görüşü ile söz sanatının kaynağı diyebileceğimiz mitler; dünyanın yaratılışı, nelerin, nasıl, nereden meydana çıktığı, sebebi ve safhaları, etrafımızı kuşatan çevrenin sırları ve özellikleri hakkında söylenen, insanoğlunun ilkel düşüncesinin sonucu meydana gelen olağanüstü anlatmalar, belki de inanışlar, anlayışlar. En eski mitlerin arasında gökyüzü cisimleri - güneş, ay, yıldız ve gezegenler hakkında söylenilen mitleri gösterebiliriz. Bu türdeki mitlerin başlı...

  6. Analysis of historical delta values for IAEA/LANL NDA training courses

    International Nuclear Information System (INIS)

    Geist, William; Santi, Peter; Swinhoe, Martyn; Bonner, Elisa

    2009-01-01

    The Los Alamos National Laboratory (LANL) supports the International Atomic Energy Agency (IAEA) by providing training for IAEA inspectors in neutron and gamma-ray Nondestructive Assay (NDA) of nuclear material. Since 1980, all new IAEA inspectors attend this two week course at LANL gaining hands-on experience in the application of NDA techniques, procedures and analysis to measure plutonium and uranium nuclear material standards with well known pedigrees. As part of the course the inspectors conduct an inventory verification exercise. This exercise provides inspectors the opportunity to test their abilities in performing verification measurements using the various NDA techniques. For an inspector, the verification of an item is nominally based on whether the measured assay value agrees with the declared value to within three times the historical delta value. The historical delta value represents the average difference between measured and declared values from previous measurements taken on similar material with the same measurement technology. If the measurement falls outside a limit of three times the historical delta value, the declaration is not verified. This paper uses measurement data from five years of IAEA courses to calculate a historical delta for five non-destructive assay methods: Gamma-ray Enrichment, Gamma-ray Plutonium Isotopics, Passive Neutron Coincidence Counting, Active Neutron Coincidence Counting and the Neutron Coincidence Collar. These historical deltas provide information as to the precision and accuracy of these measurement techniques under realistic conditions.

  7. Preparation of plant-specific NDA reference material

    International Nuclear Information System (INIS)

    Abedin-Zadeh, R.; Beetle, T.; Kuhn, E.; Terrey, D.; Turel, S.; Busca, G.; Guardini, S.

    1983-01-01

    The importance of having suitable and well characterized non-destructive assay (NDA) reference materials for the verification activities of the safeguards control authorities is stressed. The Euratom Inspectorate and the IAEA have initiated an extensive programme for the procurement and preparation of Joint Euratom/IAEA safeguards NDA reference materials with the active participation of the Ispra Establishment of the Euratom Joint Research Centre. The different type and nature of materials, condition of measurements, and plant characteristics and provisions had to be taken into account for plant-specific NDA reference materials. The preparation of each reference material was planned case by case and specific criteria such as limitations in different facilities, measurement capabilities, conditions, product availability and population variability are being ascertained. A procurement scheme was prepared describing step-by-step procedures detailing responsibilities, measurement conditions, destructive analysis schemes, desired characteristics and methods of data evaluation. This paper describes the principles and procedures carried out for the preparation of a reference MOX pin, low enriched uranium reference rods, low enriched uranium reference drums, reference MTR assemblies, and THTR reference pebbles. The scheme for each characterization technique is presented. (author)

  8. Performance Values for Non-Destructive Assay (NDA) Technique Applied to Wastes: Evaluation by the ESARDA NDA Working Group

    International Nuclear Information System (INIS)

    Rackham, Jamie; Weber, Anne-Laure; Chard, Patrick

    2012-01-01

    The first evaluation of NDA performance values was undertaken by the ESARDA Working Group for Standards and Non Destructive Assay Techniques and was published in 1993. Almost ten years later in 2002 the Working Group reviewed those values and reported on improvements in performance values and new measurement techniques that had emerged since the original assessment. The 2002 evaluation of NDA performance values did not include waste measurements (although these had been incorporated into the 1993 exercise), because although the same measurement techniques are generally applied, the performance is significantly different compared to the assay of conventional Safeguarded special nuclear material. It was therefore considered more appropriate to perform a separate evaluation of performance values for waste assay. Waste assay is becoming increasingly important within the Safeguards community, particularly since the implementation of the Additional Protocol, which calls for declaration of plutonium and HEU bearing waste in addition to information on existing declared material or facilities. Improvements in the measurement performance in recent years, in particular the accuracy, mean that special nuclear materials can now be accounted for in wastes with greater certainty. This paper presents an evaluation of performance values for the NDA techniques in common usage for the assay of waste containing special nuclear material. The main topics covered by the document are: 1- Techniques for plutonium bearing solid wastes 2- Techniques for uranium bearing solid wastes 3 - Techniques for assay of fissile material in spent fuel wastes. Originally it was intended to include performance values for measurements of uranium and plutonium in liquid wastes; however, as no performance data for liquid waste measurements was obtained it was decided to exclude liquid wastes from this report. This issue of the performance values for waste assay has been evaluated and discussed by the ESARDA

  9. Performance Values for Non-Destructive Assay (NDA) Technique Applied to Wastes: Evaluation by the ESARDA NDA Working Group

    Energy Technology Data Exchange (ETDEWEB)

    Rackham, Jamie [Babcock International Group, Sellafield, Seascale, Cumbria, (United Kingdom); Weber, Anne-Laure [Institut de Radioprotection et de Surete Nucleaire Fontenay-Aux-Roses (France); Chard, Patrick [Canberra, Forss Business and Technology park, Thurso, Caithness (United Kingdom)

    2012-12-15

    The first evaluation of NDA performance values was undertaken by the ESARDA Working Group for Standards and Non Destructive Assay Techniques and was published in 1993. Almost ten years later in 2002 the Working Group reviewed those values and reported on improvements in performance values and new measurement techniques that had emerged since the original assessment. The 2002 evaluation of NDA performance values did not include waste measurements (although these had been incorporated into the 1993 exercise), because although the same measurement techniques are generally applied, the performance is significantly different compared to the assay of conventional Safeguarded special nuclear material. It was therefore considered more appropriate to perform a separate evaluation of performance values for waste assay. Waste assay is becoming increasingly important within the Safeguards community, particularly since the implementation of the Additional Protocol, which calls for declaration of plutonium and HEU bearing waste in addition to information on existing declared material or facilities. Improvements in the measurement performance in recent years, in particular the accuracy, mean that special nuclear materials can now be accounted for in wastes with greater certainty. This paper presents an evaluation of performance values for the NDA techniques in common usage for the assay of waste containing special nuclear material. The main topics covered by the document are: 1- Techniques for plutonium bearing solid wastes 2- Techniques for uranium bearing solid wastes 3 - Techniques for assay of fissile material in spent fuel wastes. Originally it was intended to include performance values for measurements of uranium and plutonium in liquid wastes; however, as no performance data for liquid waste measurements was obtained it was decided to exclude liquid wastes from this report. This issue of the performance values for waste assay has been evaluated and discussed by the ESARDA

  10. NDA issues with RFETS vitrified waste forms

    International Nuclear Information System (INIS)

    Hurd, J.; Veazey, G.

    1998-01-01

    A study was conducted at Los Alamos National Laboratory (LANL) for the purpose of determining the feasibility of using a segmented gamma scanner (SGS) to accurately perform non-destructive analysis (NDA) on certain Rocky Flats Environmental Technology Site (RFETS) vitrified waste samples. This study was performed on a full-scale vitrified ash sample prepared at LANL according to a procedure similar to that anticipated to be used at RFETS. This sample was composed of a borosilicate-based glass frit, blended with ash to produce a Pu content of ∼1 wt %. The glass frit was taken to a degree of melting necessary to achieve a full encapsulation of the ash material. The NDA study performed on this sample showed that SGSs with either 1/2- or 2-inch collimation can achieve an accuracy better than 6 % relative to calorimetry and γ-ray isotopics. This accuracy is achievable, after application of appropriate bias corrections, for transmissions of about 1/2 % through the waste form and counting times of less than 30 minutes. These results are valid for ash material and graphite fines with the same degree of plutonium particle size, homogeneity, sample density, and sample geometry as the waste form used to obtain the results in this study. A drum-sized thermal neutron counter (TNC) was also included in the study to provide an alternative in the event the SGS failed to meet the required level of accuracy. The preliminary indications are that this method will also achieve the required accuracy with counting times of ∼30 minutes and appropriate application of bias corrections. The bias corrections can be avoided in all cases if the instruments are calibrated on standards matching the items

  11. A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

    Science.gov (United States)

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

    2012-11-01

    Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

  12. Development plan of Pu NDA system using ZnS ceramic scintillator

    International Nuclear Information System (INIS)

    Kureta, Masatoshi; Soyama, Kazuhiko; Seya, Michio; Ohzu, Akira; Haruyama, Mitsuo; Takase, Misao; Sakasai, Kaoru; Nakamura, Tatsuya; Toh, Kentaro

    2012-01-01

    Alternative techniques to neutron detection by He-3 for nuclear security and safeguards systems are necessary to be developed since He-3 shortage is serious. With support of Japanese government (the Ministry of Education, Culture, Sports, and Technology), we have started an R and D project of Pu NDA system using ZnS ceramic scintillator. Here we present development plan, production of a new type of ZnS ceramic scintillator experimentally and basic design of a PCAS alternative Pu NDA system. We are planning the demonstration tests using the alternative NDA system comparing with the current PCAS in which the He-3 counters are installed. (author)

  13. Developing Spent Fuel Assembly for Advanced NDA Instrument Calibration - NGSI Spent Fuel Project

    Energy Technology Data Exchange (ETDEWEB)

    Hu, Jianwei [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Gauld, Ian C. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Banfield, James [GE Hitachi Nuclear Energy, Wilmington, NC (United States); Skutnik, Steven [Univ. of Tennessee, Knoxville, TN (United States)

    2014-02-01

    This report summarizes the work by Oak Ridge National Laboratory to investigate the application of modeling and simulation to support the performance assessment and calibration of the advanced nondestructive assay (NDA) instruments developed under the Next Generation Safeguards Initiative Spent Fuel (NGSI-SF) Project. Advanced NDA instrument calibration will likely require reference spent fuel assemblies with well-characterized nuclide compositions that can serve as working standards. Because no reference spent fuel standard currently exists, and the practical ability to obtain direct measurement of nuclide compositions using destructive assay (DA) measurements of an entire fuel assembly is prohibitive in the near term due to the complexity and cost of spent fuel experiments, modeling and simulation will be required to construct such reference fuel assemblies. These calculations will be used to support instrument field tests at the Swedish Interim Storage Facility (Clab) for Spent Nuclear Fuel.

  14. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    Science.gov (United States)

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  15. Standard guide for the selection, training and qualification of nondestructive assay (NDA) personnel

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

    1.1 This guide contains good practices for the selection, training, qualification, and professional development of personnel performing analysis, calibration, physical measurements, or data review using nondestructive assay equipment, methods, results, or techniques. The guide also covers NDA personnel involved with NDA equipment setup, selection, diagnosis, troubleshooting, or repair. Selection, training, and qualification programs based on this guide are intended to provide assurance that NDA personnel are qualified to perform their jobs competently. This guide presents a series of options but does not recommend a specific course of action.

  16. NDA [nondestructive assay] for a facility at SRP

    International Nuclear Information System (INIS)

    Studley, R.V.

    1987-01-01

    A near-real-time accountability system with associated high accuracy assay measurements has recently been placed in service at a Savannah River Plant (SRP) facility. A computer cluster provides facility wide communication between personnel and the accountability, process control, and laboratory data systems. The cluster is also connected to communicate with process, accountability, and laboratory instrumentation and process controls plus an item tracking bar code printer/reader system. Eight high performance microprocessor-based nondestructive assay (NDA) systems which were developed at the Los Alamos National Laboratory (LANL) for this process are also connected to this cluster. With standards developed for them, these instruments are achieving the highest currently known NDA measurement accuracies

  17. IND/NDA process

    International Nuclear Information System (INIS)

    Frankel, R.; Kawin, B.

    1981-01-01

    This summary provides a brief, general discussion of new drug applications, the reasons for their submission to FDA, and general features of their evaluation by FDA. The generic statutory and regulatory foundation that underlies the purposes and implements the development and testing of new drugs is briefly outlined

  18. Tiyatro, karikatür ve film provokasyonları bağlamında Fransız basınında İslam ve Hz. Muhammed imajı

    OpenAIRE

    METİN, İsmail

    2016-01-01

    Oryantalizm ve oryantalistler, tarih boyunca İslamı kendi zihin dünyasına göre anlamış ve bu yönde çalışmalar yapmıştır. Yapılan bu çalışmalar ilmi eserler, ansiklopediler, kitaplar, makaleler başta olmak üzere, yazılı ve görsel basında da yer almıştır. Bu makale, oryantalizmin önemli merkezlerinden olan Fransada, özellikle yazılı basında, başta İslam, Kuran-ı Kerim, Hz. Muhammed olmak üzere dini değerlerin medya tarafından algılanış biçimini, karikatür ve film provokasyonları bağlamında tari...

  19. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on principles for deriving and applying Dietary Reference Values

    DEFF Research Database (Denmark)

    Tetens, Inge

    This Opinion of the EFSA Panel on Dietetic products, Nutrition, and Allergies (NDA) deals with the general principles for development and application of Dietary Reference Values (DRVs). These quantitative reference values for nutrient intakes for healthy individuals and populations are based...

  20. Efficient solutions to the NDA-NCA low-order eigenvalue problem

    International Nuclear Information System (INIS)

    Willert, J. A.; Kelley, C. T.

    2013-01-01

    Recent algorithmic advances combine moment-based acceleration and Jacobian-Free Newton-Krylov (JFNK) methods to accelerate the computation of the dominant eigenvalue in a k-eigenvalue calculation. In particular, NDA-NCA [1], builds a sequence of low-order (LO) diffusion-based eigenvalue problems in which the solution converges to the true eigenvalue solution. Within NDA-NCA, the solution to the LO k-eigenvalue problem is computed by solving a system of nonlinear equation using some variant of Newton's method. We show that we can speed up the solution to the LO problem dramatically by abandoning the JFNK method and exploiting the structure of the Jacobian matrix. (authors)

  1. CSER 94-015: New portable NDA equipment for use in SNM audits

    Energy Technology Data Exchange (ETDEWEB)

    Hess, A.L.

    1994-12-12

    A criticality safety review is presented for the use of two portable NDA detectors from Los Alamos during an IAEA inspection of the SNM at PFP. The units are an Active Well Coincidence Counter (AWCC) and a High Level Neutron Coincidence Counter (HLNCC). Approval for their employment is based on the inherent safety of the containers to be assayed, one at a time, and because their designs conform with the acceptability criteria which allow the other NDA detectors currently employed at the facility.

  2. 76 FR 59141 - Determination That LOXITANE (Loxapine Succinate) Capsules and Three Other Drug Products Were Not...

    Science.gov (United States)

    2011-09-23

    ... Applicant NDA 017525 LOXITANE (loxapine Watson Laboratories succinate) Inc., 417 Wakara Capsules, Way, Suite.../milliliter. NDA 020828 FORTOVASE Hoffmann La Roche (saquinavir) Inc., 340 Kingsland Capsule, 200 mg. St...

  3. NDA PDP Program PuO2 increased particle size specification and design

    International Nuclear Information System (INIS)

    Marshall, R.S.; Taggart, D.P.; Becker, G.K.; Woon, W.Y.

    1996-01-01

    Provisions in the National TRU Program Quality Assurance Program Plan require an assessment of performance for nondestructive waste assay (NDA) systems employed in the program. This requirement is in part fulfilled through the use of Performance Demonstration programs. In order to optimize the quality and quantity of information acquired during a given Performance Demonstration Program cycle, the assessment employed is to be carefully specified and designed. The assessment must yield measurement system performance data meaningful with respect to NDA system capability to accommodate attributes of interest known to occur in actual waste forms. The design and specification of the increased particle size PuO 2 PDP working reference materials (WRMs) is directed at providing a straightforward mechanism to assess waste NDA system capability to account for biases introduced by large PuO 2 particles. The increased particle size PuO 2 PDP WRM design addresses actual waste form attributes associated with PuO 2 particle size and distributions thereof, the issue of a known and stable WRM configuration and equally important appropriate certification and tractability considerations

  4. 78 FR 43210 - Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated...

    Science.gov (United States)

    2013-07-19

    ...., 235 East 42nd 50 mg, 75 mg, and St., New York, NY 100 mg. 10017. NDA 020239 Kytril (granisetron... Kytril (granisetron Do. HCl) Tablets, EQ 1 mg (base), EQ 2 mg (base). NDA 020336 DynaCirc CR GlaxoSmith...) Abbott Laboratories. Capsules, 100 mg. NDA 021238 Kytril (granisetron Hoffman-La Roche, HCl) Oral...

  5. ORO appraisal strategy involving use of NDA instrumentation

    International Nuclear Information System (INIS)

    Lux, C.R.

    1977-12-01

    ORO has used the following nondestructive assay (NDA) systems for verifying uranium inventories at contractor-operated installations: gamma spectroscopy, thickness-corrected gamma spectroscopy, passive neutron measurement, and random driver measurement. A brief description of each system is given and results of in-field measurements performed on contractors' inventories utilizing each system are discussed

  6. Türkiye Türkçesi Ağızlarında Lambdasizm Sigmatizm Meselesinin İzleri

    OpenAIRE

    YILDIZ, Hüseyin

    2015-01-01

    Lambdasizm / sigmasizm konusu gerek Türk lehçeleri arasında, gerekse Türkçeyle akraba olan diğer diller arasında tanıklanan örneklerden ortaya çıkmış problemlerdir. İçinde /l/ ünsüzü bulunan bazı kelimelerin bir başka dilde ya da lehçede /ş/’li olarak görülmesi, probleme sebep olan soruyu sordurmuştur: Hangisi daha arkaiktir? İlk olarak W. Schoot’un ortaya koyduğu bu problem hakkında Radloff, Gombocz, Németh, Benzing, Clauson, Meyer, Róna-Tas, Nauta, Scherner, Adamović, Ramstedt, Poppe, Räsän...

  7. NDA Position on the UK Management of Waste Graphite (December 2013)

    International Nuclear Information System (INIS)

    Norris, S.

    2016-01-01

    The purpose of this paper is to summarise a number of pieces of work that have been undertaken by the Nuclear Decommissioning Authority (NDA) to better understand the challenges of managing radioactive graphite wastes, these have led to an updated strategic position on graphite waste management. The updated strategic position takes into consideration Government’s response to Recommendation 8 from the Committee on Radioactive Waste Management’s (CoRWM), and provides the current NDA strategic position alongside circumstances where this should be reviewed. Two studies that provided input to this position are: 1. Operational Graphite Management Strategy: Credible and Preferred Options (Gate A & B); 2. The Long-term Management of Reactor Core Graphite Waste: Credible Options (Gate A). The paper highlights the key findings from the following work that has been undertaken to better inform this position: • A review by the NDA Radioactive Waste Management Directorate (RWMD)1 of the current baseline for managing radioactive graphite in England and Wales of geological disposal. The review identified some areas for optimisation and provided clarification on some aspects of the baseline e.g. the assumed ‘footprint’ of graphite wastes for a future Geological Disposal Facility (GDF). • Investigations into suitability of near-surface disposal options for graphite wastes. This included a review of the Low Level Waste Repository (LLWR) Ltd's new Environmental Safety Case (ESC) to assess the potential for graphite disposal and a feasibility study into a near-surface disposal facility for Higher Activity Waste (HAW) graphite at the Hunterston A site. • Continued monitoring of potential future treatment options. • Detailed characterisation work under the NDA’s Direct Research Portfolio using computer modelling and sample analysis to better understand any limitations of the current inventory data for graphite wastes. • Graphite behaviour work under the NDA

  8. Detection of drugs and plastic explosives using neutron tomography

    Energy Technology Data Exchange (ETDEWEB)

    Ferreira, F.J.O. [Instituto de Engenharia Nuclear (IEN), Rio de Janeiro, RJ (Brazil)], E-mail: fferreira@ien.gov.br; Crispim, V.R; Silva, A.X. [Universidade Federal do Rio de Janeiro (UFRJ), RJ (Brazil). Coordenacao dos Programas de Pos-graduacao de Engenharia (COPPE). Programa de Engenharia Nuclear], E-mail: ademir@con.ufrj.br, E-mail: verginia@com.ufrj.br

    2007-07-01

    The unique ability of neutrons to image certain elements and isotopes that are either completely undetectable or poorly detected by other Non-Destructive-Assay (NDA) methods makes neutron radiography an important tool for the NDA community. Neutron radiography, like other imaging techniques takes a number of different forms (i.e. / that is film, radioscopic, transfer methods, tomography, etc.) In this work report the Neutron Tomography System developed, which will allow inspections NDA of samples with high efficiency, in terms of minors measure time and the result analysis, and the application for detection of drugs and plastic explosives, which is very important for the combat to the terrorism and drug trafficking. The neutron tomography system developed is third generation. Therefore a rotary table driven by a step motor connected to a computerized motion control system has been installed at the sample position. In parallel to this a suitable electronic imaging device has been designed and can be controlled by a computer in order to synchronize the software the detector and of the rotary table with the aim of an automation of measurements. To obtain 2D tomography image, a system with an electronic imaging system for producing real time neutron radiography. Images are processing digital for cancel random noise effects and to optimize spatial resolution. Finally, using a (ARIEN) algorithm reconstruction of tomography images by finite element maximum entropy. The system was installed adjacent to the exit of the J-9 irradiation channel of the Argonauta Reactor in the Nuclear Engineering Institute (IEN) - which is an organ of the National Nuclear Energy Commission (CNEN - Brazil).The Argonauta reactor operates at 340 watts, being that the characteristics of the neutron beam on the plane of the image: thermal neutron flux 4,46 x10{sup 5} n/cm{sup 2}s. In the tomography assays, several encapsulated samples of paste, rock and cocaine powder and plastic explosives devices

  9. Detection of drugs and plastic explosives using neutron tomography

    International Nuclear Information System (INIS)

    Ferreira, F.J.O.; Crispim, V.R; Silva, A.X.

    2007-01-01

    The unique ability of neutrons to image certain elements and isotopes that are either completely undetectable or poorly detected by other Non-Destructive-Assay (NDA) methods makes neutron radiography an important tool for the NDA community. Neutron radiography, like other imaging techniques takes a number of different forms (i.e. / that is film, radioscopic, transfer methods, tomography, etc.) In this work report the Neutron Tomography System developed, which will allow inspections NDA of samples with high efficiency, in terms of minors measure time and the result analysis, and the application for detection of drugs and plastic explosives, which is very important for the combat to the terrorism and drug trafficking. The neutron tomography system developed is third generation. Therefore a rotary table driven by a step motor connected to a computerized motion control system has been installed at the sample position. In parallel to this a suitable electronic imaging device has been designed and can be controlled by a computer in order to synchronize the software the detector and of the rotary table with the aim of an automation of measurements. To obtain 2D tomography image, a system with an electronic imaging system for producing real time neutron radiography. Images are processing digital for cancel random noise effects and to optimize spatial resolution. Finally, using a (ARIEN) algorithm reconstruction of tomography images by finite element maximum entropy. The system was installed adjacent to the exit of the J-9 irradiation channel of the Argonauta Reactor in the Nuclear Engineering Institute (IEN) - which is an organ of the National Nuclear Energy Commission (CNEN - Brazil).The Argonauta reactor operates at 340 watts, being that the characteristics of the neutron beam on the plane of the image: thermal neutron flux 4,46 x10 5 n/cm 2 s. In the tomography assays, several encapsulated samples of paste, rock and cocaine powder and plastic explosives devices. (author)

  10. Kültür Koşullarında Levrek (Dicentrarchus labrax L., 1758 Larvalarında Ağız Bölgesinin Osteolojik Gelişimi.

    Directory of Open Access Journals (Sweden)

    Deniz Çoban

    2015-12-01

    Full Text Available Levrek larvalarında 0-42. günler arasında yoğun yetiştiricilik koşulları altında ağız boşluğunda çeneye ait elementlerin kıkırdak ve kemik gelişimleri incelenmiştir. Örnekler çalışma boyunca üç günde bir olacak şekilde elde edilmiş ve çalışma canlı yeminkesilmesi ile sonlanmıştır. Elde edilen örnekler formalinde sabitlendikten sonra alcian mavisi ve alizarin kırmızısı ile boyandı. Yumurtadan çıkan larvada ağza ait bir osteolojik oluşum tespit edilmemiştir. İlk oluşan element 3,8 mm total boyda (TB Meckel’s kıkırdağıdır. Bu oluşumu 4,6 mm TB’da trabecular bar, palato-quadrate ve hyosymplectic takip eder. 5,4 mm TB’da basibranchial, hyoid bar, maksillary ve branchial sepet oral boşluğun altında meydana gelmiştir. 7,9 mm TB’da dişe ait yapıların ilk işareti olan premaksillary oluşumu gözlenmiştir. 11,4 mm TB’da premaksillary ve dentary kıkırdak yapıda olup henüz kemikleşme başlamamış olup her ikisinde de bir sıra diş tespit edilmiştir. 15,8 mm TB’da premaksillary ve dentarynin uç bölgelerinde kemikleşme başlamıştır. Bu çalışmadan elde edilen sonuçlar diğer teleostlar ile karşılaştırılmış ve benzer bulgulara rastlanmıştır

  11. A preliminary evaluation of certain NDA techniques for RH-TRU characterization

    Energy Technology Data Exchange (ETDEWEB)

    Hartwell, J.K.; Yoon, W.Y.; Peterson, H.K. [Idaho National Engineering Lab., Idaho Falls, ID (United States)

    1997-11-01

    This report presents the results of modeling efforts to evaluate selected NDA assay methods for RH-TRU waste characterization. The target waste stream was Content Code 104/107 113-liter waste drums that comprise the majority of the INEL`s RH-TRU waste inventory. Two NDA techniques are treated in detail. One primary NDA technique examined is gamma-ray spectrometry to determine the drum fission and activation product content, and fuel sample inventory calculations using the ORIGEN code to predict the total drum inventory. A heavily shielded and strongly collimated HPGe spectrometer system was designed using MCNP modeling. Detection limits and expected precision of this approach were estimated by a combination of Monte Carlo modeling and synthetic gamma-ray spectrum generation. This technique may allow the radionuclide content of these wastes to be determined with relative standard deviations of 20 to 50% depending on the drum matrix and radionuclide. The INEL Passive/Active Neutron (PAN) assay system is the second primary technique considered. A shielded overpack for the 113-liter CC104/107 RH-TRU drums was designed to shield the PAN detectors from excessive gamma radiation. MCNP modeling suggests PAN detection limits of about 0.06 g {sup 235}U and 0.04 g {sup 239}Pu during active assays. 12 refs., 2 figs., 6 tabs.

  12. Survey of DOE NDA practices for CH-Tru waste certification--illustrated with a greater than 10,000 drum NDA data base

    International Nuclear Information System (INIS)

    Schultz, F.J.; Caldwell, J.T.; Smith, J.R.

    1988-01-01

    We have compiled a greater than 10,000 CH-TRU waste drum data base from seven DOE sites which have utilized such multiple NDA measurements within the past few years. Most of these nondestructive assay (NDA) technique assay result comparisons have been performed on well-characterized, segregated waste categories such as cemented sludges, combustibles, metals, graphite residues, glasses, etc., with well-known plutonium isotopic compositions. Waste segregation and categorization practices vary from one DOE site to another. Perhaps the most systematic approach has been in use for several years at the Rocky Flats Plant (RFP), operated by Rockwell International, and located near Golden, Colorado. Most of the drum assays in our data base result from assays of RFP wastes, with comparisons available between the original RFP assays and PAN assays performed independently at the Idaho National Engineering Laboratory (INEL) Solid Waste Examination Pilot Plant (SWEPP) facility. Most of the RFP assays were performed with hyperpure germanium (HPGe)-based SGS assay units. However, at least one very important waste category, processed first-stage sludges, is assayed at RFP using a sludge batch-sampling procedure, prior to filling of the waste drums. 5 refs., 5 figs

  13. Çeşitli Türk musikisi makamlarında ezan

    OpenAIRE

    KOPAR, Saadettin Volkan

    2010-01-01

    Bu çalışmada, geçmişten günümüze kadar okuna gelmiş geleneksel ezan makamlarının dışında bu güne kadar okunmamış veya kayıt altına alınmamış yedi farklı makamda ezan örnekleri sunulmuştur. Bu ezanlar, stüdyo ortamında okunmuş ve cd ile kayıt altına alınarak çalışmaya eklenmiştir. Okunan ezanlar notaya alınarak, makamları ile ilgili bilgiler verilmiş ve kayıtla...

  14. Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

    Science.gov (United States)

    Banerjee, Tannista; Nayak, Arnab

    2017-01-01

    This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

  15. Quality assurance in the enriched uranium operations NDA facility

    Energy Technology Data Exchange (ETDEWEB)

    May, P.K.; Ceo, R.N. [Oak Ridge Y-12 Plant, TN (United States)

    1997-11-01

    The Nondestructive Analysis (NDA) Facility at the Oak Ridge Y-12 Plant has characterized process wastes for Enriched Uranium Operations since 1978. Since that time, over 50,000 items have been analyzed. Analysis results are used to determine whether or not recovery of uranium from process wastes is economically feasible. Our instrument complement includes one large segmented gamma scanner (SGS), two smaller SGS, two solution assay systems (SAS), and Active Well Coincidence Counter (AWCC). The large SGS is used for analyzing High Efficiency Particulate Air (HEPA) filters ant 208-L drums filled with combustible contaminated waste. The smaller SGS are used to analyze 4-L containers of ash and leached residues. The SAS are used to analyze 125 ml bottles of aqueous or organic waste solutions that may contain uranium. The gamma-based NDA techniques are used to identify which process wastes can be discarded, and which must be recycled. The AWCC is used to analyze high-density materials which are not amenable to gamma-ray analysis. 1 ref., 4 figs.

  16. European Food Safety Authority; Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to beta-palmitate and increased calcium absorption pursuant to Article 14 of Regulation (EC

    DEFF Research Database (Denmark)

    Tetens, Inge

    Following a request from the European Commission, EFSA was asked to review the scientific comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to beta-palmitate and increased...... calcium absorption pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments submitted to EFSA via the European Commission Services originated from the applicant (IDACE). EFSA has reviewed the comments and shared them with the chair of the NDA Panel, Prof. Albert Flynn, and the chair of the NDA...

  17. 75 FR 32482 - Investigational New Drug Applications; Co-development of Investigational Drugs

    Science.gov (United States)

    2010-06-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0247] Investigational New Drug Applications; Co-development of Investigational Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. SUMMARY: The Food and Drug...

  18. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to physical performance

    DEFF Research Database (Denmark)

    Tetens, Inge

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) to draft guidance on scientific requirements for health claims related to physical performance. This guidance has been drawn from scientific opinions of the NDA Panel on such health...... claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in this area. It is not intended that the document should include an exhaustive list of beneficial effects and studies/outcome measures which...

  19. 78 FR 67365 - Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine...

    Science.gov (United States)

    2013-11-12

    ... the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984... No. Drug Applicant NDA 011522 ADDERALL Teva Womens Health (amphetamine Inc., 41 Moores aspartate; Rd...

  20. An experimental evaluation of a new designed apparatus (NDA) for the rapid measurement of impaired motor function in rats.

    Science.gov (United States)

    Jarrahi, M; Sedighi Moghadam, B; Torkmandi, H

    2015-08-15

    Assessment of the ability of rat to balance by rotarod apparatus (ROTA) is frequently used as a measure of impaired motor system function. Most of these methods have some disadvantages, such as failing to sense motor coordination rather than endurance and as the sensitivity of the method is low, more animals are needed to obtain statistically significant results. We have designed and tested a new designed apparatus (NDA) to measure motor system function in rats. Our system consists of a glass box containing 4 beams which placed with 1cm distance between them, two electrical motors for rotating the beams, and a camera to record the movements of the rats. The RPM of the beams is adjustable digitally between 0 and 50 rounds per minute. We evaluated experimentally the capability of the NDA for the rapid measurement of impaired motor function in rats. Also we demonstrated that the sensitivity of the NDA increases by faster rotation speeds and may be more sensitive than ROTA for evaluating of impaired motor system function. Compared to a previous version of this task, our NDA provides a more efficient method to test rodents for studies of motor system function after impaired motor nervous system. In summary, our NDA will allow high efficient monitoring of rat motor system function and may be more sensitive than ROTA for evaluating of impaired motor system function in rats. Copyright © 2015 Elsevier B.V. All rights reserved.

    1. Çevre etiği bağlamında Anadolu sığla ormanları

      OpenAIRE

      ÜRKER, Okan

      2014-01-01

      Doğal kaynak/varlık kullanımı ve yönetiminde toplumsal taleplerin hangi koşullar altında şekillendiğinin ve yönlendirildiğinin tespit edilmesi, buna ilişkin etik talebin ortaya çıkma süreçlerinin izlenmesi, bu bağlamda kamu vicdanının ve kamu yararının oluşmasında ve farklı şekillerde algılanmasında ve içselleştirilmesinde hukuk, politika gibi araçların nasıl kullanıldığının gösterilmesi, tüm bu süreçlerin çevre etiği açısından değerlendirilmesi ve sonucunda toplumsal faydanın ‘doğa ...

    2. Detection of systemic hypersensitivity to drugs using standard guinea pig assays.

      Science.gov (United States)

      Weaver, James L; Staten, David; Swann, Joslyn; Armstrong, George; Bates, Melissa; Hastings, Kenneth L

      2003-12-01

      The most commonly used assays designed to detect either skin or systemic immune-based hypersensitivity reactions are those using guinea pigs (GP). We obtained data from various FDA records to evaluate the correlation between GP assay results and reported post-marketing systemic hypersensitivity reactions. We examined the new drug application (NDA) reviews of approved drugs for the results of GP assays. Post-marketing human data were extracted from the FDA adverse event reporting system (AERS). Drug usage data were obtained from a commercial database maintained by IMS Health Inc. We found 83 (21%) of 396 drugs approved between 1978 and 1998 had reported GP test results. Among these 83 drugs, 14 (17%) were found to have positive results in at least one GP assay. Simple reporting index (RI) values for systemic hypersensitivity reactions were calculated from AERS data and usage to produce the index of adverse event reports per million shipping units of drug. A variety of definitions of positive human response were examined. A statistically significant association was seen for rash between post-marketing and clinical trials adverse event reports. No statistically significant associations between human data and GP test results were observed. These data suggest that standard GP assays have limited ability to predict human systemic hypersensitivity potential for pharmaceuticals.

    3. Nef’î Hakkında Bir Bibliyografya Denemesi An Essay Of Bibliography About Nef’i

      Directory of Open Access Journals (Sweden)

      Halil Sercan KOŞİK

      2013-03-01

      Full Text Available Nef’î who lived in the first half of 17th century was born in Hasankale one of districts of Erzurum. The poet whose real name was Ömer had a life full of struggles but he managed to produce some important works through his life. Nef’î, one of the leading poets of divan poetry was celebrated much at his age and after his death. Such a reputation is originated from the sharpness of his pen, his talent as well as his wit. Nef’î whose usage of praise and satire is extreme is known forhis mastership in using rhythm and rhyme in his poems. While attaching importance to meaning and utterance he tried to use a new language and accomplished that to a great degree. His knowledge of Persian Language and Literature played a considerable role.A lot has been written so far about Nef’î and a great many research exists about his works too. However it is obvious that there will be many works about Nef’î, a productive poet. In this study a classification of Nef’î’s works and scientific studies about him and his works will be presented. Our research focuses to illustrate which part of his works is the center of modern researches and which parts are not. In addition, it is expected that our research will provided useful information to researchers studying Nef’î as a guide for sources regarding him. On yedinci yüzyılın ilk yarısında yaşamış olan Nef’î, Erzurum’un Hasankale ilçesinde doğmuştur. Asıl adı Ömer olan şair, oldukça mücadele dolu bir hayat geçirmiş ve bu hayata aynı zamanda önemli denilebilecek eserler de sığdırabilmeyi başarmıştır. Divan şiirinin önde gelen şairlerden biri olan Nef’î, adından hem yaşadığı dönemde hem de sonrasında çokça söz ettirmiştir. Nef’î’nin böyle bir şöhrete kavuşması onun edebi yeteneği ve kıvrak zekası yanında kaleminin keskin olmasından kaynaklanmaktadır. Övdüğünü çok iyi öven, yerdiğini de çok kötü bir şekilde yeren Nef

    4. 10 CFR 707.8 - Applicant drug testing.

      Science.gov (United States)

      2010-01-01

      ... DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE PROGRAMS AT DOE SITES Procedures § 707.8 Applicant drug... final selection for employment or assignment to such a position. Provisions of this part do not prohibit contractors from conducting drug testing on applicants for employment in any position. ...

    5. Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

      Directory of Open Access Journals (Sweden)

      Lin-Chau Chang

      Full Text Available Standardised MedDRA Queries (SMQs have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA and Biologics License Application (BLA submissions to the United States Food and Drug Administration (USFDA.We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed.A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59% of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18% of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated. Most searches (75% of 227 searches with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process.SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

    6. Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

      Science.gov (United States)

      Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

      2017-01-01

      Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

    7. 76 FR 14023 - Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1...

      Science.gov (United States)

      2011-03-15

      ... 10 Grams Base/Vial, Approved Under New Drug Application 050585, Were Not Withdrawn From Sale for... milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585... active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the...

    8. The states of the art of the nondestructive assay of spent nuclear fuel assemblies. A critical review of the Spent Fuel NDA Project of the U.S. Department of Energy's Next Generation Safeguards Initiative

      International Nuclear Information System (INIS)

      Bolind, Alan Michael; Seya, Michio

      2015-12-01

      The state of the art of the nondestructive assay of spent nuclear fuel assemblies is represented by the results of the Spent Fuel Nondestructive Assay Project of the Next Generation Safeguards Initiative (NGSI) of the U.S. Department of Energy / National Nuclear Security Administration. This report surveys the fourteen advanced nondestructive assay (NDA) techniques that were examined by the NGSI. For each technique, it explains how the technique operates, the NGSI's design of an instrument that uses the technique, how the data are analyzed, and the technique's chief limitations. After this survey of the NDA techniques, the report then discusses and critiques the current paradigm of the practice of NDA of spent fuel assemblies. It shows how the current main problem in the NDA of spent fuel assemblies—namely, an unacceptably large uncertainty in the assay results—is caused primarily by using too few independent NDA measurements. Because the physics of the NDA of spent fuel assemblies is three dimensional, at least three independent NDA measurements are required. Thus, NDA results should be able to be improved dramatically by combining the fourteen advanced NDA techniques plus other existing NDA techniques into appropriate combinations of three techniques. This report evaluates the NGSI's proposed NDA combinations according to these principles. (author)

    9. 76 FR 54473 - Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

      Science.gov (United States)

      2011-09-01

      ... (formerly Docket No. 00D-0892)] Guidance on Positron Emission Tomography Drug Applications-- Content and... the availability of a guidance for industry entitled ``PET Drug Applications--Content and Format for... guidance for industry entitled ``PET Drug Applications--Content and Format for NDAs and ANDAs.'' The...

    10. 76 FR 26305 - Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To...

      Science.gov (United States)

      2011-05-06

      ... to satisfy the previously mentioned statutory requirement. The importance of obtaining these data.... Marketing Applications/Submissions In 2010, CDER and CBER received 165 new drug applications (NDA... ANDA marketing applications and submissions. It is assumed that the sponsor/applicant/submitter has...

    11. How the NDA Provides Transparency and Visibility of the Technical Deliverability of the R and D Programme - 13303

      International Nuclear Information System (INIS)

      Seed, Ian; James, Paula; Brownridge, Melanie; McMinn, Mervin

      2013-01-01

      The Nuclear Decommissioning Authority (NDA) was created under the UK Energy Act 2004 to ensure the UK historic civil public sector nuclear legacy sites are decommissioned safely, securely, cost effectively and in ways that protect the environment. The delivery will involve carrying out many unique projects within a high hazard environment requiring the very highest standards in safety, security and environmental management. Unique problems require unique solutions and there is a substantial amount of research and development required for each project. The NDA's R and D strategic objective is to ensure that delivery of the NDA's mission is technically underpinned by sufficient and appropriate research and development. This drives a requirement to provide transparency and visibility of the technical deliverability of the programme through the technical baseline and accompanying research and development requirements. The NDA need to have confidence in the technical deliverability of the Site License Companies (SLCs) plans, provide overall visibility of R and D across the NDA Estate and ensure that appropriate R and D is being carried out in a timely manner. They need to identify where coordinated R and D programmes may be advantageous as a result of common needs, risks and opportunities and ensure key R and D needs across NDA are identified, prioritised and work programmes are costed and scheduled in the Lifetime Plans for individual sites and SLCs. Evidence of the Site License Company's approach and their corresponding technical underpinning programmes is achieved through submission of a number of outputs collectively known as TBuRDs (Technical Baseline and Underpinning Research and Development Requirements). This paper is a summary of the information generated by an independent review of those TBuRDs. It highlights some of the key messages, synergies and common R and D activities across the estate. It demonstrates the value of a consistent approach to collecting R

    12. Methodology for NDA performance assessment

      International Nuclear Information System (INIS)

      Cuypers, M.; Franklin, M.; Guardini, S.

      1986-01-01

      In the framework of the RandD programme of the Joint Research Centre of the Commission of the European Communities, a considerable effort is being dedicated to performance assessment of NDA techniques taking account of field conditions. By taking account of field conditions is meant measurement samples of the size encountered in practice and training which allows inspectors to design cost efficient verification plans for the real situations encountered in the field. Special laboratory facilities referred to as PERLA are being constructed for this purpose. These facilities will be used for measurement experiments and for training. In this paper, performance assessment is discussed under the headings of measurement capability and in-field effectiveness. Considerable emphasis is given to the role of method specific measurement error models. The authors outline the advantages of giving statistical error models a sounder basis in the physical phenomenology of the measurement method

    13. Peynir Yapımında Mikrobiyal Renet Kullanımı

      Directory of Open Access Journals (Sweden)

      Mehmet Karapınar

      2015-02-01

      Full Text Available Peynir yapımında süt koagulantı olarak buzağı reneti yerine kullanılmak üzere proteazlar üzerine yapılan çalışmalar son yıllarda yoğunluk kazanmıştır. Günümüzde buzağı reneti standart bir süt koagulantı olarak önemini sürdürmekteyse de, şirden mayası üretimi her yıl giderek gereksinimi karşılayamaz duruma gelmektedir. Bunun sonucu olarak yeni renet kaynakları arasında yoğunlaşmış ve günümüzde Mucor pusillus, M. miehei, Endothia parasitica küf türlerinden elde edilen üç fungal enzim ile Bacillus cereus bakterisinden elde edilen bir bakteriyel enzim ticari olarak üretilmeye başlanmıştır.

    14. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific and technical guidance for the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on Scientific and technical guidance for the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000....../13/EC, as amended. This guidance applies to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC (as amended) or products thereof, and aims to assist applicants in the preparation and presentation of well-structured applications for exemption from labelling....... It presents a common format for the organisation of the information to be provided and outlines the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, reflecting the relative strength of evidence which may be obtained from...

    15. NDA techniques for spent fuel verification and radiation monitoring. Report on activities 6a and 6b of Task JNT C799 (SAGOR). Finnish support programme to the IAEA safeguards

      International Nuclear Information System (INIS)

      Tarvainen, M.; Levai, F.; Valentine, T.E.; Abhold, M.; Moran, B.

      1997-08-01

      A variety of NDA methods exist for measurement of spent fuel at various stages of the disposition process. Each of the methods has weaknesses and strengths that make them applicable to one or more stages in disposition. Both passive and active methods are, under favorable conditions, capable of providing either a mapping of an assembly to identify missing fuel pins or a measurement of the fissile content and some are capable of providing a mapping of a canister to identify missing assemblies or a measurement of the fissile content. However, a spent fuel measurement system capable of making routine partial defect tests of spent fuel assemblies is missing. The active NDA methods, in particular, the active neutron methods, hold the most promise for providing quantitative measurements on fuel assemblies and canisters. Application of NDA methods to shielded casks may not be practical or even possible due to the extent of radiation attenuation by the shielding materials, and none of these methods are considered to have potential for quantitative measurements once the spent fuel cask has been placed in a repository. The most practical approach to spent fuel verification is to confirm the characteristics of the spent fuel prior to loading in a canister or cask at the conditioning facility. Fissile material tracking systems in addition to containment and surveillance methods have the capability to assure continuity of the verified knowledge of the sample from loading of the canisters to final disposal and closing of the repository. (orig.)

    16. Eskişehir koşullarında yetiştirilen Reyhan (Ocimum basilicum L.) bitkisinin bazı bitkisel özelliklerin ve diurnal varyabilitesinin belirlenmesi

      OpenAIRE

      Kulan, Engin Gökhan

      2013-01-01

      Bu çalışma Eskişehir Osmangazi Üniversitesi Ziraat Fakültesi Tarla Bitkileri Bölümü deneme alanında 2010 yılında yürütülmüştür. Denemede Eskişehir ekolojik koşullarında yetiştirilen reyhan (Ocimum basilicum L.) bitkisinin verim ve verim özellikleri ile farklı biçim saatlerinin reyhanın uçucu yağı ve uçucu yağ bileşimi üzerine olan etkileri incelenmiştir. Tesadüf bloklarında bölünmüş parseller deneme desenine göre 3 tekerrürlü olarak kurulan denemede reyhan bitkileri çiçeklen...

    17. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

      Science.gov (United States)

      2008-07-10

      The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

    18. Drug nanocrystals for the formulation of poorly soluble drugs and its application as a potential drug delivery system

      International Nuclear Information System (INIS)

      Gao Lei; Zhang Dianrui; Chen Minghui

      2008-01-01

      Formulation of poorly soluble drugs is a general intractable problem in pharmaceutical field, especially those compounds poorly soluble in both aqueous and organic media. It is difficult to resolve this problem using conventional formulation approaches, so many drugs are abandoned early in discovery. Nanocrystals, a new carrier-free colloidal drug delivery system with a particle size ranging from 100 to 1000 nm, is thought as a viable drug delivery strategy to develop the poorly soluble drugs, because of their simplicity in preparation and general applicability. In this article, the product techniques of the nanocrystals were reviewed and compared, the special features of drug nanocrystals were discussed. The researches on the application of the drug nanocrystals to various administration routes were described in detail. In addition, as introduced later, the nanocrystals could be easily scaled up, which was the prerequisite to the development of a delivery system as a market product

    19. NDA for a new facility at SRP

      International Nuclear Information System (INIS)

      Studley, R.V.

      1987-01-01

      In 1980, plans were initiated to build a new facility to process high purity highly enriched 235 U. Interest in improving nuclear safeguards had been increasing in the previous few years. A basic objective of the design, therefore, included achievement of maximum performance in special nuclear material (SNM) accountability. A near-real-time accountability system with high accuracy assay measurements was developed for this purpose. Simultaneous design of facility, process equipment, and the accountability system allowed maximum integration of equipment and also permitted influence on process design and material characteristics to optimize accountability performance. This was an ideal situation in which to pursue maximum improvement in nondestructive assay (NDA) measurement performance. The resulting systems are described

    20. Environmental assessments and findings of no significant impact--FDA. Notice.

      Science.gov (United States)

      1998-05-18

      The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.

    1. 77 FR 71802 - Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

      Science.gov (United States)

      2012-12-04

      ... Positron Emission Tomography (PET) Drugs.'' The guidance is intended to assist manufacturers of PET drugs... one self-addressed adhesive label to assist that office in processing your requests. See the... ``Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.'' The guidance summarizes the...

    2. Production of NDA Working Reference Materials for the Capability Evaluation Project

      International Nuclear Information System (INIS)

      Noll, P.D. Jr.; Marshall, R.S.

      1998-01-01

      The production of Non Destructive Assay (NDA) Working Reference Materials (WRMs) that are traceable to nationally recognized standards was undertaken to support implementation of the Idaho National Engineering and Environmental Laboratory (INEEL) Nondestructive Waste Assay Capability Evaluation Project (CEP). The WRMs produced for the CEP project consist of Increased Am/Pu mass ration (IAP) and depleted Uranium (DU) WRMs. The CEP IAP/DU WRM set provides radioactive material standards for use in combination with 55 gallon drum waste matrix surrogates for the assessment of waste NDA assay system performance. The Production of WRMs is a meticulous process that is not without certain trials and tribulations. Problems may arise at any of the various stages of WRM production which include, but are not limited to; material characterization (physical, chemical, and isotopic), material blend parameters, personnel radiation exposure, gas generation phenomenon, traceability to national standards, encapsulation, statistical evaluation of the data, and others. Presented here is an overall description of the process by which the CEP WRMs were produced and certified as well as discussions pertaining to some of the problems encountered and how they were solved

    3. Functionalization of protein-based nanocages for drug delivery applications.

      Science.gov (United States)

      Schoonen, Lise; van Hest, Jan C M

      2014-07-07

      Traditional drug delivery strategies involve drugs which are not targeted towards the desired tissue. This can lead to undesired side effects, as normal cells are affected by the drugs as well. Therefore, new systems are now being developed which combine targeting functionalities with encapsulation of drug cargo. Protein nanocages are highly promising drug delivery platforms due to their perfectly defined structures, biocompatibility, biodegradability and low toxicity. A variety of protein nanocages have been modified and functionalized for these types of applications. In this review, we aim to give an overview of different types of modifications of protein-based nanocontainers for drug delivery applications.

    4. 77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

      Science.gov (United States)

      2012-02-14

      ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

    5. Roma Hukuku’nda Gemi, Han ve Ahır İşletenlerin Receptum Sorumluluğu

      OpenAIRE

      YEŞİLLER, Mehmet

      2013-01-01

      Çalışmamızda Roma Hukuku'nda gemi, han ve ahır işleten kimselerin sorumluluklarına ilişkin düzenlemeler ele alınmıştır. Roma?da özellikle gemi, han ve ahır işleten kimselerin yanlarında çalıştırdıkları kişilerin güvenilir olmamasından dolayı, taraflar arasındaki istisna sözleşmesinden kaynaklanan custodia sorumluluğuna ek olarak "actio de damno aut furto adversus nautas, caupones, stabularios ve receptum, nautae, cauponis, stabularii" sorumluluklarının düzenlendiği kaynaklardan...

    6. Menemen Ekolojik Koşullarında Lavanta (Lavandula spp.) Tür ve Çeşitlerinin Morfolojik, Verim ve Kalite Özelliklerinin Belirlenmesi

      OpenAIRE

      Karık, Ünal; Çiçek, Fatih; Çınar, Orçun

      2017-01-01

      Bu çalışma Menemen ekolojik koşullarında lavanta (Lavandula spp.) tür ve çeşitlerininmorfolojik, verim ve kalite özelliklerini belirlemek amacı ile 2015-2016yılları arasında yürütülmüştür. Çalışmada 2 farklı türe ait 8 farklı ticarilavanta çeşidi kullanılmıştır. 2 yıl sonucunda elde edilen veriler ışığında türve çeşitler arasında önemli farklılıklar bulunduğu tespit edilmiştir. Lavandintipi çeşitler, verim özellikleri açısından lavander tipi çeşitlerin önünegeçerken,  uçucu yağ oranı ve uçucu...

    7. Dilbilim Kavramları Işığında Türkçe Öğretimi

      Directory of Open Access Journals (Sweden)

      Nilay Çağlayan DİLBER

      2017-12-01

      Full Text Available Anadili olarak Türkçe öğretiminde hem öğretmen yetiştirme hem de ilköğretim öğrencisi yetiştirme anlamında dilbilime ve dilbilimin elde ettiği verilere yeterince önem verilmemektedir. Oysa gelişmiş ülkelerdeki anadili eğitimine bakıldığında dilbilimden ve verilerinden sıkça yararlanılmaktadır. Yapılan çalışmada da bu eksikliği gidermek adına dilbilim kuramlarında yer alan kavramların anadili olarak Türkçe öğretiminde somut olarak nasıl yer alabileceğini ve zaten yer aldığını göstermek amaçlanmaktadır. Bu doğrultuda F. De Saussure ile bir bilim haline gelen ve 19. yy. itibariyle kuramlar üzerine yeni kuramlar üreterek dili farklı açılardan betimleyen Genel Dilbilim ders notları, Avrupa Yapısalcılığı, Amerikan Yapısalcılığı, Üretici Dönüşümsel Dilbilgisi, Edimbilim ve Sözceleme Kuramları’nda kullanılan ve bu kuramlarla ortaya çıkan bazı kavramların Türkçe öğretiminde kullanımı somut bir şekilde örneklendirilerek verilmiştir. Bu örneklerin Türkçe ders kitaplarına, etkinliklere, öğretim materyallerine yardımcı olacağı öngörülmektedir. Ayrıca çalışmanın Türkçe öğretmen adaylarının dilbilime daha somut bir şekilde yaklaşmasına ve dilbilimin dil öğretimindeki gerekliliğini anlamalarına yardımcı olacağı düşünülmektedir.

    8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on Dihydrocapsiate

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of a synthetic dihydrocapsiate (DHC) as a food ingredient in the context of Regulation (EC) No 258/97 taking into account...

    9. 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

      Science.gov (United States)

      2013-08-23

      ... 558 [Docket No. FDA-2013-N-0839] New Animal Drugs; Withdrawal of Approval of New Animal Drug...: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request...

    10. NDA techniques for spent fuel verification and radiation monitoring. Report on activities 6a and 6b of Task JNT C799 (SAGOR). Finnish support programme to the IAEA safeguards

      Energy Technology Data Exchange (ETDEWEB)

      Tarvainen, M [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland); Levai, F [Technical Univ., Budabest (Hungary); Valentine, T E [Oak Ridge National Lab., TN (United States); Abhold, M [Los Alamos National Lab., NM (United States); Moran, B [USNRC, Washington, DC (United States)

      1997-08-01

      A variety of NDA methods exist for measurement of spent fuel at various stages of the disposition process. Each of the methods has weaknesses and strengths that make them applicable to one or more stages in disposition. Both passive and active methods are, under favorable conditions, capable of providing either a mapping of an assembly to identify missing fuel pins or a measurement of the fissile content and some are capable of providing a mapping of a canister to identify missing assemblies or a measurement of the fissile content. However, a spent fuel measurement system capable of making routine partial defect tests of spent fuel assemblies is missing. The active NDA methods, in particular, the active neutron methods, hold the most promise for providing quantitative measurements on fuel assemblies and canisters. Application of NDA methods to shielded casks may not be practical or even possible due to the extent of radiation attenuation by the shielding materials, and none of these methods are considered to have potential for quantitative measurements once the spent fuel cask has been placed in a repository. The most practical approach to spent fuel verification is to confirm the characteristics of the spent fuel prior to loading in a canister or cask at the conditioning facility. Fissile material tracking systems in addition to containment and surveillance methods have the capability to assure continuity of the verified knowledge of the sample from loading of the canisters to final disposal and closing of the repository. (orig.). 49 refs.

    11. Drug-Target Interactions: Prediction Methods and Applications.

      Science.gov (United States)

      Anusuya, Shanmugam; Kesherwani, Manish; Priya, K Vishnu; Vimala, Antonydhason; Shanmugam, Gnanendra; Velmurugan, Devadasan; Gromiha, M Michael

      2018-01-01

      Identifying the interactions between drugs and target proteins is a key step in drug discovery. This not only aids to understand the disease mechanism, but also helps to identify unexpected therapeutic activity or adverse side effects of drugs. Hence, drug-target interaction prediction becomes an essential tool in the field of drug repurposing. The availability of heterogeneous biological data on known drug-target interactions enabled many researchers to develop various computational methods to decipher unknown drug-target interactions. This review provides an overview on these computational methods for predicting drug-target interactions along with available webservers and databases for drug-target interactions. Further, the applicability of drug-target interactions in various diseases for identifying lead compounds has been outlined. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

    12. Self-Assembled Hydrogel Nanoparticles for Drug Delivery Applications

      Directory of Open Access Journals (Sweden)

      Miguel Gama

      2010-02-01

      Full Text Available Hydrogel nanoparticles—also referred to as polymeric nanogels or macromolecular micelles—are emerging as promising drug carriers for therapeutic applications. These nanostructures hold versatility and properties suitable for the delivery of bioactive molecules, namely of biopharmaceuticals. This article reviews the latest developments in the use of self-assembled polymeric nanogels for drug delivery applications, including small molecular weight drugs, proteins, peptides, oligosaccharides, vaccines and nucleic acids. The materials and techniques used in the development of self-assembling nanogels are also described.

    13. Yeni Ürün Geliştirme Takımlarında Güven ve Takım Öğrenmesi

      Directory of Open Access Journals (Sweden)

      Volkan POLAT

      2018-01-01

      Full Text Available Farklı örgütsel seviyelerde güven ve öğrenme üzerine yapılan çalışmaların yanı sıra, güvenin takım bağlamında bilgi paylaşımı ve edinimi için önemli bir faktör olduğunu bildiren birtakım çalışmalar bulunmaktadır. Ancak bugüne kadar yeni ürün geliştirme takımlarında (new product development – NPD Takım Güveni ve Takım Öğrenmesi ilişkileri hakkında çok az tartışma yapılmıştır. Bu çalışma, Takım Güveninin, çeşitli takım faktörleri (Takım Üyesi Deneyimi, Takım İstikrarı ve Takım Otonomisi ve Takım Öğrenimi arasında arabuluculuk etkisi olup olmadığını incelemeyi amaçlamaktadır.

    14. Application of nanohydrogels in drug delivery systems: recent patents review.

      Science.gov (United States)

      Dalwadi, Chintan; Patel, Gayatri

      2015-01-01

      Nanohydrogel combines the advantages of hydrogel and nano particulate systems. Similar to the hydrogel and macrogel, nanohydrogel can protect the drug and control drug release by stimuli responsive conformation or biodegradable bond into the polymer networks. Nanohydrogel has drawn huge interest due to their potential applications, such as carrier in target-specific controlled drug delivery, absorbents, chemical/biological sensors, and bio-mimetic materials. Similar to the nanoparticles, stimuli responsive nanohydrogel can easily be delivered in the liquid form for parenteral drug delivery application. This review highlights the methods to prepare nanohydrogel based on natural and synthetic polymers for diverse applications in drug delivery. It also encompasses the drug loading and drug release mechanism of the nanohydrogel formulation and patents related to the composition and chemical methods for preparation of nanohydrogel formulation with current status in clinical trials.

    15. Sosyal Pazarlama Literatür İncelemesi: Prensipler ve Teknikler Kapsamında Ele Alınan Temel Konular (1971-2014)

      OpenAIRE

      Kitapcı, Olgun; Dörtyol, İbrahim Taylan; Gülmez, Mustafa

      2018-01-01

      SosyalPazarlama kavramının doğduğu tarihten günümüze yazılmış ve Web of Science (WOS)veri tabanında yayınlanmış makalelerin, Lee ve Kotler’in 2011 yılındayazdıkları kitapta yer alan sınıflandırma çerçevesinde yorumlanmasını amaçlayanbu çalışma sözkonusu alanda zaman içerisinde hakim olan araştırma eğilimlerini ortayakoymaktadır. Bu kapsamda, ilgili veri tabanında yer alan makalelerin tamamıtaranmış ve sınıflandırılmıştır. Makalelerin temel odakları sosyal pazarlamabağlamında ele alınan temel ...

    16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on bovine lactoferrin

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment for ‘lactoferrin’ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections...

    17. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on bovine lactoferrin

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment of ‘lactoferrin’ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections...

    18. Broadly Applicable Nanowafer Drug Delivery System for Treating Eye Injuries

      Science.gov (United States)

      2015-09-01

      Systems in Systemic , Dermal, Transdermal , and Ocular Drug Delivery . Crit. Rev. Ther. Drug 2008, 25, 545–584. 14. Choy, Y. B.; Park, J.-H.; McCarey, B...AWARD NUMBER: W81XWH-13-1-0146 TITLE: Broadly Applicable Nanowafer Drug Delivery System for Treating Eye Injuries PRINCIPAL INVESTIGATOR: Dr...Broadly Applicable Nanowafer Drug Delivery System for Treating Eye Injuries” 5b. GRANT NUMBER W81XWH-13-1-0146 5c. PROGRAM ELEMENT NUMBER 6

    19. 76 FR 1181 - Oncologic Drugs Advisory Committee; Notice of Meeting

      Science.gov (United States)

      2011-01-07

      ... or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective... least two prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or...

    20. IAEA experience with authentication of in-plant NDA instrumentation

      International Nuclear Information System (INIS)

      Augustson, R.H.; Dermendjiev, E.

      1983-01-01

      The paper discusses IAEA experience with permanently installed measuring equipment, i.e. in-plant NDA instrumentation, which often has advantages over portable equipment, such as improved accuracy, automated sample handling and data collection, and capacity for higher throughput. In some cases, in-plant equipment is the only means of making a field measurement. However, the use of in-plant equipment requires an additional set of inspector procedures to ensure that the instrument is working correctly and has not been tampered with. This process of verifying instrument performance is called authentication. General guidelines for approaches to authentication have been studied and formulated by an IAEA Advisory Group Meeting held in November 1981. Procedures for specific instruments have been developed in some cases with the help of national support programmes. The field application of authentication is accomplished by incorporating specific actions into inspection procedures. Results are written down as part of the working papers and included in the final inspection report. For quantitative checks such as measurement of a working standard the results are sent along with the inspection measurements to the Agency for inclusion in the safeguards data base. The in-plant equipment may be owned by the facility, a State, a safeguards organization or the Agency. In each case, the use of the in-plant equipment will necessitate additional interactions between facility operator and inspector, in order to judge the impact on plant operation, and understand what is being measured and what can go wrong. The paper discusses the IAEA's experience gained in the field application of authentication procedures for instrument systems such as weighing and volume measuring devices, rod scanners, neutron activation systems and K-edge densitometers

    1. Toprakaltı termiti Heterotermes indicola (Wasmann) (Isoptera: Rhinotermitidae)’ya karşı indoxacarb ve chlorfenapyr’in laboratuvar koşullarında etkisi

      OpenAIRE

      MISBAH-UL-HAQ, Muhammad; KHAN, Imtiaz Ali; FARID, Abid; ULLAH, Misbah; GOUGE, Dawn H.; BAKER, Paul B.

      2016-01-01

      Indoxacarb ve chlorfenapyrin’in, Toprakaltı termiti, Heterotermes indicola (Wasmann)’da beslenme engelleyici ve bireyler arasında taşınma etkileri 2013-2014 yıllarında Gıda ve Tarım Nükleer Enstitüsü (NIFA) (Peshawar, Pakistan)’nde laboratuvar testleri ile değerlendirilmiştir. Test edilen kimyasal konsantrasyonları indoxacarb için 1-100 ppm (ağırlık/ağırlık) ve chlorfenapyrin 1 ile 7 ppm (ağırlık/ağırlık) arasında değişmiştir. Gözlemler indoxacarb’ın 50 ppm üzerindeki dozlarda hızlı ölüme seb...

    2. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014 . Scientific Opinion on the substantiation of a health claim related to zinc and normal growth pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

    3. Atık Mermer Tozunun Parke Taşlarında Kullanılması

      OpenAIRE

      FİLİZ, Mümin; ÖZEL, Cengiz; SOYKAN, Oktar; EKİZ, Yunus

      2010-01-01

      Bu çalışmada iki farklı çimento tipi (CEM II/B-M (P-LL) 32.5 N ve CEM I 42.5 R) ve iki farklı su/çimento oranında (0.50 ve 0.55) hazırlanmış olan karışımlara mermer tozunun hacim oranınca agrega ile yer değiştirmesinin, mekanik ve fiziksel özelliklere etkisi araştırılmıştır. Elde edilen verilere göre mermer tozu atığının parke taşı imalatında kullanılabilirliği TS 2524 EN 1338 standardına göre değerlendirilmiştir. Elde edilen sonuçlara göre mermer tozu kullanımı ile betonların mekanik ve f...

    4. Application of expert system technology to nondestructive waste assay - initial prototype model

      Energy Technology Data Exchange (ETDEWEB)

      Becker, G.K.; Determan, J.C. [Idaho National Engineering and Environmental Lab., Idaho Falls, ID (United States)

      1997-11-01

      Expert system technology has been identified as a technique useful for filling certain types of technology/capability gaps in existing waste nondestructive assay (NDA) applications. In particular, expert system techniques are being investigated with the intent of providing on-line evaluation of acquired data and/or directed acquisition of data in a manner that mimics the logic and decision making process a waste NDA expert would employ. The space from which information and data sources utilized in this process is much expanded with respect to the algorithmic approach typically utilized in waste NDA. Expert system technology provides a mechanism to manage and reason with this expanded information/data set. The material presented in this paper concerns initial studies and a resultant prototype expert system that incorporates pertinent information, and evaluation logic and decision processes, for the purpose of validating acquired waste NDA measurement assays. 6 refs., 6 figs.

    5. Application of expert system technology to nondestructive waste assay - initial prototype model

      International Nuclear Information System (INIS)

      Becker, G.K.; Determan, J.C.

      1997-01-01

      Expert system technology has been identified as a technique useful for filling certain types of technology/capability gaps in existing waste nondestructive assay (NDA) applications. In particular, expert system techniques are being investigated with the intent of providing on-line evaluation of acquired data and/or directed acquisition of data in a manner that mimics the logic and decision making process a waste NDA expert would employ. The space from which information and data sources utilized in this process is much expanded with respect to the algorithmic approach typically utilized in waste NDA. Expert system technology provides a mechanism to manage and reason with this expanded information/data set. The material presented in this paper concerns initial studies and a resultant prototype expert system that incorporates pertinent information, and evaluation logic and decision processes, for the purpose of validating acquired waste NDA measurement assays. 6 refs., 6 figs

    6. Recent progress on fabrication and drug delivery applications of nanostructured hydroxyapatite.

      Science.gov (United States)

      Mondal, Sudip; Dorozhkin, Sergy V; Pal, Umapada

      2018-07-01

      Through this brief review, we provide a comprehensive historical background of the development of nanostructured hydroxyapatite (nHAp), and its application potentials for controlled drug delivery, drug conjugation, and other biomedical treatments. Aspects associated with efficient utilization of hydroxyapatite (HAp) nanostructures such as their synthesis, interaction with drug molecules, and other concerns, which need to be resolved before they could be used as a potential drug carrier in body system, are discussed. This review focuses on the evolution of perceptions, practices, and accomplishments in providing improved delivery systems for drugs until date. The pioneering developments that have presaged today's fascinating state of the art drug delivery systems based on HAp and HAp-based composite nanostructures are also discussed. Special emphasis has been given to describe the application and effectiveness of modified HAp as drug carrier agent for different diseases such as bone-related disorders, carriers for antibiotics, anti-inflammatory, carcinogenic drugs, medical imaging, and protein delivery agents. As only a very few published works made comprehensive evaluation of HAp nanostructures for drug delivery applications, we try to cover the three major areas: concepts, practices and achievements, and applications, which have been consolidated and patented for their practical usage. The review covers a broad spectrum of nHAp and HAp modified inorganic drug carriers, emphasizing some of their specific aspects those needed to be considered for future drug delivery applications. This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants Therapeutic Approaches and Drug Discovery > Nanomedicine for Respiratory Disease Nanotechnology Approaches to Biology > Cells at the Nanoscale. © 2017 Wiley Periodicals, Inc.

    7. Farklı Bölgelerin Üzümlerinden Üretilen Türk Şaraplarında Resveratrol Düzeyleri

      Directory of Open Access Journals (Sweden)

      Belkıs Adıgüzel Çaylak

      2015-02-01

      Full Text Available Resveratrol (3,5,4’ trihidroksistilben, fitoaleksin adı verilen bir polifenol çeşididir. Polifenoller üzümlerin kabuklarında, çekirdeklerinde ve saplarında bulunan maddelerdir. Fenolik bileşikler, özellikle flavanoller şarap alımıyla ilgili bilinen sağlık yararları açısından antioksidan özelliklere sahiptirler. Birçok çalışma, üzümlerde stres koşullarında bir savunma metaboliti olarak sentezlenen resveratrolün şarapta bulunduğunu göstermiştir. Şarap insanlarda kansere, iltihaplanmalara ve koroner kalp hastalıklarına karşı koruyucu özellikleri olduğu bilinen polifenol bileşikleri büyük oranda içermektedir. Hücre ve hayvanlarda yapılan çalışmalar, kırmızı şarabın, lösemi, deri, akciğer ve prostat kanserleri gibi pek çok kanser türünde koruyucu etkisi olduğunu göstermektedir. In-vivo çalışmalardan alınan son bilgiler, resveratrolün kanserin başlangıç, gelişme ve ilerleme safhalarında etkili bir ajan olabileceği hakkında bilgi vermektedir. Farklı ülkelerdeki şarapların içerdiği resveratrol miktarının belirlenmesi ile ilgili birçok araştırma olmasına rağmen, Türkiye’de çok az benzer çalışmalar bulunmaktadır. Bu çalışmada, Türkiye’nin farklı bölgelerinde yetişen üzümlerden üretilen şaraplar önemli şarap üreticilerinden temin edilmiş ve resveratrol miktarları Yüksek Performanslı Sıvı Kromatografisi cihazı kullanılarak belirlenmiştir. Elde edilen sonuçlar resveratrol konsantrasyonunun üzüm çeşidine ve bölgelere göre değişebileceğini göstermiştir.

    8. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific opinion on niacin and contribution to normal energy-yielding metabolism: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      2015-01-01

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

    9. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

    10. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific opinion on biotin and contribution to normal energy-yielding metabolism: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      2015-01-01

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

    11. Electrosprayed nanoparticles for drug delivery and pharmaceutical applications

      Science.gov (United States)

      Sridhar, Radhakrishnan; Ramakrishna, Seeram

      2013-01-01

      Nanotechnology based Pharma has emerged significantly and has influenced the Pharma industry up to a considerable extent. Nanoparticles technology holds a good share of the nanotech Pharma and is significant in comparison with the other domains. Electrospraying technology answers the potential needs of nanoparticle production such as scalability, reproducibility, effective encapsulation etc. Many drugs have been electrosprayed with and without polymer carriers. Drug release characteristics are improved with the incorporation of biodegradable polymer carriers which sustain the release of encapsulated drug. Electrospraying is acknowledged as an important technique for the preparation of nanoparticles with respect to pharmaceutical applications. Herein we attempted to consolidate the reports pertaining to electrospraying and their corresponding therapeutic application area. PMID:23512013

    12. Interactive CD based training on NDA instruments for facility operators and international inspectors

      International Nuclear Information System (INIS)

      Horley, E.C.; Smith, H.A.

      1996-01-01

      Interactive multimedia training is rapidly becoming a popular and highly effective medium for learning. An interactive CD based training module on the Active Well Coincidence counter is being developed for on-site training at nuclear facility, including foreign facilities. The training module incorporates interactive text, graphics and video that demonstrate the operating principles, and the use and set-up of the instrument. The user is in control of the pace of learning and of the directions taken to acquire information based on personal need. By being in control, the user stays highly motivated. A mix of visuals (text and graphics), audio clips (in different languages), and video (with audio) clips also keeps the interest level high. Skill reviews and evaluations can be incorporated into the training to provide feedback to the student. In addition, general background information is provided on gamma and neutron based MC and A measurements. This material serves as a condensed MC and A encyclopedia. By supplying an interactive CD with an NDA instrument, nuclear facilities will have greater assurance operators are properly trained in the set-up and operation of the NDA-equipment

    13. Sustained Release Drug Delivery Applications of Polyurethanes

      Directory of Open Access Journals (Sweden)

      Michael B. Lowinger

      2018-05-01

      Full Text Available Since their introduction over 50 years ago, polyurethanes have been applied to nearly every industry. This review describes applications of polyurethanes to the development of modified release drug delivery. Although drug delivery research leveraging polyurethanes has been ongoing for decades, there has been renewed and substantial interest in the field in recent years. The chemistry of polyurethanes and the mechanisms of drug release from sustained release dosage forms are briefly reviewed. Studies to assess the impact of intrinsic drug properties on release from polyurethane-based formulations are considered. The impact of hydrophilic water swelling polyurethanes on drug diffusivity and release rate is discussed. The role of pore formers in modulating drug release rate is examined. Finally, the value of assessing mechanical properties of the dosage form and approaches taken in the literature are described.

    14. Development of Applications about Hazards and Preventions of Drug Based On Android

      Science.gov (United States)

      Hartatik; Febriyanto, F.; Munawaroh, H.

      2018-03-01

      The number of drug abuse was increase among the younger generation, it caused younger generation fall into drug abuse, and it will lead to physical and mental damage. The lack of knowledge of drugs danger is one of the most potential problems, so in this study we made an application about the types, dangers, and how to avoid its abusement. The application built using PHP programming language with codeiniter framework on admin part, while the parsing data between mobile application server using Javascript Object Notation (JSON). This application has been tested and 85% respondents stated that this application provides positive benefits especially for the socialization of drug abuse.

    15. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

      Science.gov (United States)

      2011-02-03

      ...; formerly Docket No. 00D-0892] Draft Guidance on Positron Emission Tomography Drug Applications--Content and... Applications for Certain Positron Emission Tomography Drug Products; Availability,'' issued on March 10, 2000... and ANDAs.'' The draft guidance is intended to assist manufacturers of certain positron emission...

    16. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to choline and “development of brain” pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

    17. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to “Femilub” and maintenance of vaginal moisture pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion...

    18. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to caffeine and increased alertness pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from SmithKline Beecham Limited, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver...

    19. Meyve Konservelerinde ve Sularında Bozulmalara Neden Olan Küf Mantarları

      Directory of Open Access Journals (Sweden)

      Jale Acar

      2015-02-01

      Full Text Available Bakteriler, meyve suları ve konservelerinin bozulmalarında pek önemli rol oynamadıkları halde mayalar ve özellikle küf mantarları bu bozulmalarda önemli bir yer alırlar. Çeşitli mikroorganizmaların gelişme isteklerinin farklı olması buna neden olmaktadır. Küf mantarlarının büyük bir kısmı ancak aerob koşullar altında gelişebilirler. Bu gelişme en fazla yüzeydedir. Konserve kutularının hermetikli olan kapatılması ve tepe boşluğunda çok az oksijen bulunması yüzeyde küf mantarlarının gelişmesini önlemekle beraber Byssochlamys cinsinden küf mantarları anaerob koşullar altında fazla olmasa bile gelişebilmektedirler. Küf mantarları bakterilere oranla az miktarda suya gereksinim duyarlar. Aspergillus glaucus ve birçok Penicillium türleri kserofil olup aktif suyun çok düşük olduğu 0.70-0.75 gelişebilmelerine karşın bu değer bakterilerde 0.90-0.98 arasındadır. Çok az miktardaki su örneğin, yüzeydeki kondense su pastörizasyonda öldürülemeyen veya sonradan herhangi bir şekilde reçel kabına giren küflerin gelişmesine yardımcı olabilir. Sonradan bulaşma özellikle evlerde yapılan ve soğuduktan sonra kapağı kapatılan, özellikle reçel kabı selofan kağıdı ile kapatılıyorsa, sık sık görülmektedir. Diğer taraftan kaplar reçel soğutulmadan kapatılacak olursa suyun kondense olma miktarı artmaktadır.

    20. Ruminations On NDA Measurement Uncertainty Compared TO DA Uncertainty

      International Nuclear Information System (INIS)

      Salaymeh, S.; Ashley, W.; Jeffcoat, R.

      2010-01-01

      It is difficult to overestimate the importance that physical measurements performed with nondestructive assay instruments play throughout the nuclear fuel cycle. They underpin decision making in many areas and support: criticality safety, radiation protection, process control, safeguards, facility compliance, and waste measurements. No physical measurement is complete or indeed meaningful, without a defensible and appropriate accompanying statement of uncertainties and how they combine to define the confidence in the results. The uncertainty budget should also be broken down in sufficient detail suitable for subsequent uses to which the nondestructive assay (NDA) results will be applied. Creating an uncertainty budget and estimating the total measurement uncertainty can often be an involved process, especially for non routine situations. This is because data interpretation often involves complex algorithms and logic combined in a highly intertwined way. The methods often call on a multitude of input data subject to human oversight. These characteristics can be confusing and pose a barrier to developing and understanding between experts and data consumers. ASTM subcommittee C26-10 recognized this problem in the context of how to summarize and express precision and bias performance across the range of standards and guides it maintains. In order to create a unified approach consistent with modern practice and embracing the continuous improvement philosophy a consensus arose to prepare a procedure covering the estimation and reporting of uncertainties in non destructive assay of nuclear materials. This paper outlines the needs analysis, objectives and on-going development efforts. In addition to emphasizing some of the unique challenges and opportunities facing the NDA community we hope this article will encourage dialog and sharing of best practice and furthermore motivate developers to revisit the treatment of measurement uncertainty.

    1. RUMINATIONS ON NDA MEASUREMENT UNCERTAINTY COMPARED TO DA UNCERTAINTY

      Energy Technology Data Exchange (ETDEWEB)

      Salaymeh, S.; Ashley, W.; Jeffcoat, R.

      2010-06-17

      It is difficult to overestimate the importance that physical measurements performed with nondestructive assay instruments play throughout the nuclear fuel cycle. They underpin decision making in many areas and support: criticality safety, radiation protection, process control, safeguards, facility compliance, and waste measurements. No physical measurement is complete or indeed meaningful, without a defensible and appropriate accompanying statement of uncertainties and how they combine to define the confidence in the results. The uncertainty budget should also be broken down in sufficient detail suitable for subsequent uses to which the nondestructive assay (NDA) results will be applied. Creating an uncertainty budget and estimating the total measurement uncertainty can often be an involved process, especially for non routine situations. This is because data interpretation often involves complex algorithms and logic combined in a highly intertwined way. The methods often call on a multitude of input data subject to human oversight. These characteristics can be confusing and pose a barrier to developing and understanding between experts and data consumers. ASTM subcommittee C26-10 recognized this problem in the context of how to summarize and express precision and bias performance across the range of standards and guides it maintains. In order to create a unified approach consistent with modern practice and embracing the continuous improvement philosophy a consensus arose to prepare a procedure covering the estimation and reporting of uncertainties in non destructive assay of nuclear materials. This paper outlines the needs analysis, objectives and on-going development efforts. In addition to emphasizing some of the unique challenges and opportunities facing the NDA community we hope this article will encourage dialog and sharing of best practice and furthermore motivate developers to revisit the treatment of measurement uncertainty.

    2. Microencapsulation of protein drugs for drug delivery: strategy, preparation, and applications.

      Science.gov (United States)

      Ma, Guanghui

      2014-11-10

      Bio-degradable poly(lactide) (PLA)/poly(lactide-glycolide) (PLGA) and chitosan microspheres (or microcapsules) have important applications in Drug Delivery Systems (DDS) of protein/peptide drugs. By encapsulating protein/peptide drugs in the microspheres, the serum drug concentration can be maintained at a higher constant value for a prolonged time, or injection formulation can be changed to orally or mucosally administered formulation. PLA/PLGA and chitosan are most often used in injection formulation and oral formulation. However, in the preparation and applications of PLA/PLGA and chitosan microspheres containing protein/peptide drugs, the problems of broad size distribution and poor reproducibility of microspheres, and deactivation of protein during the preparation, storage and release, are still big challenges. In this article, the techniques for control of the diameter of microspheres and microcapsules will be introduced at first, then the strategies about how to maintain the bioactivity of protein drugs during preparation and drug release will be reviewed and developed in our research group. The membrane emulsification techniques including direct membrane emulsification and rapid membrane emulsification processes were developed to prepare uniform-sized microspheres, the diameter of microspheres can be controlled from submicron to 100μm by these two processes, and the reproducibility of products can be guaranteed. Furthermore, compared with conventional stirring method, the big advantages of membrane emulsification process were that the uniform microspheres with much higher encapsulation efficiency can be obtained, and the release behavior can be adjusted by selecting microsphere size. Mild membrane emulsification condition also can prevent the deactivation of proteins, which frequently occurred under high shear force in mechanical stirring, sonification, and homogenization methods. The strategies for maintaining the bioactivity of protein drug were

    3. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to iodine and contribution to normal cognitive development pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

    4. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to hyaluronic acid and protection of the skin against dehydration pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

    5. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to iodine and contribution to normal thyroid function pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

    6. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to “complex carbohydrates” and “contribute to satiety” pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...

    7. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to prunes and contribution to normal bowel function pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...

    8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to OptiEFAX™ and maintenance of normal blood concentrations of triglycerides pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

    9. Applications of polymeric nanocapsules in field of drug delivery systems.

      Science.gov (United States)

      Rong, Xinyu; Xie, Yinghua; Hao, Xiaomei; Chen, Tao; Wang, Yingming; Liu, Yuanyuan

      2011-09-01

      Drug-loaded polymeric nanocapsules have exhibited potential applications in the field of drug delivery systems in recent years. This article entails the biodegradable polymers generally used for preparing nanocapsules, which include both natural polymers and synthetic polymers. Furthermore, the article presents a general review of the different preparation methods: nanoprecipitation method, emulsion-diffusion method, double emulsification method, emulsion-coacervation method, layer-by-layer assembly method. In addition, the analysis methods of nanocapsule characteristics, such as mean size, morphology, surface characteristics, shell thickness, encapsulation efficiency, active substance release, dispersion stability, are mentioned. Also, the applications of nanocapsules as carriers for use in drug delivery systems are reviewed, which primarily involve targeting drug delivery, controlled/sustained release drug delivery systems, transdermal drug delivery systems and improving stability and bioavailability of drugs. Nanocapsules, prepared with different biodegradable polymers, have received more and more attention and have been regarded as one of the most promising drug delivery systems.

    10. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Cynatine ® and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Roxlor Nutra LLC, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health...

    11. Advances in the synthesis and application of nanoparticles for drug delivery.

      Science.gov (United States)

      Park, Wooram; Na, Kun

      2015-01-01

      The continuous development of drug delivery systems (DDSs) has been extensively researched by the need to maximize therapeutic efficacy while minimizing undesirable side effects. Nanoparticle technology was recently shown to hold great promise for drug delivery applications in nanomedicine due to its beneficial properties, such as better encapsulation, bioavailability, control release, and lower toxic effect. Despite the great progress in nanomedicine, there remain many limitations for clinical application. To overcome these limitations, advanced nanoparticles for drug delivery have been developed to enable the spatially and temporally controlled release of drugs in response to specific stimuli at disease sites. Furthermore, the controlled self-assembly of organic and inorganic materials may enable their use in theranostic applications. This review presents an overview of a recent advanced nanoparticulate system that can be used as a potential drug delivery carrier and focuses on the potential applications of nanoparticles in various biomedical fields for human health care. © 2015 Wiley Periodicals, Inc.

    12. Tarihsel süreç içinde peyzaj tasarım ve uygulama çalışmalarında yapı malzemelerinin kullanımının irdelenmesi

      OpenAIRE

      Shakouri, Nasim

      2010-01-01

      Peyzaj, sayısız materyallerden oluşan görsel bir bütünlük olarak tanımlanmaktadır. Bu materyaller zaman içindeki değişimlerle, peyzaj tipi ve karakterini belirlemektedir. Peyzaj mimarlığında kullanılan materyaller, canlı ve cansız materyaller olarak ayrıca tanımlanmaktadır. Cansız materyaller kavramı içinde, peyzaj mimarlığında kullanılan yapısal öğelerin oluşturmasında önemli rol oynayan yapı malzemeleri de yer almaktadır. Peyzaj mimarlığında kullanılan yapısal malzemelerin özellikl...

    13. Drug-targeting methodologies with applications: A review

      Science.gov (United States)

      Kleinstreuer, Clement; Feng, Yu; Childress, Emily

      2014-01-01

      Targeted drug delivery to solid tumors is a very active research area, focusing mainly on improved drug formulation and associated best delivery methods/devices. Drug-targeting has the potential to greatly improve drug-delivery efficacy, reduce side effects, and lower the treatment costs. However, the vast majority of drug-targeting studies assume that the drug-particles are already at the target site or at least in its direct vicinity. In this review, drug-delivery methodologies, drug types and drug-delivery devices are discussed with examples in two major application areas: (1) inhaled drug-aerosol delivery into human lung-airways; and (2) intravascular drug-delivery for solid tumor targeting. The major problem addressed is how to deliver efficiently the drug-particles from the entry/infusion point to the target site. So far, most experimental results are based on animal studies. Concerning pulmonary drug delivery, the focus is on the pros and cons of three inhaler types, i.e., pressurized metered dose inhaler, dry powder inhaler and nebulizer, in addition to drug-aerosol formulations. Computational fluid-particle dynamics techniques and the underlying methodology for a smart inhaler system are discussed as well. Concerning intravascular drug-delivery for solid tumor targeting, passive and active targeting are reviewed as well as direct drug-targeting, using optimal delivery of radioactive microspheres to liver tumors as an example. The review concludes with suggestions for future work, considereing both pulmonary drug targeting and direct drug delivery to solid tumors in the vascular system. PMID:25516850

    14. Lactococcus lactis Subsp. Lactis Suşlarında Yüksek Sıklıkta Konjugal Transfer Sistemlerinin Analizi

      Directory of Open Access Journals (Sweden)

      Çağla Tükel

      2015-02-01

      Full Text Available Bu çalışmada L. lactis subsp. lactis suşlarında laktoz fermentasyonu özelliğini kodlayan altı farklı plazmidin yüksek sıklıkta konjugal aktarım yeteneği araştırıldı. Bu plazmidlerin konjugal transfer sıklıkları; iki seks faktörünün interaksiyonuna bağlı olarak (Clu ve Agg, Clu-/Agg-, Agg+ x Clu-/Agg+, Agg- ya da Clu+/Agg- x Clu-/Agg- konjugasyon eşleri için 1.5x10-5–1.0x10-7 ve Clu+/Agg- x Clu-/Agg+ konjugasyon eşleri için 7.1x10-2-2.7x10-3 oranlarında değişim gösterdi. Laktoz plazmidlerinin stabiliteleri ise; doğal suşlarda %82-96, MG1390 alıcı suşu için tanımlanan konjugantlarda %77-98 ve MCL8060 alıcı suşu için tanımlanan konjugantlarda ise %44-67 arasında saptandı.

    15. Domates Pulpu ve Salçasında Viskozite (Konsistens ve Renk Üzerine Proses Koşullarının Etkisi

      Directory of Open Access Journals (Sweden)

      Aziz Ekşi

      2015-02-01

      Full Text Available Kıvam ve renk, domates pulpu ve salçada kaliteyi belirleyen ve ticarette üzerinde en çok durulan iki önemli etkendir. Domates salçasında renk ve kıvam ile hammaddenin durumu arasında yakın bir ilişki bulunduğu bilinmektedir. Ancak her iki kalite öğesini ve özellikle kıvamı, hammadde olduğu kadar, proses koşulları da etkilemektedir.

    16. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scienti......Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... on the scientific substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise. The Panel considers that citrulline-malate is sufficiently characterised. The claimed effect proposed by the applicant is “improved recovery from muscle fatigue”. Faster recovery...... function. The evidence provided by the applicant did not establish that a faster reduction of blood lactate concentrations through a dietary intervention leads to faster recovery from muscle fatigue by contributing to the restoration of muscle function after exercise. No conclusions could be drawn from...

    17. Multifunctional Nanoparticles for Drug Delivery Applications Imaging, Targeting, and Delivery

      CERN Document Server

      Prud'homme, Robert

      2012-01-01

      This book clearly demonstrates the progression of nanoparticle therapeutics from basic research to applications. Unlike other books covering nanoparticles used in medical applications, Multifunctional Nanoparticles for Drug Delivery Applications presents the medical challenges that can be reduced or even overcome by recent advances in nanoscale drug delivery. Each chapter highlights recent progress in the design and engineering of select multifunctional nanoparticles with topics covering targeting, imaging, delivery, diagnostics, and therapy.

    18. İçme ve sulama sularında bor kirliliği ve bor giderme yöntemleri

      Directory of Open Access Journals (Sweden)

      Meltem Bilici Başkan

      2014-03-01

      Full Text Available Periyodik cetvelin 3A grubunda yer alan bor yüksek iyonlaşma potansiyeline sahip olması nedeniyle yarı metal olarak kabul edilir. Yerkabuğundaki ortalama bor konsantrasyonu 10 mg/kg'dır. Bor doğada Ca, Na ve Mg'un tuzları şeklinde bulunur. Yüksek konsantrasyonlarda ve ekonomik boyutlardaki bor yatakları; borun oksijen ile bağlanmış bileşikleri şeklinde daha çok Türkiye ve ABD'nin kurak, volkanik ve hidrotermal aktivitesi olan bölgelerinde bulunmaktadır. Bor, bitkiler için gerekli bir mikro besin elementi olmanın yanı sıra, gerekli tüm besin elementleri içerisinde, eksiklik belirtilerine neden olan miktarı ile toksik etki yapan miktarı, birbirine çok yakın olan tek elementtir. Bor su ortamında genellikle borik asit ve kısmen de borat tuzları formlarında bulunmaktadır. Pek çok endüstride kullanım alanı bulan bor bileşiklerinin endüstriyel gelişmelere bağlı olarak yüzeysel sularda bulunan konsantrasyonu artış göstermektedir. Yüzeysel sularda bulunan bor aynı zamanda evsel atıksulardan da kaynaklanmaktadır. Türkiye'de içme ve sulama sularını en çok kirleten toksik elementlerin başında bor gelmektedir. Bu nedenle bor giderimi hem insan sağlığı açısından hem de sağlıklı tarım ürünü yetiştirilebilmesi açısından oldukça önemlidir. Sulardan bor giderimi için uygulanan temel yöntemler arasında iyon değişimi, ultrafiltrasyon, ters osmoz ve adsorbsiyon gelmektedir.

    19. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Rhodiola rosea L. extract and reduction of mental fatigue pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...

    20. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to DHA and contribution to normal brain development pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from DSM Nutritional Products, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver...

    1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Slendesta® Potato Extract and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 19 24/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Kemin Foods LC, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...

    2. Fast critical assembly safeguards: NDA methods for highly enriched uranium. Summary report, October 1978-September 1979

      International Nuclear Information System (INIS)

      Bellinger, F.O.; Winslow, G.H.

      1980-12-01

      Nondestructive assay (NDA) methods, principally passive gamma measurements and active neutron interrogation, have been studied for their safeguards effectiveness and programmatic impact as tools for making inventories of highly enriched uranium fast critical assembly fuel plates. It was concluded that no NDA method is the sole answer to the safeguards problem, that each of those emphasized here has its place in an integrated safeguards system, and that each has minimum facility impact. It was found that the 185-keV area, as determined with a NaI detector, was independent of highly-enriched uranium (HEU) plate irradiation history, though the random neutron driver methods used here did not permit accurate assay of irradiated plates. Containment procedures most effective for accurate assaying were considered, and a particular geometry is recommended for active interrogation by a random driver. A model, pertinent to that geometry, which relates the effects of multiplication and self-absorption, is described. Probabilities of failing to detect that plates are missing are examined

    3. Derin suda dairesel silindir arkasında meydana gelen akış yapısının örgü teller ile kontrol edilmesi

      Directory of Open Access Journals (Sweden)

      Burcu Oğuz

      2016-08-01

      Full Text Available Bu çalışmada amaç derin su içerisine yerleştirilen silindire (bacalar, yüksek binalar vb. ve arkasındaki bir cisme veya cisimlere girdap kopması sonucu etki eden daimi olmayan yüklerin etkisinin ve şiddetinin azaltılması ve optimum değerlerin (tel kalınlığı ve geçirgenlik oranı, β belirlenmesidir. Bu amaçla çapı D=50 mm olan dairesel silindir etrafına sarılan farklı kalınlık ve geçirgenlik oranına sahip örgü tellerin etkisi Re_D=5000 değerinde araştırılmıştır. Geçirgenlik oranları β=0.5-0.8 aralığında 0.1 artımlarla dört farklı değerdedir. Silindir üzerine sarılmış tellerin kalınlıkları b=1 mm, 2 mm, 3mm ve 4mm’dir. Silindir arkasında meydana gelen akış yapısı, silindir etrafına sarılan örgü tellerle kontrol edilmeye çalışılmıştır. Deneyler PIV (parçacık görüntülemeli hız ölçme tekniği kullanılarak yürütülmüştür. Tüm geçirgenlik oranlarında, Türbülans Kinetik Enerji (TKE ve Reynolds kayma gerilmesi değerleri b=1 mm ve 2 mm tel kalınlıklarında, örgüsüz silindirin değeri ile kıyaslandığında artmakta fakat b=3 mm ve 4 mm kalınlıklarında azalmaktadır. Geçirgenlik oranı, β=0.6 değerinde ve tel kalınlığı b=4 mm durumunda TKE ve Reynolds kayma gerilmesi değerleri, örgü tellerinin silindir arkasında meydana gelen akışı kontrol ettiğini göstermektedir. Frekans değerlerinin sonuçları da örgü tellerin, silindir arkasındaki akışı, geçirgenlik oranı β=0.6 ve b=4 mm tel kalınlığında en iyi kontrolü sağladığını net bir şekilde açıklamaktadır

    4. Application of radioimmunoassay for virus and anticancer drugs

      Energy Technology Data Exchange (ETDEWEB)

      Toyoshima, S. (Keio Univ., Tokyo (Japan). School of Medicine)

      1980-05-01

      Recent progress in RIA for virus and anticancer drugs was described. DNA and RNA virus and antivirus antibody which could be detected by RIA were mentioned, and then causes of arteriosclerosis, Paget's disease, multiple sclerosis, and diabetus mellitus were analysed virologically. Diagnostic significance of RIA was also described. Application of RIA to the measurement of interferon and carcinogenic virus at substantial level and recent information of viral hepatitis obtained by RIA were stated. Finally, application of RIA to the measurement of anticancer drugs acting on protective mechanism of the living body and measurement range by RIA were stated.

    5. Application of radioimmunoassay for virus and anticancer drugs

      Energy Technology Data Exchange (ETDEWEB)

      Toyoshima, S [Keio Univ., Tokyo (Japan). School of Medicine

      1980-05-01

      Recent progress in RIA for virus and anticancer drugs was described. DNA and RNA virus and antivirus antibody which could be detected by RIA were mentioned, and then causes of arteriosclerosis, Paget's disease, multiple sclerosis, and diabetus mellitus were analysed virologically. Diagnostic significance of RIA was also described. Application of RIA to the measurement of interferon and carcinogenic virus at substantial level and recent information of viral hepatitis obtained by RIA were stated. Finally, application of RIA to the measurement of anticancer drugs acting on protective mechanism of the living body and measurement range by RIA were stated.

    6. İstanbul’da 1999 Yılında Sonuçlanmış Boşanma Davalarında Boşanma Nedenlerinin Değerlendirilmesi

      Directory of Open Access Journals (Sweden)

      Halim Dişsever

      2000-12-01

      Full Text Available Bu çalışmada İstanbul'da 1999 yılında sonuçlanmış boşanma davalarından rastlantısal örnekleme yöntemiyle seçilen 3060 boşanma olgusu incelenerek, boşanma nedenleri ve diğer değişkenler arasındaki ilişkilerin değerlendirilmesi amaçlanmıştır İncelenen ve davası sonuçlanmış toplam 3060 boşanma davasının %67.1’si kailin (2053, %32.9'u (1007 erkek taralından açılmıştır, boşanma nedenlerine göre dağılım incelendiğinde ilk sırayı şiddetli geçimsizlik, ikinci sırayı alkol kötüye kullanımı, üçüncü sırayı cana kast ve pek fena muamele. i sırayı ise terk boşanma nedeninin aldığı görülmektedir. Boşanan çiftlerin %41.6 sı (1272 çift çocuksuz olup. %40.4 ü (12.36 çift evliliklerinin ilk 5 yılı içinde boşanmışlardır. Çocukların çoğunun yaşları küçük olduğundan velayetlerin annelere verilme oranı daha yüksektir. Olguların %7.6’smıla (233 çift eşlerden birinin, %28.2’ sinde (864 çift her ikisinin İstanbul nüfusuna kayıtlı olduğu, %64.2’sinde (196.3 çift her ikisinin nüfus kaydının İstanbul dışında olduğu saptanmıştır. Boşanma sonrası eşler ve çocukları ruhsal ve ekonomik sorunlarla karşı karşıya kalmaktadır. Sosyal güvenceleri, eşlerin nafaka durumları, işsizlik ve çocukların eğitini durumu göz önüne alındığında sosyal destek mekanizmalarının daha ila güçlendirilmesi toplum ruh sağlığı açısından faydalı olacaktır. Anahtar Kelimeler: Boşanma, boşanma nedenleri.

    7. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on Dietary Reference Values for energy

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived dietary reference values for energy, which are provided as average requirements (ARs) of specified age and sex groups. For children and adults, total energy expenditure (TEE...

    8. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

      Science.gov (United States)

      2010-10-26

      ... 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran AGENCY...) is amending the animal drug regulations by removing those portions that reflect approval of eight new...

    9. [Application of Imaging Mass Spectrometry for Drug Discovery].

      Science.gov (United States)

      Hayasaka, Takahiro

      2016-01-01

      Imaging mass spectrometry (IMS) can reveal the distribution of biomolecules on tissue sections. In this process, the biomolecules are directly ionized within tissue sections using matrix-assisted laser desorption/ionization, and then their distribution is visualized by pseudo-color based on the relative signal intensity. The biomolecules, such as fatty acids, phospholipids, glycolipids, peptides, proteins, and neurotransmitters, have been analyzed at a spatial resolution of 5 μm. A special instrument for IMS analysis was developed by Shimadzu. The IMS analysis does not require the labeling of biomolecules and is capable of analyzing all the ionized biomolecules. Interest in this method has expanded to many research fields, including biology, agriculture, medicine, and pharmacology. The technique is especially relevant to the drug discovery process. As practiced currently, drug discovery is expensive and time consuming, requiring the preparation of probes for each drug and its metabolites, followed by systematic probe tracking in animal models. The IMS technique is expected to overcome these drawbacks by revealing the distribution of drugs and their metabolites using only a single analysis. In this symposium, I introduced the methodology and applications of IMS and discussed the feasibility of its application to drug discovery in the near future.

    10. Nasturi Toplumunda Hayvan Yetiştiriciliği ve Ticareti (XIX. Yüzyılın İkinci Yarısında)

      OpenAIRE

      DALYAN, Murat Gökhan

      2010-01-01

      XIX. Yüzyılda Hakkâri ve Urmiye bölgesinde yaşayan Nasturiler arasında ekonomik olarak hayvancılık mühim bir yer işgal etmiştir. Beslenen hayvanların tür olarak dağılışında genel olarak coğrafi ve tarım alanlarının yapısı etkili olmuştur. Bu bağlamda tarım alanlarının fazla olduğu Urmiye’de büyükbaş hayvancılık gerçekleştirilirken; Hakkâri dağlarında ise daha çok küçükbaş hayvancılık yapılmıştır. Yük hayvanı olarak da özelikle engebeli arazi yapısından dolayı katır beslenmiştir. Nasturiler ar...

    11. Küresel Ekonomik Kriz Türkiye İşgücü Piyasasında Cinsiyet Eşitsizliğini Derinleştirdi mi?

      OpenAIRE

      ÇETİNKAYA, Emel; YILDIRIMALP, Sinem

      2013-01-01

      İşgücü piyasalarında cinsiyet eşitsizliği, tüm dünyada olduğu gibi Türkiye işgücü piyasasında da önemli bir sorun olarak karşımıza çıkmaktadır. Zaman zaman yaşanan krizler işgücü piyasalarını ve özellikle kadın işgücünü olumsuz yönde etkilemektedir. 2007 yılında ABD’de başlayan küresel ekonomik kriz tüm ülke ekonomileri gibi Türkiye ekonomisini ve işgücü piyasalarını da 2008 yılının özellikle ikinci yarısından itibaren ciddi bir şekilde etkilemeye başlamıştır. Bu çalışma, küresel ekonomik kri...

    12. Drug knowledge bases and their applications in biomedical informatics research.

      Science.gov (United States)

      Zhu, Yongjun; Elemento, Olivier; Pathak, Jyotishman; Wang, Fei

      2018-01-03

      Recent advances in biomedical research have generated a large volume of drug-related data. To effectively handle this flood of data, many initiatives have been taken to help researchers make good use of them. As the results of these initiatives, many drug knowledge bases have been constructed. They range from simple ones with specific focuses to comprehensive ones that contain information on almost every aspect of a drug. These curated drug knowledge bases have made significant contributions to the development of efficient and effective health information technologies for better health-care service delivery. Understanding and comparing existing drug knowledge bases and how they are applied in various biomedical studies will help us recognize the state of the art and design better knowledge bases in the future. In addition, researchers can get insights on novel applications of the drug knowledge bases through a review of successful use cases. In this study, we provide a review of existing popular drug knowledge bases and their applications in drug-related studies. We discuss challenges in constructing and using drug knowledge bases as well as future research directions toward a better ecosystem of drug knowledge bases. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

    13. Yoğurt Yapımında Yararlanılan L. bulgaricus ve S. thermophilus’un Proteolitik Aktivitelerinin Belirlenmesi

      Directory of Open Access Journals (Sweden)

      Sevda Kılıç

      2015-02-01

      Full Text Available Yoğurt bakterilerinin süte aşılandıktan sonra enzimatik etkinlikleri sonucu proteinleri parçalamaları olayına proteoliz adı verilir. Bu olay sırasında ortamda gerekli gelişme faktörleri meydana geldiğinden S. thermophilus’un gelişmesi ve çoğalması hızlandırılmış olur. Simbiyotik faaliyet gösteren bu bakteriler için gerekli ve yararlı olan proteoliz olayının yoğurt yapımında ancak belirli bir düzeyde meydana gelmesi istenir. ASPERGER, tirosin aminoasiti ile aroma oluşumu arasında bir ilişkinin olduğunu, tirosin içeriğinin 0.05-0.1 mg/ml olması durumunda yoğurtların istenen aromaya sahip olabileceğini bildirmiştir. 0.125 mg/ml tirosin içeren yoğurt örneklerinde ise hafif acı tat oluştuğu bildirilmiştir. Bundan hareketle yoğurt bakterileri olan L. bulgaricus ile S. thermophilus’ a ait suşların proteolitik aktiviteleri HULL yöntemine göre tirosin ekivalantı üzerinden belirlenmeye çalışılmıştır. Araştırmada genellikle yüksek asitlik oluşturabilen L. bulgaricus suşlarının daha fazla proteolitik aktivite gösterdikleri saptanmıştır. Ancak bütün bakteri suşları için bu durumun geçerli olmadığı da belirlenmiştir. 20 L. bulgaricus suşuna ait değerlerin 0.105-0.215 mg tirosin/ml sınırları arasında değiştiği gözlenmiştir. S. thermophilus’un denemeye alınan 20 suşu için saptanan değerler de 0.080-0.070 mg tirosin/ml arasında belirlenmiş olup değerlerin L. bulgaricus’ a ait değerlerden çok düşük olduğu anlaşılmıştır.

    14. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary reference values for water

      DEFF Research Database (Denmark)

      Tetens, Inge

      This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the setting of dietary reference values for water for specific age groups. Adequate Intakes (AI) have been defined derived from a combination of observed intakes in population groups with desirable...

    15. Asymmetrical Polymer Vesicles for Drug delivery and Other Applications

      Directory of Open Access Journals (Sweden)

      Yi Zhao

      2017-06-01

      Full Text Available Scientists have been attracted by polymersomes as versatile drug delivery systems since the last two decades. Polymersomes have the potential to be versatile drug delivery systems because of their tunable membrane formulations, stabilities in vivo, various physicochemical properties, controlled release mechanisms, targeting abilities, and capacities to encapsulate a wide range of drugs and other molecules. Asymmetrical polymersomes are nano- to micro-sized polymeric capsules with asymmetrical membranes, which means, they have different outer and inner coronas so that they can exhibit better endocytosis rate and endosomal escape ability than other polymeric systems with symmetrical membranes. Hence, asymmetrical polymersomes are highly promising as self-assembled nano-delivery systems in the future for in vivo therapeutics delivery and diagnostic imaging applications. In this review, we prepared a summary about recent research progresses of asymmetrical polymersomes in the following aspects: synthesis, preparation, applications in drug delivery and others.

    16. Biocompatibility of Chitosan Carriers with Application in Drug Delivery

      Directory of Open Access Journals (Sweden)

      Ana Grenha

      2012-09-01

      Full Text Available Chitosan is one of the most used polysaccharides in the design of drug delivery strategies for administration of either biomacromolecules or low molecular weight drugs. For these purposes, it is frequently used as matrix forming material in both nano and micron-sized particles. In addition to its interesting physicochemical and biopharmaceutical properties, which include high mucoadhesion and a great capacity to produce drug delivery systems, ensuring the biocompatibility of the drug delivery vehicles is a highly relevant issue. Nevertheless, this subject is not addressed as frequently as desired and even though the application of chitosan carriers has been widely explored, the demonstration of systems biocompatibility is still in its infancy. In this review, addressing the biocompatibility of chitosan carriers with application in drug delivery is discussed and the methods used in vitro and in vivo, exploring the effect of different variables, are described. We further provide a discussion on the pros and cons of used methodologies, as well as on the difficulties arising from the absence of standardization of procedures.

    17. Bıldırcın ve Ördek Yumurtalarında Maya-Küf ve Total Bakteri Açısından İncelenmesi

      Directory of Open Access Journals (Sweden)

      Işın Var

      2015-02-01

      Full Text Available Bıldırcın yumurtası, besin değeri yönünden tavuk yumurtasından oransal olarak daha zengin kabul edilmektedir. Daha çok salata, pasta, mayonez vb. yapımında yaygın olarak kullanılan ördek yumurtası (Pekin ördeği tavuk yumurtasına göre daha büyük olup, ağırlıkları 70-90 g arasında değişmektedir. Bıldırcın yumurtası son yıllarda özellikle küçük çocuk ve yaşlı beslenmesinde önem kazanmıştır. Bunun yanısıra bazı hastalıkların tedavisi amacıyla da halk arasında oldukça yaygın kullanılmaktadır. Özellikle çiğ olarak tüketilen bıldırcın yumurtaları zaman zaman içerdikleri patojen mikroorganizmalarla tehlikeli olabilmektedirler. Bu çalışmada bıldırcın ve ördek yumurtalarında maya-küf ve total bakteri aranmıştır. Bıldırcın ve ördek yumurtalarının özellikle kabuğunda hem total bakteri hem de maya-küf bulunmuştur. Bıldırcın yumurtasının akı ve sarısında ise zaman zaman kontaminasyonla karşılaşılmıştır.

    18. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on establishing Food-Based Dietary Guidelines

      DEFF Research Database (Denmark)

      Tetens, Inge

      This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) provides guidance on the translation of nutrient based dietary advice into guidance, intended for the European population as a whole, on the contribution of different foods or food groups to an overall diet...

    19. The application of machine learning techniques in the clinical drug therapy.

      Science.gov (United States)

      Meng, Huan-Yu; Jin, Wan-Lin; Yan, Cheng-Kai; Yang, Huan

      2018-05-25

      The development of a novel drug is an extremely complicated process that includes the target identification, design and manufacture, and proper therapy of the novel drug, as well as drug dose selection, drug efficacy evaluation, and adverse drug reaction control. Due to the limited resources, high costs, long duration, and low hit-to-lead ratio in the development of pharmacogenetics and computer technology, machine learning techniques have assisted novel drug development and have gradually received more attention by researchers. According to current research, machine learning techniques are widely applied in the process of the discovery of new drugs and novel drug targets, the decision surrounding proper therapy and drug dose, and the prediction of drug efficacy and adverse drug reactions. In this article, we discussed the history, workflow, and advantages and disadvantages of machine learning techniques in the processes mentioned above. Although the advantages of machine learning techniques are fairly obvious, the application of machine learning techniques is currently limited. With further research, the application of machine techniques in drug development could be much more widespread and could potentially be one of the major methods used in drug development. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

    20. Roma Hukuku’nda Gemi, Han ve Ahır İşletenlerin Receptum Sorumluluğu

      Directory of Open Access Journals (Sweden)

      Mehmet YEŞİLLER

      2013-04-01

      Full Text Available Çalışmamızda Roma Hukuku'nda gemi, han ve ahır işleten kimselerin sorumluluklarına ilişkin düzenlemeler ele alınmıştır. Roma?da özellikle gemi, han ve ahır işleten kimselerin yanlarında çalıştırdıkları kişilerin güvenilir olmamasından dolayı, taraflar arasındaki istisna sözleşmesinden kaynaklanan custodia sorumluluğuna ek olarak "actio de damno aut furto adversus nautas, caupones, stabularios ve receptum, nautae, cauponis, stabularii" sorumluluklarının düzenlendiği kaynaklardan anlaşılmaktadır. Praetor Edictum'larıyla sağlanan ve haksız fiil benzerlerine dayanan söz konusu bu uygulamaların, Roma'da istisna sözleşmesinin koruyamadığı alana ilişkin olarak geniş uygulama imkanı buldukları görülmektedir.

    1. Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

      International Nuclear Information System (INIS)

      Kishore, R.

      1990-01-01

      The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

    2. Damla Sulama Koşullarında Aşılı ve Aşısız Karpuzlarda Bitki, Su ve Verim İlişkilerinin İrdelenmesi

      Directory of Open Access Journals (Sweden)

      Selçuk ÖZMEN

      2014-09-01

      Full Text Available Bu çalışma, 2006-2008 yılları arasında Çukurova Üniversitesi, Ziraat Fakültesi, Tarımsal Yapılar ve Sulama Bölümü deneme alanında yürütülmüştür. Araştırmada, damla sulama koşullarında aşılı ve aşısız karpuzlarda bitki, su ve verim ilişkileri irdelenmiştir. Denemede; tam sulanan aşılı (Crimson Tide+Jumbo:CTJ ve aşısız (Crimson Tide: CT konuları ele alınmıştır. Sulama suyu, sulama aralıkları arasında oluşan toplam A Sınıfı buharlaşma kabından okunan değerlere göre hesaplanmıştır. Çalışmada, konulara göre, sulama suyu (IW ve bitki su tüketimleri (ET, sırasıyla, 266.2–413.5 mm (12–16 sulama ve 433.1-520.6 mm arasında değişmiş; en yüksek IW ve mevsimlik ET ise, sırasıyla, 413.5 mm ve 520.6 mm ile CTJ konusundan 2006 yılında elde edilmiştir. Karpuz bitkisinde en yüksek ortalama aylık ET, 214.0 mm ile CTJ konusunda Mayıs ayında ölçülmüş; bu ayda ortalama çim kıyas bitki su tüketimi (ETo, 163.1 mm olarak belirlenmiştir. Bitki katsayısı (Kc değerlerinin; deneme yılları için, başlangıç, mevsim ortası ve mevsim sonudönemlerinde, sırasıyla, 0.240.67, 0.87-1.66 ve 0.83-0.93 olarak değiştiği saptanmıştır. Son yılki çalışmada; toplam kök yoğunluğunun aşılı konularda aşısızlara kıyasla % 4 daha fazla; yaprak su potansiyeli (YSP değerlerlerinin -0.20 ile -0.70 MPa arasında değiştiği ve aşılı konuların daha yüksek YSP değerlerine sahip olduğu saptanmıştır. Aşılama ile verim, toplam su kullanma randımanı (TWUE ve su kullanım randımanı (IWUE artarken sulama suyunun ET içerisindeki kullanım oranı (IWc aşısız konularında daha yüksek olduğu belirlenmiştir. En yüksek verim 712.8 kg/ha ile CTJ konusundan 2008 yılından elde edilmiştir

    3. Electrospinning of polymeric nanofibers for drug delivery applications.

      Science.gov (United States)

      Hu, Xiuli; Liu, Shi; Zhou, Guangyuan; Huang, Yubin; Xie, Zhigang; Jing, Xiabin

      2014-07-10

      Electrospinning has been recognized as a simple and versatile method for fabrication of polymer nanofibers. Various polymers that include synthetic, natural, and hybrid materials have been successfully electrospun into ultrafine fibers. The inherently high surface to volume ratio of electrospun fibers can enhance cell attachment, drug loading, and mass transfer properties. Drugs ranging from antibiotics and anticancer agents to proteins, DNA, RNA, living cells, and various growth factors have been incorporated into electrospun fibers. This article presents an overview of electrospinning techniques and their application in drug delivery. Copyright © 2014 Elsevier B.V. All rights reserved.

    4. Tam Zamanında Üretim Sistemlerinde Hata Önleyiciler: Poka-

      OpenAIRE

      BAY, Murat; ÇİÇEK, Ercan

      2007-01-01

      Günümüzde, birçok işletme yalın üretime üretim performansının artması için geçmektedir. İstatistiksel proses kontrol gibi araçlar hatayı göstermekte, ancak önlememektedir. Poka-Yoke’nin altında yatan temel düşünce ise, çalışanların dikkatsizliklerini önlemektir. Bu çalışmada, poka-yoke sistemleri özellikle kurulum ve kullanım maliyetinin düşük olması ve maliyet kazancı olduğu için incelenmiştir

    5. Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2)

      DEFF Research Database (Denmark)

      Sjödin, Anders Mikael

      2017-01-01

      EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim published in 2011. Since then, the NDA Panel has gained considerable experience...... developments in this area. This guidance document presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims which fall under Articles 13(5), 14 and 19 of Regulation (EC) No 1924/2006. This guidance outlines...... the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim....

    6. The role of drug profiles as similarity metrics: applications to repurposing, adverse effects detection and drug-drug interactions.

      Science.gov (United States)

      Vilar, Santiago; Hripcsak, George

      2017-07-01

      Explosion of the availability of big data sources along with the development in computational methods provides a useful framework to study drugs' actions, such as interactions with pharmacological targets and off-targets. Databases related to protein interactions, adverse effects and genomic profiles are available to be used for the construction of computational models. In this article, we focus on the description of biological profiles for drugs that can be used as a system to compare similarity and create methods to predict and analyze drugs' actions. We highlight profiles constructed with different biological data, such as target-protein interactions, gene expression measurements, adverse effects and disease profiles. We focus on the discovery of new targets or pathways for drugs already in the pharmaceutical market, also called drug repurposing, in the interaction with off-targets responsible for adverse reactions and in drug-drug interaction analysis. The current and future applications, strengths and challenges facing all these methods are also discussed. Biological profiles or signatures are an important source of data generation to deeply analyze biological actions with important implications in drug-related studies. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

    7. Seaweed Polysaccharide-Based Nanoparticles: Preparation and Applications for Drug Delivery

      Directory of Open Access Journals (Sweden)

      Jayachandran Venkatesan

      2016-01-01

      Full Text Available In recent years, there have been major advances and increasing amounts of research on the utilization of natural polymeric materials as drug delivery vehicles due to their biocompatibility and biodegradability. Seaweed polysaccharides are abundant resources and have been extensively studied for several biological, biomedical, and functional food applications. The exploration of seaweed polysaccharides for drug delivery applications is still in its infancy. Alginate, carrageenan, fucoidan, ulvan, and laminarin are polysaccharides commonly isolated from seaweed. These natural polymers can be converted into nanoparticles (NPs by different types of methods, such as ionic gelation, emulsion, and polyelectrolyte complexing. Ionic gelation and polyelectrolyte complexing are commonly employed by adding cationic molecules to these anionic polymers to produce NPs of a desired shape, size, and charge. In the present review, we have discussed the preparation of seaweed polysaccharide-based NPs using different types of methods as well as their usage as carriers for the delivery of various therapeutic molecules (e.g., proteins, peptides, anti-cancer drugs, and antibiotics. Seaweed polysaccharide-based NPs exhibit suitable particle size, high drug encapsulation, and sustained drug release with high biocompatibility, thereby demonstrating their high potential for safe and efficient drug delivery.

    8. Porous silicon-cyclodextrin based polymer composites for drug delivery applications.

      Science.gov (United States)

      Hernandez-Montelongo, J; Naveas, N; Degoutin, S; Tabary, N; Chai, F; Spampinato, V; Ceccone, G; Rossi, F; Torres-Costa, V; Manso-Silvan, M; Martel, B

      2014-09-22

      One of the main applications of porous silicon (PSi) in biomedicine is drug release, either as a single material or as a part of a composite. PSi composites are attractive candidates for drug delivery systems because they can display new chemical and physical characteristics, which are not exhibited by the individual constituents alone. Since cyclodextrin-based polymers have been proven efficient materials for drug delivery, in this work β-cyclodextrin-citric acid in-situ polymerization was used to functionalize two kinds of PSi (nanoporous and macroporous). The synthesized composites were characterized by microscopy techniques (SEM and AFM), physicochemical methods (ATR-FTIR, XPS, water contact angle, TGA and TBO titration) and a preliminary biological assay was performed. Both systems were tested as drug delivery platforms with two different model drugs, namely, ciprofloxacin (an antibiotic) and prednisolone (an anti-inflammatory), in two different media: pure water and PBS solution. Results show that both kinds of PSi/β-cyclodextrin-citric acid polymer composites, nano- and macro-, provide enhanced release control for drug delivery applications than non-functionalized PSi samples. Copyright © 2014 Elsevier Ltd. All rights reserved.

    9. Barış Harekâtı Sonrasında Adana’dan Kıbrıs’a Gerçekleştirilen Nüfus Nakli (1975-1976)

      OpenAIRE

      ÇANAK, Erdem

      2015-01-01

      1571-1878 yılları arasında Osmanlı Devleti’nin hâkimiyeti altında bulunan Kıbrıs, 1878 yılında geçici olarak, Lozan Antlaşması ile de resmen İngiltere’ye geçmiştir. Bu durumdan faydalanmak isteyen Rumlar da “Enosis”e yönelik faaliyetlerine hız vermişlerdir. Adadaki Türklerin var olma mücadelesine neden olan bu süreç, 1974 Barış Harekâtı ile neticelenmiştir. Ancak Türkler, Barış Harekâtı’na kadar olan dönemde maruz kaldıkları baskıdan dolayı zaman zaman başta Türkiye olmak üzere dünyanın farkl...

    10. Stimulus-responsive liposomes as smart nanoplatforms for drug delivery applications.

      Science.gov (United States)

      Zangabad, Parham Sahandi; Mirkiani, Soroush; Shahsavari, Shayan; Masoudi, Behrad; Masroor, Maryam; Hamed, Hamid; Jafari, Zahra; Taghipour, Yasamin Davatgaran; Hashemi, Hura; Karimi, Mahdi; Hamblin, Michael R

      2018-02-01

      Liposomes are known to be promising nanoparticles (NPs) for drug delivery applications. Among different types of self-assembled NPs, liposomes stand out for their non-toxic nature, and their possession of dual hydrophilic-hydrophobic domains. Advantages of liposomes include the ability to solubilize hydrophobic drugs, the ability to incorporate different hydrophilic and lipophilic drugs at the same time, lessening the exposure of host organs to potentially toxic drugs and allowing modification of the surface by a variety of different chemical groups. This modification of the surface, or of the individual constituents, may be used to achieve two important goals. Firstly, ligands for active targeting can be attached that are recognized by cognate receptors over-expressed on the target cells of tissues. Secondly, modification can be used to impart a stimulus-responsive or "smart" character to the liposomes, whereby the cargo is released on demand only when certain internal stimuli (pH, reducing agents, specific enzymes) or external stimuli (light, magnetic field or ultrasound) are present. Here, we review the field of smart liposomes for drug delivery applications.

    11. Vişne ve Nar Suyu ve Konsantratlarında Antosiyaninlerin Degradasyonu

      Directory of Open Access Journals (Sweden)

      Narmela Asafı

      2015-02-01

      Full Text Available Nar ve vişne suyu konsantratlarında antosiyaninlerin parçalanması üzerine sıcaklığın etkisi incelenmiştir. 70°Bx'lik konsantratlardan 45°Bx ve 15° Bx lik örnekler hazırlanarak -18°C, 5°C, 20°C ve 37°C depolanmıştır. Depolanma süresince, sıcaklık dercesine bağlı olarak değişik aralıklarla alman örneklerde antosiyanin kaybı saptanarak parçalanma hızı incelenmiştir. Elde edilen bulgulara göre antosiyaninlerin parçalanma­sı birinci dereceden bir reaksiyon kinetiğine göre gelişmektedir. Tüm örneklerde beklendiği gibi sıcaklık derecesi yükseldikçe antosiyaninlerin degradasyon hızları artmaktadır. Örneğin 15° Bx'lik vişne suyunda -18°C'de hız konsantı k=0.534 x 10-3 gün-1 olduğu halde, 37°C'de k= 184 x 10-3 gün-1 'e yükselmiştir. Aynı şekilde 15° Bx'lik vişne suyunda -18°C'de hız konstantı k= 0.203 x 10-3 gün-1 olduğu halde 37°C'de k= 94 x10-3 gün-1'e yükselmiştir. Ayrıca reaksiyonun sıcaklığa bağımlılığı, Arrhenius eşitliğinden yararlanarak açıklanmaya çalışılmıştır. Nar suyu ve konsantratlannda antosiyaninlerin degradasyon hızı, vişne suyu ve konsantratlarında olduğundan daha yüksektir. Böylece nar suyu ve konsantratlarında depolama süresince sıcaklığa bağlı olarak hızla renk kaybı oluşmaktadır. Ayrıca doğal briksindeki vişne suyunda antosiyaninler, konsantratlarda olduğundan daha stabil olduğu halde nar suyunda bunun aksine konsantratlardaki antosiyaninlerin daha stabil ol­duğu anlaşılmaktadır.

    12. Tıbbi Adaçayı (Salvia officinalis L.’nda Farklı Hasat Zamanlarının Uçucu Yağ ve Fenolik Bileşikler ile Antioksidan Aktivite Üzerine Etkisi

      Directory of Open Access Journals (Sweden)

      Müge BAŞYİĞİT

      2016-11-01

      Full Text Available Bu araştırma, bir yıl süreyle 12 ayı temsil edecek şekilde farklı zamanlarda hasat edilen tıbbi adaçayı (Salvia officinalis L.’nın herba ve yaprak verimi, yaprakların taşıdığı uçucu yağ oranı ve kompozisyonu, ekstrede  Folin-Ciocalteu kolorimetrik metodu kullanılarak toplam fenolik madde miktarı, fenolik bileşikleri, serbest radikal süpürücü aktivitesi (DPPH ve demir iyonu indirgeme gücü (FRAP yöntemlerine göre antioksidan aktivitelerini belirlemek amacıyla yapılmıştır. Tıbbi adaçayında taze herba verimi 500.0-961.0 kg/da, kuru herba verimi 223.4-556.6 kg/da, kuru yaprak verimi 129.6-367.2 kg/da, uçucu yağ oranı %0.83-3.33, toplam fenolik madde miktarı 14.54-30.83 mg/g arasında değişim göstermiştir. Yaz ve güz aylarında hasat edilen bitkilerin herba ve yaprak verimleri, uçucu yağ oranları ve verimleri ile toplam fenolik madde miktarları kış ve bahar aylarında hasat edilen bitkilere göre daha yüksek bulunmuştur. Tıbbi adaçayının uçucu yağ kompozisyonunu oluşturan en önemli bileşenlerin 1,8-sineol (%11.93-31.87, α-tuyon (%15.72-26.26, β-tuyon (%4.51-27.67 ve kamfor (%3.65-23.02 olduğu, 1,8-sineol ve kamfor oranları ilkbahar aylarında daha düşük oranlarda, α- ve β-tuyon oranları ise ilkbahar aylarında daha yüksek oranlarda bulunduğu tespit edilmiştir. Tıbbi adaçayının en önemli fenolik bileşenlerinin ise rosmarinik asit (15.15-100.57 mg/g, naringin (9.59-41.81 mg/g, hesperidin (9.80-53.26 mg/g ve rutin (0.73-10.04 mg/g olduğu, en yüksek antioksidan aktivite Mayıs ve Haziran aylarında biçilen ve en düşük antioksidan aktivite ise Mart ve Nisan aylarında biçilen tıbbi adaçayı yapraklarında gözlenmiştir.

    13. 3D printing applications for transdermal drug delivery.

      Science.gov (United States)

      Economidou, Sophia N; Lamprou, Dimitrios A; Douroumis, Dennis

      2018-06-15

      The role of two and three-dimensional printing as a fabrication technology for sophisticated transdermal drug delivery systems is explored in literature. 3D printing encompasses a family of distinct technologies that employ a virtual model to produce a physical object through numerically controlled apparatuses. The applicability of several printing technologies has been researched for the direct or indirect printing of microneedle arrays or for the modification of their surface through drug-containing coatings. The findings of the respective studies are presented. The range of printable materials that are currently used or potentially can be employed for 3D printing of transdermal drug delivery (TDD) systems is also reviewed. Moreover, the expected impact and challenges of the adoption of 3D printing as a manufacturing technique for transdermal drug delivery systems, are assessed. Finally, this paper outlines the current regulatory framework associated with 3D printed transdermal drug delivery systems. Copyright © 2018 Elsevier B.V. All rights reserved.

    14. Yeşilırmak Nehir Teraslarında Toprakların Oluşumu ve Sınıflandırılması

      Directory of Open Access Journals (Sweden)

      Alper Durak

      2014-02-01

      Full Text Available Bu çalışmada ana materyali alüviyaller olan, Yeşilırmak nehir terasları üzerinde oluşmuş topraklar incelenmiştir. Bu amaçla çalışma alanında 4 farklı profil açılmıştır. Açılan profillerden horizon esasına göre toplam 27 adet örnek alınmış ve laboratuvarda fiziksel ve kimyasal analizleri yapılmıştır. Tanımlanan profiller Toprak Taksonomisi’ne göre, Alt grup düzeyinde; Kum Ocağı ve Çakıl profilleri Typic Ustipsamments, Havaalanı profili Typic Haplustolls ve Mera profili ise Typic Argiustolls olarak sınıflandırılmıştır. Toprakların pH değerleri 7,38-8,41 arasında değişmekte olup, topraklar hafif ve kuvvetli bazik reaksiyonlu olarak sınıflandırılmıştır. Toprakların çoğunda, pH değerleri profil içinde düzensiz olarak dağılmıştır. Bir kısmında is pH değerlerinde derinliğe bağlı olarak artış görülmüştür. Çalışma alanı topraklarında kireç %0,8-25,4 arasında değişmiştir. Toprakların kireç içerikleri geniş sınırlar içinde değişmesine rağmen, büyük çoğunluğu fazla kireçli olarak sınıflandırılmıştır. Toprakların önemli bir kısmında, kireç profil içinde düzensiz olarak dağılmıştır. Topraklarda organik madde içeriği %0,14-6,11 arasındadır. Toprakların organik madde içerikleri geniş sınırlar içerisinde değişim göstermesine rağmen, büyük çoğunluğunun organik madde içeriği düşük düzeydedir. Organik madde içeriği sadece iki profilin yüzey horizonlarında %4’ün üzerindedir. Çalışma sonunda alüviyal ana materyal, tekstür, topoğrafya ve zamanın; tanımlanan toprakların oluşumunu farklı derecede etkilediği ortaya konmuştur.

    15. The application of nanomaterials in controlled drug delivery for bone regeneration.

      Science.gov (United States)

      Shi, Shuo; Jiang, Wenbao; Zhao, Tianxiao; Aifantis, Katerina E; Wang, Hui; Lin, Lei; Fan, Yubo; Feng, Qingling; Cui, Fu-zhai; Li, Xiaoming

      2015-12-01

      Bone regeneration is a complicated process that involves a series of biological events, such as cellular recruitment, proliferation and differentiation, and so forth, which have been found to be significantly affected by controlled drug delivery. Recently, a lot of research studies have been launched on the application of nanomaterials in controlled drug delivery for bone regeneration. In this article, the latest research progress in this area regarding the use of bioceramics-based, polymer-based, metallic oxide-based and other types of nanomaterials in controlled drug delivery for bone regeneration are reviewed and discussed, which indicates that the controlling drug delivery with nanomaterials should be a very promising treatment in orthopedics. Furthermore, some new challenges about the future research on the application of nanomaterials in controlled drug delivery for bone regeneration are described in the conclusion and perspectives part. Copyright © 2015 Wiley Periodicals, Inc.

    16. NECSA'S Need to Establish a Nuclear Forensics Specific NDA Facility for On-Site Categorization of Seized Nuclear Materials

      International Nuclear Information System (INIS)

      Boshielo, P.; Mogafe, R.

      2015-01-01

      The increase of nuclear material that are out of regulatory control is becoming a serious concern and threat and thereby continuously seeking urgent interventions and counteractions from the international community aspiring effective control over all nuclear material and peaceful uses of nuclear technologies globally. In South Africa the nuclear forensics initiative approach and its execution have been adopted, established and managed by the South African Nuclear Energy Corporation (NECSA) to support the country's nuclear safeguards system and nuclear security investigations plan to fight against the illicit trafficking of nuclear and radioactive materials. On this nuclear forensics initiative approach adopted by Necsa, the development and later execution of a Non-Destructive Analyses (NDA) facility capability for quick categorization of any seized nuclear material by law-enforcement agencies is currently envisaged as a critical initiative to comprehend nuclear forensics Laboratory analytical or characterization techniques. The main objective for this NDA facility is planned to be used for performing nuclear material screening process for material categorization purposes to generate information and results which will be open to law enforcement agencies for prosecution processes and also for the safeguards reporting to the IAEA (ITDB). The NDA technique is therefore found to be a critical tool needed at NECSA as an Early-Checking-Point or first-line material check point for all seized nuclear materials in determining some characteristics of the materials and collection of data without having to destroy or changing the morphology of the material. (author)

    17. Application for disability pension and change in use of prescribed drugs. A regional Danish cohort study.

      Science.gov (United States)

      Petersen, Thomas T; Fonager, Kirsten; Bøggild, Henrik; Pedersen, Lars; Mortensen, Jens T

      2009-06-01

      To investigate if a pending application for disability pension had an influence on the applicant's purchase of medical drugs, with a particular focus on musculoskeletal disorders and the use of painkillers. We performed a registry-based follow-up study including 12,020 applicants for disability pension in a Danish county from 1995 to 2000 and linked this information to a database of drug prescriptions. Purchase of drug was calculated for the 6-month period just before the decision and for the 6-month period 2 years later. Changes in a 2-year time period were estimated by differences in purchase rates. Furthermore, the proportion of applicants with an increased purchase of drugs and the proportion of applicants who ceased buying drugs were estimated. The results were stratified by diagnosis and result of application (awarded/rejected). The analyses were furthermore restricted to musculoskeletal disorders and the use of painkillers. At baseline 81% had a purchase and after the 2-year time period 11% ceased buying prescribed drugs. Half of all applicants increased the purchase of drugs. For musculoskeletal disorders one third had an increased purchase rate of painkillers while one fourth ceased purchase of drugs with variations in different diagnostic subgroups. The major changes of drug purchase after a pending application for disability pension are probably ascribed to characteristics of the diseases underlying the disability.

    18. Construction and characterization of a pure protein hydrogel for drug delivery application.

      Science.gov (United States)

      Xu, Xu; Xu, ZhaoKang; Yang, XiaoFeng; He, YanHao; Lin, Rong

      2017-02-01

      Injectable hydrogels have a variety of applications, including regenerative medicine, tissue engineering and controlled drug delivery. In this paper, we reported on a pure protein hydrogel based on tetrameric recombinant proteins for the potential drug delivery application. This protein hydrogel was formed instantly by simply mixing two recombinant proteins (ULD-TIP1 and ULD-GGGWRESAI) through the specific protein-peptide interaction. The protein hydrogel was characterized by rheology and scanning electron microscopy (SEM). In vitro cytotoxicity test indicated that the developed protein hydrogel had no apparent cytotoxicity against L-929 cells and HCEC cells after 48h incubation. The formed protein hydrogels was gradually degraded after incubation in phosphate buffered solution (PBS, pH=7.4) for a period of 144h study, as indicated by in vitro degradation test. Encapsulation of model drug (sodium diclofenac; DIC) were achieved by simple mixing of drugs with hydrogelator and the entrapped drugs was almost completely released from hydrogels within 24h via a diffusion manner. As a conclusion, the simple and mild preparation procedure and good biocompatibility of protein hydrogel would render its good promising candidate for drug delivery applications. Copyright © 2016 Elsevier B.V. All rights reserved.

    19. Waste characterization methods at belgoprocess and the importance of NDA

      International Nuclear Information System (INIS)

      Botte, J.; Luycx, P.

      2003-01-01

      Waste characterization in the end cycle becomes more and more important. Several methods are available for a radiological characterization: from copying the waste producers declaration over a calculation based on known characteristics or measured values to combinations of several techniques. The decision on what technique(s) to be used will be based on several criteria. One also has to evaluate at what stage of the waste treatment process the characterization has to be performed. Recently belgoprocess has performed large efforts and investments to assure a good waste characterization. These are concentrated in studies on historical and recent waste, resulting in isotopic vectors and the purchase of several NDA devices in order to cover the whole scala of waste the company treats. The measuring results always need to be integrated with isotopic vectors. (orig.)

    20. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary Reference Values for carbohydrates and dietary fibre

      DEFF Research Database (Denmark)

      Tetens, Inge

      This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the establishment of Dietary Reference Values for carbohydrates and dietary fibre. Nutritionally, two broad categories of carbohydrates can be differentiated: “glycaemic carbohydrates”, i.e. carbohydrates...

    1. Farklı Durum Çeşitlerinden Mahalli ve Laboratuvar Koşullarında Yapılmış Bulguların Bazı Vitamin ve Mineral İçerikleri

      Directory of Open Access Journals (Sweden)

      Berrin Özkaya

      2015-02-01

      Full Text Available Araştırmada 5 farklı durum buğdayının, bunlardan mahalli ve laboratuvar koşullarında yapılan bulguların bazı kimyasal özellikleri ile tiamin, riboflavin ve mineral içerikleri karşılaştırılmıştır. Buğdayların yapımı sırasında buğdayların tiamin, özellikle de riboflavin miktarları azalmıştır. Mahalli koşullarda yapılan bulgurların tiamin ve riboflavin miktarları laboratuvarda yapılanlara kıyasla biraz düşük çıkmıştır. Bulgurların mineral içerikleri (Fe, Cu, Zn, Mn, Ca ve Mg miktarları yapıldıktan buğdaylara kıyasla daha düşük çıkmış, mahalli ve laboratuvar koşullarında yapılan bulgurların mineral madde miktarlarında önemli bir fark görülmemiştir.

    2. Peyniraltı Suyu Tozundan Hazırlanan Sentetik Besi Ortamında Lactobacillus bulgaricus Suşlarının Oluşturduğu Laktik Asit Miktarı Üzerine bir Araştırma

      OpenAIRE

      Beyatlı, Yavuz; Tulumoğlu, Şener

      1991-01-01

      Peyniraltı suyu tozundan altı farklı sentetik besi ortamı hazırlanmıştır. Bu besi ortamlarında 12 adet L. bulgaricus suşunun oluşturduğu laktik asit miktarları tespit edilmiştir. Katkılı besi ortamlarında oluşan laktik asit miktarları, katkısız besi ortamları ile kıyaslandığında daha fazla bulunmuştur. 12 adet L. bulgaricus suşu arasında en fazla laktik asit üretenlerin L. bulgaricus B1, L. bulgaricus B4 ve L. bulgaricus B11 suşları olduğu görülmüştür.  

    3. Manufacture and Drug Delivery Applications of Silk Nanoparticles.

      Science.gov (United States)

      Wongpinyochit, Thidarat; Johnston, Blair F; Seib, F Philipp

      2016-10-08

      Silk is a promising biopolymer for biomedical and pharmaceutical applications due to its outstanding mechanical properties, biocompatibility and biodegradability, as well its ability to protect and subsequently release its payload in response to a trigger. While silk can be formulated into various material formats, silk nanoparticles are emerging as promising drug delivery systems. Therefore, this article covers the procedures for reverse engineering silk cocoons to yield a regenerated silk solution that can be used to generate stable silk nanoparticles. These nanoparticles are subsequently characterized, drug loaded and explored as a potential anticancer drug delivery system. Briefly, silk cocoons are reverse engineered first by degumming the cocoons, followed by silk dissolution and clean up, to yield an aqueous silk solution. Next, the regenerated silk solution is subjected to nanoprecipitation to yield silk nanoparticles - a simple but powerful method that generates uniform nanoparticles. The silk nanoparticles are characterized according to their size, zeta potential, morphology and stability in aqueous media, as well as their ability to entrap a chemotherapeutic payload and kill human breast cancer cells. Overall, the described methodology yields uniform silk nanoparticles that can be readily explored for a myriad of applications, including their use as a potential nanomedicine.

    4. Nano-Star-Shaped Polymers for Drug Delivery Applications.

      Science.gov (United States)

      Yang, Da-Peng; Oo, Ma Nwe Nwe Linn; Deen, Gulam Roshan; Li, Zibiao; Loh, Xian Jun

      2017-11-01

      With the advancement of polymer engineering, complex star-shaped polymer architectures can be synthesized with ease, bringing about a host of unique properties and applications. The polymer arms can be functionalized with different chemical groups to fine-tune the response behavior or be endowed with targeting ligands or stimuli responsive moieties to control its physicochemical behavior and self-organization in solution. Rheological properties of these solutions can be modulated, which also facilitates the control of the diffusion of the drug from these star-based nanocarriers. However, these star-shaped polymers designed for drug delivery are still in a very early stage of development. Due to the sheer diversity of macromolecules that can take on the star architectures and the various combinations of functional groups that can be cross-linked together, there remain many structure-property relationships which have yet to be fully established. This review aims to provide an introductory perspective on the basic synthetic methods of star-shaped polymers, the properties which can be controlled by the unique architecture, and also recent advances in drug delivery applications related to these star candidates. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

    5. Farklı Tip Türk Rakılarında Temel Uçucu Bileşiklerin Gaz Kromatografisinde Doğrudan Enjeksiyonla Belirlenmesi

      Directory of Open Access Journals (Sweden)

      Seda Özkandan

      2015-02-01

      Full Text Available Bu çalışmada, tek üzüm çeşidinden (Misket, yaş üzümden ve kuru üzüm suması melas alkolü karışımından üretilen farklı tipteki rakıların bileşimleri ve temel uçucu bileşikleri araştırılmıştır. Metanol ve temel uçucu bileşikler (asetaldehit, asetal, metil asetat, etil asetat, 2-bütanol, n-propanol, izobütanol, n-bütanol, aktif amil alkol, izoamil alkol, trans anetol ve estragol AB referans yöntemine göre GC- FID ile belirlenmiştir. Rakıların temel uçucu bileşiklerini, sırasıyla, anason kaynaklı trans anetol ve suma kaynaklı yüksek alkoller, esterler, aldehitler ve uçucu asitler oluşturmuştur. Rakılarda, toplam uçucu madde miktarları uçar asit dahil, 124.99-163.40 g/hL mA arasında, trans anetol miktarları 1038-1380 mg/L arasında, metanol miktarları 43.96-56.91 g/hL mA arasında değişmiştir. En yüksek toplam uçucu madde miktarı Misket üzümünden elde edilen rakıda bulunmuştur. Tek çeşitten ve yaş üzümden üretilen rakıların, karışımdan üretilen rakılara göre daha yüksek miktarlarda toplam uçucu madde ve özellikle yüksek alkoller içerdikleri belirlenmiştir. Yüksek alkol miktarları bakımından tipler arasındaki fark önemli bulunmuştur (P<0.05. Trans anetol miktarı en yüksek yaş üzüm rakısında, en düşük misket rakısında belirlenmiştir. Öte yandan, genel olarak rakıların bileşimlerinin TGK Distile Alkollü İçkiler Tebliği’ne uygun oldukları saptanmıştır.

    6. Jung Işığında Heba Heba In The Light Of Jung

      Directory of Open Access Journals (Sweden)

      Esra SAZYEK

      2013-09-01

      Full Text Available Hasan Ali Toptaş, is one of the important authors of Turkishliterature, in his novel called Heba discusses inward looking personalityof Ziya, who lives in the same childish purity during his life consistingof all periods of childhood, military service, marriage and death. Due tothis property, he lives world of dreams and fantasies rather than reeltime. 16 years after he lost his wife and unborn son as casualties inbomb attack, Yazıköy where he breaks away from the crowd of the cityand settle in here, feeds his this side. Thus, the hours passing in thenature, turn into a worship. However, whole peace of Ziya, who hasfound what he seeks in Yazıköy, ends by killing of Kenan. This periodwhen everything has became complicated, is followed by killing of himas being lynched because of the gossips about him.When you reread the novel focusing on a wasted life, of whichtragic events are finished by death in the light of Jungian psychology, itturns into a story of award to reach immortality obtained after thesorrows felt.Experiences of Ziya in Yazıköy resembling Heaven until he isdismissed, realize on the cusp of a magical environment is surroundedby dreams and fantasies. Appearance of unconscious plane by means ofsymbolical contents in dreams indicates that Yazıköy representsunconscious world beyond being a geographic and travelling from thecity to natural follows a way from conscious towards unconscious.Exploring of Ziya moving in unknown darkness of unconsciousthe inner treasure in the deepest, requires passing the each phase fromsurface towards center with a different figure of unconscious named as"archetype" by Jung.In this study, dimensions of period in question will be discussedin terms of Jungian psychology; trails of his thoughts will be examinedin detail by its aspects are reflected on contextual dimension of thenovel. Türk edebiyatının önemli yazarlarından olan Hasan Ali Toptaş, Heba adlı romanında çocukluk, askerlik, evlilik

    7. Microencapsulation of indocyanine green for potential applications in image-guided drug delivery.

      Science.gov (United States)

      Zhu, Zhiqiang; Si, Ting; Xu, Ronald X

      2015-02-07

      We present a novel process to encapsulate indocyanine green (ICG) in liposomal droplets at high concentration for potential applications in image-guided drug delivery. The microencapsulation process follows two consecutive steps of droplet formation by liquid-driven coaxial flow focusing (LDCFF) and solvent removal by oil phase dewetting. These biocompatible lipid vesicles may have important applications in drug delivery and fluorescence imaging.

    8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of lycopene, vitamin E, lutein and selenium and “ helps to prepare and activate tannin g ” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health clai...

    9. NDA technology for uranium resource evaluation. Progress report July 1-December 31, 1979

      International Nuclear Information System (INIS)

      Evans, M.L.

      1980-08-01

      This report describes work performed during the time period from July 1, 1979 to December 31, 1979, on the contract for Nondestructive Nuclear Analysis (NDA) Technology for Uranium Resource Evaluation in Group Q-1. Calculational effort was focused on improving the accuracy with which detector response function maps can be generated for subsequent enfolding with ONETRAN angular flux data. Experimental effort was highlighted by a field test of the prototype photoneutron logging probe at the Grand Junction DOE calibration facility. The probe demonstrated adequate durability in the field and sufficient sensitivity to uranium to function at competitive logging speeds

    10. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on Dietary Reference Values for biotin

      DEFF Research Database (Denmark)

      Tetens, Inge

      2014-01-01

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for biotin. Biotin is a water-soluble vitamin which serves as a co-factor for several carboxylases that play critical roles in the synthesis...

    11. Nef‛î Divanında Gönül Heart in the Dȋvȃn of Nef‛ȋ’

      Directory of Open Access Journals (Sweden)

      Münire Nurefşan KAPAL

      2012-09-01

      Full Text Available Heart is one of the most common subject which place at Turkish Classical Literature of poetry’s Divan. The concept not only of Classical Literature, but also Folk Literature and oral culture among the topics deal with a lot of culture. İf there are love and lover in the beyit, heart of the lover absolutely take place in the world of the word at the same time. The poet who lived in the first half of the seventeeth century and found fame as a teacher of ode Nef‛î has included the concepts and comparisons in his Dîvân. The word, there are more than in the ghazals. The poet who wrote poetry in general, for the Sultan and statesmen, using exaggerated and a style full of praise; but in his ghazals he writes classic ghazal style and tells as to be in love and enthusiastic words. In his Dîvân, there is no mystical maning of this word. Heart which deal with a variety of interest of the meaning is extased, in love and a mirror showing the beauty lover. In this article, detail definitions of heart concept with various sources will be analyzed together with meanings of words and evaluated by statistical methods. Gönül, klasik edebiyat şairlerinin, divanlarında en çok rastlanan ve işlenen konularından biridir. Kavram sedece klasik edebiyatın değil, halk edebiyatının ve sözlü kültür sahasının da çok işlediği konular arasındadır. Aşk ve âşıklık söz konusu olduğu zaman elbette âşığın gönlü de beyitlerin kelime dünyasında hemen yerini alır. Bu itibarla hangi klasik edebiyat şairinin divanına bakılsa, hemen hemen hepsinde gönül kavramına ait mecazlar ve mazmunlar bulunduğu görülür. XVII. yüzyılın ilk yarısında yaşamış ve bir kaside üstadı olarak şöhret bulmuş olan şair Nef‛î, divanında gönülle ilgili kavram ve benzetmelere yer vermiştir. Kelime, geçiş sıklığı itbariyle daha çok gazellerde yer alır. Kasidelerini genel olarak padişah ve devlet adamlarına ithafen yazan ve m

    12. An analytical solution for percutaneous drug absorption: application and removal of the vehicle.

      Science.gov (United States)

      Simon, L; Loney, N W

      2005-10-01

      The methods of Laplace transform were used to solve a mathematical model developed for percutaneous drug absorption. This model includes application and removal of the vehicle from the skin. A system of two linear partial differential equations was solved for the application period. The concentration of the medicinal agent in the skin at the end of the application period was used as the initial condition to determine the distribution of the drug in the skin following instantaneous removal of the vehicle. The influences of the diffusion and partition coefficients, clearance factor and vehicle layer thickness on the amount of drug in the vehicle and the skin were discussed.

    13. Application of lean manufacturing concepts to drug discovery: rapid analogue library synthesis.

      Science.gov (United States)

      Weller, Harold N; Nirschl, David S; Petrillo, Edward W; Poss, Michael A; Andres, Charles J; Cavallaro, Cullen L; Echols, Martin M; Grant-Young, Katherine A; Houston, John G; Miller, Arthur V; Swann, R Thomas

      2006-01-01

      The application of parallel synthesis to lead optimization programs in drug discovery has been an ongoing challenge since the first reports of library synthesis. A number of approaches to the application of parallel array synthesis to lead optimization have been attempted over the years, ranging from widespread deployment by (and support of) individual medicinal chemists to centralization as a service by an expert core team. This manuscript describes our experience with the latter approach, which was undertaken as part of a larger initiative to optimize drug discovery. In particular, we highlight how concepts taken from the manufacturing sector can be applied to drug discovery and parallel synthesis to improve the timeliness and thus the impact of arrays on drug discovery.

    14. Enhanced performance of magnesium alloy for drug-eluting vascular scaffold application

      Science.gov (United States)

      Dong, Hongzhou; Li, Daikun; Mao, Daoyong; Bai, Ningning; Chen, Yashi; Li, Qing

      2018-03-01

      Bio-absorbable magnesium alloys drug-eluting vascular scaffold was developed to resolve the defect of permanent metal and drug-eluting stents, most notably a chronic vessel wall inflammation and the risk of stent thrombosis. Nevertheless, violent chemical reaction and rapid degradation under physiological conditions limits their application. Furthermore, multifunctional drug-eluting stents which could reduce the formation of thrombus and repair the damaged vessels need more attention to fundamentally cure the coronary artery disease. Herein, a drug delivery system (Mg/MgO/PLA-FA) which can realize sustainable release of ferulaic acid was designed via anodic oxidation process and dip coating process. Electrochemical tests and immersion experiments showed that the superior anticorrosion behavior, it is due to the dense MgO-PLA composite layer. The released ferulaic acid can effectively decrease platelets adhesion and aggregation during the early stage of implantation. Besides, hemolysis tests showed that the composite coatings endowed the Mg alloy with a low hemolysis ratio. The Mg/MgO/PLA-FA composite materials may be appropriate for applications on biodegradable Mg alloys drug-eluting stents.

    15. Self-emulsifying drug delivery systems (SEDDS): formulation development, characterization, and applications.

      Science.gov (United States)

      Singh, Bhupinder; Bandopadhyay, Shantanu; Kapil, Rishi; Singh, Ramandeep; Katare, O

      2009-01-01

      Self-emulsifying drug delivery systems (SEDDS) possess unparalleled potential in improving oral bioavailability of poorly water-soluble drugs. Following their oral administration, these systems rapidly disperse in gastrointestinal fluids, yielding micro- or nanoemulsions containing the solubilized drug. Owing to its miniscule globule size, the micro/nanoemulsifed drug can easily be absorbed through lymphatic pathways, bypassing the hepatic first-pass effect. We present an exhaustive and updated account of numerous literature reports and patents on diverse types of self-emulsifying drug formulations, with emphasis on their formulation, characterization, and systematic optimization strategies. Recent advancements in various methodologies employed to characterize their globule size and shape, ability to encapsulate the drug, gastrointestinal and thermodynamic stability, rheological characteristics, and so forth, are discussed comprehensively to guide the formula-tor in preparing an effective and robust SEDDS formulation. Also, this exhaustive review offers an explicit discussion on vital applications of the SEDDS in bioavailability enhancement of various drugs, outlining an overview on myriad in vitro, in situ, and ex vivo techniques to assess the absorption and/ or permeation potential of drugs incorporated in the SEDDS in animal and cell line models, and the subsequent absorption pathways followed by them. In short, the current article furnishes an updated compilation of wide-ranging information on all the requisite vistas of the self-emulsifying formulations, thus paving the way for accelerated progress into the SEDDS application in pharmaceutical research.

    16. General scientific guidance for stakeholders on health claim applications

      DEFF Research Database (Denmark)

      Sjödin, Anders Mikael

      2016-01-01

      of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5, 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need...... based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed.......The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation...

    17. An Overview of Chitosan Nanoparticles and Its Application in Non-Parenteral Drug Delivery

      Directory of Open Access Journals (Sweden)

      Munawar A. Mohammed

      2017-11-01

      Full Text Available The focus of this review is to provide an overview of the chitosan based nanoparticles for various non-parenteral applications and also to put a spotlight on current research including sustained release and mucoadhesive chitosan dosage forms. Chitosan is a biodegradable, biocompatible polymer regarded as safe for human dietary use and approved for wound dressing applications. Chitosan has been used as a carrier in polymeric nanoparticles for drug delivery through various routes of administration. Chitosan has chemical functional groups that can be modified to achieve specific goals, making it a polymer with a tremendous range of potential applications. Nanoparticles (NP prepared with chitosan and chitosan derivatives typically possess a positive surface charge and mucoadhesive properties such that can adhere to mucus membranes and release the drug payload in a sustained release manner. Chitosan-based NP have various applications in non-parenteral drug delivery for the treatment of cancer, gastrointestinal diseases, pulmonary diseases, drug delivery to the brain and ocular infections which will be exemplified in this review. Chitosan shows low toxicity both in vitro and some in vivo models. This review explores recent research on chitosan based NP for non-parenteral drug delivery, chitosan properties, modification, toxicity, pharmacokinetics and preclinical studies.

    18. Recent Advances in the Application of Vitamin E TPGS for Drug Delivery

      Science.gov (United States)

      Yang, Conglian; Wu, Tingting; Qi, Yan; Zhang, Zhiping

      2018-01-01

      D-ɑ-tocopheryl polyethylene glycol succinate (Vitamin E TPGS or TPGS) has been approved by FDA as a safe adjuvant and widely used in drug delivery systems. The biological and physicochemical properties of TPGS provide multiple advantages for its applications in drug delivery like high biocompatibility, enhancement of drug solubility, improvement of drug permeation and selective antitumor activity. Notably, TPGS can inhibit the activity of ATP dependent P-glycoprotein and act as a potent excipient for overcoming multi-drug resistance (MDR) in tumor. In this review, we aim to discuss the recent advances of TPGS in drug delivery including TPGS based prodrugs, nitric oxide donor and polymers, and unmodified TPGS based formulations. These potential applications are focused on enhancing delivery efficiency as well as the therapeutic effect of agents, especially on overcoming MDR of tumors. It also demonstrates that the clinical translation of TPGS based nanomedicines is still faced with many challenges, which requires more detailed study on TPGS properties and based delivery system in the future. PMID:29290821

    19. Uncertainty analysis of NDA waste measurements using computer simulations

      International Nuclear Information System (INIS)

      Blackwood, L.G.; Harker, Y.D.; Yoon, W.Y.; Meachum, T.R.

      2000-01-01

      Uncertainty assessments for nondestructive radioassay (NDA) systems for nuclear waste are complicated by factors extraneous to the measurement systems themselves. Most notably, characteristics of the waste matrix (e.g., homogeneity) and radioactive source material (e.g., particle size distribution) can have great effects on measured mass values. Under these circumstances, characterizing the waste population is as important as understanding the measurement system in obtaining realistic uncertainty values. When extraneous waste characteristics affect measurement results, the uncertainty results are waste-type specific. The goal becomes to assess the expected bias and precision for the measurement of a randomly selected item from the waste population of interest. Standard propagation-of-errors methods for uncertainty analysis can be very difficult to implement in the presence of significant extraneous effects on the measurement system. An alternative approach that naturally includes the extraneous effects is as follows: (1) Draw a random sample of items from the population of interest; (2) Measure the items using the NDA system of interest; (3) Establish the true quantity being measured using a gold standard technique; and (4) Estimate bias by deriving a statistical regression model comparing the measurements on the system of interest to the gold standard values; similar regression techniques for modeling the standard deviation of the difference values gives the estimated precision. Actual implementation of this method is often impractical. For example, a true gold standard confirmation measurement may not exist. A more tractable implementation is obtained by developing numerical models for both the waste material and the measurement system. A random sample of simulated waste containers generated by the waste population model serves as input to the measurement system model. This approach has been developed and successfully applied to assessing the quantity of

    20. İmar Meclisi Raporlarında Borçlanma ve Selem Uygulaması (1845-1846 / Borrowing and Selem Practices in Ottoman Era According to "Macalis Imariyya (Development Counsils" Reports

      Directory of Open Access Journals (Sweden)

      Tahir Bilirli

      2016-06-01

      Full Text Available İmar Meclisi Raporlarında Borçlanma ve Selem Uygulaması (1845-1846 Öz Bu makale, Osmanlı Devleti'nde 1845 yılında ilan edilen Tensikât-ı mülkiye kararı çerçevesinde geçici olarak olarak kurulan İmar Meclisleri'nin görevlerini incelemektedir. Makalede, bu meclislerin özellikle halkın borç para alma durumları ile selem usulü denilen mahsulün hasattan önce satılması konusundaki faaliyetleri incelenmektedir. Hasat zamanından önce alınan vergi, ahaliyi borçlanmaya yöneltmekte, bu da halkın fahiş faiz oranlarıyla tefecilerden borç almalarına ve ürünün hasat edilmeden önce daha düşük fiyatlara satılmasına sebep olmaktaydı. Bu durum gelir kaybı nedeniyle hem tebaya hem de devlete zarar vermekteydi. İmar Meclisi memurları yaşanan bu sıkıntının giderilmesi noktasında yerinde durum tespiti yapmışlardır. Makalenin birinci bölümünde İmar Meclisleri'nin kuruluşu ve görevleri hakkında bilgi verilmektedir. İkinci bölümde makalenin ana konusu olan borçlanma ve selem usulünün uygulanmasının meclis raporlarına nasıl yansıdığı arşiv belgelerine göre ele alınmıştır. Makalenin sonuç bölümünde arşiv belgelerinde elde edilen veriler doğrultusunda değerlendirme yapılmıştır. Borrowing and Selem Practices in Ottoman Era According to "Macalis Imariyya (Development Counsils" Reports Abstract This article examines the mission of Macalis Imariyya (Develepment Counsils which were founded by the decree of Tankisat al-Mulkiyye declared in 1845. In the article, the activity of these Counsils about the indebtedness status of the people and the selling of products before the harvest -called “selem”- particularly examined. The tax collection before harvest period was impelling the people borrowing from usurers with excessive interest rates and to sell the product at nearly half price. This case was damaging both the state and the citizens because of income loss. Development Council

    1. Nanodiamond and its application to drug delivery

      Directory of Open Access Journals (Sweden)

      Eiji Osawa

      2012-08-01

      Full Text Available Quasi-spherical diamond crystals having an average diameter of 3.7±0.6 nm are attracting much attention as an ideal material in carbon nanotechnology. In contrast to the other popular nanocarbons including fullerenes, carbon nanotubes and graphenes, our single-nanodiamond can be produced in uniform shape/size on industrial scale. Thus, the most serious problem in nanocarbon industry that persisted in the past 25 years, namely the technical failure to produce highly crystalline nanocarbons in narrow shape/size range does not exist in our diamond from the beginning. Among potential applications of the single-nanodiamond under development, this review concentrates on its highly promising role as a drug carrier, especially for therapeutic-resistant cancer. An interesting possibility of intercalation is proposed as the mechanism of drug transport through blood, which takes into accounts of the spontaneous formation of nanographene layer on the [111] facets, which is then extensively oxidized during oxidative soot removal process to give nanographene oxide partial surface, capable of intercalating drug molecules to prevent them from leaking and causing undesirable side effects during transportation to target malignant cells. A perspective of quantifying the drug delivery process by anticipating orders of magnitude in the number of administered detonation nanodiamond (DND particles is suggested.

    2. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on Dietary Reference Values for pantothenic acid

      DEFF Research Database (Denmark)

      Tetens, Inge

      2014-01-01

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for pantothenic acid. Pantothenic acid is a water-soluble vitamin, which is a component of coenzyme A (CoA) and acyl-carrier proteins. Pantothenic...

    3. Experience of joint use NDA instruments between Japan and IAEA in inspection fields

      International Nuclear Information System (INIS)

      Yoshii, Hiroshi; Aoki, Minoru; Shimizu, Toku

      1997-01-01

      In order to implement more effective and efficient safeguards scheme in Japan, Japan and IAEA established joint use program of NDA instruments which was commenced in 1989 from LEU fuel fabrication facilities. The joint use program was proposed by Science and Technology Agency (STA) in the 10th (1989) Joint Japan and IAEA Committee, and it was agreed. Subsequently, Japan and IAEA established working group of the joint use program, whose prepared necessary joint use procedures. Currently, the joint use program has been expanding to almost facilities in domestic, and has been contributing reduce the facility operator's burden for the for inspection activities. (author)

    4. Application of Fused Deposition Modelling (FDM) Method of 3D Printing in Drug Delivery.

      Science.gov (United States)

      Long, Jingjunjiao; Gholizadeh, Hamideh; Lu, Jun; Bunt, Craig; Seyfoddin, Ali

      2017-01-01

      Three-dimensional (3D) printing is an emerging manufacturing technology for biomedical and pharmaceutical applications. Fused deposition modelling (FDM) is a low cost extrusion-based 3D printing technique that can deposit materials layer-by-layer to create solid geometries. This review article aims to provide an overview of FDM based 3D printing application in developing new drug delivery systems. The principle methodology, suitable polymers and important parameters in FDM technology and its applications in fabrication of personalised tablets and drug delivery devices are discussed in this review. FDM based 3D printing is a novel and versatile manufacturing technique for creating customised drug delivery devices that contain accurate dose of medicine( s) and provide controlled drug released profiles. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

    5. Hayvan Islahında Güncel Bir Yaklaşım: CRISPR/Cas9 Genom Modifikasyon Sistemi

      Directory of Open Access Journals (Sweden)

      Fatih Bilgi

      2016-12-01

      Full Text Available Genom modifikasyonları, verimin arttırılmasında ve hastalıklara karşı direncin kazandırılması konusunda önemli avantajlar sağlama potansiyeli içermektedir. Bireyin zaten sahip olduğu bir genin susturulmasını ya da ifade edilmesini sağlayan gen düzenlenmesi yöntemleri (gene editing çevreyi en az etkileyerek genetik yapının geliştirilmesi konusunda önemli olanaklar sağlamaktadır. Son zamanlarda yeni genetik düzenleme yöntemleri geliştirilmiştir. Bunlar ZFN (Zinc Finger Nuclease’ler, TALEN (Transcription Activator-like Effector Nuclease’ler ve CRISPR/Cas nükleaz sistemleridir. CRISPR/Cas sistemi yabancı genetik materyalleri yok etmek için RNA güdümlü nükleazları kullanan bir mikrobiyal immün sistem olup, bu sistemin günümüzde hayvanlarda basit ve etkili bir gen düzenleme mekanizması olarak kullanılabilme potansiyeli değerlendirilmektedir. Bu derlemede CRISPR/Cas9 sistemi ve hayvan ıslahında kullanılabilirliği özetlenmiştir.

    6. 42 CFR 2a.5 - Contents of application; research projects in which drugs will be administered.

      Science.gov (United States)

      2010-10-01

      ... application; research projects in which drugs will be administered. (a) In addition to the information... drug shall contain: (1) Identification of the drugs to be administered in the research project and a... project will be conducted. (b) An application for an authorization of confidentiality with respect to a...

    7. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the modification of the authorisation of a health claim related to cocoa flavanols and maintenance of normal endotheliumdependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924

      DEFF Research Database (Denmark)

      Tetens, Inge

      2014-01-01

      Following an application from Barry Callebaut Belgium NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification of the authoris......Following an application from Barry Callebaut Belgium NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the modification...... of the authorisation of a health claim related to “cocoa flavanols help maintain the elasticity of blood vessels, which contributes to normal blood flow”, pursuant to Article 13(5) of Regulation (EC) No 1924/2006. The modification concerns an extension of the authorised conditions of use of the claim to a high......-flavanols (HF) cocoa extract to be consumed in capsules, tablets or added to “other foods, including beverages”. Cocoa flavanols, which are the subject of the health claim, have been sufficiently characterised. Maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect...

    8. Recent activities of the ESARDA working group on NDA

      International Nuclear Information System (INIS)

      Harry, R.J.S.

      1983-01-01

      The European Safeguards Research and Development Association, ESARDA, has one of the largest coordinated safeguards and development programs in the world. There are several working groups for specific R and D activities. One of these is the ''ESARDA Working Group on Techniques and Standards for non-Destructive Analysis''. The NDA working group has initiated the international project of the preparation of uranium oxide certified reference materials for the gamma spectrometric determination of the enrichment, which are made in a collaboration with the US NBS and the European Communities' Central Bureau for Nuclear Measurements, CBNM, at Geel. The possibility of a similar type of reference material for Pu isotopic abundance measurements is investigated at CBNM, and the pilot samples may become available for intercomparisons. Safeguards acceptability and users manual have been considered carefully. The working group has undertaken an intercomparison on the determination of plutonium isotopic ratios by gamma spectrometry, using NBS-SRM's-946, -947 and 948. A new exercise on 0,5 gram samples of seven different isotopic compositions samples will be executed under the name PIDIE (Plutonium Isotopic Determination Intercomparison Exercise)

    9. Cürufa Olan Bakır Kayıplarında Farklı Kroze Kullanımının Etkisi

      OpenAIRE

      RÜŞEN, Aydın

      2017-01-01

      Bakır işletmelerinde ergitme aşamasında cürufa olan bakır kayıpları sektördeki önemli problemlerdenbiridir. Bu çalışmada, Eti Bakır İşletmelerinden (EBİ) temin edilen flaş fırın cürufu ve flaş fırın matı eşitmiktarlarda alınarak farklı oranlarda kolemanit (2CaO·3B2O3·5H2O) ilavesi (%0, %2, %4 ve %6) ilekarıştırılıp alumina (Al2O3) krozelerde 1250oC’de ve azot atmosferi altında 2 saat boyunca ergitmedeneylerine tabi tutulmuştur. Böylece, alümina kroze (AK) kullanılan deneylerde cürufa olan bak...

    10. SynergyFinder: a web application for analyzing drug combination dose-response matrix data.

      Science.gov (United States)

      Ianevski, Aleksandr; He, Liye; Aittokallio, Tero; Tang, Jing

      2017-08-01

      Rational design of drug combinations has become a promising strategy to tackle the drug sensitivity and resistance problem in cancer treatment. To systematically evaluate the pre-clinical significance of pairwise drug combinations, functional screening assays that probe combination effects in a dose-response matrix assay are commonly used. To facilitate the analysis of such drug combination experiments, we implemented a web application that uses key functions of R-package SynergyFinder, and provides not only the flexibility of using multiple synergy scoring models, but also a user-friendly interface for visualizing the drug combination landscapes in an interactive manner. The SynergyFinder web application is freely accessible at https://synergyfinder.fimm.fi ; The R-package and its source-code are freely available at http://bioconductor.org/packages/release/bioc/html/synergyfinder.html . jing.tang@helsinki.fi. © The Author(s) 2017. Published by Oxford University Press.

    11. In situ object counting system (ISOCSi3TM) technique: A cost-effective tool for NDA verification in IAEA Safeguards

      International Nuclear Information System (INIS)

      Nizhnik, V.; Belian, A.; Shephard, A.; Lebrun, A.

      2011-01-01

      Nuclear material measurements using the ISOCS technique are playing an increasing role in IAEA verification activities. The ISOCS capabilities include: a high sensitivity to the presence of U and Pu; the ability to detect very small amounts of material; and the ability to measure items of different shapes and sizes. In addition, the numerical absolute efficiency calibration of a germanium detector used in the technique does not require any calibration standards or reference materials. The ISOCS modelling software performs an absolute efficiency calibration for items with various container shapes, container wall materials, material compositions, material fill-heights, U/Pu weight fractions and even heterogeneously distributed emitting materials. In a number of cases, some key parameters, such as the matrix density and U/Pu weight fraction, can be determined in addition to the emitting material mass and isotopic composition. These capabilities provide a verification solution suitable for a majority of cases where quantitative and isotopic analysis should be performed. Taking into account these advantages, the technique becomes a cost-effective solution for nuclear material non-destructive assay (NDA) verification. At present, the IAEA uses the ISOCS for a wide range of applications including the quantitative analysis of U scrap materials, U/Pu contaminated solid wastes, U fuel elements, U hold-up materials. Additionally, the ISOCS is also applied to some specific verification cases such as the measurement of PuBe neutron sources and the quantification of fission products in solid wastes. In reprocessing facilities with U/Pu waste compaction or facilities with item re-batching, the continuity-of-knowledge can be assured by applying either video surveillance systems together with seals (requiring attaching/detaching and verification activities for each seal) or verification of operator declarations using quantitative measurements for items selected on a random basis

    12. Determining plutonium mass in spent fuel with non-destructive assay techniques - NGSU research overview and update on 6 NDA techniques

      Energy Technology Data Exchange (ETDEWEB)

      Tobin, Stephen J [Los Alamos National Laboratory; Conlin, Jeremy L [Los Alamos National Laboratory; Evans, Louise G [Los Alamos National Laboratory; Hu, Jianwei [Los Alamos National Laboratory; Blanc, Pauline C [Los Alamos National Laboratory; Lafleur, Adrienne M [Los Alamos National Laboratory; Menlove, Howard O [Los Alamos National Laboratory; Schear, Melissa A [Los Alamos National Laboratory; Swinhoe, Martyn T [Los Alamos National Laboratory; Croft, Stephen [Los Alamos National Laboratory; Fensin, Michael L [Los Alamos National Laboratory; Freeman, Corey R [Los Alamos National Laboratory; Koehler, William E [Los Alamos National Laboratory; Mozin, V [Los Alamos National Laboratory; Sandoval, N P [Los Alamos National Laboratory; Lee, T H [KAERI; Cambell, L W [PNNL; Cheatham, J R [ORNL; Gesh, C J [PNNL; Hunt, A [IDAHO STATE UNIV; Ludewigt, B A [LBNL; Smith, L E [PNNL; Sterbentz, J [INL

      2010-09-15

      This poster is one of two complementary posters. The Next Generation Safeguards Initiative (NGSI) of the U.S. DOE has initiated a multi-lab/university collaboration to quantify the plutonium (Pu) mass in, and detect the diversion of pins from, spent nuclear fuel assemblies with non-destructive assay (NDA). This research effort has the goal of quantifying the capability of 14 NDA techniques as well as training a future generation of safeguards practitioners. By November of 2010, we will be 1.5 years into the first phase (2.5 years) of work. This first phase involves primarily Monte Carlo modelling while the second phase (also 2.5 years) will focus on experimental work. The goal of phase one is to quantify the detection capability of the various techniques for the benefit of safeguard technology developers, regulators, and policy makers as well as to determine what integrated techniques merit experimental work, We are considering a wide range of possible technologies since our research horizon is longer term than the focus of most regulator bodies. The capability of all of the NDA techniques will be determined for a library of 64 17 x 17 PWR assemblies [burnups (15, 30, 45, 60 GWd/tU), initial enrichments (2, 3, 4, 5%) and cooling times (1, 5, 20, 80 years)]. The burnup and cooling time were simulated with each fuel pin being comprised of four radial regions. In this paper an overview of the purpose will be given as well as a technical update on the following 6 neutron techniques: {sup 252}Cf Interrogation with Prompt Neutron Detection, Delayed Neutrons, Differential Die-Away, Differential Die-Away Self-Interrogation, Passive Neutron Albedo Reactivity, Self-Integration Neutron Resonance Densitometry. The technical update will quantify the anticipated performance of each technique for the 64 assemblies of the spent fuel library.

    13. Determining plutonium mass in spent fuel with non-destructive assay techniques - NGSI research overview and update on 6 NDA techniques

      International Nuclear Information System (INIS)

      Tobin, Stephen J.; Conlin, Jeremy L.; Evans, Louise G.; Hu, Kianwei; Blanc, P.C.; Lafleur, Am; Menlove, H.O.; Schear, M.A.; Swinhoe, M.T.; Croft, S.; Fensin, M.L.; Freeman, C.R.; Koehler, W.E.; Mozin, V.; Sandoval, N.P.; Lee, T.H.; Cambell, L.W.; Cheatham, J.R.; Gesh, C.J.; Hunt, A.; Ludewigt, B.A.; Smith, L.E.; Sterbentz, J.

      2010-01-01

      This poster is one of two complementary posters. The Next Generation Safeguards Initiative (NGSI) of the U.S. DOE has initiated a multi-lab/university collaboration to quantify the plutonium (Pu) mass in, and detect the diversion of pins from, spent nuclear fuel assemblies with non-destructive assay (NDA). This research effort has the goal of quantifying the capability of 14 NDA techniques as well as training a future generation of safeguards practitioners. By November of 2010, we will be 1.5 years into the first phase (2.5 years) of work. This first phase involves primarily Monte Carlo modelling while the second phase (also 2.5 years) will focus on experimental work. The goal of phase one is to quantify the detection capability of the various techniques for the benefit of safeguard technology developers, regulators, and policy makers as well as to determine what integrated techniques merit experimental work, We are considering a wide range of possible technologies since our research horizon is longer term than the focus of most regulator bodies. The capability of all of the NDA techniques will be determined for a library of 64 17 x 17 PWR assemblies (burnups (15, 30, 45, 60 GWd/tU), initial enrichments (2, 3, 4, 5%) and cooling times (1, 5, 20, 80 years)). The burnup and cooling time were simulated with each fuel pin being comprised of four radial regions. In this paper an overview of the purpose will be given as well as a technical update on the following 6 neutron techniques: 252 Cf Interrogation with Prompt Neutron Detection, Delayed Neutrons, Differential Die-Away, Differential Die-Away Self-Interrogation, Passive Neutron Albedo Reactivity, Self-Integration Neutron Resonance Densitometry. The technical update will quantify the anticipated performance of each technique for the 64 assemblies of the spent fuel library.

    14. Travma Sonrası Kesici Diş Kırıkları Yüzde Sabit İz kapsamında Değerlendirilmeli mi

      Directory of Open Access Journals (Sweden)

      Mehmet Hakan Özdemir

      2014-04-01

      Full Text Available Türk Ceza Kanununda tanımlanan yaralanma suçlarının adli tıp açısından değerlendirilmesinde kullanılan kriterlerden biri de yüzde sabit iz kavramıdır. Bu suçlarının adli tıp açısından değerlendirilmesinde kullanılan klavuzda, yüzde sabit iz; yüz sınırları içerisinde oluşan yaralanmanın “iyileştikten sonra gün ışığında veya iyi aydınlatılmış ortamda , insanlar arası sözel diyaloğ  mesafesinden (1-2 metre ilk bakışta belirgin bir şekilde fark edilme” durumu olarak değerlendirilmektedir. Dişler ağız içinde yer almakla birlikte aynı zamanda yüz sınırları içindedir. Dinlenme pozisyonunda anatomik olarak dudaklarımız birbirinden hafif açık durmaktadır. Bu konumda özellikle üst kesici dişlerimiz üst dudaktan 2 mm aşağıda görünür haldedir. Cinsiyet farklılıklarına bağlı olarak genç kadınlarda dinlenme pozisyonunda sadece üst kesici dişler görülürken, genç erkeklerde hafif olmakla birlikte alt kesici dişler de görülmektedir. Yaş ilerledikçe yer çekimi kuvvetine bağlı doku sarkmalarıyla tersi bir durum gözlemlenir. Yaş ilerledikçe kadınlarda üst kesici dişler çok az görülürken daha çok alt kesici dişler görülmekte, erkeklerde ise üst kesici dişler görülmeyip  daha belirgin olarak alt kesici dişler görülmektedir. Eğer üst solunum yollarında bir obstrüksiyon varsa, ağızdan nefes alındığı için dudaklar arası açıklık artmakta  ve kesici dişler daha çok görülmektedir.  İnsanlar günlük yaşamında dudakları tam kapalı kalmadığından konuşma, gülme gibi işlevleri sırasında da özellikle kesici dişler görünür pozisyonda olmakta, bu dişlerdeki kırıklar ve eksiklikler daha görünür hale gelmektedir. Yüzde sabit iz ya da yüzün daimi değişikliği kavramları; insanların iletişim kurma, toplum içinde bulunma-yer alma, kendini iyi hissetme anlamında yüzün özel önemi nedeniyle, Türk Ceza

    15. Turizm Ürünlerinin Pazarlanmasında Fiziksel Kanıt Stratejileri

      OpenAIRE

      Yıldırgan, Recep; Zengin, Burhanettin

      2014-01-01

      Hizmet sektöründe sunulan ürünler, çoğunlukla soyut özellik taşıdığından bu ürünlerin pazarlamasında bazı somut verilerden yararlanmak gerekmektedir. Turizm işletmeleri de ürünlerini daha etkin pazarlayabilmek için bünyelerindeki fiziksel şartları, mekan, dizayn, ışık, renk, logo, işaret simge, ve bunun gibi unsurlarla somut hale getirerek hedef kitlelerin beğenisine sunarlar. Turizm pazarlaması karması açısından fiziksel kanıt elemanı olarak adlandırılan bu unsurlar, müşterinin turisti...

    16. 76 FR 33310 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

      Science.gov (United States)

      2011-06-08

      ... Promius Pharma, LLC, mononitrate) 200 Somerset Tablets, 20 mg. Corporate Blvd., 7th Floor, Bridgewater, NJ.... Suspension. NDA 050560 Cefizox (ceftizoxime Astellas Pharma US, sodium) Powder for Inc., 3 Parkway Injection... USP, EQ 500 mg (base) and 1 gram (g) (base) Vials. ANDA 063294 Cefizox (ceftizoxime Astellas Pharma US...

    17. In Vitro Drug Transfer Due to Drug Retention in Human Epidermis Pretreated with Application of Marketed Estradiol Transdermal Systems.

      Science.gov (United States)

      Krishnaiah, Yellela S R; Pavurala, Naresh; Yang, Yang; Manda, Prashanth; Katragadda, Usha; Yang, Yongsheng; Shah, Rakhi; Fang, Guodong; Khan, Mansoor A

      2017-08-01

      Study objective was to assess skin-to-skin drug transfer potential that may occur due to drug retention in human epidermis (DRE) pretreated with application of estradiol transdermal drug delivery systems (TDDS) and other estradiol transdermal dosage forms (gels and sprays). TDDS (products-A, B, and C) with varying formulation design and composition, and other estradiol transdermal products (gel and spray) were applied to heat separated human epidermis (HSE) and subjected to in vitro drug permeation study. Amounts of DRE were quantified after 24 h. The DRE with product-B was significantly (P  0.05) amounts of DRE. A separate in vitro permeation study was carried out to determine amounts of drug transferred from drug-retaining epidermis to untreated HSE. The amounts of drug transferred, due to DRE after 8 h, with product-C were significantly (P drug transfer due to the DRE after labeled period of using estradiol TDDS, though the clinical relevance of these findings is yet to be determined.

    18. 75 FR 42455 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

      Science.gov (United States)

      2010-07-21

      ... Endo Pharmaceuticals NDA 17-255 MPI DTPA Chelate multidose (kit for Medi-Physics, Inc., d/b/a GE... 7.5 mg/750 mg ANDA 40-312 Innofem (estradiol tablets USP), 0.5 Novo Nordisk, Inc., 100 College Rd... Ranbaxy, Inc., U.S. Agent for Ranbaxy Tablets, 1,000 mg Laboratories Limited, 600 College Rd. East...

    19. Nuclear Resonance Fluorescence for Safeguards Applications

      Energy Technology Data Exchange (ETDEWEB)

      Ludewigt, Bernhard A; Quiter, Brian J; Ambers, Scott D

      2011-02-04

      In nuclear resonance fluorescence (NRF) measurements, resonances are excited by an external photon beam leading to the emission of {gamma} rays with specific energies that are characteristic of the emitting isotope. The promise of NRF as a non-destructive analysis technique (NDA) in safeguards applications lies in its potential to directly quantify a specific isotope in an assay target without the need for unfolding the combined responses of several fissile isotopes as often required by other NDA methods. The use of NRF for detection of sensitive nuclear materials and other contraband has been researched in the past. In the safeguards applications considered here one has to go beyond mere detection and precisely quantify the isotopic content, a challenge that is discussed throughout this report. Basic NRF measurement methods, instrumentation, and the analytical calculation of NRF signal strengths are described in Section 2. Well understood modeling and simulation tools are needed for assessing the potential of NRF for safeguards and for designing measurement systems. All our simulations were performed with the radiation transport code MCNPX, a code that is widely used in the safeguards community. Our initial studies showed that MCNPX grossly underestimated the elastically scattered background at backwards angles due to an incorrect treatment of Rayleigh scattering. While new, corrected calculations based on ENDF form factors showed much better agreement with experimental data for the elastic scattering of photons on an uranium target, the elastic backscatter is still not rigorously treated. Photonuclear scattering processes (nuclear Thomson, Delbruck and Giant Dipole Resonance scattering), which are expected to play an important role at higher energies, are not yet included. These missing elastic scattering contributions were studied and their importance evaluated evaluated against data found in the literature as discussed in Section 3. A transmission experiment

    20. Live Cell in Vitro and in Vivo Imaging Applications: Accelerating Drug Discovery

      Directory of Open Access Journals (Sweden)

      Neil O Carragher

      2011-04-01

      Full Text Available Dynamic regulation of specific molecular processes and cellular phenotypes in live cell systems reveal unique insights into cell fate and drug pharmacology that are not gained from traditional fixed endpoint assays. Recent advances in microscopic imaging platform technology combined with the development of novel optical biosensors and sophisticated image analysis solutions have increased the scope of live cell imaging applications in drug discovery. We highlight recent literature examples where live cell imaging has uncovered novel insight into biological mechanism or drug mode-of-action. We survey distinct types of optical biosensors and associated analytical methods for monitoring molecular dynamics, in vitro and in vivo. We describe the recent expansion of live cell imaging into automated target validation and drug screening activities through the development of dedicated brightfield and fluorescence kinetic imaging platforms. We provide specific examples of how temporal profiling of phenotypic response signatures using such kinetic imaging platforms can increase the value of in vitro high-content screening. Finally, we offer a prospective view of how further application and development of live cell imaging technology and reagents can accelerate preclinical lead optimization cycles and enhance the in vitro to in vivo translation of drug candidates.

    1. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014 . Scientific Opinion on the safety of vitamin D - enriched UV - treated baker‘s yeast

      DEFF Research Database (Denmark)

      Tetens, Inge; Poulsen, Morten

      2014-01-01

      , fine pastry and food supplements. The Panel considers that the provided compositional data, the specification, the data from batch testing, data on the stability on the production process are sufficient and do not give rise to safety concerns. The Panel concludes that the data provided are sufficient...... and do not give rise to safety concerns.The applicant intends to use the NFI as an alternative source of vitamin D for food supplements and for fortification of yeast-leavened bread, rolls and fine pastry at maximum concentrations of 5 μg vitamin D2 per 100 g of these foods. The applicant provided....../100 g bread, rolls and fine pastry, it is highly unlikely that Tolerable Upper Intake Levels as established by EFSA (EFSA NDA Panel, 2012) are exceeded. The Panel considers that UV-treated baker’s yeast exhibiting an enhanced content of vitamin D2 is safe under the intended conditions of use....

    2. Applications of fiber-optics-based nanosensors to drug discovery.

      Science.gov (United States)

      Vo-Dinh, Tuan; Scaffidi, Jonathan; Gregas, Molly; Zhang, Yan; Seewaldt, Victoria

      2009-08-01

      Fiber-optic nanosensors are fabricated by heating and pulling optical fibers to yield sub-micron diameter tips and have been used for in vitro analysis of individual living mammalian cells. Immobilization of bioreceptors (e.g., antibodies, peptides, DNA) selective to targeting analyte molecules of interest provides molecular specificity. Excitation light can be launched into the fiber, and the resulting evanescent field at the tip of the nanofiber can be used to excite target molecules bound to the bioreceptor molecules. The fluorescence or surface-enhanced Raman scattering produced by the analyte molecules is detected using an ultra-sensitive photodetector. This article provides an overview of the development and application of fiber-optic nanosensors for drug discovery. The nanosensors provide minimally invasive tools to probe subcellular compartments inside single living cells for health effect studies (e.g., detection of benzopyrene adducts) and medical applications (e.g., monitoring of apoptosis in cells treated with anticancer drugs).

    3. Superparamagnetic nanoparticles for biomedical applications: Possibilities and limitations of a new drug delivery system

      Energy Technology Data Exchange (ETDEWEB)

      Neuberger, Tobias [Musculoskeletal Research Unit, Equine Hospital, Vetsuisse Faculty Zurich, University of Zurich, Winterthurerstr. 260, 8057 Zurich (Switzerland); Schoepf, Bernhard [Musculoskeletal Research Unit, Equine Hospital, Vetsuisse Faculty Zurich, University of Zurich, Winterthurerstr. 260, 8057 Zurich (Switzerland); Hofmann, Heinrich [Laboratory of Powder Technology, Institute of Materials, Swiss Federal Institute of Technology, EPFL, 1015 Lausanne (Switzerland); Hofmann, Margarete [MatSearch Pully, Chemin Jean Pavillard, 14, CH-1009 Pully (Switzerland); Rechenberg, Brigitte von [Musculoskeletal Research Unit, Equine Hospital, Vetsuisse Faculty Zurich, University of Zurich, Winterthurerstr. 260, 8057 Zurich (Switzerland)]. E-mail: bvonrechenberg@vetclinics.unizh.ch

      2005-05-15

      Nanoparticles can be used in biomedical applications, where they facilitate laboratory diagnostics, or in medical drug targeting. They are used for in vivo applications such as contrast agent for magnetic resonance imaging (MRI), for tumor therapy or cardiovascular disease. Very promising nanoparticles for these applications are superparamagnetic nanoparticles based on a core consisting of iron oxides (SPION) that can be targeted through external magnets. SPION are coated with biocompatible materials and can be functionalized with drugs, proteins or plasmids. In this review, the characteristics and applications of SPION in the biomedical sector are introduced and discussed.

    4. Superparamagnetic nanoparticles for biomedical applications: Possibilities and limitations of a new drug delivery system

      International Nuclear Information System (INIS)

      Neuberger, Tobias; Schoepf, Bernhard; Hofmann, Heinrich; Hofmann, Margarete; Rechenberg, Brigitte von

      2005-01-01

      Nanoparticles can be used in biomedical applications, where they facilitate laboratory diagnostics, or in medical drug targeting. They are used for in vivo applications such as contrast agent for magnetic resonance imaging (MRI), for tumor therapy or cardiovascular disease. Very promising nanoparticles for these applications are superparamagnetic nanoparticles based on a core consisting of iron oxides (SPION) that can be targeted through external magnets. SPION are coated with biocompatible materials and can be functionalized with drugs, proteins or plasmids. In this review, the characteristics and applications of SPION in the biomedical sector are introduced and discussed

    5. Synthesis of an amphiphilic dendrimer-like block copolymer and its application on drug delivery

      KAUST Repository

      Wang, Shuaipeng; Song, Xiaowan; Feng, Xiaoshuang; Chen, Peng; Qian, Jiasheng; Xia, Ru; Miao, Jibin

      2014-01-01

      . The application on drug delivery of dendrimer-like diblock copolymer PEEGE-G2-b-PEO(OH)12 using DOX as a model drug was also studied. The drug loading content and encapsulation efficiency were found at 13.07% and 45.75%, respectively. In vitro release experiment

    6. Computational Fragment-Based Drug Design: Current Trends, Strategies, and Applications.

      Science.gov (United States)

      Bian, Yuemin; Xie, Xiang-Qun Sean

      2018-04-09

      Fragment-based drug design (FBDD) has become an effective methodology for drug development for decades. Successful applications of this strategy brought both opportunities and challenges to the field of Pharmaceutical Science. Recent progress in the computational fragment-based drug design provide an additional approach for future research in a time- and labor-efficient manner. Combining multiple in silico methodologies, computational FBDD possesses flexibilities on fragment library selection, protein model generation, and fragments/compounds docking mode prediction. These characteristics provide computational FBDD superiority in designing novel and potential compounds for a certain target. The purpose of this review is to discuss the latest advances, ranging from commonly used strategies to novel concepts and technologies in computational fragment-based drug design. Particularly, in this review, specifications and advantages are compared between experimental and computational FBDD, and additionally, limitations and future prospective are discussed and emphasized.

    7. [Pharmaceutical application of cyclodextrins as multi-functional drug carriers].

      Science.gov (United States)

      Uekama, Kaneto

      2004-12-01

      Owing to the increasingly globalized nature of the cyclodextrin (CyD)-related science and technology, development of the CyD-based pharmaceutical formulation is rapidly progressing. The pharmaceutically useful CyDs are classified into hydrophilic, hydrophobic, and ionic derivatives. Because of the multi-functional characteristics and bioadaptability, these CyDs are capable of alleviating the undesirable properties of drug molecules through the formation of inclusion complexes or the form of CyD/drug conjugates. This review outlines the current application of CyDs in drug delivery and pharmaceutical formulation, focusing on the following evidences. 1) The hydrophilic CyDs enhance the rate and extent of bioavailability of poorly water-soluble drugs. 2) The amorphous CyDs such as 2-hydroxypropyl-beta-CyD are useful for inhibition of polymorphic transition and crystallization rates of drugs during storage. 3) The delayed release formulation can be obtained by the use of enteric type CyDs such as O-carboxymethyl-O-ethyl-beta-CyD. 4) The hydrophobic CyDs are useful for modification of the release site and/or time profile of water-soluble drugs with prolonged therapeutic effects. 5) The branched CyDs are particularly effective in inhibiting the adsorption to hydrophobic surface of containers and aggregation of polypeptide and protein drugs. 6) The combined use of different CyDs and/or pharmaceutical additives can serve as more functional drug carriers, improving efficacy and reducing side effects. 7) The CyD/drug conjugates may provide a versatile means for the constructions of not only colonic delivery system but also site-specific drug release system, including gene delivery. On the basis of the above-mentioned knowledge, the advantages and limitations of CyDs in the design of advanced dosage forms will be discussed.

    8. Potential applications for halloysite nanotubes based drug delivery systems

      Science.gov (United States)

      Sun, Lin

      could be released in a sustained manner; (2) cytotoxicity test confirmed the biocompatibility of HNTs and methotrexate coated HNTs; (3) proliferation test confirmed the growth inhibition of released methotrexate on osteosarcoma cells; and (4) nylon-6 could prolong the sustained release of methotrexate from polyelectrolytes coated HNTs. Another application comes from the prevention of surgical site infection. It is a common complication in surgery, which may prolong hospital stay, increase mortality rate, and cause additional financial burden for patients. By directly releasing antibiotics at the surgical site, it is supposed to enhance the drug efficacy and improve the treatment outcome. Therefore, the same HNTs based system was tested with E. coli in vitro to show the potential of delivering antibiotics to enhance the prevention of surgical site infection. Nitrofurantoin was incorporated within HNTs using the layer-by-layer coating technique, and the drug coated HNTs were filled into nylon-6 again. Results showed that (1) nitrofurantoin could be incorporated with this HNTs based drug delivery system, and released in a sustained manner; (2) nylon-6 could prolong the sustained release of nitrofurantoin from polyelectrolytes coated HNTs; and (3) released nitrofurantoin could severely inhibit E. coil growth. Therefore, a tunable drug delivery system based on HNTs was developed, and a great potential of medical application in drug delivery was shown.

    9. Development of novel drug delivery systems using phage display technology for clinical application of protein drugs.

      Science.gov (United States)

      Nagano, Kazuya; Tsutsumi, Yasuo

      2016-01-01

      Attempts are being made to develop therapeutic proteins for cancer, hepatitis, and autoimmune conditions, but their clinical applications are limited, except in the cases of drugs based on erythropoietin, granulocyte colony-stimulating factor, interferon-alpha, and antibodies, owing to problems with fundamental technologies for protein drug discovery. It is difficult to identify proteins useful as therapeutic seeds or targets. Another problem in using bioactive proteins is pleiotropic actions through receptors, making it hard to elicit desired effects without side effects. Additionally, bioactive proteins have poor therapeutic effects owing to degradation by proteases and rapid excretion from the circulatory system. Therefore, it is essential to establish a series of novel drug delivery systems (DDS) to overcome these problems. Here, we review original technologies in DDS. First, we introduce antibody proteomics technology for effective selection of proteins useful as therapeutic seeds or targets and identification of various kinds of proteins, such as cancer-specific proteins, cancer metastasis-related proteins, and a cisplatin resistance-related protein. Especially Ephrin receptor A10 is expressed in breast tumor tissues but not in normal tissues and is a promising drug target potentially useful for breast cancer treatment. Moreover, we have developed a system for rapidly creating functional mutant proteins to optimize the seeds for therapeutic applications and used this system to generate various kinds of functional cytokine muteins. Among them, R1antTNF is a TNFR1-selective antagonistic mutant of TNF and is the first mutein converted from agonist to antagonist. We also review a novel polymer-conjugation system to improve the in vivo stability of bioactive proteins. Site-specific PEGylated R1antTNF is uniform at the molecular level, and its bioactivity is similar to that of unmodified R1antTNF. In the future, we hope that many innovative protein drugs will be

    10. Mass Spectrometry in Clinical Laboratory: Applications in Therapeutic Drug Monitoring and Toxicology.

      Science.gov (United States)

      Garg, Uttam; Zhang, Yan Victoria

      2016-01-01

      Mass spectrometry (MS) has been used in research and specialized clinical laboratories for decades as a very powerful technology to identify and quantify compounds. In recent years, application of MS in routine clinical laboratories has increased significantly. This is mainly due to the ability of MS to provide very specific identification, high sensitivity, and simultaneous analysis of multiple analytes (>100). The coupling of tandem mass spectrometry with gas chromatography (GC) or liquid chromatography (LC) has enabled the rapid expansion of this technology. While applications of MS are used in many clinical areas, therapeutic drug monitoring, drugs of abuse, and clinical toxicology are still the primary focuses of the field. It is not uncommon to see mass spectrometry being used in routine clinical practices for those applications.

    11. Drugs@FDA: FDA Approved Drug Products

      Science.gov (United States)

      ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

    12. Prediction of Human Pharmacokinetic Profile After Transdermal Drug Application Using Excised Human Skin.

      Science.gov (United States)

      Yamamoto, Syunsuke; Karashima, Masatoshi; Arai, Yuta; Tohyama, Kimio; Amano, Nobuyuki

      2017-09-01

      Although several mathematical models have been reported for the estimation of human plasma concentration profiles of drug substances after dermal application, the successful cases that can predict human pharmacokinetic profiles are limited. Therefore, the aim of this study is to investigate the prediction of human plasma concentrations after dermal application using in vitro permeation parameters obtained from excised human skin. The in vitro skin permeability of 7 marketed drug products was evaluated. The plasma concentration-time profiles of the drug substances in humans after their dermal application were simulated using compartment models and the clinical pharmacokinetic parameters. The transdermal process was simulated using the in vitro skin permeation rate and lag time assuming a zero-order absorption. These simulated plasma concentration profiles were compared with the clinical data. The result revealed that the steady-state plasma concentration of diclofenac and the maximum concentrations of nicotine, bisoprolol, rivastigmine, and lidocaine after topical application were within 2-fold of the clinical data. Furthermore, the simulated concentration profiles of bisoprolol, nicotine, and rivastigmine reproduced the decrease in absorption due to drug depletion from the formulation. In conclusion, this simple compartment model using in vitro human skin permeation parameters as zero-order absorption predicted the human plasma concentrations accurately. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

    13. Application of PBPK modelling in drug discovery and development at Pfizer.

      Science.gov (United States)

      Jones, Hannah M; Dickins, Maurice; Youdim, Kuresh; Gosset, James R; Attkins, Neil J; Hay, Tanya L; Gurrell, Ian K; Logan, Y Raj; Bungay, Peter J; Jones, Barry C; Gardner, Iain B

      2012-01-01

      Early prediction of human pharmacokinetics (PK) and drug-drug interactions (DDI) in drug discovery and development allows for more informed decision making. Physiologically based pharmacokinetic (PBPK) modelling can be used to answer a number of questions throughout the process of drug discovery and development and is thus becoming a very popular tool. PBPK models provide the opportunity to integrate key input parameters from different sources to not only estimate PK parameters and plasma concentration-time profiles, but also to gain mechanistic insight into compound properties. Using examples from the literature and our own company, we have shown how PBPK techniques can be utilized through the stages of drug discovery and development to increase efficiency, reduce the need for animal studies, replace clinical trials and to increase PK understanding. Given the mechanistic nature of these models, the future use of PBPK modelling in drug discovery and development is promising, however, some limitations need to be addressed to realize its application and utility more broadly.

    14. Cell-specific prediction and application of drug-induced gene expression profiles.

      Science.gov (United States)

      Hodos, Rachel; Zhang, Ping; Lee, Hao-Chih; Duan, Qiaonan; Wang, Zichen; Clark, Neil R; Ma'ayan, Avi; Wang, Fei; Kidd, Brian; Hu, Jianying; Sontag, David; Dudley, Joel

      2018-01-01

      Gene expression profiling of in vitro drug perturbations is useful for many biomedical discovery applications including drug repurposing and elucidation of drug mechanisms. However, limited data availability across cell types has hindered our capacity to leverage or explore the cell-specificity of these perturbations. While recent efforts have generated a large number of drug perturbation profiles across a variety of human cell types, many gaps remain in this combinatorial drug-cell space. Hence, we asked whether it is possible to fill these gaps by predicting cell-specific drug perturbation profiles using available expression data from related conditions--i.e. from other drugs and cell types. We developed a computational framework that first arranges existing profiles into a three-dimensional array (or tensor) indexed by drugs, genes, and cell types, and then uses either local (nearest-neighbors) or global (tensor completion) information to predict unmeasured profiles. We evaluate prediction accuracy using a variety of metrics, and find that the two methods have complementary performance, each superior in different regions in the drug-cell space. Predictions achieve correlations of 0.68 with true values, and maintain accurate differentially expressed genes (AUC 0.81). Finally, we demonstrate that the predicted profiles add value for making downstream associations with drug targets and therapeutic classes.

    15. Recent advances in inkjet dispensing technologies: applications in drug discovery.

      Science.gov (United States)

      Zhu, Xiangcheng; Zheng, Qiang; Yang, Hu; Cai, Jin; Huang, Lei; Duan, Yanwen; Xu, Zhinan; Cen, Peilin

      2012-09-01

      Inkjet dispensing technology is a promising fabrication methodology widely applied in drug discovery. The automated programmable characteristics and high-throughput efficiency makes this approach potentially very useful in miniaturizing the design patterns for assays and drug screening. Various custom-made inkjet dispensing systems as well as specialized bio-ink and substrates have been developed and applied to fulfill the increasing demands of basic drug discovery studies. The incorporation of other modern technologies has further exploited the potential of inkjet dispensing technology in drug discovery and development. This paper reviews and discusses the recent developments and practical applications of inkjet dispensing technology in several areas of drug discovery and development including fundamental assays of cells and proteins, microarrays, biosensors, tissue engineering, basic biological and pharmaceutical studies. Progression in a number of areas of research including biomaterials, inkjet mechanical systems and modern analytical techniques as well as the exploration and accumulation of profound biological knowledge has enabled different inkjet dispensing technologies to be developed and adapted for high-throughput pattern fabrication and miniaturization. This in turn presents a great opportunity to propel inkjet dispensing technology into drug discovery.

    16. EFSA Panel on Di etetic Products, Nutrition and Allergie s (NDA); Scientific Opinion on the substantiation of a health claim relate d to OXY 280 and reduction of body weight pur suant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Actina, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related...... relative to the placebo, and that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel notes that no studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause...

    17. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Vitis vinifera L. seeds extract and “helps to decrease swollen legs” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to Vitis vinifera L. seeds extract and “helps to decrease swollen legs”. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. Upon EFSA’s request for clarification, the applicant stated that the claimed effect was “helps to decrease...

    18. Biodegradable PLGA-b-PEG polymeric nanoparticles: synthesis, properties, and nanomedical applications as drug delivery system

      Energy Technology Data Exchange (ETDEWEB)

      Locatelli, Erica; Comes Franchini, Mauro, E-mail: mauro.comesfranchini@unibo.it [University of Bologna, Dipartimento di Chimica Industriale Toso Montanari (Italy)

      2012-12-15

      During the past decades many synthetic polymers have been studied for nanomedicine applications and in particular as drug delivery systems. For this purpose, polymers must be non-toxic, biodegradable, and biocompatible. Polylactic-co-glycolic acid (PLGA) is one of the most studied polymers due to its complete biodegradability and ability to self-assemble into nanometric micelles that are able to entrap small molecules like drugs and to release them into body in a time-dependent manner. Despite fine qualities, using PLGA polymeric nanoparticles for in vivo applications still remains an open challenge due to many factors such as poor stability in water, big diameter (150-200 nm), and the removal of these nanocarriers from the blood stream by the liver and spleen thus reducing the concentration of drugs drastically in tumor tissue. Polyethylene glycol (PEG) is the most used polymers for drug delivery applications and the first PEGylated product is already on the market for over 20 years. This is due to its stealth behavior that inhibits the fast recognition by the immune system (opsonization) and generally leads to a reduced blood clearance of nanocarriers increasing blood circulation time. Furthermore, PEG is hydrophilic and able to stabilize nanoparticles by steric and not ionic effects especially in water. PLGA-PEG block copolymer is an emergent system because it can be easily synthesized and it possesses all good qualities of PLGA and also PEG capability so in the last decade it arose as one of the most promising systems for nanoparticles formation, drug loading, and in vivo drug delivery applications. This review will discuss briefly on PLGA-b-PEG synthesis and physicochemical properties, together with its improved qualities with respect to the single PLGA and PEG polymers. Moreover, we will focus on but in particular will treat nanoparticles formation and uses as new drug delivery system for nanomedical applications.

    19. Drug Delivery and Cosmeceutical Applications of Poly- Lactic Acid Based Novel Constructs - A Review.

      Science.gov (United States)

      Ruiz-Ruiz, Federico; Mancera-Andrade, Elena Ivonne; Parra-Saldivar, Roberto; Keshavarz, Tajalli; Iqbal, Hafiz M N

      2017-01-01

      Poly (lactic acid) (PLA) based novel constructs have been engineered for targeted applications in various biomedical sectors of the modern world. In this context, a special focus has been given to pharmaceutical and cosmeceutical industries. In this review, we extensively reviewed, analyzed and compiled salient information from the authentic bibliographic sources including PubMed, Scopus, Elsevier, Springer, Bentham Science and other scientific databases. A focused review question and inclusion/exclusion criterion were adopted to appraise the quality of retrieved peer-reviewed research literature. Recently, bio-based constructs are being engineered for target applications in different bio- and non-bio sectors of the modern world to address the growing human health-related serious concerns. The utilization of properly designed and structured materials thus allows the creation of a well-defined environment that induces a series of directed measures, and so on. Over the last few years, PLA-based novel constructs have received exceptional attention as potential candidates for various biotechnological and biomedical applications at large and drug delivery in particular. Owing to their unique characteristics including biocompatibility, together with the adjustable thermomechanical and tunable control drug release, PLA has raised interesting applications in many sectors of the medical world. So far, many of such PLA-based bio-constructs have been exploited in drug delivery systems, cosmeceutical products, and therapeutic uses. In recent years, many new applications have been reported for PLA-based materials at the micro- and nano- level, resulting in novel requests for specific drug delivery and cosmeceutical sectors. In summary, this review summarizes recent research on different aspects of PLA and PLA-based novel constructs and their potential biomedical applications. Moreover, with the aid of nanotechnology, PLA has made a positive impact in emerging sectors such as

    20. Advances in the Applications of Polyhydroxyalkanoate Nanoparticles for Novel Drug Delivery System

      Directory of Open Access Journals (Sweden)

      Anupama Shrivastav

      2013-01-01

      Full Text Available Drug delivery technology is emerging as an interdisciplinary science aimed at improving human health. The controlled delivery of pharmacologically active agents to the specific site of action at the therapeutically optimal rate and dose regimen has been a major goal in designing drug delivery systems. Over the past few decades, there has been considerable interest in developing biodegradable drug carriers as effective drug delivery systems. Polymeric materials from natural sources play an important role in controlled release of drug at a particular site. Polyhydroxyalkanoates, due to their origin from natural sources, are given attention as candidates for drug delivery materials. Biodegradable and biocompatible polyhydroxyalkanoates are linear polyesters produced by microorganisms under unbalanced growth conditions, which have emerged as potential polymers for use as biomedical materials for drug delivery due to their unique physiochemical and mechanical properties. This review summarizes many of the key findings in the applications of polyhydroxyalkanoates and polyhydroxyalkanoate nanoparticles for drug delivery system.

    1. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

      Science.gov (United States)

      2011-07-21

      ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

    2. Geçmişten Günümüze Edebiyat Ders Planlarında Ve Kitaplarında Yahya Kemal ve Şiirleri From The Past Till Present Day Yahya Kemal And His Poets In Literature Curriculums And Course Books

      Directory of Open Access Journals (Sweden)

      Tevfik SÜTÇÜ

      2013-07-01

      prepared within the framework of literature curriculums ofTurkish Language and Literature course. Türk Edebiyatının XX. yüzyılda yetiştirdiği önemli şairlerinden biri Yahya Kemal Beyatlı’dır. Yahya Kemal, yaşadığı dönemin siyasi, sosyal ve tarihî hadiselerinin içinde yer almasının yanında, Türk edebiyatı ile ilgili önemli ve dikkat çekici hassasiyetleri olan bir şairimizdir. Bütün bu özellikleri ile birlikte Yahya Kemal, Türk şairleri arasında meydana getirdiği eserleri ile Türk dilinin güzel şiir örneklerini vermiş bir şahsiyettir. O, şiirlerinde ele aldığı farklı temaların yanında, şiirlerini meydana getirirken kullandığı dil, biçim ve şekil özellikleri ile öne çıkmış ve şairin bu özelliği hemen her dönemin edebiyat araştırmacıları ve eleştirmenleri tarafından kabul ve teslim edilmiştir.Öğretim kurumlarımızda edebiyat derslerinde edebiyatın diğer türleri ile beraber şiirle ilgili estetik beğenilerin geliştirilmesi ve edebiyat bilgilerinin öğretilmesi hedeflenir. Ülkemizde 1924’ten itibaren okullarımızda bütün diğer ders programları ile beraber edebiyat programlarını yeniden düzenleme çalışmaları da başlar. Cumhuriyet döneminde edebiyat öğretimindeki yönelimlerden birisi, edebiyat derslerinde okutulacak metinlerin çağdaş sanatçıların eserlerinden seçilmesi gerektiği yönündedir. Bu itibarla öğrencilere okuduklarından zevk alması ve yaşayan dilin örnekleriyle karşılaştırılması yanında, bazı metinlerden hareketle edebiyattaki tür ve şekil bilgisine ait konuların öğretilmesi, kavratılması ve tanıtılması mümkün olacaktır. Bütün bu özelliklere sahip olan Yahya Kemal’in eserlerinin ve metinlerinin, okul ders kitaplarında hemen her zaman yer alması isabetli bir tercih olmuştur ve olacaktır.Bu makalede, hangi yıllardan itibaren ve hangi dönemlerde Yahya Kemal’in hangi eserlerinin yoğun olarak ders kitaplarında yer ald

    3. Synthesis and characterization of novel dual-responsive nanogels and their application as drug delivery systems

      Science.gov (United States)

      Peng, Jinrong; Qi, Tingting; Liao, Jinfeng; Fan, Min; Luo, Feng; Li, He; Qian, Zhiyong

      2012-03-01

      In this study, a temperature/pH dual-response nanogel based on NIPAm, MAA, and PEGMA was synthesized via emulsion polymerization and characterized by 1H-NMR, FT-IR, TEM and DLS. By introducing a novel initiator, through which PEG-AIBN-PEG was synthesized, it was revealed that the PEG segments from PEG-AIBN-PEG with a dosage of initiator had a significant influence over the macro-state and stability of the nanogels. In order to optimize the feeding prescription for better application as a drug delivery system, the effect of the co-monomer contents on the response to stimuli (temperature and pH value) and cytotoxicity of the nanogels has been studied in detail. The results demonstrated that the responsiveness, reversibility and volume phase transition critical value of the nanogels could be controlled by adjusting the feeding ratio of the co-monomers in the synthesis process. MTT assay results revealed that nanogels with appropriate compositions showed good biocompatibility and relatively low toxicity. Most importantly, by studying the drug loading behavior, it was found that the dimensions of the drug molecules had a considerable influence on the drug loading efficiency and loading capacity of the nanogels, and that the mechanism by which drug molecule sizes influence the drug loading behavior of nanogels needs further investigation. The results indicated that such PNMP nanogels might have potential applications in drug delivery and other medical applications, but that the drug loading mechanism must be further developed.

    4. Application of Stable Isotope in Detection of Veterinary Drug Residues

      International Nuclear Information System (INIS)

      Wang Wei; Liu Zhanfeng; Du Xiaoning

      2010-01-01

      In recent years, there has happened a series of significant food safety events worldwide, which lower down consumers' confidence in food safety, and they are taking increasing care about the sources of their foods. The safety problem of animal-origin foods has become a global topic for discussion. Therefore, it is a pressing task to establish a precise, sensitive and reliable method for analyzing veterinary drug residue. An introduction of the present status regarding veterinary drug residue analysis was made in the paper, and it briefly summarized the limit of detection (LOD) and quantification (LOQ) which could be reached in veterinary drug residue analysis by isotopic internal standard method domestically and abroad. The paper also made a review of the progress in applied research of stable isotope labeled compound in veterinary drug residue analysis of, such as, antibiotic medicines, furans and sulfonamides. The paper elucidated the great importance of the application of stable isotopes in the sane development of China's food safety system. (authors)

    5. Çocukluk Çağında Anogenıtal Verru ve Cinsel İstismar

      Directory of Open Access Journals (Sweden)

      Dua Sumeyra Demirkıran

      2014-04-01

      Full Text Available Çocuklarda anogenital bölgede cinsel yolla bulaşan hastalıkların varlığı cinsel istismarın delilidir. Human papilloma virüs (HPV yetişkinlerin %80 ini etkileyen, en sık görülen cinsel yolla geçen hastalık kabul edilmektedir. Bu virüsün oluşturduğu verrülerin çocuklarda görülmesi cinsel istismar kanısı oluşturmaktadır. Çalışmamızda anogonital verrü (AGV ile ilgili literatür derlemesi yaparak AGV'li çocuk olgularına adli tıp yönünden yaklaşım önerilerini sunmayı amaçladık. Yapılan çalışmalara göre HPV'nin cinsel istismar dışında farklı bulaş yollarının olduğu bilimsel olarak saptanmıştır. Bu nedenle AGV'li çocuklara yaklaşımda cinsel istismar ön yargısının kırılması gerektiği kanaati oluşmuştur. Çocukların ve ailelerin "cinsel istismar" psikolojisinden uzak tutulmalıdır. Bu olgulara multidisipliner yaklaşılarak bulaş yolu hakkında kanaat oluştuktan sonra adli olgu açısından değerlendirilmelidir. Anahtar kelimeler: anogenital verrü, bulaş yolları, cinsel istismar

    6. Elucidating antimalarial drug targets/mode-of-action by application of system biology technologies

      CSIR Research Space (South Africa)

      Becker, J

      2008-11-01

      Full Text Available targets/mode-of-action by application of systems biology technologies J BECKER, L MTWISHA, B CRAMPTON AND D MANCAMA CSIR Biosciences, PO Box 395, Pretoria, 0001, South Africa Email: JBecker@csir.co.za – www.csir.co.za INTRODUCTION Malaria is one... The objective of this study was to use systems biology tools to unravel the drug target/mode-of-action (MoA) of an antimalarial drug (cyclohexylamine) with a known drug target/MoA, by analysing differential expression profiles of drug treated vs untreated...

    7. Biocompatible fluorescent zein nanoparticles for simultaneous bioimaging and drug delivery application

      International Nuclear Information System (INIS)

      Girija Aswathy, Ravindran; Sivakumar, Balasubramanian; Brahatheeswaran, Dhandayudhapani; Fukuda, Takahiro; Yoshida, Yasuhiko; Maekawa, Toru; Sakthi Kumar, D

      2012-01-01

      We report the synthesis of 5-fluorouracil (5-FU) loaded biocompatible fluorescent zein nanoparticles. Zein is the storage protein in corn kernels that has a variety of unique characteristics and functionalities that makes zein valuable in various commercial applications. It is classified as generally recognized as safe (GRAS) by the Food and Drug Administration (FDA). We synthesized zein nanoparticles of around 800 nm in size and conjugated with quantum dot ZnS:Mn. The nanoparticle was in turn encapsulated with the drug 5-FU. The luminescent properties of these nanoparticles were studied by using fluorescence microscopy. The nanoparticles were characterized and the drug release profile was studied. The biocompatibility of zein nanoparticle and the cytotoxicity with drug-loaded nanoparticle was studied in L929 and MCF-7 cell lines. The nanoparticles were successfully employed for cellular imaging. In vitro drug release studies were also performed. The biocompatibility of the nanoparticle showed that nanoparticles at higher concentrations are compatible for cells and are expected to be promising agents for the targeted delivery of drugs in the near future

    8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the sci......Following an application from Health Concern B.V., submitted for authorisation of a claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... on the scientific substantiation of a health claim related to a combination of plant sterols and Cholesternorm®mix and reduction of blood LDL-cholesterol concentrations. The food which is the subject of the health claim is a combination of plant sterols (free and in esterified form) and Cholesternorm......®mix and provides at the levels of the proposed conditions of use around 0.52 g plant sterols, 0.95 g linoleic acid, 0.13 g alpha-linolenic acid and 0.13 g pectins per day. The combination of plant sterols and Cholesternorm®mix, which is the subject of the claim, is sufficiently characterised in relation...

    9. Geçmişten Günümüze Türk Polis Teşkilatında Rütbeler From Past To Present Police Ranks In Turkish National Police

      Directory of Open Access Journals (Sweden)

      Bülent AKKAYA

      2013-07-01

      Full Text Available Law enforcement (police as the Ottoman State and previousperiods was carried out by soldiers and other officials. Until it is calledinternal security service, military police units in carrying out this task.For this reason, the current sense, the police are not able to drive a veryold history. The use of present-day of the word police was in 1845 withthe establishment of the Turkish National Police.That rank highly with the word police, meaning owned degreesand position. Law enforcement the rank of staff education, successfuloperation, owned by a good record to take the title refers to thehierarchical profession. Policing is a career profession. Police officersmust be in a hierarchical structure. Of command within the policesystem degrees and ranks of police officers has to be a profession. Forthis reason, police ranks are quite important in a police organization.Many scientific studies are still being made about TurkishNational Police with the establishment and the development of it.However, historical developments of ranks in Turkish National Policehave not been revealed in a collective manner. In this study scanningthe police ranks of legislative texts, names, profession and evaluationwere performed. Police ranks like Police chief, the Commissioner camefrom Ottoman bureaucracy to Turkish Republic. These police ranksclasses in each other and show continuity with the texts of thelegislation. After giving information about police ranks which used inTurkish National Police, some useful assessments were made for today. Kolluk görevi Osmanlı Devleti ve daha önceki dönemlerde askerler ve diğer görevliler tarafından yerine getirilmiştir. İç güvenlik hizmetini yürüten birimlere polis adı verilene kadar asker kimseler tarafından bu görev yerine getirilmiştir. Bu nedenle bugünkü anlamda polis teşkilatı tarihini çok eskilere götürmek mümkün değildir. Polis kelimesinin günümüzdeki anlamında kullanılması ise 1845 yılında

    10. Polisiye Roman Temsilcisi Ümit Deniz’in Romanlarında Cinayet Kurgusu The Murder Plot in The Novels of Umit Deniz

      Directory of Open Access Journals (Sweden)

      Nurullah ULUTAŞ

      2012-09-01

      Full Text Available Crime fiction, a genre that arose in modern times, deals with the social depression of the bourgeoisie class, which grew bigger in parallel with urbanization. In this genre, the social depression experienced by the modern individual is handled from a crime-centered point of view. The criminal is presented as an afflicted person who suffers from adaptation problems in society. The fact that murder takes a lot of space in these novels turns the concept of death into something ordinary in the minds of modern individuals. This style is carried into fiction through the richness of the rational analytical thinking in Western novels and attracts a large number of readers. The essential elements being mystery, intrigue, tension, crime and murder, the reader is kept alert and interested to follow the sequence of events. The aim of this study is to examine Umit Deniz’s method of creating a murder plot and in the light of the author’s seven novels to look into the psychological impact of murder on society. The techniques that the author makes use of in his writing process are also examined in order to shed light on the difference between crime fiction in Turkish Literature and crime fiction in the West. The main characters, murder plots, modern and traditional patterns, the use of inverted sentences, the fictional means that the author uses in order to keep the story flowing, are reviewed from a technical and theoritical point of view. The plot and any defects therein are criticized from a text-centered point of view. Modern zamanlara özgü bir tür olan polisiye roman, kentleşme ile gelişmeye başlayan burjuvazinin sosyal bunalımlarını suç merkezli olarak ele alır. Suçlunun topluma uyumsuz kişiler olarak yansıtıldığı bu romanlarda, cinayetlere fazla yer verilmesi, modern insan zihninde ölümün sıradanlaşmasına yol açar. Batı romanında rasyonel analitik düşünme zenginliği ile kurguya taşınan bu tarz, geniş okur

    11. Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.

      Science.gov (United States)

      Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle

      2014-12-01

      The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition. Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics.

    12. Automated applications of sandwich-cultured hepatocytes in the evaluation of hepatic drug transport.

      Science.gov (United States)

      Perry, Cassandra H; Smith, William R; St Claire, Robert L; Brouwer, Kenneth R

      2011-04-01

      Predictions of the absorption, distribution, metabolism, excretion, and toxicity of compounds in pharmaceutical development are essential aspects of the drug discovery process. B-CLEAR is an in vitro system that uses sandwich-cultured hepatocytes to evaluate and predict in vivo hepatobiliary disposition (hepatic uptake, biliary excretion, and biliary clearance), transporter-based hepatic drug-drug interactions, and potential drug-induced hepatotoxicity. Automation of predictive technologies is an advantageous and preferred format in drug discovery. In this study, manual and automated studies are investigated and equivalence is demonstrated. In addition, automated applications using model probe substrates and inhibitors to assess the cholestatic potential of drugs and evaluate hepatic drug transport are examined. The successful automation of this technology provides a more reproducible and less labor-intensive approach, reducing potential operator error in complex studies and facilitating technology transfer.

    13. İnsani Güvenlik Kavramı Bağlamında Çevre Güvenliği

      Directory of Open Access Journals (Sweden)

      Engin İ. ERDEM

      2016-12-01

      Full Text Available Güvenlik çalışmaları Soğuk Savaş’ın sona ermesinden sonraki dönemde giderek genişleyen bir günde­me sahip olmuştur. Bu makalede genişleyen güvenlik gündeminde yer alan insani güvenlik kavramı bağlamında çevresel güvenlik konusu incelenecektir. Çalışma öncelikle insani güvenlik kavramının ne zaman ortaya çıktığını ve farklı insanı güvenlik tanımlarından bahsetmektedir. 1994 yılı Birleşmiş Milletler Kalkınma Raporu insani güvenlik kavramının ortaya çıkışı açısından dönüm noktası olurken, tanımlar arasında iki tanesi ağırlık kazanmıştır. Geniş tanımlamada yoksulluk ve kalkınma temel dinamikler olarak alınırken dar insani güvenlik tanımlamasında fiziki şiddetin kullanılması baz olarak alınmıştır. Öte yandan, insani güvenlik etrafındaki tartışmaların önemli ölçüde normatif ve kuramsal boyutlara sahip olduğu görülmektedir. Bu sebeple makale başlıca uluslararası ilişkiler teorilerinin in­sani güvenlik olgusuna nasıl baktıklarına da yer vermektedir. Realist teoriler insani güvenlik kavramı ile ilgilenmezken liberal, inşacı ve eleştirel kuramların insani güvenlik olgusu ile ilgili oldukları görül­mektedir. Çalışmanın daha sonraki bölümü başta küresel ısınma olmak üzere çeşitli çevre sorunlarının insani güvenlik ve devletlerarası ilişkiler açısından nasıl tehlike oluşturduklarını analiz etmektedir. Bu bağlamda önemli bir konu çevresel güvensizlik ya da çevre felaketlerinden kaynaklanan devlet içi ve uluslararası göçlerin devletlerin istikrarını bozabilecek olması ve devletlerarası çatışmalara yol açabilme­sidir. Çevresel güvenlik sorunları Darfur ve Suriye’de olduğu gibi sıcak çatışmaların ortaya çıkmasında önemli bir etkiye sahip olabilmektedirler. Çalışmanın sonuç kısmı, insani güvenlik ve çevresel güvenlik kavramlarının güvenlik çalışmaları alan

    14. Kuş Gölü (Bandırma Makrobentik Omurgasız Faunası Hakkında Bir Ön Araştırma.

      Directory of Open Access Journals (Sweden)

      Süleyman Balık

      2015-12-01

      Full Text Available Kuş Gölü’nün makrobentik omurgasız faunasını belirlemek amacıyla 1987 ve 1988 yılları arasında aylık periyotlar halinde, bir yıl süre ile 5 istasyonda arazi çalışması yapılmıştır. Ekman grab ile alınan çamur örnekleri 500 μm göz açıklığındaki elekten geçirilmiş ve örnekler %4’lük formaldehit solüsyonunda tespit edilmiştir. Araştırma sonucunda, Oligochaeta sınıfından 10, Chironomidae familyasından 5 ve Ceratopogonidae familyasından 1 olmak üzere toplam 16 takson tespit edilmiştir. Kuş gölü’nde metrekarede ortalama 6759 birey tespit edilmiş, grupların oransal dağılımında %81,94 ile Oligochaeta bireylerinin en baskın grubu oluşturduğu, bu grubu Chironomidae (%17,90 ve Ceratopogonidae (%0,16 larvalarının takip ettiği saptanmıştır. Tespit edilen grupların istasyonlara göre oransal dağılımlarında ise, 1. istasyonun en zengin (%28,71, 4. istasyonun en fakir (%12,77 istasyon olduğu gözlenmiştir

    15. Kozak Yöresi Fıstıkçamı (Pinus pinea L. ormanlarında fıstık verimi ile artım ve bazı meteorolojik olaylar arasındaki ilişkiler

      Directory of Open Access Journals (Sweden)

      Dr. Mustafa BATUR

      2016-01-01

      Full Text Available Bu çalışmada, Kozak yöresindeki fıstıkçamı ormanlarında fıstık veriminin çap artımı ve meteorolojik olaylarla ilişkileri araştırılmıştır.İlişkilerin ortaya konması için 2006-2011 yılları arasındaki yıllık çap artım verileri, meteorolojik veriler ve örnek ağaçlara ait fıstık verimleri kullanılmıştır.Yapılan değerlendirmede; çap artımı ile fıstık verimi arasında önemli bir bulunamamıştır. Ancak, bazı meteorolojik olaylar ile fıstık verimi arasında ilişkilerin olduğu saptanmıştır. Özellikle, kabuklu fıstık verimi ile bir önceki yılın vejetasyon dönemindeki toplam yağış miktarı arasında R2=0,81, iki yıl önceki vejetasyon dönemindeki toplam yağış miktarı arasında R2=0,79 seviyesinde ilişki saptanmıştır. Fıstık veriminin kozalakların olgunlaştığı yıldaki meteorolojik olaylardan daha çok tozlaşma ve kozalakların büyüme dönemlerindeki meteorolojik verilerle ilişkili olduğu tahmin edilmektedir.

    16. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health

      DEFF Research Database (Denmark)

      Tetens, Inge

      The Panel on Dietetic Products, Nutrition and Allergies (NDA) has been asked by the European Food Safety Authority (EFSA) to draft guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health. This guidance has been drawn from scientific opinions...

    17. Emerging technologies, recent developments, and novel applications for drug metabolite identification.

      Science.gov (United States)

      Lu, Wenjie; Xu, Youzhi; Zhao, Yinglan; Cen, Xiaobo

      2014-01-01

      Drug metabolite identification and metabolic characteristics analysis play a crucial role in new drug research and development, because they can lead to varied efficacy, severe adverse reactions, and even toxicity. Classical methodologies for metabolite identification have mainly been based on mass spectrometry (MS) coupled with gas chromatography (GC) or liquid chromatography (LC), and some other techniques are used as complementary approaches, such as nuclear magnetic resonance (NMR). Over the past decade, more and more newly emerging techniques or technologies have been applied to metabolite identification, and are making the procedure easier and more robust, such as LC-NMR-MS, ion mobility MS, ambient ionization techniques, and imaging MS. A novel application of drug metabolite identification based on "omics" known as pharmacometabonomics is discussed, which is an interdisciplinary field that combines pre-dose metabolite profiling and chemometrics methods for data analysis and modeling, aiming to predict the responses of individuals to drugs.

    18. Stereotipik Davranışların Azaltılmasında Kullanılan Yöntemlerin Etkililiği: Betimsel ve Meta Analizi

      Directory of Open Access Journals (Sweden)

      Özlem Toper Korkmaz

      2010-07-01

      Full Text Available Yineleyici, tekrarlanan davranış olarak tanımlanan stereotipi, farklı gelişimsel yetersizlik türlerinde görülmekle beraber, yaygın olarak otistik bozukluk (otizm gösteren bireylerde de gözlenmekte ve otistik bozukluğun ayırıcı tanı ölçütlerinden birini oluşturmaktadır. Geçmişten günümüze çeşitli yöntemlerin stereotipik davranışların azaltılmasında kullanıldığı görülmektedir. Bu çalışmada da stereotipik davranışların azaltılmasında kullanılan yöntemlerin etkililiklerini incelemek amaçlanmıştır. Bu amaçla 1996 ile 2010 yılları arasında tarama yapılarak otistik bozukluk gösteren bireylerde vokal ya da motor stereotipi veya her ikisinin birden azaltılmasının amaçlandığı toplam 18 araştırma betimsel ve meta analizi yapılarak incelenmiştir. Araştırmanın betimsel analiz sonuçları stereotipik davranışların azaltılmasında kullanılan yöntemlerin etkili olduğunu gösterirken, meta analizi sonuçları yöntemlerin “şüpheli” olduğu sonucunu göstermiştir. Stereotypic behavior is defined repetitive behaviors observed various types of developmental disorders, especially in autism and is also a discriminative criterion to diagnose the autism. Various procedures have been used to reduce the stereotypic behaviors in individuals with these behaviors. The purpose of this study is to investigate the procedures’ effectiveness about reducing the stereotypic behaviors. A total of 18 studies were examined published in between 1996 and 2010 about reducing vocal stereotypy, motor stereotypy or both of them. Descriptive and meta-analysis were carried out on these studies. Whereas results of descriptive analysis revealed that the examined procedures are effective to reduce the stereotypic behaviors, results of meta-analysis showed that these procedures are “uncertain”.

    19. Nanodiamonds as novel nanomaterials for biomedical applications: drug delivery and imaging systems.

      Science.gov (United States)

      Kaur, Randeep; Badea, Ildiko

      2013-01-01

      Detonation nanodiamonds (NDs) are emerging as delivery vehicles for small chemical drugs and macromolecular biotechnology products due to their primary particle size of 4 to 5 nm, stable inert core, reactive surface, and ability to form hydrogels. Nanoprobe technology capitalizes on the intrinsic fluorescence, high refractive index, and unique Raman signal of the NDs, rendering them attractive for in vitro and in vivo imaging applications. This review provides a brief introduction of the various types of NDs and describes the development of procedures that have led to stable single-digit-sized ND dispersions, a crucial feature for drug delivery systems and nanoprobes. Various approaches used for functionalizing the surface of NDs are highlighted, along with a discussion of their biocompatibility status. The utilization of NDs to provide sustained release and improve the dispersion of hydrophobic molecules, of which chemotherapeutic drugs are the most investigated, is described. The prospects of improving the intracellular delivery of nucleic acids by using NDs as a platform are exemplified. The photoluminescent and optical scattering properties of NDs, together with their applications in cellular labeling, are also reviewed. Considering the progress that has been made in understanding the properties of NDs, they can be envisioned as highly efficient drug delivery and imaging biomaterials for use in animals and humans.

    20. Current applications of miniaturized chromatographic and electrophoretic techniques in drug analysis.

      Science.gov (United States)

      Aturki, Zeineb; Rocco, Anna; Rocchi, Silvia; Fanali, Salvatore

      2014-12-01

      In the last decade, miniaturized separation techniques have become greatly popular in pharmaceutical analysis. Miniaturized separation methods are increasingly utilized in all processes of drug discovery as well as quality control of pharmaceutical preparation. The great advantages presented by the analytical miniaturized techniques, including high separation efficiency and resolution, rapid analysis and minimal consumption of reagents and samples, make them an attractive alternative to the conventional chromatographic methods for drug analysis. The purpose of this review is to give a general overview of the applicability of capillary electrophoresis (CE), capillary electrochromatography (CEC) and micro/capillary/nano-liquid chromatography (micro-LC/CLC/nano-LC) for the analysis of pharmaceutical formulations, active pharmaceutical ingredients (API), drug impurity testing, chiral drug separation, determination of drugs and metabolites in biological fluids. The results concerning the use of CEC, micro-LC, CLC, and nano-LC in the period 2009-2013, while for CE, those from 2012 up to the review draft are here summarized and some specific examples are discussed. Copyright © 2014 Elsevier B.V. All rights reserved.

    1. Farklı stres koşullarında Rhodotorula glutinis’ten antioksidan üretimi için biyoproses koşullarının geliştirilmesi

      OpenAIRE

      ÜNLÜ BÜYÜKTOPÇU, Ayşe Ezgi

      2012-01-01

         Çalışmada, antioksidan enzimler sınıfında yer alan süperoksit dismutaz (SOD) ve katalaz (KAT) enzimlerinin, Rhodotorula glutinis mayasından yüksek aktivite ile üretimi için biyoproses koşulları araştırılmıştır. Küçük ölçek (100 ml) ve kesikli işletimde sıcaklık, başlangıç ph değeri, karbon ve azot kaynaklarının etkisi incelendikten sonra, deney tasarımı yapılmıştır. SOD aktivitesinin optimum koşullarında küçük ...

    2. Nanodiamonds as novel nanomaterials for biomedical applications: drug delivery and imaging systems

      Directory of Open Access Journals (Sweden)

      Kaur R

      2013-01-01

      Full Text Available Randeep Kaur, Ildiko BadeaDrug Design and Discovery Research Group, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, CanadaAbstract: Detonation nanodiamonds (NDs are emerging as delivery vehicles for small chemical drugs and macromolecular biotechnology products due to their primary particle size of 4 to 5 nm, stable inert core, reactive surface, and ability to form hydrogels. Nanoprobe technology capitalizes on the intrinsic fluorescence, high refractive index, and unique Raman signal of the NDs, rendering them attractive for in vitro and in vivo imaging applications. This review provides a brief introduction of the various types of NDs and describes the development of procedures that have led to stable single-digit-sized ND dispersions, a crucial feature for drug delivery systems and nanoprobes. Various approaches used for functionalizing the surface of NDs are highlighted, along with a discussion of their biocompatibility status. The utilization of NDs to provide sustained release and improve the dispersion of hydrophobic molecules, of which chemotherapeutic drugs are the most investigated, is described. The prospects of improving the intracellular delivery of nucleic acids by using NDs as a platform are exemplified. The photoluminescent and optical scattering properties of NDs, together with their applications in cellular labeling, are also reviewed. Considering the progress that has been made in understanding the properties of NDs, they can be envisioned as highly efficient drug delivery and imaging biomaterials for use in animals and humans.Keywords: dispersion, surface functionalization, toxicity, carriers, fluorescence, light scattering

    3. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary Reference Values for carbohydrates and dietary fibre

      OpenAIRE

      Tetens, Inge

      2011-01-01

      This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) deals with the establishment of Dietary Reference Values for carbohydrates and dietary fibre. Nutritionally, two broad categories of carbohydrates can be differentiated: “glycaemic carbohydrates”, i.e. carbohydrates digested and absorbed in the human small intestine, and „dietary fibre‟, non-digestible carbohydrates passing to the large intestine. In this Opinion, dietary fibre is defined as non-digestible car...

    4. Ortaöğretim Tarih Ders Kitaplarında Yer Alan Barış ve Antlaşmalar Üzerine Bir Değerlendirme

      Directory of Open Access Journals (Sweden)

      Özgür Aktaş

      2013-05-01

      Full Text Available Bu çalışmanın amacı ortaöğretim tarih ders kitaplarında yer alan antlaşma ve barış konularının içeriğinin nasıl düzenlendiğini değerlendirmektir. Araştırmanın yöntemi doküman analizine dayanmaktadır. Bu çalışmada ders kitaplarında anlatılan antlaşmaların anlatılış tarzları tespit edilmiştir. Antlaşmalar iki gruba ayrılarak değerlendirilmiştir. Birincisi doğrudan anlatılan antlaşmalar, ikincisiyse bir parça ya da metin içerisinde anlatılan antlaşmalardır. Ortaöğretim tarih ders kitaplarına bakıldığında antlaşmalar ve barışlar önemli oranda yer tutmaktadır. Tarih ders kitaplarında savaşlar ve antlaşmalar anlatılırken zengin görsellerin kullanıldığı görülmektedir. Bununla beraber antlaşmalar anlatılırken akıl yürütme, tartışma, eleştirel düşünme gibi tekniklerin kullanılmasında eksiklikler olduğu görülmektedir. Türkiye Cumhuriyeti İnkılâp Tarihi ve Atatürkçülük tarih ders kitabında antlaşmalar çoğunlukla doğrudan anlatılmıştır. Çağdaş Türk ve Dünya Tarihi dersinin programına alınması öğrencilerinde bilmeleri gereken savaşları ve antlaşmaları da fazlasıyla arttırmıştır. Bu antlaşmaların daha iyi anlatılmasının en iyi yolunun konunun öğretimini kolaylaştıracak etkinlik kitaplarının geliştirilmesi olduğu düşünülmektedir. Anahtar Kelimeler: Savaş, Antlaşma, Barış, Tarih, Tarih Eğitimi  A Study into Peaces and Treaties in the History Course Books of Secondary EducationAbstract: The purpose of the current study was to investigate how the content of the treaties and peace subjects in the history course books of secondary education was arranged. The method of the research based on document analysis. In this study, the styles of giving the treaties told in the course books were determined. The treaties were classified in two groups and analysed. First one was the treaties directly told and the second one was

    5. Dağıtım Kanallarında Çatışma Nasıl Önlenebilir?/Prevention of Conflict in Distribution Channels

      OpenAIRE

      Güreş, Nuriye

      2014-01-01

      Müşteri memnuniyetinin önem kazandığı günümüzde, müşterinin talep ettiği ürün ve hizmetleri doğru yerde, doğru zamanda ve doğru fiyattan sunmak işletmeler açısından büyük önem arz etmektedir. Bu noktada, ürün ve hizmetlerin müşterilere ulaştırılmasında etkin rol oynayan dağıtım kanallarının önemi ortaya çıkmaktadır. Dolayısıyla bu çalışmada, müşterilere istedikleri ürün ve hizmetleri ulaştırmada çok önemli yeri olan dağıtım kanalları üzerinde durularak, dağıtım kanallarında çeşitli sebeplerl...

    6. Mesoporous Silica Nanomaterials for Applications in Catalysis, Sensing, Drug Delivery and Gene Transfection

      Energy Technology Data Exchange (ETDEWEB)

      Radu, Daniela Rodica [Iowa State Univ., Ames, IA (United States)

      2004-01-01

      The central theme of this dissertation is represented by the versatility of mesoporous silica nanomaterials in various applications such as catalysis and bio-applications, with main focus on biological applications of Mesoporous Silica Nanospheres (MSN). The metamorphosis that we impose to these materials from catalysis to sensing and to drug and gene delivery is detailed in this dissertation. First, we developed a synthetic method that can fine tune the amount of chemically accessible organic functional groups on the pores surface of MSN by exploiting electrostatic and size matching between the cationic alkylammonium head group of the cetyltrimethylammonium bromide (CTAB) surfactant and various anionic organoalkoxysilane precursors at the micelle-water interface in a base-catalyzed condensation reaction of silicate. Aiming nature imitation, we demonstrated the catalytic abilities of the MSNs, We utilized an ethylenediamine functional group for chelating Cu2+ as a catalytic functional group anchored inside the mesopores. Thus, a polyalkynylene-based conducting polymer (molecular wire) was synthesized within the Cu-functionalized MSNs silica catalyst. For sensing applications, we have synthesized a poly(lactic acid) coated mesoporous silica nanosphere (PLA-MSN) material that serves as a fluorescence sensor system for detection of amino-containing neurotransmitters in neutral aqueous buffer. We exploited the mesoporosity of MSNs for encapsulating pharmaceutical drugs. We examined bio-friendly capping molecules such as polyamidoamine dendrimers of generations G2 to G4, to prevent the drug leaching. Next, the drug delivery system employed MSNs loaded with Doxorubicin, an anticancer drug. The results demonstrated that these nano-Trojan horses have ability to deliver Doxorubicin to cancer cells and induce their death. Finally, to demonstrate the potential of MSN as an universal cellular transmembrane nanovehicle, we anchored positively charged dendrimers on

    7. Nanotechnology-based polymeric bio(muco)adhesive platforms for controlling drug delivery - properties, methodologies and applications

      International Nuclear Information System (INIS)

      Carvalho, Flavia Chiva; Chorilli, Marlus; Gremiao, Maria Palmira Daflon

      2014-01-01

      Studies using bio(muco)adhesive drug delivery systems have recently gained great interest, which can promote drug targeting and more specific contact of the drug delivery system with the various absorptive membranes of the body. This technological platform associated with nanotechnology offers potential for controlling drug delivery; therefore, they are excellent strategies to increase the bioavailability of drugs. The objective of this work was to study nanotechnology-based polymeric bio(muco)adhesive platforms for controlling drug delivery, highlighting their properties, how the bio(muco)adhesion can be measured and their potential applications for different routes of administration. (author)

    8. Antimicrobial Peptides: Multifunctional Drugs for Different Applications

      Directory of Open Access Journals (Sweden)

      Lea-Jessica Albrecht

      2012-02-01

      Full Text Available Antimicrobial peptides (APs are an important part of the innate immune system in epithelial and non-epithelial surfaces. So far, many different antimicrobial peptides from various families have been discovered in non-vertebrates and vertebrates. They are characterized by antibiotic, antifungal and antiviral activities against a variety of microorganisms. In addition to their role as endogenous antimicrobials, APs participate in multiple aspects of immunity. They are involved in septic and non-septic inflammation, wound repair, angiogenesis, regulation of the adaptive immune system and in maintaining homeostasis. Due to those characteristics AP could play an important role in many practical applications. Limited therapeutic efficiency of current antimicrobial agents and the emerging resistance of pathogens require alternate antimicrobial drugs. The purpose of this review is to highlight recent literature on functions and mechanisms of APs. It also shows their current practical applications as peptide therapeutics and bioactive polymers and discusses the possibilities of future clinical developments.

    9. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on Dietary Reference Values for protein

      DEFF Research Database (Denmark)

      Tetens, Inge

      This opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) deals with the setting of Dietary Reference Values (DRVs) for protein. The Panel concludes that a Population Reference Intake (PRI) can be derived from nitrogen balance studies. Several health outcomes possibly...... for growth and maintenance. For pregnancy, an intake of 1, 9 and 28 g/d in the first, second and third trimesters, respectively, is proposed in addition to the PRI for non-pregnant women. For lactation, a protein intake of 19 g/d during the first six months, and of 13 g/d after six months, is proposed...

    10. Eğirdir orman fidanlığı’nda diken ardıcı (Juniperus oxycedrus fidan yetiştirme sıklığının fidan morfolojisine etkileri

      Directory of Open Access Journals (Sweden)

      Esra ALIM

      2017-07-01

      Full Text Available Bu çalışmada, farklı yetiştirme sıklıklarının diken ardıcı (Juniperus oxycedrus L. subsp. oxycedrus’nın (1+0 çıplak köklü fidanlarının morfolojik özellikleri üzerindeki etkilerini ortaya koymak amaçlanmıştır. Araştırma Eğirdir Orman Fidanlığında kurulan deneme alanlarında yürütülmüştür. Denemede; 1.5 cm, 3 cm, 6 cm ve 9 cm mesafe olacak şekilde kontrol dâhil 5 farklı yetiştirme sıklığı uygulanmıştır. Araştırma sonuçlarına göre diken ardıcı fidanlarının morfolojik özellikleri (kök boğazı çapı, yan kök sayısı, gürbüzlük indisi, kalite indisi, fidan, gövde ve kök taze ağırlıkları ile fidan, gövde ve kök kuru ağırlıkları üzerine yetiştirme sıklığının önemli etkilerinin olduğu belirlenmiştir. Ekim yastıklarında yetiştirme sıklığı azaldıkça daha kalın çaplı, gövde taze ve kuru ağırlığı daha fazla ve daha çok yan kök sayısına sahip olan fidanlar elde edilmiştir. Çalışmada, elde edilen fidanlar arasında en yüksek kök boğazı çapı ve yan kök sayısı kontrol dışındaki ekim sıklıklarından elde edilen fidanlarda olduğu tespit edilmiştir. Fidan ağırlıkları bakımından ise en iyi sonucu 3 cm ekim sıklığı verirken, en düşük sonuç kontrol fidanlarında meydana gelmiştir. Eğirdir Orman Fidanlığı koşullarında 3 cm ekim sıklığının uygulanmasının kaliteli diken ardıcı fidan üretimi için yeterli olacağı düşünülmektedir.

    11. Gamma ray NDA assay system for total plutonium and isotopics in plutonium product solutions

      International Nuclear Information System (INIS)

      Cowder, L.R.; Hsue, S.T.; Johnson, S.S.; Parker, J.L.; Russo, P.A.; Sprinkle, J.K.; Asakura, Y.; Fukuda, T.; Kondo, I.

      1979-01-01

      A LASL-designed gamma-ray NDA instrument for assay of total plutonium and isotopics of product solutions at Tokai-Mura is currently installed and operating. The instrument is, optimally, a densitometer that uses radioisotopic sources for total plutonium measurements at the K absorption edge. The measured transmissions of additional gamma-ray lines from the same radioisotopic sources are used to correct for self-attenuation of passive gamma rays from plutonium. The corrected passive data give the plutonium isotopic content of freshly separated to moderately aged solutions. This off-line instrument is fully automated under computer control, with the exception of sample positioning, and operates routinely in a mode designed for measurement control. A one-half percent precision in total plutonium concentration is achieved with a 15-minute measurement

    12. Application of three-dimensional printing for colon targeted drug delivery systems.

      Science.gov (United States)

      Charbe, Nitin B; McCarron, Paul A; Lane, Majella E; Tambuwala, Murtaza M

      2017-01-01

      Orally administered solid dosage forms currently dominate over all other dosage forms and routes of administrations. However, human gastrointestinal tract (GIT) poses a number of obstacles to delivery of the drugs to the site of interest and absorption in the GIT. Pharmaceutical scientists worldwide have been interested in colon drug delivery for several decades, not only for the delivery of the drugs for the treatment of colonic diseases such as ulcerative colitis and colon cancer but also for delivery of therapeutic proteins and peptides for systemic absorption. Despite extensive research in the area of colon targeted drug delivery, we have not been able to come up with an effective way of delivering drugs to the colon. The current tablets designed for colon drug release depend on either pH-dependent or time-delayed release formulations. During ulcerative colitis the gastric transit time and colon pH-levels is constantly changing depending on whether the patient is having a relapse or under remission. Hence, the current drug delivery system to the colon is based on one-size-fits-all. Fails to effectively deliver the drugs locally to the colon for colonic diseases and delivery of therapeutic proteins and peptides for systemic absorption from the colon. Hence, to overcome the current issues associated with colon drug delivery, we need to provide the patients with personalized tablets which are specifically designed to match the individual's gastric transit time depending on the disease state. Three-dimensional (3D) printing (3DP) technology is getting cheaper by the day and bespoke manufacturing of 3D-printed tablets could provide the solutions in the form of personalized colon drug delivery system. This review provides a bird's eye view of applications and current advances in pharmaceutical 3DP with emphasis on the development of colon targeted drug delivery systems.

    13. Medical applications of membranes: Drug delivery, artificial organs and tissue engineering

      NARCIS (Netherlands)

      Stamatialis, Dimitrios; Papenburg, B.J.; Girones nogue, Miriam; Saiful, S.; Bettahalli Narasimha, M.S.; Schmitmeier, Stephanie; Wessling, Matthias

      2008-01-01

      This paper covers the main medical applications of artificial membranes. Specific attention is given to drug delivery systems, artificial organs and tissue engineering which seem to dominate the interest of the membrane community this period. In all cases, the materials, methods and the current

    14. Application of ion exchange resin in floating drug delivery system.

      Science.gov (United States)

      Upadhye, Abhijeet A; Ambike, Anshuman A; Mahadik, Kakasaheb R; Paradkar, Anant

      2008-10-01

      The purpose of this study was to explore the application of low-density ion exchange resin (IER) Tulsion(R) 344, for floating drug delivery system (FDDS), and study the effect of its particle size on rate of complexation, water uptake, drug release, and in situ complex formation. Batch method was used for the preparation of complexes, which were characterized by physical methods. Tablet containing resin with high degree of crosslinking showed buoyancy lag time (BLT) of 5-8 min. Decreasing the particle size of resin showed decrease in water uptake and drug release, with no significant effect on the rate of complexation and in situ complex formation for both preformed complexes (PCs) and physical mixtures (PMs). Thus, low-density and high degree of crosslinking of resin and water uptake may be the governing factor for controlling the initial release of tablet containing PMs but not in situ complex formation. However, further sustained release may be due to in situ complex formation.

    15. Criticality Safety Evaluation for Small Sample Preparation and Non-Destructive Assay (NDA) Operations in Wing 7 Basement of the CMR Facility

      Energy Technology Data Exchange (ETDEWEB)

      Kunkle, Paige Elizabeth [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Zhang, Ning [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

      2017-08-02

      Nuclear Criticality Safety (NCS) has reviewed the fissionable material small sample preparation and NDA operations in Wing 7 Basement of the CMR Facility. This is a Level-1 evaluation conducted in accordance with NCS-AP-004 [Reference 1], formerly NCS-GUIDE-01, and the guidance set forth on use of the Standard Criticality Safety Requirements (SCSRs) [Reference 2]. As stated in Reference 2, the criticality safety evaluation consists of both the SCSR CSED and the SCSR Application CSED. The SCSR CSED is a Level-3 CSED [Reference 3]. This Level-1 CSED is the SCSR Application CSED. This SCSR Application (Level-1) evaluation does not derive controls, it simply applies controls derived from the SCSR CSED (Level-3) for the application of operations conducted here. The controls derived in the SCSR CSED (Level-3) were evaluated via the process described in Section 6.6.5 of SD-130 (also reproduced in Section 4.3.5 of NCS-AP-004 [Reference 1]) and were determined to not meet the requirements for consideration of elevation into the safety basis documentation for CMR. According to the guidance set forth on use of the SCSRs [Reference 2], the SCSR CSED (Level-3) is also applicable to the CMR Facility because the process and the normal and credible abnormal conditions in question are bounded by those that are described in the SCSR CSED. The controls derived in the SCSR CSED include allowances for solid materials and solution operations. Based on the operations conducted at this location, there are less-than-accountable (LTA) amounts of 233U. Based on the evaluation documented herein, the normal and credible abnormal conditions that might arise during the execution of this process will remain subcritical with the following recommended controls.

    16. Gıdaların İyonize Radyasyonla Muhafazasında Radyasyonun Mikroorganizmalar Üzerine Etkileri

      OpenAIRE

      Özbilgin, Seher; Acar, Jale

      2015-01-01

      Gıdalarda bulunabilen mikroorganizmalar iyonlaştırıcı radyasyonla öldürülmekte veya gelişmeleri durdurulmaktadır. Bu da iyonlaştırıcı radyasyonun direkt veya indirekt etkisiyle gerçekleşmektedir. Mikroorganizmanın cinsi, vejetatif veya spor formda oluşu, ortamın bileşimi ve sıcaklık gibi faktörler ışınlara karşı duyarlılığı etkilemektedir. Mikroorganizmalar arasında bakteriler, küf ve mayalara kıyasla ışınlara daha dirençli olup, sporlu bakteriler ve özellikle C. botulinum’ un ışınlara karşı...

    17. Novel approach for a PTX/VEGF dual drug delivery system in cardiovascular applications-an innovative bulk and surface drug immobilization.

      Science.gov (United States)

      Wulf, Katharina; Teske, Michael; Matschegewski, Claudia; Arbeiter, Daniela; Bajer, Dalibor; Eickner, Thomas; Schmitz, Klaus-Peter; Grabow, Niels

      2018-06-01

      The successive incorporation of several drugs into the polymeric bulk of implants mostly results in loss of considerable quantity of one drug, and/or the loss in quality of the coating and also in changes of drug release time points. A dual drug delivery system (DDDS) based on poly-L-lactide (PLLA) copolymers combining the effective inhibition of smooth muscle cell proliferation while simultaneously promoting re-endothelialization was successfully developed. To overcome possible antagonistic drug interactions and the limitation of the polymeric bulk material as release system for dual drugs, a novel concept which combines the bulk and surface drug immobilization for a DDDS was investigated. The advantage of this DDDS is that the bulk incorporation of fluorescein diacetate (FDAc) (model drug for paclitaxel (PTX)) via spray coating enhanced the subsequent cleavable surface coupling of vascular endothelial growth factor (VEGF) via the crosslinker bissulfosuccinimidyl suberate (BS 3 ). In the presence of the embedded FDAc, the VEGF loading and release are about twice times higher than in absence. Furthermore, the DDDS combines the diffusion drug delivery (FDAc or PTX) and the chemical controlled drug release, VEGF via hydrolysable ester bonds, without loss in quantity and quality of the drug release curves. Additionally, the performed in vitro biocompatibility study showed the bimodal influences of PTX and VEGF on human endothelial EA.hy926 cells. In conclusion, it was possible to show the feasibility to develop a novel DDDS which has a high potential for the medical application due to the possible easy and short modification of a polymer-based PTX delivery system.

    18. Chemical functionalization of hyaluronic acid for drug delivery applications

      Energy Technology Data Exchange (ETDEWEB)

      Vasi, Ana-Maria [“Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental Protection, 73 Prof. dr. docent Dimitrie Mangeron Street, 700050 Iasi (Romania); Popa, Marcel Ionel, E-mail: mipopa@ch.tuiasi.ro [“Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental Protection, 73 Prof. dr. docent Dimitrie Mangeron Street, 700050 Iasi (Romania); Butnaru, Maria [“Grigore T. Popa” University of Medicine Pharmacy, Faculty of Medical Bioengineering, 9-13 Kogalniceanu Street, 700454 Iasi (Romania); Dodi, Gianina [“Gheorghe Asachi” Technical University of Iasi, Faculty of Chemical Engineering and Environmental Protection, 73 Prof. dr. docent Dimitrie Mangeron Street, 700050 Iasi (Romania); SCIENT — Research Center for Instrumental Analysis, S.C. CROMATEC PLUS, 18 Sos. Cotroceni, 060114 Bucharest (Romania); Verestiuc, Liliana [“Grigore T. Popa” University of Medicine Pharmacy, Faculty of Medical Bioengineering, 9-13 Kogalniceanu Street, 700454 Iasi (Romania)

      2014-05-01

      Functionalized hyaluronic acid (HA) derivatives were obtained by ring opening mechanism of maleic anhydride (MA). FTIR and H{sup 1} NMR spectroscopy were used to confirm the chemical linkage of MA on the hyaluronic acid chains. Thermal analysis (TG-DTG and DSC) and GPC data for the new products revealed the formation of new functional groups, without significant changes in molecular weight and thermal stability. New gels based on hyaluronic acid modified derivatives were obtained by acrylic acid copolymerization in the presence of a redox initiation system. The resulted circular and interconnected pores of the gels were visualized by SEM. The release profiles of an ophthalmic model drug, pilocarpine from tested gels were studied in simulated media. Evaluation of the cytotoxicity and cell proliferation properties indicates the potential of the new systems to be used in contact with biological media in drug delivery applications. - Highlights: • New functionalized hyaluronic acid was prepared by ring opening of maleic anhydride. • Gels with circular pores based on acrylic acid copolymerization were formulated. • In vitro drug loading/release profile was evaluated in simulated ophthalmic media. • The cytotoxicity indicates the potential of derivatives to be used in vivo.

    19. Magnetite Nanoparticles Coated with Rifampicin and Chlortetracycline for Drug Delivery Applications

      International Nuclear Information System (INIS)

      Nadejde, Claudia; Ciurlica, Ecaterina Foca-nici; Creanga, Dorina; Carlescu, Aurelian; Badescu, Vasile

      2010-01-01

      Four types of biocompatible magnetic fluids based on superparamagnetic nanoparticles with Fe 3 O 4 cores were functionalized with antibiotics (rifampicin or chlortetracycline) as potential candidates for in vivo biomedical applications, such as magnetically controlled drug delivery. The synthesis consisted in coprecipitation of iron oxide in basic, as well as in acid medium, followed by the dispersion of the resulted magnetite nanoparticles in aqueous solution containing the antibiotic. The chosen method to prepare the magnetite-core/drug-shell systems avoided intermediate organic coating of the magnetic nanoparticles. Comparative analysis of the rheological features of the aqueous magnetic fluid samples was performed. The structural features of the coated magnetic particles were investigated by X-Ray Diffraction (XRD), Transmission Electron Microscopy (TEM) and Vibrating Sample Magnetometry (VSM). Good crystallinity and adequate stability in time were evidenced. Drug delivery curves were spectrophotometrically provided.

    20. Çevre Korunmasında Atığın Atıkla Giderilmesi Prensibi / Principle Of Removal With Waste Of Waste In Environmental Protection

      Directory of Open Access Journals (Sweden)

      Utkan Özdemir

      2012-12-01

      Full Text Available Çevresel problemler göz önüne alındığında, katı atıkların bertarafı birçok dünya ülkesinin temel problemlerinden birisidir. Bu doğrultuda farklı kaynaklarda oluşan ve büyük ölçüde çeşitlilik gösteren katı atıkların bir kısmının tekrar kullanımı hedeflenmektedir. Böylece ekonomik fayda sağlanmaya çalışılmaktadır. Katı atıkların yarattığı çevre kirliliğine, su kaynaklarında meydana gelen ekolojik problemlerin de eklenmesi insanlık için daha büyük risklerin habercisidir. Dolayısıyla katı atıkların bertarafında önemli yeri olan tekrar kullanımın, sadece ekonomik faydası değil, “atığın atıkla giderim” esasına katkısı da tartışılmaya başlanmıştır. Tüketim hızının giderek arttığı dünyada, özellikle tarımsal kökenli atıkların, su arıtımında adsorbent olarak kullanılmasıyla yüksek arıtma verimleri sağlandığı gözlemlenmiştir. Bu durumu takip eden çeşitli araştırmalar, muz kabuğu, ayçiçeği sapı, pirinç kabuğu, portakal kabuğu gibi tarımsal kökenli atıkların yanı sıra kül ve arıtma çamuru gibi atıkların da organik ve inorganik bir takım kirleticilerin su ortamından arıtılmasında önemli rol oynadıklarını göstermiştir. Böylece adsorbent maliyeti nedeniyle çoğu zaman işletmeler tarafından uygun görülmeyen ve pilot ölçekli çalışma olarak kalan adsorpsiyon prosesinin kullanılabilirliğinin arttırılması şansı doğmuştur. Adsorpsiyon proseslerinin yaygınlaştırılması ile atıksu arıtımında elde edilebilecek yüksek verimlerin yanı sıra bu proseslerde adsorbent olarak kullanılan atıkların bertarafı da sağlanmış olacaktır. Aynı zamanda bu durum atıkların başka proseslerde de benzer şekilde değerlendirilmelerinin önünü açmaktadır. Bu çalışmada özellikle endüstriyel bazda kullanımlarında ekonomik ve çevresel faydalar sağlayacak atık kökenli adsorbentlerin türleri ve

    1. Marmara Bölgesi Islah Zonu’nda (200-600 m kızılçam (Pinus brutia Ten. döl denemeleri: 12. yaş sonuçları

      Directory of Open Access Journals (Sweden)

      Yrd.Doç.Dr. Murat ALAN

      2016-07-01

      Full Text Available Marmara Bölgesi Islah Zonu’nda seçilen 158 plus ağaç birinci seri ve altı adet tohum bahçesinde bulunan 160 adetklon ikinci seri olacak şekilde gruplandırılmış, toplanan açık tozlaşma ürünü tohumlardan üretilen fidanlarla iki seri kızılçam (Pinus brutia Ten. döl denemesi kurulmuştur. Deneme alanlarında 12. arazi yaşına ait boy ve göğüs çapı ölçülmüş, bu değerler kullanılarak genetik parametreler ve Best Linear Unbiased Prediction (BLUP yöntemi ile ailelerin ıslah değerleri tahmin edilmiştir. Birinci seri deneme alanlarının ortak değerlendirilmesinde boy ve çap için bireysel kalıtım derecesi sırasıyla 0,24 ve 0,16; aile ortalamaları kalıtım derecesi ise 0,52 ve 0,55; ikinci seri deneme alanlarında bireysel kalıtım derecesi aynı sırayla 0,29 ve 0,12; aile ortalamaları kalıtım derecesi ise 0,54 ve 0,45 olarak hesaplanmıştır. Boy ve göğüs çapı arasındaki genetik korelasyon birinci seri denemelerde 0,48 ve ikinci seri denemelerde ise 0,50 olarak tahmin edilmiştir. Dördüncü yaştaki boy ile 12. yaştaki boy arasında genetik korelasyon birinci seri denemelerde 0,81 ve ikinci seri denemelerde ise 0,70 bulunmuştur. B tipi genetik korelasyonlar ise birinci ve ikinci seride 0,54 - 1,00 arasında tahmin edilmiş, genotip çevre etkileşimi açısından uygulamayı etkileyecek düzeyde bulunmamıştır. Birinci seri denemelerde plus ağaç seçimleriyle genetik kazanç düşük olurken, İkinci seri denemelerde fenotipik tohum bahçelerinden boy için %4, göğüs çapı için %5 en iyi 30 klonla genetik tohum bahçesi kurulduğunda ise yine aynı sırayla %13 ve %11 genetik kazanç tahmin edilmiştir. Boy ve göğüs çapı için en yüksek ıslah değerine ulaşan 32, 35, 40 ve 188 nolu tohum bahçeleri, ağaçlandırmalarda kullanıldığında daha fazla boy ve çapa ulaşabilen bireyler elde edilebileceği anlaşılmıştır.Anahtar Kelimeler: Kalıtım derecesi, ıslah de

    2. 78 FR 48177 - Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin

      Science.gov (United States)

      2013-08-07

      ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0883] Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin AGENCY: Food and Drug... Purdue Pharma L.P. (Purdue), One Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily...

    3. Near-infrared light-responsive liposomal contrast agent for photoacoustic imaging and drug release applications.

      Science.gov (United States)

      Sivasubramanian, Kathyayini; Mathiyazhakan, Malathi; Wiraja, Christian; Upputuri, Paul Kumar; Xu, Chenjie; Pramanik, Manojit

      2017-04-01

      Photoacoustic imaging has become an emerging tool for theranostic applications. Not only does it help in release and therapeutic applications. We explore near-infrared light-sensitive liposomes coated with gold nanostars (AuNSs) for both imaging and drug release applications using a photoacoustic imaging system. Being amphiphilic, the liposomes lipid bilayer and the aqueous core enable encapsulation of both hydrophobic and hydrophilic drugs. The AuNSs on the surface of the liposomes act as photon absorbers due to their intrinsic surface plasmon resonance. Upon excitation by laser light at specific wavelength, AuNSs facilitate rapid release of the contents encapsulated in the liposomes due to local heating and pressure wave formation (photoacoustic wave). Herein, we describe the design and optimization of the AuNSs-coated liposomes and demonstrate the release of both hydrophobic and hydrophilic model drugs (paclitaxel and calcein, respectively) through laser excitation at near-infrared wavelength. The use of AuNSs-coated liposomes as contrast agents for photoacoustic imaging is also explored with tissue phantom experiments. In comparison to blood, the AuNSs-coated liposomes have better contrast (approximately two times) at 2-cm imaging depth.

    4. Kruvaziyer turizmine yönelik tur uygulamalarında değer zinciri analizi

      OpenAIRE

      Öz, Mehmet Doğan

      2015-01-01

      Bu çalışma, değer zinciri yöntemini detaylı bir şekilde incelemenin yanı sıra, kruvaziyer turizmi tur organizasyonunda değer zincirinde yer alması gereken değişkenleri ortaya çıkarmak amacını taşımaktadır. Çalışma nitel araştırma yöntemi ile gerçekleştirilmiş olup, veri toplama aşamasında mülakat tekniği kullanılmıştır. Çalışmada, birincil kaynak olarak Aydın’ın Kuşadası ilçesinde bulunan kruvaziyer turizmi ile ilgili olan seyahat acentelerinden faydalanılmıştır. Bu şirketlerin Kuşadası liman...

    5. Associated-particle sealed-tube neutron generators and hodoscopes for NDA applications

      International Nuclear Information System (INIS)

      Rhodes, E.; Peters, C.W.

      1991-01-01

      With radioisotope sources, gamma-ray transmission hodoscopes can inspect canisters and railcars to monitor rocket motors, can detect nuclear warheads by their characteristic strong gamma-ray absorption, or can count nuclear warheads inside a missile by low-resolution tomography. Intrinsic gamma-ray radiation from warheads can also be detected in a passive mode. Neutron hodoscopes can use neutron transmission, intrinsic neutron emission, or reactions stimulated by a neutron source, in treaty verification roles. Gamma-ray and neutron hodoscopes can be combined with a recently developed neutron diagnostic probe system, based on a unique associated-particle sealed-tube neutron generator (APSTNG) that interrogates the object of interest with a low-intensity beam of 14-MeV neutrons, and that uses flight-time to electronically collimate transmitted neutrons and to tomographically image nuclides identified by reaction gamma-rays. Gamma-ray spectra of resulting neutron reactions identify nuclides associated with all major chemicals in chemical warfare agents, explosives, and drugs, as well as many pollutants and fissile and fertile special nuclear material. 5 refs., 12 figs

    6. Theory and Applications of Covalent Docking in Drug Discovery: Merits and Pitfalls

      Directory of Open Access Journals (Sweden)

      Hezekiel Mathambo Kumalo

      2015-01-01

      Full Text Available he present art of drug discovery and design of new drugs is based on suicidal irreversible inhibitors. Covalent inhibition is the strategy that is used to achieve irreversible inhibition. Irreversible inhibitors interact with their targets in a time-dependent fashion, and the reaction proceeds to completion rather than to equilibrium. Covalent inhibitors possessed some significant advantages over non-covalent inhibitors such as covalent warheads can target rare, non-conserved residue of a particular target protein and thus led to development of highly selective inhibitors, covalent inhibitors can be effective in targeting proteins with shallow binding cleavage which will led to development of novel inhibitors with increased potency than non-covalent inhibitors. Several computational approaches have been developed to simulate covalent interactions; however, this is still a challenging area to explore. Covalent molecular docking has been recently implemented in the computer-aided drug design workflows to describe covalent interactions between inhibitors and biological targets. In this review we highlight: (i covalent interactions in biomolecular systems; (ii the mathematical framework of covalent molecular docking; (iii implementation of covalent docking protocol in drug design workflows; (iv applications covalent docking: case studies and (v shortcomings and future perspectives of covalent docking. To the best of our knowledge; this review is the first account that highlights different aspects of covalent docking with its merits and pitfalls. We believe that the method and applications highlighted in this study will help future efforts towards the design of irreversible inhibitors.

    7. Convective transport of highly plasma protein bound drugs facilitates direct penetration into deep tissues after topical application

      Science.gov (United States)

      Dancik, Yuri; Anissimov, Yuri G; Jepps, Owen G; Roberts, Michael S

      2012-01-01

      AIMS To relate the varying dermal, subcutaneous and muscle microdialysate concentrations found in man after topical application to the nature of the drug applied and to the underlying physiology. METHODS We developed a physiologically based pharmacokinetic model in which transport to deeper tissues was determined by tissue diffusion, blood, lymphatic and intersitial flow transport and drug properties. The model was applied to interpret published human microdialysis data, estimated in vitro dermal diffusion and protein binding affinity of drugs that have been previously applied topically in vivo and measured in deep cutaneous tissues over time. RESULTS Deeper tissue microdialysis concentrations for various drugs in vivo vary widely. Here, we show that carriage by the blood to the deeper tissues below topical application sites facilitates the transport of highly plasma protein bound drugs that penetrate the skin, leading to rapid and significant concentrations in those tissues. Hence, the fractional concentration for the highly plasma protein bound diclofenac in deeper tissues is 0.79 times that in a probe 4.5 mm below a superficial probe whereas the corresponding fractional concentration for the poorly protein bound nicotine is 0.02. Their corresponding estimated in vivo lag times for appearance of the drugs in the deeper probes were 1.1 min for diclofenac and 30 min for nicotine. CONCLUSIONS Poorly plasma protein bound drugs are mainly transported to deeper tissues after topical application by tissue diffusion whereas the transport of highly plasma protein bound drugs is additionally facilitated by convective blood, lymphatic and interstitial transport to deep tissues. PMID:21999217

    8. Bazı Çemen (Trigonella foenum-graecum Hatlarında Yağ ve Yağ Asitleri Bileşenlerinin Araştırılması

      Directory of Open Access Journals (Sweden)

      Mehmet Küçük

      2015-02-01

      Full Text Available Bu çalışmada, Ankara Üniversitesi, Ziraat Fakültesi, Tarla Bitkileri Bölümü’nde geliştirilen 7 çemen hattının ve 1 standart çeşidin yağ oranları ve yağ asidi bileşenleri araştırılmıştır. Araştırma sonuçlarına göre, yağ oranları %4.01 ile %5.89 arasında değişim göstermiştir. Çemen hatlarında en yüksek yağ asidi olarak linoleik asit bulunmuş, bunu sırasıyla linolenik, oleik ve miristik asitler izlemiştir. Ortalama değerler olarak %44.64 linoleik asit, %23.12 linolenik asit, %19.34 oleik ve %10.24 miristik asit değerleri elde edilmiştir.

    9. Ziştovi ve Yaş Antlaşması Arasında Tuna Kıyısında Bir Osmanlı Kenti: Silistre (1791–1793 The Danube Coast Between The Treaty Of Ziştovi And Yaş An Ottoman City: Silistra (1791 – 1793

      Directory of Open Access Journals (Sweden)

      Hava SELÇUK

      2013-07-01

      Full Text Available Silistra Otoman Empire was an important port city on the banksthe Danube River. Therefore, especially in the river trade and battelswere important tasks. The Province of Silistra had a strategical importance by economical and military means. İt was also on the route of Ottoman-Russian and Otoman-Austria wars geographically. Silistra which is consulted both İbrail and rationing of İstanbul has an important function (cureal, hardtack, Weapons etc.. This study has been used as a source the book number 50 of Şeryiyye registries((1791-1793. Before and after the book number 50 in these treaties treaties from Silistra political, social, economic, and military issues contains information . Ser’iyye Sicilleri, that's court records, is an important source in revealing the political, judicial and social conditions of Ottoman society. Seri'yye Sicili Numbered 50 of Silistra, at Bulgarian archive “National Biblioteque”, forms the backbone of this paper. The record book in question includes 233 documents covering (apostasy, Austrian Prisoners such the economic and social events as heritage cases, family, appointment decisions of some officials, ship building, ambassy, tax (cereal, duhan, adat-ı ağnam. Bandit, the grain ship with move conversion topics are explored. The imperial orders (ferman and emir which all shed light on the military issues have been recorded in the ser'iye sicilleri. Based on the court records between 1791 and 1793 of Silistra, it will be mentioned about the social life of the town. Silistre Osmanlı Devleti’nin Tuna Nehri kıyısında bulunan önemlibir liman kenti idi. Bu nedenle özellikle nehir ticareti ve donanmasavaşlarında önemli görevler üslenmekte idi. Ekonomik ve askerî açıdanstratejik bir konuma sahip olan Silistre coğrafi açıdan da Osmanlı-Rusve Osmanlı-Avusturya savaşlarının ana güzergâhı üzerindeydi. Bunedenle Silistre gerek İbrail, gerek İstanbul’un iaşe ihtiyacınınkarşılanmasında

    10. User profiles of a smartphone application to support drug adherence--experiences from the iNephro project.

      Directory of Open Access Journals (Sweden)

      Stefan Becker

      Full Text Available PURPOSE: One of the key problems in the drug therapy of patients with chronic conditions is drug adherence. In 2010 the initiative iNephro was launched (www.inephro.de. A software to support regular and correct drug intake was developed for a smartphone platform (iOS. The study investigated whether and how smartphone users deployed such an application. METHODS: Together with cooperating partners the mobile application "Medikamentenplan" ("Medication Plan" was developed. Users are able to keep and alter a list of their regular medication. A memory function supports regular intake. The application can be downloaded free of charge from the App Store™ by Apple™. After individual consent of users from December 2010 to April 2012 2042338 actions were recorded and analysed from the downloaded applications. Demographic data were collected from 2279 users with a questionnaire. RESULTS: Overall the application was used by 11688 smartphone users. 29% (3406/11688 used it at least once a week for at least four weeks. 27% (3209/11688 used the application for at least 84 days. 68% (1554/2279 of users surveyed were male, the stated age of all users was between 6-87 years (mean 44. 74% of individuals (1697 declared to be suffering from cardiovascular disease, 13% (292 had a previous history of transplantation, 9% (205 were suffering from cancer, 7% (168 reported an impaired renal function and 7% (161 suffered from diabetes mellitus. 69% (1568 of users were on <6 different medications, 9% (201 on 6 - 10 and 1% (26 on more than 10. CONCLUSION: A new smartphone application, which supports drug adherence, was used regularly by chronically ill users with a wide range of diseases over a longer period of time. The majority of users so far were middle-aged and male.

    11. Derin Yapı Yüzey Yapı İlişkisi Bağlamında Temel Dil Becerileri Üzerine Bir Analiz Çalışması

      Directory of Open Access Journals (Sweden)

      Bilginer ONAN

      2015-07-01

      Full Text Available Bu çalışmada, derin yapı yüzey yapı ilişkileri bağlamında, ana dili eğitiminde temel dil becerileri olarak kabul edilen dinleme, konuşma, okuma ve yazma kavramları analiz edilmiştir. Birinci bölümde, ilk kez Port Royal Gramer Okulu tarafından ortaya konan ve 1960’larda Noam Chomsky tarafından Üretimci Dönüşümsel Dil Bilgisi kuramıyla tekrar gündeme getirilen derin yapı ve yüzey yapı kavramları hakkında bilgi verilmiştir. Çalışmanın ikinci bölümünde ise derin yapı ve yüzey yapı ilişkileri çerçevesinde dinleme, konuşma, okuma ve yazma becerileri analiz edilmiştir. Çalışmanın amacı, dilin iki temel boyutu olan anlam ve biçim ilişkileri bağlamında, temel dil becerilerinin eğitimi sürecinde belirleyici olan unsurları tespit ederek, sürecin programlanmasına yönelik öneriler geliştirmektir. Çalışma çerçevesinde yapılan analizlerde boğumlama, bürün olguları, beden dili, üretici kelime hazinesi, alıcı kelime hazinesi, akıcılık, metin türü, yazım ve noktalama, bağdaşıklık, tutarlılık, ön bilgi, kelime tanıma, kelime ayırt etme, edinilmiş bilgi, önvarsayım, sezdirim kavramlarının derin yapı yüzey yapı ilişkileri bağlamında temel dil becerilerinin geliştirilmesinde süreci etkileyen unsurlar olduğu tespit edilmiştir. Bu kavramlar arasında boğumlama, bürün olgusu, beden dili, akıcılık, bağdaşıklık, metin türü, kelime tanıma, kelime ayırt etme, yazım ve noktalama, doğrudan yüzey yapıyla ilgilidir. Üretici kelime hazinesi, akıcılık, alıcı kelime hazinesi, tutarlılık, ön bilgi, edinilmiş bilgi, önvarsayım ve sezdirim kavramları ise derin yapıyı ilgilendirmektedir. Akıcılık kavramının bütün dil becerileriyle ilgili olduğu belirlenmiştir.

    12. High intensity focused ultrasound technology, its scope and applications in therapy and drug delivery.

      Science.gov (United States)

      Phenix, Christopher Peter; Togtema, Melissa; Pichardo, Samuel; Zehbe, Ingeborg; Curiel, Laura

      2014-01-01

      Ultrasonography is a safe, inexpensive and wide-spread diagnostic tool capable of producing real-time non-invasive images without significant biological effects. However, the propagation of higher energy, intensity and frequency ultrasound waves through living tissues can induce thermal, mechanical and chemical effects useful for a variety of therapeutic applications. With the recent development of clinically approved High Intensity Focused Ultrasound (HIFU) systems, therapeutic ultrasound is now a medical reality. Indeed, HIFU has been used for the thermal ablation of pathological lesions; localized, minimally invasive ultrasound-mediated drug delivery through the transient formation of pores on cell membranes; the temporary disruption of skin and the blood brain barrier; the ultrasound induced break-down of blood clots; and the targeted release of drugs using ultrasound and temperature sensitive drug carriers. This review seeks to engage the pharmaceutical research community by providing an overview on the biological effects of ultrasound as well as highlighting important therapeutic applications, current deficiencies and future directions.

    13. Nanotechnology in drug delivery and tissue engineering: from discovery to applications.

      Science.gov (United States)

      Shi, Jinjun; Votruba, Alexander R; Farokhzad, Omid C; Langer, Robert

      2010-09-08

      The application of nanotechnology in medicine, referred to as nanomedicine, is offering numerous exciting possibilities in healthcare. Herein, we discuss two important aspects of nanomedicine, drug delivery and tissue engineering, highlighting the advances we have recently experienced, the challenges we are currently facing, and what we are likely to witness in the near future.

    14. Nanotechnology in Drug Delivery and Tissue Engineering: From Discovery to Applications

      OpenAIRE

      Shi, Jinjun; Votruba, Alexander R.; Farokhzad, Omid C.; Langer, Robert

      2010-01-01

      The application of nanotechnology in medicine, referred to as nanomedicine, is offering numerous exciting possibilities in healthcare. Herein, we discuss two important aspects of nanomedicine—drug delivery and tissue engineering—highlighting the advances we have recently experienced, the challenges we are currently facing, and what we are likely to witness in the near future.

    15. Applications of covalent organic frameworks (COFs): From gas storage and separation to drug delivery

      Institute of Scientific and Technical Information of China (English)

      Ming-Xue Wu; Ying-Wei Yang

      2017-01-01

      Covalent organic frameworks (COFs) are an emerging class of porous covalent organic structures whose backbones were composed of light elements (B,C,N,O,Si) and linked by robust covalent bonds to endow such material with desirable properties,i.e.,inherent porosity,well-defined pore aperture,ordered channel structure,large surface area,high stability,and multi-dimension.As expected,the abovementioned properties of COFs broaden the applications of this class of materials in various fields such as gas storage and separation,catalysis,optoelectronics,sensing,small molecules adsorption,and drug delivery.In this review,we outlined the synthesis of COFs and highlighted their applications ranging from the initial gas storage and separation to drug delivery.

    16. İkinci Dünya Savaşı Sonrasında Sovyet Tehdidi Karşısında Kalan Türkiye'nin Batı İle İşbirliği Yapma Süreci After the Second World War Against the Soviet Threat in Western Turkey to Cooperate With the Remaining Process

      Directory of Open Access Journals (Sweden)

      Osman YALÇIN

      2013-07-01

      Full Text Available Second World War began on the ashes of First World War.Unresolved problems were the main reason that caused The SecondWorld War. Turkey did not bow to pressures and started a new period oftime giving a National Combat. However, Second World War causedimportant problems for Turkey too. Import and export rates decreased.As soon as Second World War was over, although both sides laidtheir arms, Turkey had to keep 1.700.000 armed soldiers. Economicalproblems and being threatened by Soviets were quite important problemareas. In this situation, Turkey tried to find different ways to improve itsrelations with Western countries. American aid was received to meet therequirements of Turkish Army. American aid is known as TrumanDoctrine and Marshal Aid. Turkey which was included into this aid wassupported in this extent. As a result of this support, weapon systems were bought very cheap. After a while, substitute parts of those weapon systems created important cost.Turkey, took pain over being active member of international organizations, too. Being a member of United Nations, Turkey sent troops Korean War and attended the war there. Turkish army showed great bravery. After this success and determination, Turkey strengthened its position in international area being a NATO member. As a result of this situation, Turkey both took itself secure position against Soviet threat and has become a country which gives important support to peace since 1950s. Latest examples of this are Bosnian War, Kosovo Expedition and Afghanistan Expedition. İkinci Dünya Savaşı, Birinci Dünya Savaşı’nın külleri üzerinde başlamıştır. Çözümsüz kalan uluslar arası sorunlar bu savaşın en önemli nedeni olmuştur. Türkiye Batılı devletlerin dayatmalarına boyun eğmemiş ve Milli Mücadele vererek yeni bir dönem başlatmıştır. Ne var ki, 2. Dünya Savaşı Türkiye için de önemli sorunlara neden olmuştur. Savaş yıllarında ithalat ve ihracat miktarı d

    17. Zile Elbaşoğlu Camii’nin Sıvalar Altında Kalan Gizemi The Mystery Of The Zile-Elbaşoğlu Mosque Remains Under Plasters

      Directory of Open Access Journals (Sweden)

      Ali Murat AKTEMUR

      2013-09-01

      Full Text Available Elbaşoğlu Mosque was built in 1801 by Ahmet Aga, clean-cutstone architecture, square, rectangular with remarkable inscriptionsElbaşoğlu Mosque is one of the local mosque, wood-backed and woodenceilings. Until 2007, the walls and the ceiling, and even the altar,wooden support, wood columns, wooden gallery, galleries, in short, allthe wooden elements of the mosque was covered with oil on sweet-limeplaster. In 2007, during the repair of the roof of a simple chance, withplaster falling due to the flowing water under the pen-and-repair workon the emergence of ornaments and wooden decorations samples, thenstopped cleaning and scraper operations in the administration of theGeneral Directorate of Foundations in the interior of the mosque penrichsamples of work, with examples of wooden decorative plaster underthe mystery was revealed.Cover at the top of the walls combined with Harim calligraphy ona black background with spots, including a concave border of the beltframed verse was written. Verse generation raised on the corners of theceiling moldings created crash of beads, triangle, octagon in the middleof a field, and thus created the split surfaces. Located in the middle ofthe octagon octagon-shaped belly, finished with carving technique,baroque decorated with floral motifs. the four corners of the triangularroof panels are decorated with reliefs excess plastic plant. Pen-workdecoration floral motifs on the walls, gallery, pulpits, pillars, such asthe carved wooden elements fall floral and geometric motifs are carvedin the mosque offers a wealth of eye-catching as almost free space left.Made in 1801, in the early years of the Republic, the region'sunique sweet-lime paint on plaster taken off this rich decoration, woodart and pen-work ornamentation Turkey offers one of the richest. Tokat Zile’de Elbaşoğlu Ahmet Ağa tarafından 1801 yılında inşa ettirilen, düzgün kesme taş mimarisi, kitabeleri ile dikkat çeken, kareye yakın dikd

    18. Nicole Krauss’un Aşkın Tarihi Adlı Romanında Tarihi İzlekler

      OpenAIRE

      KALAY, Faruk

      2014-01-01

      Modern edebiyatta önemli Yahudi Amerikan yazarlarından olan Nicole Krauss Yahuditoplumundaki yabancılaşma, yalnızlık ve göç konularına değinir. Başarılı romanı olanAşkın Tarihi II. Dünya Savaşı süresince Holokost’a maruz kalan ve etkilerini hissedenYahudi karakterle ilgilidir. Tarihle bütünleşen bu karakterler gerçek hayattakiinsanlardan ve olaylardan esinlenmiştir. Krauss romanında postmodern teknikleri dekullanır. Örneğin iç içe anlatım tekniği okuyucuya romanın kurgusal mı yoksa gerçek mio...

    19. A Review of the Effect of Processing Variables on the Fabrication of Electrospun Nanofibers for Drug Delivery Applications

      Directory of Open Access Journals (Sweden)

      Viness Pillay

      2013-01-01

      Full Text Available Electrospinning is a fast emerging technique for producing ultrafine fibers by utilizing electrostatic repulsive forces. The technique has gathered much attention due to the emergence of nanotechnology that sparked worldwide research interest in nanomaterials for their preparation and application in biomedicine and drug delivery. Electrospinning is a simple, adaptable, cost-effective, and versatile technique for producing nanofibers. For effective and efficient use of the technique, several processing parameters need to be optimized for fabricating polymeric nanofibers. The nanofiber morphology, size, porosity, surface area, and topography can be refined by varying these parameters. Such flexibility and diversity in nanofiber fabrication by electrospinning has broadened the horizons for widespread application of nanofibers in the areas of drug and gene delivery, wound dressing, and tissue engineering. Drug-loaded electrospun nanofibers have been used in implants, transdermal systems, wound dressings, and as devices for aiding the prevention of postsurgical abdominal adhesions and infection. They show great promise for use in drug delivery provided that one can confidently control the processing variables during fabrication. This paper provides a concise incursion into the application of electrospun nanofibers in drug delivery and cites pertinent processing parameters that may influence the performance of the nanofibers when applied to drug delivery.

    20. Nanotechnology in Drug Delivery and Tissue Engineering: From Discovery to Applications

      Science.gov (United States)

      Shi, Jinjun; Votruba, Alexander R.; Farokhzad, Omid C.; Langer, Robert

      2010-01-01

      The application of nanotechnology in medicine, referred to as nanomedicine, is offering numerous exciting possibilities in healthcare. Herein, we discuss two important aspects of nanomedicine—drug delivery and tissue engineering—highlighting the advances we have recently experienced, the challenges we are currently facing, and what we are likely to witness in the near future. PMID:20726522

    1. A Performance/Cost Evaluation for a GPU-Based Drug Discovery Application on Volunteer Computing

      Science.gov (United States)

      Guerrero, Ginés D.; Imbernón, Baldomero; García, José M.

      2014-01-01

      Bioinformatics is an interdisciplinary research field that develops tools for the analysis of large biological databases, and, thus, the use of high performance computing (HPC) platforms is mandatory for the generation of useful biological knowledge. The latest generation of graphics processing units (GPUs) has democratized the use of HPC as they push desktop computers to cluster-level performance. Many applications within this field have been developed to leverage these powerful and low-cost architectures. However, these applications still need to scale to larger GPU-based systems to enable remarkable advances in the fields of healthcare, drug discovery, genome research, etc. The inclusion of GPUs in HPC systems exacerbates power and temperature issues, increasing the total cost of ownership (TCO). This paper explores the benefits of volunteer computing to scale bioinformatics applications as an alternative to own large GPU-based local infrastructures. We use as a benchmark a GPU-based drug discovery application called BINDSURF that their computational requirements go beyond a single desktop machine. Volunteer computing is presented as a cheap and valid HPC system for those bioinformatics applications that need to process huge amounts of data and where the response time is not a critical factor. PMID:25025055

    2. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

      Science.gov (United States)

      2013-09-25

      ... FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is...

    3. 42 CFR 447.502 - Definitions.

      Science.gov (United States)

      2010-10-01

      .... Brand name drug means a single source or innovator multiple source drug. Bundled sale means an... incurred by the State in the operation of the covered outpatient drug benefit including systems costs for... NDA and a covered outpatient drug approved under a product license approval (PLA), establishment...

    4. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Barry Callebaut Belgium nv, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation...... of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. Cocoa flavanols are sufficiently characterised. The claimed effect is “help maintain endothelium-dependent vasodilation which contributes to healthy blood flow”. The target population proposed...... by the applicant is the general healthy adult population. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. In weighing the evidence, the Panel took into account that cocoa flavanols consumed for 12 weeks have been shown to increase fasting ED...

    5. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . Scientific opinion on Dietary Reference Values for fluoride

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for fluoride, which are provided as Adequate Intake (AI) from all sources, including non-dietary sources. Fluoride is not an essential nutrient...... and adults, including pregnant and lactating women. For pregnant and lactating women, the AI is based on the body weight before pregnancy and lactation. Reliable and representative data on the total fluoride intake of the European population are not available. © European Food Safety Authority, 2013...

    6. Mastitis Olgularında Virusların Rolü "The roles of Viruses in Mastitis"

      OpenAIRE

      ALPAY, Gizem; YEŞİLBAĞ, Kadir

      2014-01-01

      Bu derlemede özellikle sığır mastitis olgularının etiyolojisinde virusların rolleri irdelenmiştir. Viruslar sığır mastitis olgularında hem hazırlayıcı hem de primer etiyolojik ajan olarak rol oynayabilirler. Bovine herpesvirus 2, vaccinia virus, sığır çiçeği virusu, yalancı sığır çiçeği virusu, vesicular stomatitis virusu, şap hastalığı virusu ve bovine papillomavirus memede lezyon oluşturarak memenin doğal savunma mekanizmasını sekteye uğratırlar. Bovine herpesvirus 1, bovine viral diarrhoea...

    7. Trakyada Yeşilyurt Gazetesine Göre 1944 Yılında II. Dünya Savaşı ve Kırklareli

      Directory of Open Access Journals (Sweden)

      Türkan Vahibe DOĞRUÖZ

      2016-08-01

      Full Text Available Gazeteler günlük ya da haftalık olarak, özel bir konuda veya genel konularla ilgili güncel olayları ve gelişmeleri okuyucularına ileten yazılı belgelerdir. Bu belgeler aynı zamanda yayınladıkları dönemi günümüze taşıyan birincil kaynaklardır. İl özelinde çıkan yerel gazetelerde ilde yaşanan siyasi, ekonomik, sosyal ve kültürel gelişmelere ilişkin okuyuculara ve araştırmacılara bilgi sağlarlar. Ali Rıza Dursunkaya tarafından 31 Ağustos 1925 tarihinde yayın hayatına başlayan Trakya’da Yeşilyurt gazetesi de Kırklareli’nin ilk yerel gazetesi olma özelliğini taşımaktadır. Günümüze kadar yayım hayatına devam eden gazete Kırklareli’nde yaşanan siyasi, ekonomik, sosyal ve kültürel olayları bizlere ulaştırmaya devam etmektedir. Çalışmamızda Trakya’da Yeşilyurt gazetesinin II. Dünya Savaşı’nın son yıllarına rastlayan 1944 yılına ait 07 2. Kanun (Ocak 1944- 29 2. Kanun 1944 tarihleri arasında haftada iki gün Salı ve Cuma günleri yayımlanan 1313-1413 sayıları incelenecektir. Böylece Türkiye’nin II. Dünya Savaşı sırasında yaşadığı zor günler Kırklareli örneği ile anlatılmaya çalışılacaktır. Amacımız II. Dünya Savaşı’nın yaşandığı günlerde siyasi, ekonomik, sosyal ve kültürel açıdan Kırklareli’nde yaşananları o günün gazete haberlerini kronolojik bir sıra takip ederek mevcut durumu incelemektir. Trakya’da Yeşilyurt gazetesi ile ilgili olarak böyle bir çalışmanın daha önce yapılmamış olması göz önüne alındığında dönemle ilgili Kırklareli iline yeni bir bakış açısı getireceği düşünülmektedir. İkinci Dünya Savaşı’nın son yıllarına tekabül eden ve Türkiye’nin zor zamanlarına tanıklık etmiş savaş haberleri dışında eğitim, ekonomi, tarım kooperatif, kültür, sanat, sağlık, spor, haberleriyle halka ışık tutacaktır.

    8. Neoliberal Eğitim Politikaları ve Eğitimde Fırsat Eşitliği Bağlamında Uluslararası Sınavların (PISA, TIMSS ve PIRLS Analizi

      Directory of Open Access Journals (Sweden)

      Halim Güner

      2014-12-01

      Full Text Available Ekonomi ve eğitim ilişkisi birçok araştırmaya konu olmuş ve eğitim süreçlerinin ekonomik politikalara hizmet etmesi kabul edilen bir olgudur. Kapital sistemin oluşturduğu eşitsiz yarış sisteminin yeniden oluşturucusu yine eğitim süreçleri olarak düşünülmektedir. Eğitimin dünya genelinde belirli bir standarda ulaşıp, birçok ülkede benzer politikalar ile pazar ekonomisine hizmet edecek yapıya kavuşturulması neoliberal politikaların bir amacı olduğu düşünülmektedir. Ülkeler arasında benzer eğitim politikaları oluşturmanın etkili bir yolu günümüzde yapılan uluslararası sınavlardır. TIMSS, PISA ve PIRLS gibi sınavlar ülkelerin eğitim karnelerini ve ilişkili birçok değişkeni ülkelerin gündemine getirerek reform yapma gereksinimi algısı oluşturmaktadır. Bu reform algısının temel hedefinde ise dünya pazarında daha rekabetçi bir ekonomi için daha yarışçı bir eğitim anlayışıdır. Eğitimin insani gelişimden ziyade ekonomiye hizmet edecek donanımlı bireyler yetiştirmeye odaklanması sonucunda eşitsizlik sosyo-ekonomik duruma göre daha da derinleşmektedir. Her ne kadar uluslararası sınavların raporlarında eğitim eşitsizliğin giderilip öğrenciler arasındaki farkın kapatılması yönünde tavsiyeler barındırsa bile ülkelerin eğitim reformlarında özelleştirmeye gitmeleri ve değişimi takip eden öğretmen kalitesinin farklılık göstermesi nedeniyle öğrenci başarısındaki açı daha da büyümektedir. Bu araştırmanın amacı da bu sorunları literatür çerçevesinde işlemektir. Böylece hızlı reformların olduğu ülkemizde değişim adımlarının daha hesaplı atılmasında katkı sağlanması umulmaktadır.

    9. Poly(amidoamine) (PAMAM) dendrimers: from biomimicry to drug delivery and biomedical applications.

      Science.gov (United States)

      Esfand, R; Tomalia, D A.

      2001-04-01

      Poly(amidoamine) (PAMAM) dendrimers are the first complete dendrimer family to be synthesized, characterized and commercialized. Based on this extensive activity, they are recognized as a unique new class of synthetic nanostructures. Dendrimers allow the precise control of size, shape and placement of functional groups that is desirable for many life science applications. From this perspective, this review focuses on crucial properties of biomimetic dendrimers that will broaden the potential for their use as macromolecular vectors in novel drug delivery and biomedical applications.

    10. Akut myeloid lösemi hastasında kronik dissemine kandidiyazisin başarılı tedavisi

      OpenAIRE

      K, Ozturk E; N, Soyer; S, Bayraktaroglu; M, Hekimgil; M, Tobu; B, Arda

      2014-01-01

      Kronik dissemine kandidiyazis (KDK) sistemik yaygın bir kandida enfeksiyonu çeşididir ve nötropenik hastaları etkiler. Bu vaka sunumunda remisyon indüksiyon kemoterapisi sırasında KDK tanısı alan ve sırasıyla amfoterisin B ve flukonazol ile tedavi edilen bir akut myeloid lösemi olgusu sunulmuştur. Kemoterapi sonrası geniş spektrumlu antibiyotiklere yanıtsız ateş ortaya çıktı. Lipozomal amfoterisin B (Lip-Amf-B) tedavisi başlandı. Serum galaktomannan (GM) testi ve kan kültürleri negatifti. Yük...

    11. EFSA NDA Panel (EFSA Panel on Panel on Dietetic Products Nutrition and Allergies), 2014. Scientific Opinion on Dietary Reference Values for iodine

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for iodine, which are provided as Adequate Intake (AI). Iodine is essential for the synthesis of thyroid hormones. Through these hormones, iodine...... stores in conditions of adequate iodine status before pregnancy and considers that a full compensation for the iodine secreted in breast milk is not justified for the derivation of an AI for iodine for lactating women....

    12. Standard guide for making quality nondestructive assay measurements

      CERN Document Server

      American Society for Testing and Materials. Philadelphia

      2009-01-01

      1.1 This guide is a compendium of Quality Measurement Practices for performing measurements of radioactive material using nondestructive assay (NDA) instruments. The primary purpose of the guide is to assist users in arriving at quality NDA results, that is, results that satisfy the end user’s needs. This is accomplished by providing an acceptable and uniform basis for the collection, analysis, comparison, and application of data. The recommendations are not compulsory or prerequisites to achieving quality NDA measurements, but are considered contributory in most areas. 1.2 This guide applies to the use of NDA instrumentation for the measurement of nuclear materials by the observation of spontaneous or stimulated nuclear radiations, including photons, neutrons, or the flow of heat. Recommended calibration, operating, and assurance methods represent guiding principles based on current NDA technology. The diversity of industry-wide nuclear materials measurement applications and instrumentation precludes disc...

    13. Self-Assembled Nanocarriers Based on Amphiphilic Natural Polymers for Anti- Cancer Drug Delivery Applications.

      Science.gov (United States)

      Sabra, Sally; Abdelmoneem, Mona; Abdelwakil, Mahmoud; Mabrouk, Moustafa Taha; Anwar, Doaa; Mohamed, Rania; Khattab, Sherine; Bekhit, Adnan; Elkhodairy, Kadria; Freag, May; Elzoghby, Ahmed

      2017-01-01

      Micellization provides numerous merits for the delivery of water insoluble anti-cancer therapeutic agents including a nanosized 'core-shell' drug delivery system. Recently, hydrophobically-modified polysaccharides and proteins are attracting much attention as micelle forming polymers to entrap poorly soluble anti-cancer drugs. By virtue of their small size, the self-assembled micelles can passively target tumor tissues via enhanced permeation and retention effect (EPR). Moreover, the amphiphilic micelles can be exploited for active-targeted drug delivery by attaching specific targeting ligands to the outer micellar hydrophilic surface. Here, we review the conjugation techniques, drug loading methods, physicochemical characteristics of the most important amphiphilic polysaccharides and proteins used as anti-cancer drug delivery systems. Attention focuses on the mechanisms of tumor-targeting and enhanced anti-tumor efficacy of the encapsulated drugs. This review will highlight the remarkable advances of hydrophobized polysaccharide and protein micelles and their potential applications as anti-cancer drug delivery nanosystems. Micellar nanocarriers fabricated from amphiphilic natural polymers hold great promise as vehicles for anti-cancer drugs. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

    14. İkinci Dünya Savaşı Sırasında Yaşanan Gıda Sıkıntısı Ve Ekmek Karnesi Uygulaması Food Shortage And Pass In Bread During The World War II

      Directory of Open Access Journals (Sweden)

      Sabit DOKUYAN

      2013-07-01

      Full Text Available During the World War II, Turkey has managed to stay out of the war although it was difficult. However, the country has suffered from economic difficulties. Application of war period had difficult situationsfor people and the level of production decreased since young peoplewere enlisted. The people, who lived in poverty in the big cities, couldnot get their own necessities. The people, who did not see the war, sawseverely hunger and poverty. The application of pass in bread wasapplied within the framework of the national conservation law convictedcitizens to be able to live with only bread. The bread distributionapplication, which did not influence the rich people, influenced badlythe poor people. The government tried to protect its officers and soldierson the subject of food supply. Jobbery showed itself at the top level, andthe easy way of making Money often used. The government did notsuccess on the precautions of difficulties. Although the difficultiesdecreased after the end of war was seen, shortage of food supply wenton after the period of war. The people saw Republican People’s Party asa reason of the difficulties and they powered to the party in selections,which were made in 1950. The justification of pass in bread application,which was in effect in 1942 and 1946, modes of administration,vicissitudes which occured in the enforcement process and rationingsystem, are interpreted in this work. İkinci Dünya Savaşı sırasında Türkiye, zor da olsa savaş dışında kalmayı başarmıştır. Fakat ülke, ekonomik anlamda büyük sıkıntılar çekmiştir. Savaş dönemine ait uygulamalar halkı zor duruma sokmuş, genç nüfusun askere alınmasıyla da üretim durma seviyesine gerilemiştir. Büyük şehirlerde yaşayan halk, temel gıda ihtiyaçlarını gideremez hale gelmiştir. Savaşı görmeyen halk, açlığı ve yokluğu en şiddetli şekilde yaşamıştır. Dönem içerisinde uygulanma imkânı bulan Milli Korunma Kanunu

    15. Application of the Pareto principle to identify and address drug-therapy safety issues.

      Science.gov (United States)

      Müller, Fabian; Dormann, Harald; Pfistermeister, Barbara; Sonst, Anja; Patapovas, Andrius; Vogler, Renate; Hartmann, Nina; Plank-Kiegele, Bettina; Kirchner, Melanie; Bürkle, Thomas; Maas, Renke

      2014-06-01

      Adverse drug events (ADE) and medication errors (ME) are common causes of morbidity in patients presenting at emergency departments (ED). Recognition of ADE as being drug related and prevention of ME are key to enhancing pharmacotherapy safety in ED. We assessed the applicability of the Pareto principle (~80 % of effects result from 20 % of causes) to address locally relevant problems of drug therapy. In 752 cases consecutively admitted to the nontraumatic ED of a major regional hospital, ADE, ME, contributing drugs, preventability, and detection rates of ADE by ED staff were investigated. Symptoms, errors, and drugs were sorted by frequency in order to apply the Pareto principle. In total, 242 ADE were observed, and 148 (61.2 %) were assessed as preventable. ADE contributed to 110 inpatient hospitalizations. The ten most frequent symptoms were causally involved in 88 (80.0 %) inpatient hospitalizations. Only 45 (18.6 %) ADE were recognized as drug-related problems until discharge from the ED. A limited set of 33 drugs accounted for 184 (76.0 %) ADE; ME contributed to 57 ADE. Frequency-based listing of ADE, ME, and drugs involved allowed identification of the most relevant problems and development of easily to implement safety measures, such as wall and pocket charts. The Pareto principle provides a method for identifying the locally most relevant ADE, ME, and involved drugs. This permits subsequent development of interventions to increase patient safety in the ED admission process that best suit local needs.

    16. [Application of ultrasound-enhanced gene and drug delivery to the ocular tissue].

      Science.gov (United States)

      Sonoda, Shozo; Yamashita, Toshifumi; Suzuki, Ryo; Maruyama, Kazuo; Sakamoto, Taiji

      2013-01-01

      Visual images provide an immensely rich source of information about the external world. Eye has characteristic structure sensory cells are arranged along the eye wall, and is filled inside with vitreous body. In recent years, intravitreal injection of anti-vascular endothelial growth factor (VEGF) agent had widely spread, and numerous number of patients who suffered ocular angiogenic disease such as diabetic retinopathy, age-related macular degeneration and retinal vascular occlusion for the disease, were treated and spared the blindness. Vitreous cavity was regarded as reservoir of drug, intravitreal injection is thought a sort of drug delivery. However, with regard to the administration of a selective drug deliver, it has not yet been solved. Our aim is to establish a new method of gene transfer, drug delivery using low-energy ultrasound to the eye, to date, we confirmed drug and gene deliver to the ocular tissue such as cornea, conjunctiva and retina with high efficiency. In addition, tissue damage was minimal. We have also shown that ultrasound irradiation with combination of a microbubbles or bubble liposome could be introduced drug and gene more effectively. Based on these knowledge, we will focus on development of a new device for intraocular ultrasound exposure and potential for therapeutic application of ultrasound to humans retinal disease such as retinal artery obstruction.

    17. Evaluation On Earthware Moulds Unearthed During The İznik Kilns Excavations / İznik Çini Fırınları Kazısı’nda Ortaya Çıkarılan Pişmiş Toprak Kalıp Parçalarının Değerlendirilmesi

      Directory of Open Access Journals (Sweden)

      Vesile Belgin DEMİRSAR ARLI

      2018-04-01

      Full Text Available A large number of mould fragments, used in the moulded ware, were found during the Iznik Kiln Excavation. Mould findings, made from red hard paste, have thick and flat bases, depressed spherical/spheroid or conical bodies, and flat spouts. Only three example among the mould fragments found is excluded from this generalization. This mould piece, have a low foot and one mould slightly flaring edge. Diameters of the spouts, the bases and heights vary between 14 and 23,6 cm, 6 and 10 cm, and 5 and 9 cm, respectively. Like in body decorations, patterns on the interiors of moulds applied in the carved and pressed technique, consist of geometrical, intricate herbal and braided compositions. These mould fragments include examples that completely overlap with the patterns we see on body fragments. The mould fragment, which consists of four connecting pieces, strikes attention with its inscriptions. However, letters visible on the obtained fragments do not represent a meaningful word, which suggests the inscription may have been intended as a decoration. Aside from these, fluting moulds constitute a separate group. These fragments have similarities to the moulds used in non-Anatolian Islamic ceramics and in Anatolia. [TR: İznik Çini Fırınları kazı çalışmaları sırasında, kalıba baskı tekniğinde kullanılan çok sayıda kalıp parçası da ele geçmiştir. Kırmızı sert hamurdan imal edilmiş kazı buluntusu kalıplar; kalın düz dipli, konik ya da basık küre gövdeli, düz ağızlıdır. Ele geçen kalıp parçaları arasında yalnızca üç örnek bu genellemenin dışında kalmaktadır. Bunlar, alçak ayaklı olup biri hafif dışa dönük kenarlıdır. Bu kalıpların ağız çapları 14-23,5 cm, dip çapları 6-10 cm, yükseklikleri 5-9 cm aralığında değişmektedir. Kalıpların iç yüzeyine oyma, kazıma ve baskı teknikleriyle uygulanan desenleri de kalıp baskı tekniğinde yapılmış gövde parçalarında olduğu gibi

    18. Pnömatik Ekim Makinalarında Farklı Tip Dağıtma Başlıkları, Hava Hızı ve Gübreleme Normunun Akış Düzgünlüğüne Etkisi

      OpenAIRE

      Güler, İbrahim Ethem; Uygan, Fatih

      2010-01-01

      Bu araştırma pnömatik tahıl ekim makinalarında kullanılan farklı tip dağıtma başlıklarında, hava hızının ve gübreleme normunun akış düzgünlüğüne etkisini belirlemek için yapılmıştır. Araştırmada üç farklı tip dağıtma başlığı (T, Huni ve Y), üç farklı hava hızında (26, 31, 36 m/s) denenmiştir. Denemelerde Diamonyum fosfat (DAP) ve Triple süper fosfat (TSP) gübreleri kullanılmıştır. Gübreleme normları 12, 16 ve 20 kg/da, makina ilerleme hızı 1,5 m/s ve sıra arası olarak 10 cm alınmıştır. Araştı...

    19. Türkiye’de entomofagi hakkında bir kamuoyu araştırması

      OpenAIRE

      CANHİLAL, Ramazan; YÜKSEL, Ebubekir

      2018-01-01

      Yenilebilir böcekler, gelecekte dünyanın gıda kıtlığını gidermek içiniyi bir potansiyele sahiptir ve küresel açlığı ve yetersiz beslenmeyi azaltmayayardımcı olabilirler. Entomofagi dünyanın bazı kesiminde oldukçayaygın olmasına rağmen batı ülkelerinde hala kabul görmemiştir. Türkiye’dekigenç neslin entomofagiyekarşı tutumlarını ve entomofagiyi reddetme nedenlerini belirlemek için, 2017yılında Erciyes Üniversitesi kampüsünde 610 katılımcı üzerinde bir anketçalışması yapılmıştır. Erciyes Üniver...

    20. Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.

      Science.gov (United States)

      2006-11-13

      The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a "health care entity." In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.

    1. Sonochemically synthesized biocompatible zirconium phosphate nanoparticles for pH sensitive drug delivery application.

      Science.gov (United States)

      Kalita, Himani; Prashanth Kumar, B N; Konar, Suraj; Tantubay, Sangeeta; Kr Mahto, Madhusudan; Mandal, Mahitosh; Pathak, Amita

      2016-03-01

      The present work reports the synthesis of biocompatible zirconium phosphate (ZP) nanoparticles as nanocarrier for drug delivery application. The ZP nanoparticles were synthesized via a simple sonochemical method in the presence of cetyltrimethylammonium bromide and their efficacy for the delivery of drugs has been tested through various in-vitro experiments. The particle size and BET surface area of the nanoparticles were found to be ~48 nm and 206.51 m(2)/g respectively. The conventional MTT assay and cellular localization studies of the particles, performed on MDA-MB-231 cell lines, demonstrate their excellent biocompatibility and cellular internalization behavior. The loading of curcumin, an antitumor drug, onto the ZP nanoparticles shows the rapid drug uptake ability of the particles, while the drug release study, performed at two different pH values (at 7.4 and 5) depicts pH sensitive release-profile. The MTT assay and cellular localization studies revealed higher cellular inhibition and better bioavailability of the nanoformulated curcumin compared to free curcumin. Copyright © 2015 Elsevier B.V. All rights reserved.

    2. Illicit drugs and pharmaceuticals in the environment - Forensic applications of environmental data. Part 1: Estimation of the usage of drugs in local communities

      Energy Technology Data Exchange (ETDEWEB)

      Kasprzyk-Hordern, Barbara, E-mail: b.kasprzyk-hordern@hud.ac.u [University of Huddersfield, Department of Chemical and Biological Sciences, Queensgate, Huddersfield HD1 3DH (United Kingdom); University of Glamorgan, Sustainable Environment Research Centre, Faculty of Health, Sport and Science, Pontypridd CF37 1DL (United Kingdom); Dinsdale, Richard M.; Guwy, Alan J. [University of Glamorgan, Sustainable Environment Research Centre, Faculty of Health, Sport and Science, Pontypridd CF37 1DL (United Kingdom)

      2009-06-15

      Pharmaceuticals and recently also illicit drugs have been recognised as emerging environmental contaminants due to their potential environmental impact: frequent occurrence, persistence and risk to aquatic life and humans. This manuscript is part one of the two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. An attempt to use wastewater data is made in order to verify patterns of the usage of drugs (in particular illicit) in local communities. The average usage of cocaine in South Wales was estimated at 0.9 g day{sup -1} 1000 people{sup -1}, which equals 1 tonne of this drug used or disposed of to sewage annually in Wales. The calculated usage of amphetamine denoted 2.5 g day{sup -1} 1000 people{sup -1} and is suspected to be an overestimate. Because no analysis of enantiomers of amphetamine was undertaken, no distinction between amphetamine's legal and illicit usage could be made. - Wastewater as an indicative source of information can be used in forensic applications.

    3. Illicit drugs and pharmaceuticals in the environment - Forensic applications of environmental data. Part 1: Estimation of the usage of drugs in local communities

      International Nuclear Information System (INIS)

      Kasprzyk-Hordern, Barbara; Dinsdale, Richard M.; Guwy, Alan J.

      2009-01-01

      Pharmaceuticals and recently also illicit drugs have been recognised as emerging environmental contaminants due to their potential environmental impact: frequent occurrence, persistence and risk to aquatic life and humans. This manuscript is part one of the two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. An attempt to use wastewater data is made in order to verify patterns of the usage of drugs (in particular illicit) in local communities. The average usage of cocaine in South Wales was estimated at 0.9 g day -1 1000 people -1 , which equals 1 tonne of this drug used or disposed of to sewage annually in Wales. The calculated usage of amphetamine denoted 2.5 g day -1 1000 people -1 and is suspected to be an overestimate. Because no analysis of enantiomers of amphetamine was undertaken, no distinction between amphetamine's legal and illicit usage could be made. - Wastewater as an indicative source of information can be used in forensic applications.

    4. The application of carbon nanotubes in target drug delivery systems for cancer therapies

      Science.gov (United States)

      Zhang, Wuxu; Zhang, Zhenzhong; Zhang, Yingge

      2011-10-01

      Among all cancer treatment options, chemotherapy continues to play a major role in killing free cancer cells and removing undetectable tumor micro-focuses. Although chemotherapies are successful in some cases, systemic toxicity may develop at the same time due to lack of selectivity of the drugs for cancer tissues and cells, which often leads to the failure of chemotherapies. Obviously, the therapeutic effects will be revolutionarily improved if human can deliver the anticancer drugs with high selectivity to cancer cells or cancer tissues. This selective delivery of the drugs has been called target treatment. To realize target treatment, the first step of the strategies is to build up effective target drug delivery systems. Generally speaking, such a system is often made up of the carriers and drugs, of which the carriers play the roles of target delivery. An ideal carrier for target drug delivery systems should have three pre-requisites for their functions: (1) they themselves have target effects; (2) they have sufficiently strong adsorptive effects for anticancer drugs to ensure they can transport the drugs to the effect-relevant sites; and (3) they can release the drugs from them in the effect-relevant sites, and only in this way can the treatment effects develop. The transporting capabilities of carbon nanotubes combined with appropriate surface modifications and their unique physicochemical properties show great promise to meet the three pre-requisites. Here, we review the progress in the study on the application of carbon nanotubes as target carriers in drug delivery systems for cancer therapies.

    5. Bioactivity of Hybrid Polymeric Magnetic Nanoparticles and Their Applications in Drug Delivery.

      Science.gov (United States)

      Mohammed, Leena; Ragab, Doaa; Gomaa, Hassan

      2016-01-01

      Engineered magnetic nanoparticles (MNPs) possess unique properties and hold great potential in biomedicine and clinical applications. With their magnetic properties and their ability to work at cellular and molecular level, MNP have been applied both in-vitro and in-vivo in targeted drug delivery and imaging. Focusing on Iron Oxide Superparamagnetic nanoparticles (SPIONs), this paper elaborates on the recent advances in development of hybrid polymeric-magnetic nanoparticles. Their main applications in drug delivery include Chemotherapeutics, Hyperthermia treatment, Radio-therapeutics, Gene delivary, and Biotheraputics. Physiochemical properties such as size, shape, surface and magnetic properties are key factors in determining their behavior. Additionally tailoring SPIONs surface is often vital for desired cell targetting and improved efficiency. Polymer coating is specifically reviewed with brief discussion of SPIONs administration routes. Commonly used drug release models for describing release mechanisms and the nanotoxicity aspects are also discussed. This review focus on superparamagnetic nanoparticles coated with different types of polymers starting with the key physiochemical features that dominate their behavior. The importance of surface modification is addressed. Subsequently, the major classes of polymer modified iron oxide nanoparticles is demonstrated according to their clinical use and application. Clinically approved nanoparticles are then addressed and the different routes of administration are mentioned. Lastly, mathematical models of drug release profile of the common used nanoparticles are addressed. MNPs emerging in recent medicine are remarkable for both imaging and therapeutics, particularly, as drug carriers for their great potential in targeted delivery and cancer treatment. Targeting ability and biocompatibility can be improved though surface coating which provides a mean to alter the surface features including physical characteristics and

    6. Çocukluk çağı kabızlığında elektrolit içeren polietilen glikol kullanımı Orijinal Araştırma

      OpenAIRE

      Önal, Zerrin; Usta, Merve; Doğan, Yaşar; Kutlu, Tufan; Çokuğraş, Fügen; Erkan, Tülay

      2008-01-01

      Amaç: Bir yaşından büyük çocuklarda tedavide elektrolit içeren polietilen glikol PEG 3350 kullanımının etkinliği ve güvenilirliğini araştırmak Gereç ve Yöntem: Çalışmaya yaşları 1 ile 12 yaş arasında olan 50 olgu alındı Olguların hepsine elektrolit içeren polietilen glikol tedavisi başlandı Tedavi etkinliği olarak ağrısız yumuşak dışkılama amaçlandı Her hasta için başvuru esnasında öykü ve fizik muayeneyi içeren bilgi formu dolduruldu Tam kan sayımı karaciğer ve böbrek işlev testleri ile elek...

    7. Fabrication of Calcium Phosphate-Based Nanocomposites Incorporating DNA Origami, Gold Nanorods, and Anticancer Drugs for Biomedical Applications.

      Science.gov (United States)

      Zhang, Hongbo; Qu, Xiangmeng; Chen, Hong; Kong, Haixin; Ding, Ruihua; Chen, Dong; Zhang, Xu; Pei, Hao; Santos, Hélder A; Hai, Mingtan; Weitz, David A

      2017-10-01

      DNA origami is designed by folding DNA strands at the nanoscale with arbitrary control. Due to its inherent biological nature, DNA origami is used in drug delivery for enhancement of synergism and multidrug resistance inhibition, cancer diagnosis, and many other biomedical applications, where it shows great potential. However, the inherent instability and low payload capacity of DNA origami restrict its biomedical applications. Here, this paper reports the fabrication of an advanced biocompatible nano-in-nanocomposite, which protects DNA origami from degradation and facilities drug loading. The DNA origami, gold nanorods, and molecular targeted drugs are co-incorporated into pH responsive calcium phosphate [Ca 3 (PO 4 ) 2 ] nanoparticles. Subsequently, a thin layer of phospholipid is coated onto the Ca 3 (PO 4 ) 2 nanoparticle to offer better biocompatibility. The fabricated nanocomposite shows high drug loading capacity, good biocompatibility, and a photothermal and pH-responsive payload release profile and it fully protects DNA origami from degradation. The codelivery of DNA origami with cancer drugs synergistically induces cancer cell apoptosis, reduces the multidrug resistance, and enhances the targeted killing efficiency toward human epidermal growth factor receptor 2 positive cells. This nanocomposite is foreseen to open new horizons for a variety of clinical and biomedical applications. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

    8. Synthesis of an amphiphilic dendrimer-like block copolymer and its application on drug delivery

      KAUST Repository

      Wang, Shuaipeng

      2014-10-27

      Dendrimer-like amphiphilic copolymer is a kind of three-dimensional spherical structure polymer. An amphiphilic dendrimer-like diblock copolymer, PEEGE-G2-b-PEO(OH)12, constituted of a hydrophobic poly(ethoxyethyl glycidol ether) inner core and a hydrophilic poly(ethylene oxide) outer layer, has been successfully synthesized by the living anionic ring-opening polymerization method. The intermediates and targeted products were characterized with 1H NMR spectroscopy and gel permeation chromatography. The application on drug delivery of dendrimer-like diblock copolymer PEEGE-G2-b-PEO(OH)12 using DOX as a model drug was also studied. The drug loading content and encapsulation efficiency were found at 13.07% and 45.75%, respectively. In vitro release experiment results indicated that the drug-loaded micelles exhibited a sustained release behavior under acidic media.

    9. A Performance/Cost Evaluation for a GPU-Based Drug Discovery Application on Volunteer Computing

      Directory of Open Access Journals (Sweden)

      Ginés D. Guerrero

      2014-01-01

      Full Text Available Bioinformatics is an interdisciplinary research field that develops tools for the analysis of large biological databases, and, thus, the use of high performance computing (HPC platforms is mandatory for the generation of useful biological knowledge. The latest generation of graphics processing units (GPUs has democratized the use of HPC as they push desktop computers to cluster-level performance. Many applications within this field have been developed to leverage these powerful and low-cost architectures. However, these applications still need to scale to larger GPU-based systems to enable remarkable advances in the fields of healthcare, drug discovery, genome research, etc. The inclusion of GPUs in HPC systems exacerbates power and temperature issues, increasing the total cost of ownership (TCO. This paper explores the benefits of volunteer computing to scale bioinformatics applications as an alternative to own large GPU-based local infrastructures. We use as a benchmark a GPU-based drug discovery application called BINDSURF that their computational requirements go beyond a single desktop machine. Volunteer computing is presented as a cheap and valid HPC system for those bioinformatics applications that need to process huge amounts of data and where the response time is not a critical factor.

    10. Farklı Yemlerle Beslemenin Gökkuşağı Alabalığı (Oncorhynchus mykiss)’nda Hematokrit ve Hemoglobin Miktarı Üzerine Etkileri / The Effects of Liver Feed on Hematocrit and Hemoglobin Levels of Rainbow Trout (Oncorhynchus mykiss)

      OpenAIRE

      Atamanalp, Muhammed; Bayır, Abdulkadir; Sirkecioğlu, A. Necdet; Yanık, Telat; Yılmaz, Mehtap; Cengiz, Mehtap

      2010-01-01

      ÖZET: Bu araştırmada beslenme-kan parametre ilişkisini ortaya koymak amacıyla kontrollü yetiştirme şartlarında tutulan gökkuşağı alabalıkları (Oncorhynchus mykiss)’ nda rasyona karaciğer ilavesinin hematokrit ve hemoglobin değerleri üzerine etkileri belirlenmeye çalışılmıştır. Karaciğerle beslenen balıklarda gerek hemoglobin gerekse hematokrit değerleri, karaciğer + kuru karma yem ve yalnızca kuru karma yemle beslenen gruplara nazaran &...

    11. Feature Issue Introduction: Bio-Optics in Clinical Applications, Nanotechnology, and Drug Discovery

      OpenAIRE

      Nordstrom, Robert J.; Almutairi, Adah; Hillman, Elizabeth M.C.

      2010-01-01

      The editors introduce the Biomedical Optics Express feature issue, “Bio-Optics in Clinical Applications, Nanotechnology, and Drug Discovery,” which combines three technical areas from the 2010 Optical Society of America (OSA), Biomedical Optics (BIOMED) Topical Meeting held on 11–14 April in Miami, FL and includes contributions from conference attendees.

    12. Photopatternable Magnetic Hollowbots by Nd-Fe-B Nanocomposite for Potential Targeted Drug Delivery Applications

      Directory of Open Access Journals (Sweden)

      Hui Li

      2018-04-01

      Full Text Available In contrast to traditional drug administration, targeted drug delivery can prolong, localize, target and have a protected drug interaction with the diseased tissue. Drug delivery carriers, such as polymeric micelles, liposomes, dendrimers, nanotubes, and so on, are hard to scale-up, costly, and have short shelf life. Here we show the novel fabrication and characterization of photopatternable magnetic hollow microrobots that can potentially be utilized in microfluidics and drug delivery applications. These magnetic hollowbots can be fabricated using standard ultraviolet (UV lithography with low cost and easily accessible equipment, which results in them being easy to scale up, and inexpensive to fabricate. Contact-free actuation of freestanding magnetic hollowbots were demonstrated by using an applied 900 G external magnetic field to achieve the movement control in an aqueous environment. According to the movement clip, the average speed of the magnetic hollowbots was estimated to be 1.9 mm/s.

    13. Mathematical Model to Predict Skin Concentration after Topical Application of Drugs

      Directory of Open Access Journals (Sweden)

      Hiroaki Todo

      2013-12-01

      Full Text Available Skin permeation experiments have been broadly done since 1970s to 1980s as an evaluation method for transdermal drug delivery systems. In topically applied drug and cosmetic formulations, skin concentration of chemical compounds is more important than their skin permeations, because primary target site of the chemical compounds is skin surface or skin tissues. Furthermore, the direct pharmacological reaction of a metabolically stable drug that binds with specific receptors of known expression levels in an organ can be determined by Hill’s equation. Nevertheless, little investigation was carried out on the test method of skin concentration after topically application of chemical compounds. Recently we investigated an estimating method of skin concentration of the chemical compounds from their skin permeation profiles. In the study, we took care of “3Rs” issues for animal experiments. We have proposed an equation which was capable to estimate animal skin concentration from permeation profile through the artificial membrane (silicone membrane and animal skin. This new approach may allow the skin concentration of a drug to be predicted using Fick’s second law of diffusion. The silicone membrane was found to be useful as an alternative membrane to animal skin for predicting skin concentration of chemical compounds, because an extremely excellent extrapolation to animal skin concentration was attained by calculation using the silicone membrane permeation data. In this chapter, we aimed to establish an accurate and convenient method for predicting the concentration profiles of drugs in the skin based on the skin permeation parameters of topically active drugs derived from steady-state skin permeation experiments.

    14. Huzursuzlukla Yuvaya Dönüş: Fatih-Harbiye Ve Bir Tereddüdün Romanı’nda Aşılamayan Kriz

      Directory of Open Access Journals (Sweden)

      Jale Özata Dirlikyapan

      2017-12-01

      Full Text Available Döneminin en önemli romancı ve düşünce adamlarından biri olan Peyami Safa (1899-1961, hemen her devride romanları üzerine düşünülen ve söz söylenen bir yazar olmuştur. Özellikle ilk dönem romanlarının şematik yapısından sıkça söz edilmiş ve bu romanlar çoğunlukla “ulusal alegori” düşüncesi etrafında değerlendirilmişlerdir. Fatih-Harbiye ve Bir Tereddüdün Romanı kitaplarındaki kadın-erkek ilişkileri çoğunlukla bir medeniyet krizinin görünümleri olarak ele alınmış, romanlardaki bazı önemli detaylar görmezden gelinebilmiştir. Her iki romanın sonunda da Batıyı temsil eden değerler savuşturulmuş gibi görünse de, aslında romanlar bir tür bezginlik, boşvermişlik ve huzursuzlukla son bulur. Peyami Safa genelde söylendiği gibi dişil, irrasyonel, kozmopolit unsurları bünyesinden kovmayı arzular görünse de, tam da dişil, irrasyonel veya “vahşi ölçüde samimi” olanın alanındayken kısmen daha özgür bir bilinçle nitelikli edebiyat yapıyordur. Birbirine sıkı sıkıya bağlı olan bu unsurlar, yazarın “milli ideal” etrafında ördüğü kürsü konuşmaları tarafından gizlenmeye, baskılanmaya çalışılsa da, bunları ele alışı sayesinde Peyami Safa’daki “büyük romancı” kendini gösterebilmiştir

    15. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      2015-01-01

      Following an application from Han-Asiabiotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion...... in blood pressure when Symbiosal® was consumed instead of table salt for eight weeks in the context of a salt-restricted diet, but that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study...

    16. Strategies of bringing drug product marketing applications to meet current regulatory standards.

      Science.gov (United States)

      Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

      2015-08-01

      In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

    17. Kıl Keçi ve Saanen x Kıl Keçi Melezlerinin (F1, G1, Çiftçi Şartlarında Süt Verim Özellikleri Bakımından Karşılaştırılması

      Directory of Open Access Journals (Sweden)

      Hilal Tozlu Çelik

      2014-11-01

      Full Text Available Bu araştırma, Amasya ili Sarılar köyü, özel bir işletmede 2011-2012 yılları arasında yetiştirilen Saanen x Kıl keçi melezleri (F1, G1 ve Kıl keçilerinde süt verimi özellikleri üzerine genotip, yıl ve yaş faktörlerinin etkisini ortaya koymak amacıyla yapılmıştır. Araştırmada 2011 ve 2012 yıllarında günlük ortalama süt verimi (GOSV, laktasyon süresi (LS ve laktasyon süt verimi (LSV üzerine genotipin etkili olduğu bulunmuştur. 2011 yılında yaşın tüm genotiplerde GOSV ve LSV etkisinin olduğu tespit edilmiştir. Araştırmada 2012 yılında yaşın tüm genotiplerde GOSV ve LS'ne etkisinin olduğu saptanmıştır. F1 genotipinde ve Kıl keçilerde yılın GOSV, LSV ve LS üzerine etkili olduğu bulunmuştur. G1 genotipinde yılın sadece LS üzerine etkisi olduğu saptanmıştır. Sonuç olarak çiftçi şartlarında yetiştirilen Saanen x Kıl keçi F1 ve G1 genotipinin süt verim özelliklerinin Kıl keçilerden daha yüksek olduğu söylenebilir.

    18. Quantum dots in imaging, drug delivery and sensor applications.

      Science.gov (United States)

      Matea, Cristian T; Mocan, Teodora; Tabaran, Flaviu; Pop, Teodora; Mosteanu, Ofelia; Puia, Cosmin; Iancu, Cornel; Mocan, Lucian

      2017-01-01

      Quantum dots (QDs), also known as nanoscale semiconductor crystals, are nanoparticles with unique optical and electronic properties such as bright and intensive fluorescence. Since most conventional organic label dyes do not offer the near-infrared (>650 nm) emission possibility, QDs, with their tunable optical properties, have gained a lot of interest. They possess characteristics such as good chemical and photo-stability, high quantum yield and size-tunable light emission. Different types of QDs can be excited with the same light wavelength, and their narrow emission bands can be detected simultaneously for multiple assays. There is an increasing interest in the development of nano-theranostics platforms for simultaneous sensing, imaging and therapy. QDs have great potential for such applications, with notable results already published in the fields of sensors, drug delivery and biomedical imaging. This review summarizes the latest developments available in literature regarding the use of QDs for medical applications.

    19. Data-intensive drug development in the information age: applications of Systems Biology/Pharmacology/Toxicology.

      Science.gov (United States)

      Kiyosawa, Naoki; Manabe, Sunao

      2016-01-01

      Pharmaceutical companies continuously face challenges to deliver new drugs with true medical value. R&D productivity of drug development projects depends on 1) the value of the drug concept and 2) data and in-depth knowledge that are used rationally to evaluate the drug concept's validity. A model-based data-intensive drug development approach is a key competitive factor used by innovative pharmaceutical companies to reduce information bias and rationally demonstrate the value of drug concepts. Owing to the accumulation of publicly available biomedical information, our understanding of the pathophysiological mechanisms of diseases has developed considerably; it is the basis for identifying the right drug target and creating a drug concept with true medical value. Our understanding of the pathophysiological mechanisms of disease animal models can also be improved; it can thus support rational extrapolation of animal experiment results to clinical settings. The Systems Biology approach, which leverages publicly available transcriptome data, is useful for these purposes. Furthermore, applying Systems Pharmacology enables dynamic simulation of drug responses, from which key research questions to be addressed in the subsequent studies can be adequately informed. Application of Systems Biology/Pharmacology to toxicology research, namely Systems Toxicology, should considerably improve the predictability of drug-induced toxicities in clinical situations that are difficult to predict from conventional preclinical toxicology studies. Systems Biology/Pharmacology/Toxicology models can be continuously improved using iterative learn-confirm processes throughout preclinical and clinical drug discovery and development processes. Successful implementation of data-intensive drug development approaches requires cultivation of an adequate R&D culture to appreciate this approach.

    20. Machine Learning-based Virtual Screening and Its Applications to Alzheimer's Drug Discovery: A Review.

      Science.gov (United States)

      Carpenter, Kristy A; Huang, Xudong

      2018-06-07

      Virtual Screening (VS) has emerged as an important tool in the drug development process, as it conducts efficient in silico searches over millions of compounds, ultimately increasing yields of potential drug leads. As a subset of Artificial Intelligence (AI), Machine Learning (ML) is a powerful way of conducting VS for drug leads. ML for VS generally involves assembling a filtered training set of compounds, comprised of known actives and inactives. After training the model, it is validated and, if sufficiently accurate, used on previously unseen databases to screen for novel compounds with desired drug target binding activity. The study aims to review ML-based methods used for VS and applications to Alzheimer's disease (AD) drug discovery. To update the current knowledge on ML for VS, we review thorough backgrounds, explanations, and VS applications of the following ML techniques: Naïve Bayes (NB), k-Nearest Neighbors (kNN), Support Vector Machines (SVM), Random Forests (RF), and Artificial Neural Networks (ANN). All techniques have found success in VS, but the future of VS is likely to lean more heavily toward the use of neural networks - and more specifically, Convolutional Neural Networks (CNN), which are a subset of ANN that utilize convolution. We additionally conceptualize a work flow for conducting ML-based VS for potential therapeutics of for AD, a complex neurodegenerative disease with no known cure and prevention. This both serves as an example of how to apply the concepts introduced earlier in the review and as a potential workflow for future implementation. Different ML techniques are powerful tools for VS, and they have advantages and disadvantages albeit. ML-based VS can be applied to AD drug development. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

    1. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on Dietary Reference Values for zinc

      DEFF Research Database (Denmark)

      Tetens, Inge

      2014-01-01

      Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values for zinc, using a two-stage factorial approach and reference values for body weight. The first stage of estimating physiological requirements used studies...... from 2.4 to 11.8 mg/day. PRIs for infants and children were derived by assuming a coefficient of variation of 10 %, and range from 2.9 to 14.2 mg/day. For pregnancy and lactation, additional zinc requirements related to fetal and maternal tissues and transfer of zinc into breast milk, respectively...

    2. Designing an intuitive web application for drug discovery scientists.

      Science.gov (United States)

      Karamanis, Nikiforos; Pignatelli, Miguel; Carvalho-Silva, Denise; Rowland, Francis; Cham, Jennifer A; Dunham, Ian

      2018-01-11

      We discuss how we designed the Open Targets Platform (www.targetvalidation.org), an intuitive application for bench scientists working in early drug discovery. To meet the needs of our users, we applied lean user experience (UX) design methods: we started engaging with users very early and carried out research, design and evaluation activities within an iterative development process. We also emphasize the collaborative nature of applying lean UX design, which we believe is a foundation for success in this and many other scientific projects. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

    3. Kobi niteliğindeki sağlık kuruluşlarında iç kontrol sistemi ve önemi

      Directory of Open Access Journals (Sweden)

      Güler GÜNEY

      2014-06-01

      Full Text Available Büyük küçük tüm sağlık kuruluşlarının, sürekliliklerini sağlayabilmeleri ve hedeflerine ulaşabilmeleri bakımından en önemli kriter etkili bir iç kontrol sistemine sahip olmalarıdır. Özellikle Türkiye gibi ekonomisi gelişmekte olan, ticari aktörlerinin çok büyük bir kısmı KOBİ statüsünde olan ülkelerde, ekonomik hayatı hareketlendirmek, sermaye piyasalarının gelişmesi ve işlerliğinin kuvvetlenmesinin sağlanmasında da yine en temel kriter etkin ve etkili bir iç kontrol siteminin varlığıdır. Çünkü etkili bir iç kontrol sistemi; hata, hile ve yolsuzlukların önlenmesinde ve işletme içinde uygulanan politika ve prosedürlerin uygulanma düzeyi ve verimliliğinin sağlanmasında da önemli bir etkendir. İster büyük, ister küçük olsun her işletmede etkin olan ya da olmayan bir iç kontrol mevcuttur. Ancak bu kontrollerin işletmede belirlenmiş bulunan belli politika ve prosedürlere göre yapılıp yapılmadığı ya da etkin olup olmadıkları tartışılabilmektedir. Ülkemizdeki sağlık kuruluşlarından, özellikle sermaye piyasalarında işlem gören kuruluşlarda mevzuatlar gereği iç kontrol sistemi kurulmuş olmasma rağmen, bu iç kontrol sisteminin tamamıyla örgütsel amaçlar doğrultusunda etkili ve verimli şekilde çalıştığını söylemek mümkün değildir. Ülkemizdeki KOBİ niteliğindeki sağlık kuruluşlarının hatırı bir kısmında ise iç kontrol sisteminin oldukça yetersiz ve zayıf olarak nitelenebilecek şekilde uygulandığı ifade edilebilir. Bu da diğer tüm KOBÎ'lerde olduğu gibi sağlık alanındaki kuruluşların büyüme, gelişme ve kurumsallaşması üzerine olumsuz etkide bulunmaktadır. Daha da önemlisi de kurumların örgütsel amaçlarını gerçekleştirmesinde zorluklarla karşılaşmasına sebep olmaktadır. Başka bir deyişle, etkin iç kontrol sisteminin işletmelerin ilgililerine fayda sağlaması gereklidir. Böylece i

    4. Applicator for in-vitro ultrasound-activated targeted drug delivery

      Science.gov (United States)

      Gerold, B.; Gourevich, D.; Volovick, A.; Xu, D.; Arditti, F.; Prentice, P.; Cochran, S.; Gnaim, J.; Medan, Y.; Wang, L.; Melzer, A.

      2012-10-01

      Reducing toxicity and improving uptake of cancer drugs in tumors are important goals of targeted drug delivery (TDD). Ultrasonic drug release from various encapsulants has been a focus of many research groups. However, a single standard ultrasonic device, viable for use by biologists, is not currently present in the market. The device reported here is designed to allow investigation of the impact of ultrasound on cellular uptake and cell viability in-vitro. In it, single-element transducers with different operating frequencies are mounted below a standard 96-well plate. The plate is moved above the transducers, such that each line of wells can be sonicated at a different frequency. To assess the device, 96-well plates were seeded with cells and sonicated using different ultrasonic parameters, with and without doxorubicin. Cell viability was measured by colorimetric MTT assay and the uptake of doxorubicin by cells was also determined. The device proved to be highly viable in preliminary tests; it demonstrated that change in ultrasonic parameters produces different effect on cells. For example, increase in uptake of doxorubicin was demonstrated following ultrasound application. The growing interest in ultrasound-activated TDD emphasizes the need for standardization of the ultrasound device and the one reported here may offer some indications of how that may be achieved. It is planned to further improve the prototype by increasing the number of ultrasonic frequencies and degrees of freedom for each transducer.

    5. Clinical applications of fast liquid chromatography: a review on the analysis of cardiovascular drugs and their metabolites.

      Science.gov (United States)

      Baranowska, Irena; Magiera, Sylwia; Baranowski, Jacek

      2013-05-15

      One of the major challenges facing the medicine today is developing new therapies that enhance human health. To help address these challenges the utilization of analytical technologies and high-throughput automated platforms has been employed; in order to perform more experiments in a shorter time frame with increased data quality. In the last decade various analytical strategies have been established to enhance separation speed and efficiency in liquid chromatography applications. Liquid chromatography is an increasingly important tool for monitoring drugs and their metabolites. Furthermore, liquid chromatography has played an important role in pharmacokinetics and metabolism studies at these drug development stages since its introduction. This paper provides an overview of current trends in fast chromatography for the analysis of cardiovascular drugs and their metabolites in clinical applications. Current trends in fast liquid chromatographic separations involve monolith technologies, fused-core columns, high-temperature liquid chromatography (HTLC) and ultra-high performance liquid chromatography (UHPLC). The high specificity in combination with high sensitivity makes it an attractive complementary method to traditional methodology used for routine applications. The practical aspects of, recent developments in and the present status of fast chromatography for the analysis of biological fluids for therapeutic drug and metabolite monitoring, pharmacokinetic studies and bioequivalence studies are presented. Copyright © 2013 Elsevier B.V. All rights reserved.

    6. Performance results from the first integrated NDA VXI safeguards system

      International Nuclear Information System (INIS)

      Bot, D.; Messner, R.

      1999-01-01

      The VIFM system is the first integrated safeguard system to be developed and deployed by the IAEA. The system is also noteworthy in that it is the most versatile of any NDA system thus far deployed. Due to the high level of functionality, the VIFM is probably the most 'tested' of all IAEA systems. This paper discusses the results obtained from detailed in field and laboratory testing of a variety of VIFM configurations ranging from simple single systems to highly integrated system implementations. A total of 4 sites have had VIFM equipment installed. Data collected from these sites have been of very high quality and consistency despite the failure of commercial hard disk drive equipment. The systematic failure of these drives have been corrected using a variety of methods and performance since those corrections have been excellent with no equipment failures. The tests carried out also included the test of a twisted pair to coaxial cable interface. This interface was required in order to allow installation even with a significant facility cabling limitation. The performance obtained from the system utilizing this device showed no degradation as compared to that of systems utilizing direct coaxial cable connections. To conclude, the VIFM system, has been reliable even after partial failure of commercial off-the-shelf components which required the systems to operate on full fail-safe backup. These tests have thus shown both the reliable operation of the VIFM in normal operating conditions as well as the most adverse

    7. Target-mediated drug disposition with drug-drug interaction, Part I: single drug case in alternative formulations.

      Science.gov (United States)

      Koch, Gilbert; Jusko, William J; Schropp, Johannes

      2017-02-01

      Target-mediated drug disposition (TMDD) describes drug binding with high affinity to a target such as a receptor. In application TMDD models are often over-parameterized and quasi-equilibrium (QE) or quasi-steady state (QSS) approximations are essential to reduce the number of parameters. However, implementation of such approximations becomes difficult for TMDD models with drug-drug interaction (DDI) mechanisms. Hence, alternative but equivalent formulations are necessary for QE or QSS approximations. To introduce and develop such formulations, the single drug case is reanalyzed. This work opens the route for straightforward implementation of QE or QSS approximations of DDI TMDD models. The manuscript is the first part to introduce DDI TMDD models with QE or QSS approximations.

    8. Siyaset ve Apolitizm Arasında Mısır’da Selefi Hareket: ed-Da’vetu’s-Selefiyye Örneği

      Directory of Open Access Journals (Sweden)

      Nurullah ÇAKMAKTAŞ

      2015-09-01

      Full Text Available İslam’ı anlama ve yorumlama yöntemlerinden biri olarak Selefilik, geçmişi İslam tarihinin ilk dönemlerine kadar uzanan bir düşünce ekolüdür. Fakat 20. yy’da İslam dünyasında kurulan ulus devletler içinde ise Selefilik, bu düşüce ekolü olma özelliğinin yanında İslami hareket bünyesine giren bir karakter de kazanmıştır. Özellikle 11 Eylül saldırılarının akabinde aceleye getirilen analizler sonucu şiddet ile özdeşleştirilen Selefiliğin içinde, siyasal mücadeleyi ve şiddeti bir değişim yöntemi olarak kabul etmeyen ve çok daha büyük toplumsal desteğe sahip selefi hareketler bulunmaktadır. Eğitim, irşat ve davet yöntemleri ile toplumun ve devletin İslamlaşmasını savunan söz konusu bu apolitik selefi hareketlerin büyüklüğünün ve etkinliğinin tam anlamıyla farkına ancak Arap devrimleri sonrası varılabilmiştir. Biz de bu araştırmamızda, söz konusu sürecin ön plana çıkardığı apolitik bir selefi hareket olan, 25 Ocak Devrimi sonrasında siyasallaşan ve fakat Temmuz 2013’te gerçekleşen askeri darbenin akabinde tekrardan karakteristik özellikleri olan apolitikliğe geri döndüğünü düşündüğümüz ed-Da’vetu’s-Selefiyye grubunu; ortaya çıkışı, yapısı, faaliyet alanları, düşünce esasları, siyaset düşüncesi, benimsediği yöntem ve yaşadığı dönüşümler çerçevesinde Mısır özelinde incelemeye çalıştık

    9. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on Dietary Reference Values for cobalamin (vitamin B12)

      DEFF Research Database (Denmark)

      Tetens, Inge

      2015-01-01

      Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for cobalamin (vitamin B12). The Panel considers that the approach based on a combination of biomarkers of cobalamin status, i.e. serum....... For pregnancy and lactation, additional cobalamin intakes related to the accumulation of cobalamin in fetal tissues and transfer of cobalamin into breast milk are considered and AIs of 4.5 and 5 μg/day, respectively, are proposed....

    10. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to Preservation ® and “ rapid recovery of cellular activity post stress ” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from ICP Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Malta, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to Preservation® and “rapid recovery of cellular activity post stress”. The Panel considers that Preservation®, which contains an extract of prickly pear cactus Opuntia ficus-indica, is sufficiently characterised. The claimed effect is “rapid recovery of cellular activity...

    11. Text Mining for Drugs and Chemical Compounds: Methods, Tools and Applications.

      Science.gov (United States)

      Vazquez, Miguel; Krallinger, Martin; Leitner, Florian; Valencia, Alfonso

      2011-06-01

      Providing prior knowledge about biological properties of chemicals, such as kinetic values, protein targets, or toxic effects, can facilitate many aspects of drug development. Chemical information is rapidly accumulating in all sorts of free text documents like patents, industry reports, or scientific articles, which has motivated the development of specifically tailored text mining applications. Despite the potential gains, chemical text mining still faces significant challenges. One of the most salient is the recognition of chemical entities mentioned in text. To help practitioners contribute to this area, a good portion of this review is devoted to this issue, and presents the basic concepts and principles underlying the main strategies. The technical details are introduced and accompanied by relevant bibliographic references. Other tasks discussed are retrieving relevant articles, identifying relationships between chemicals and other entities, or determining the chemical structures of chemicals mentioned in text. This review also introduces a number of published applications that can be used to build pipelines in topics like drug side effects, toxicity, and protein-disease-compound network analysis. We conclude the review with an outlook on how we expect the field to evolve, discussing its possibilities and its current limitations. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

    12. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to carbohydrate solutions and maintenance of physical performance during endurance exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from the British Specialist Nutrition Association Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies...... (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and maintenance of physical performance during endurance exercise. The food, which is proposed by the applicant to be the subject of the health claim, is “carbohydrate solutions...... of physical performance during endurance exercise as compared to “water–electrolyte solutions” cannot be established on the basis of the information provided. Maintenance of physical performance during endurance exercise is a beneficial physiological effect. Three meta-analyses of human intervention studies...

    13. Sonochemically synthesized biocompatible zirconium phosphate nanoparticles for pH sensitive drug delivery application

      Energy Technology Data Exchange (ETDEWEB)

      Kalita, Himani, E-mail: hkalita74@gmail.com [Department of Chemistry, Indian Institute of Technology Kharagpur, West Bengal 721302 (India); Prashanth Kumar, B.N., E-mail: prasanthkumar999@gmail.com [School of Medical Science and Technology, Indian Institute of Technology Kharagpur, West Bengal 721302 (India); Konar, Suraj, E-mail: suraj.konar@gmail.com [Department of Chemistry, Indian Institute of Technology Kharagpur, West Bengal 721302 (India); Tantubay, Sangeeta, E-mail: sang.chem2@gmail.com [Department of Chemistry, Indian Institute of Technology Kharagpur, West Bengal 721302 (India); Mahto, Madhusudan Kr., E-mail: mahtomk0@gmail.com [Department of Chemistry, Indian Institute of Technology Kharagpur, West Bengal 721302 (India); Mandal, Mahitosh, E-mail: mahitosh@smst.iitkgp.ernet.in [School of Medical Science and Technology, Indian Institute of Technology Kharagpur, West Bengal 721302 (India); Pathak, Amita, E-mail: ami@chem.iitkgp.ernet.in [Department of Chemistry, Indian Institute of Technology Kharagpur, West Bengal 721302 (India)

      2016-03-01

      The present work reports the synthesis of biocompatible zirconium phosphate (ZP) nanoparticles as nanocarrier for drug delivery application. The ZP nanoparticles were synthesized via a simple sonochemical method in the presence of cetyltrimethylammonium bromide and their efficacy for the delivery of drugs has been tested through various in-vitro experiments. The particle size and BET surface area of the nanoparticles were found to be ~ 48 nm and 206.51 m{sup 2}/g respectively. The conventional MTT assay and cellular localization studies of the particles, performed on MDA-MB-231 cell lines, demonstrate their excellent biocompatibility and cellular internalization behavior. The loading of curcumin, an antitumor drug, onto the ZP nanoparticles shows the rapid drug uptake ability of the particles, while the drug release study, performed at two different pH values (at 7.4 and 5) depicts pH sensitive release-profile. The MTT assay and cellular localization studies revealed higher cellular inhibition and better bioavailability of the nanoformulated curcumin compared to free curcumin. - Highlights: • Biocompatible zirconium phosphate nanoparticles were synthesized by a simple sonochemical approach. • Curcumin was rapidly loaded onto the particles by the aid by hydrogen bond formation. • The curcumin loaded zirconium phosphate nanoparticles depict pH triggered drug release phenomenon. • The nanoformulated curcumin showed enhanced anti-tumor activity as compared to the native curcumin.

    14. Sonochemically synthesized biocompatible zirconium phosphate nanoparticles for pH sensitive drug delivery application

      International Nuclear Information System (INIS)

      Kalita, Himani; Prashanth Kumar, B.N.; Konar, Suraj; Tantubay, Sangeeta; Mahto, Madhusudan Kr.; Mandal, Mahitosh; Pathak, Amita

      2016-01-01

      The present work reports the synthesis of biocompatible zirconium phosphate (ZP) nanoparticles as nanocarrier for drug delivery application. The ZP nanoparticles were synthesized via a simple sonochemical method in the presence of cetyltrimethylammonium bromide and their efficacy for the delivery of drugs has been tested through various in-vitro experiments. The particle size and BET surface area of the nanoparticles were found to be ~ 48 nm and 206.51 m"2/g respectively. The conventional MTT assay and cellular localization studies of the particles, performed on MDA-MB-231 cell lines, demonstrate their excellent biocompatibility and cellular internalization behavior. The loading of curcumin, an antitumor drug, onto the ZP nanoparticles shows the rapid drug uptake ability of the particles, while the drug release study, performed at two different pH values (at 7.4 and 5) depicts pH sensitive release-profile. The MTT assay and cellular localization studies revealed higher cellular inhibition and better bioavailability of the nanoformulated curcumin compared to free curcumin. - Highlights: • Biocompatible zirconium phosphate nanoparticles were synthesized by a simple sonochemical approach. • Curcumin was rapidly loaded onto the particles by the aid by hydrogen bond formation. • The curcumin loaded zirconium phosphate nanoparticles depict pH triggered drug release phenomenon. • The nanoformulated curcumin showed enhanced anti-tumor activity as compared to the native curcumin.

    15. Çocuk Kitaplarında Mülteciler ve Kültürleşme Stratejileri- Refugees and Acculturation Strategies in Children’s Books

      Directory of Open Access Journals (Sweden)

      Elif Emine BALTA

      2018-04-01

      Full Text Available İnsanın veya insanların sosyal, ekonomik, siyasi veya başka sebeplerden dolayı yaşadıkları yerden farklı bir yere doğru hareket etmesi veya yerleşmesi olarak tanımlanabilen göç, insanın varoluşundan bu yana olan bir hadisedir. Göç, ister ilkel ister günümüzdeki örnekleri gibi karmaşık olsun insanların daha iyiyi arama bulma çabasından kaynaklanmaktadır. Buna rağmen göçe karar verme, göç süreci ve sonrasında yeniye alışma ve uyum sağlama zorluklarla doludur. Çocuğun küresel dünyanın bir parçası olması, toplumsal sorunların farkında olması, farklı insan, yaşayış ve kültürlerin var olabileceğinin bilincinde olması ve önyargılarından arınması için sosyal problemlerin örnekleriyle karşılaşması gerekmektedir. Türk çocuk edebiyatında son birkaç yılda mülteci ve sığınmacı göçleri ile ilgili konuların işlendiği görülmektedir. Bu çocuk kitapları, mültecilerin toplumsal kabul görmeleri noktasında düşünülerek yazılmış, toplumda farkındalık yaratmayı amaçlayan bir anlamda güdümlü eserler olarak karşımıza çıkmaktadır. Çocukların empati yapabilmelerine imkân tanıyacak eserlerin varlığı bu bağlamda sevindiricidir. Bu çalışmada, Umut Sokağı Çocukları, Kömür Karası Çocuk, Kuş Olsam Evime Uçsam, Juju Beni Unutma, Halepli Zeynep adlı kitaplar kültürleşme modeli perspektifinden değerlendirilmiştir. Türk toplumunun, özellikle çocukların vicdanına seslenen bu kitapların ortak noktasının mültecileri anlamak için çaba göstermeye odaklanma olduğu söylenebilir. Mültecilerin göç etme ve Türkiye’ye uyum sağlama süreçlerinde yaşadıkları, duygu ve düşünceleri çocuk bakış açısıyla sunulmuştur. Bununla birlikte Türk halkının mültecilere tavrının ve bu tavrın çocuk ruhuna yansımasının gerçekçi biçimde aktarıldığını söylemek mümkündür.

    16. Sakarya Özel Eğitim Kurumunda Eğitim Gören Çocukların Beslenme Tarzında Ebeveynlerin Bilgi ve Tutumlarının İncelenmesi

      Directory of Open Access Journals (Sweden)

      Süleyman KALELİ

      2017-06-01

      Full Text Available Beslenme büyüme ve gelişimin sağlanması, sağlıklı bir yaşam ve sağlıklı bir gelecek için çocukluk evresinde çok önemlidir. Otizm ve down sendromu bir takım benzerlikleri ve farklılıkları gösteren genetik hastalıklar arasında yer almaktadır. Down sendromlu veya otistik çocuklar beslenme açısından riskli bir gruptur. Bu araştırma Sakarya Özel Eğitim Kurumunda eğitim gören çocukların beslenme tarzları ve ebeveynlerin çocuk beslenmesine yönelik tutumlarının incelenmesi amacıyla planlanmıştır. 30 Gönüllü öğrenci velilerine demografik bilgiler haricinde evet/hayır içeren 17 (S1, S2,…,S17 soru sorulmuştur. Ayrıca okul çağında sıkça kullanılan 22 adet gıda maddesi tablosundaki yiyeceklerin sıklığı sorgulanmıştır. S4 (%45,2 evet ve %54,8 hayır, S8 (%41,9 evet ve %54,8 hayır, S15 (%32,3 evet ve %67,7 hayır ve S16’ da ise (%3,2 evet ve %96,8 hayır hayır cevaplarının oranı evet cevabına göre yüksek bulunurken diğer soruların cevaplarında evet oranı yüksek bulunmuştur. Öğün aralarında çocuğun isteklerinin karşılanmaması, çocuğun acıkınca yemek yedirilmemesi, çocuğun her gün düzenli olarak akşam yemeği yememesi aile bireylerinin çocuk besleme bilgisinde yetersiz olduğu düşünülmektedir. Bununla birlikte otistik çocukların cips, gazlı içecekler, lahmacun-pide türü gıdalara az yer verilmesi ve süt ve süt ürünleri, yumurta, kuru baklagiller ekmek ve makarna gibi yiyeceklere yönelmesi olumlu bir beslenme alışkanlığını göstermektedir.

    17. Multi-objective evolutionary optimization for constructing neural networks for virtual reality visual data mining: application to geophysical prospecting.

      Science.gov (United States)

      Valdés, Julio J; Barton, Alan J

      2007-05-01

      A method for the construction of virtual reality spaces for visual data mining using multi-objective optimization with genetic algorithms on nonlinear discriminant (NDA) neural networks is presented. Two neural network layers (the output and the last hidden) are used for the construction of simultaneous solutions for: (i) a supervised classification of data patterns and (ii) an unsupervised similarity structure preservation between the original data matrix and its image in the new space. A set of spaces are constructed from selected solutions along the Pareto front. This strategy represents a conceptual improvement over spaces computed by single-objective optimization. In addition, genetic programming (in particular gene expression programming) is used for finding analytic representations of the complex mappings generating the spaces (a composition of NDA and orthogonal principal components). The presented approach is domain independent and is illustrated via application to the geophysical prospecting of caves.

    18. Data evaluation for operator-inspector differences for a specific NDA instrument

      International Nuclear Information System (INIS)

      Franklin, M.

      1984-01-01

      The Joint Research Centre (JRC) of the European Commission is developing a number of NDA instruments for safeguards use. In particular the JRC has developed a photo neutron active interrogation device (Phonid) for the assay of U-235 in bulk quantities. This report describes new statistical results for the D statistic in the context of data evaluation algorithms for the Phonid instrument. The Phonid instrument is useful for this purpose because its error propagation structure is well characterised and yet not trivially simple. The data evaluation for Phonid data is derived from its error propagation modelling plus new results for the sampling distribution of the D statistic. The problem of assigning an uncertainty to the D statistic value without any diversion strategy assumptions has long been an unresolved problem. The results described in this report provide the solution to this problem by considering the sampling distribution of the D statistic given the population of discrepancies. Discrepancy is defined as the difference between operator declared values and the true values measured by the inspector. This approach provides estimable expressions for the sampling moments of the D statistic without making any assumption about the cause (diversion, clerical error, measurement error) of the discrepancy. The report also provides a general discussion of the distinction between planning a verification and performing the data analysis after the verification has been carried out

    19. Sinema-Resim İlişkisi Bağlamında David Lynch ve ‘Silgikafa’ Filmi

      OpenAIRE

      Güngör, Arif Can

      2016-01-01

      Sinema geçmişten günümüze kadar tüm sanat dallarından yararlanmış, özellikle görsel bir sanat olan resim sanatıyla estetik açıdan çok yakın bir ilişki içinde bulunmuştur. Sinemanın resim sanatından yararlanmasında en önemli etken yönetmenin bu sanatla kurduğu bağ olmuş, özellikle ressam yönetmenler estetik anlamda resmin olanaklarından yararlanarak filmlerine plastik bir değer katmışlardır. Bu makalenin amacı sinema sanatı ile resim sanatı arasındaki ilişkiyi ressam yönetmen David Lynch ve on...

    20. Topraktan Pestisitlerin Arındırılmasında Önemli Bir Araç: Fitoremediasyon

      OpenAIRE

      TİRYAKİ, Osman; POTUR, Tayfun

      2018-01-01

      Pestisitler bitki koruma önlemleri arasındaen fazla uygulananıdır.Ancak, pestisitlerin tarımsal alanlarda bilinçsiz ve yoğun bir şekilde kullanımı bazı ekosistem problemlerine neden olur.Pestisitlerin sınıflandırma şekillerinden biri de topraktaki yarılanma sürelerine göre yapılanıdır. Bu sınıflandırmada pestisitler kalıcı değil, orta derece kalıcı, kalıcı ve devamlı kalıcı olarak 4 gruba ayrılırlar. Kullanılan pestisitler arasında toprakta çok çabuk parçalananları olduğu gi...

    1. “Citation Style Language” Uygulaması: APA Kaynak Gösterme Biçiminin Türkçeye Adaptasyonu=“Citation Style Language” Application: The Adaptation of APA Style to Turkish Language

      Directory of Open Access Journals (Sweden)

      Kasım Binici

      2013-10-01

      Full Text Available Bibliyografya yönetim programları, araştırma metinlerin yazımında yazarlara büyük avantajlar sağlamaktadır.Akademik çevrede EndNote, RefWorks, Zotero, Mendeley en popüler yazılımlardır. Türkçe kaynak gösterme kurallarının tanımlı olduğu biçim dosyalarının olmaması nedeniyle araştırma metni yazımında bu programlar işlevsiz kalmaktadır. Bu çalışmada, APA kaynak gösterme biçiminin Türkçeye adaptasyonu sağlanarak CSL uygulaması ile biçim dosyasında kodlar yazılmıştır. Yeni biçim dosyası Zotero ve Mendeley programlarında çalışabilirliği test edilerek kişilerin kullanımına sunulmuştur. Çalışma neticesinde oluşturulan APA-TR dosyası sayesinde Türkçe araştırma metinlerinin yazımında CSL uygulamasını tercih eden bibli- yografya yönetim yazılımların kullanımı mümkün olmuştur./Bibliography managment tools provide great advantage for researchers with writing their articles or research papers. In academic environment, EndNote, RefWorks, Zotero, Mendeley are the most popular software programms. Due to the lack of style files in which citation rules in Turkish language are described,these softwares stay functionless. In this study by providing turkish adaptation of APA citation style, new codes were written into the style file via CSL application. New style file is presented to users after testing its workability in Zotero and Mendeley programms. Thanks to APA-TR style file created as a result of the study,it is possibble to use bibliography managment tools which prefer CSL application in writing research papers Turkish language.

    2. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Wheat Polar Lipid Extract and protection of the skin against dehydration pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Extraction Purification Innovation France, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to Wheat Polar Lipid Extract and protection of the skin against dehydration. The Panel considers that Wheat Polar Lipid Extract is sufficiently characterised. The claimed effect is “contributes to improve skin hydration”. The target population proposed by the applicant...... can be drawn from one uncontrolled pilot study, nor from one study which was not carried out with the food which is the subject of the claim. In weighing the evidence, the Panel took into account that one human intervention study reported an effect of consumption of Wheat Polar Lipid Extract...

    3. From Protein Structure to Small-Molecules: Recent Advances and Applications to Fragment-Based Drug Discovery.

      Science.gov (United States)

      Ferreira, Leonardo G; Andricopulo, Adriano D

      2017-01-01

      Fragment-based drug discovery (FBDD) is a broadly used strategy in structure-guided ligand design, whereby low-molecular weight hits move from lead-like to drug-like compounds. Over the past 15 years, an increasingly important role of the integration of these strategies into industrial and academic research platforms has been successfully established, allowing outstanding contributions to drug discovery. One important factor for the current prominence of FBDD is the better coverage of the chemical space provided by fragment-like libraries. The development of the field relies on two features: (i) the growing number of structurally characterized drug targets and (ii) the enormous chemical diversity available for experimental and virtual screenings. Indeed, fragment-based campaigns have contributed to address major challenges in lead optimization, such as the appropriate physicochemical profile of clinical candidates. This perspective paper outlines the usefulness and applications of FBDD approaches in medicinal chemistry and drug design. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

    4. DFT application for chlorin derivatives photosensitizer drugs modeling

      Science.gov (United States)

      Machado, Neila; Carvalho, B. G.; Téllez Soto, C. A.; Martin, A. A.; Favero, P. P.

      2018-04-01

      Photodynamic therapy is an alternative form of cancer treatment that meets the desire for a less aggressive approach to the body. It is based on the interaction between a photosensitizer, activating light, and molecular oxygen. This interaction results in a cascade of reactions that leads to localized cell death. Many studies have been conducted to discover an ideal photosensitizer, which aggregates all the desirable characteristics of a potent cell killer and generates minimal side effects. Using Density Functional Theory (DFT) implemented in the program Vienna Ab-initio Simulation Package, new chlorin derivatives with different functional groups were simulated to evaluate the different absorption wavelengths to permit resonant absorption with the incident laser. Gaussian 09 program was used to determine vibrational wave numbers and Natural Bond Orbitals. The chosen drug with the best characteristics for the photosensitizer was a modified model of the original chlorin, which was called as Thiol chlorin. According to our calculations it is stable and is 19.6% more efficient at optical absorption in 708 nm in comparison to the conventional chlorin e6. Vibrational modes, optical and electronic properties were predicted. In conclusion, this study is an attempt to improve the development of new photosensitizer drugs through computational methods that save time and contribute to decrease the numbers of animals for model application.

    5. Microengineering methods for cell-based microarrays and high-throughput drug-screening applications

      International Nuclear Information System (INIS)

      Xu Feng; Wu Jinhui; Wang Shuqi; Gurkan, Umut Atakan; Demirci, Utkan; Durmus, Naside Gozde

      2011-01-01

      Screening for effective therapeutic agents from millions of drug candidates is costly, time consuming, and often faces concerns due to the extensive use of animals. To improve cost effectiveness, and to minimize animal testing in pharmaceutical research, in vitro monolayer cell microarrays with multiwell plate assays have been developed. Integration of cell microarrays with microfluidic systems has facilitated automated and controlled component loading, significantly reducing the consumption of the candidate compounds and the target cells. Even though these methods significantly increased the throughput compared to conventional in vitro testing systems and in vivo animal models, the cost associated with these platforms remains prohibitively high. Besides, there is a need for three-dimensional (3D) cell-based drug-screening models which can mimic the in vivo microenvironment and the functionality of the native tissues. Here, we present the state-of-the-art microengineering approaches that can be used to develop 3D cell-based drug-screening assays. We highlight the 3D in vitro cell culture systems with live cell-based arrays, microfluidic cell culture systems, and their application to high-throughput drug screening. We conclude that among the emerging microengineering approaches, bioprinting holds great potential to provide repeatable 3D cell-based constructs with high temporal, spatial control and versatility.

    6. Microengineering methods for cell-based microarrays and high-throughput drug-screening applications

      Energy Technology Data Exchange (ETDEWEB)

      Xu Feng; Wu Jinhui; Wang Shuqi; Gurkan, Umut Atakan; Demirci, Utkan [Department of Medicine, Demirci Bio-Acoustic-MEMS in Medicine (BAMM) Laboratory, Center for Biomedical Engineering, Brigham and Women' s Hospital, Harvard Medical School, Boston, MA (United States); Durmus, Naside Gozde, E-mail: udemirci@rics.bwh.harvard.edu [School of Engineering and Division of Biology and Medicine, Brown University, Providence, RI (United States)

      2011-09-15

      Screening for effective therapeutic agents from millions of drug candidates is costly, time consuming, and often faces concerns due to the extensive use of animals. To improve cost effectiveness, and to minimize animal testing in pharmaceutical research, in vitro monolayer cell microarrays with multiwell plate assays have been developed. Integration of cell microarrays with microfluidic systems has facilitated automated and controlled component loading, significantly reducing the consumption of the candidate compounds and the target cells. Even though these methods significantly increased the throughput compared to conventional in vitro testing systems and in vivo animal models, the cost associated with these platforms remains prohibitively high. Besides, there is a need for three-dimensional (3D) cell-based drug-screening models which can mimic the in vivo microenvironment and the functionality of the native tissues. Here, we present the state-of-the-art microengineering approaches that can be used to develop 3D cell-based drug-screening assays. We highlight the 3D in vitro cell culture systems with live cell-based arrays, microfluidic cell culture systems, and their application to high-throughput drug screening. We conclude that among the emerging microengineering approaches, bioprinting holds great potential to provide repeatable 3D cell-based constructs with high temporal, spatial control and versatility.

    7. A review of integrating electroactive polymers as responsive systems for specialized drug delivery applications.

      Science.gov (United States)

      Pillay, Viness; Tsai, Tong-Sheng; Choonara, Yahya E; du Toit, Lisa C; Kumar, Pradeep; Modi, Girish; Naidoo, Dinesh; Tomar, Lomas K; Tyagi, Charu; Ndesendo, Valence M K

      2014-06-01

      Electroactive polymers (EAPs) are promising candidate materials for the design of drug delivery technologies, especially in conditions where an "on-off" drug release mechanism is required. To achieve this, EAPs such as polyaniline, polypyrrole, polythiophene, ethylene vinyl acetate, and polyethylene may be blended into responsive hydrogels in conjunction with the desired drug to obtain a patient-controlled drug release system. The "on-off" drug release mechanism can be achieved through the environmental-responsive nature of the interpenetrating hydrogel-EAP complex via (i) charged ions initiated diffusion of drug molecules; (ii) conformational changes that occur during redox switching of EAPs; or (iii) electroerosion. These release mechanisms are not exhaustive and new release mechanisms are still under investigation. Therefore, this review seeks to provide a concise incursion and critical overview of EAPs and responsive hydrogels as a strategy for advanced drug delivery, for example, controlled release of neurotransmitters, sulfosalicyclic acid from cross-linked hydrogel, and vaccine delivery. The review further discusses techniques such as linear sweep voltammetry, cyclic voltammetry, impedance spectroscopy, and chronoamperometry for the determination of the redox capability of EAPs. The future implications of the hydrogel-EAP composites include, but not limited to, application toward biosensors, DNA hybridizations, microsurgical tools, and miniature bioreactors and may be utilized to their full potential in the form of injectable devices as nanorobots or nanobiosensors. Copyright © 2013 Wiley Periodicals, Inc.

    8. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to a combination of thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil and maintenance of normal hair pursuant to Article 13

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following two applications from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health...... claim related to a combination of thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil (Cucurbita pepo L.) and maintenance of normal hair. The Panel considers that the specified combination is sufficiently characterised. The claimed effects are “contributes to reduce......, riboflavin, niacin, pantothenic acid, pyridoxine, D-biotin and pumpkin seed oil (Cucurbita pepo L.) and maintenance of normal hair....

    9. Digital Drug Dosing: Dosing in Drug Assays by Light-Defined Volumes of Hydrogels with Embedded Drug-Loaded Nanoparticles

      DEFF Research Database (Denmark)

      Faralli, Adele; Melander, Fredrik; Larsen, Esben Kjær Unmack

      2014-01-01

      Polyethylene glycol (PEG)-based hydrogels are widely used for biomedical applications, including matrices for controlled drug release. We present a method for defining drug dosing in screening assays by light-activated cross-linking of PEG-diacrylate hydrogels with embedded drug-loaded liposome...

    10. Capillary electrophoresis: principles and applications in illicit drug analysis.

      Science.gov (United States)

      Tagliaro, F; Turrina, S; Smith, F P

      1996-02-09

      Capillary electrophoresis, which appeared in the early 1980s, is now rapidly expanding into many scientific disciplines, including analytical chemistry, biotechnology and biomedical and pharmaceutical sciences. In capillary electrophoresis,electrokinetic separations are carried out in tiny capillaries at high voltages (10-30 kV), thus obtaining high efficiencies (N > 10(5)) and excellent mass sensitivities (down to 10(-18)-10(-20) moles). The main features of capillary electrophoresis are: versatility of application (from inorganic ions to large DNA fragments), use of different separation modes with different selectivity, extremely low demands on sample volume, negligible running costs, possibility of interfacing with different detection systems, ruggedness and simplicity of instrumentation. Capillary electrophoresis applications in forensic sciences have appeared only recently, but are now rapidly growing, particularly in forensic toxicology. The present paper briefly describes the basic principles of capillary electrophoresis, from both the instrumental and analytical points of view. Furthermore, the main applications in the analysis of illicit/controlled drugs in both illicit preparations and biological samples are presented and discussed (43 references). It is concluded that the particular separation mechanism and the high complementarity of this technique to chromatography makes capillary electrophoresis a new powerful tool of investigation in the hands of forensic toxicologists.

    11. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C-reactive protein” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C‑reactive protein”. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect is “helps to support joint function by maintaining low levels of plasma...

    12. Transdermal microneedles for drug delivery applications

      International Nuclear Information System (INIS)

      Teo, Ai Ling; Shearwood, Christopher; Ng, Kian Chye; Lu Jia; Moochhala, Shabbir

      2006-01-01

      Transdermal drug delivery (TDD) has many advantages, the main one being the ability to maintain the prolonged release of drugs to attain optimal blood concentrations. Unfortunately, nature has provided a very effective protective barrier, the stratum corneum (sc), which limits TDD to certain types of drugs with specific properties. In order to enhance TDD, the idea of using microneedles to painlessly penetrate the sc barrier has previously been proposed. In this paper, we will review the different microneedles that are currently being developed as well as our own efforts in this area. Based on our experiences, we will offer our view on the key parameters for effective transdermal microneedle design as well as future directions in this area

    13. Transdermal microneedles for drug delivery applications

      Energy Technology Data Exchange (ETDEWEB)

      Teo, Ai Ling [Defence Medical and Environmental Research Institute, DSO National Laboratories (Kent Ridge), 27 Medical Drive, 12-00, Singapore 117510 (Singapore); Shearwood, Christopher [School of Mechanical and Aerospace Engineering, 50 Nanyang Avenue, Singapore 639798 (Singapore); Ng, Kian Chye [Defence Medical and Environmental Research Institute, DSO National Laboratories (Kent Ridge), 27 Medical Drive, 12-00, Singapore 117510 (Singapore); Lu Jia [Defence Medical and Environmental Research Institute, DSO National Laboratories (Kent Ridge), 27 Medical Drive, 12-00, Singapore 117510 (Singapore); Moochhala, Shabbir [Defence Medical and Environmental Research Institute, DSO National Laboratories (Kent Ridge), 27 Medical Drive, 12-00, Singapore 117510 (Singapore)]. E-mail: mshabbir@dso.org.sg

      2006-07-25

      Transdermal drug delivery (TDD) has many advantages, the main one being the ability to maintain the prolonged release of drugs to attain optimal blood concentrations. Unfortunately, nature has provided a very effective protective barrier, the stratum corneum (sc), which limits TDD to certain types of drugs with specific properties. In order to enhance TDD, the idea of using microneedles to painlessly penetrate the sc barrier has previously been proposed. In this paper, we will review the different microneedles that are currently being developed as well as our own efforts in this area. Based on our experiences, we will offer our view on the key parameters for effective transdermal microneedle design as well as future directions in this area.

    14. 12 Mart Romanlarında Kadın Tanımlamaları The Caharacterization Of Women In The March Twelfth Novels

      Directory of Open Access Journals (Sweden)

      Ahmet ALVER

      2012-12-01

      Full Text Available It is estimated that between 1970 and 1980 more than 5,000 people died in politically motivated violence in Turkey. The ‘March 12th novels’ is a retroactive umbrella term used to describe the works of fiction written this period. Their inspiration is the events surrounding the March 12th military intervention; the military takeover, the battle between revolutionary left wing activists and nationalists, and the political and social fallout of the intervention. It is during this period of persecution and oppression that the March 12th novels were written and they provide an invaluable source for anyone wanting to understand the effects of the persecution and atrocities committed by the state on its people.This article examines the characterization of women in 1970s Turkey through number of March 12 novels written by particularly female novelists. It studies the characterization of revolutionary women; their treatment by wider society, and the price they paid for being revolutionary. Along with revolutionary women, the article also focuses other examples of female figures such as bourgeois women who are presented as perfect consumers willing to accept subjugation to the patriarchy in exchange for material wealth, whilst, on the other hand, rural women are presented as ignorant and almost bestial creatures who view the female body as nothing more than a vehicle for reproduction and the satisfaction of men.This article in particular has focused upon works such as 47”liler (The Generation of ’47 written by Füruzan, Şafak (The Dawn by Sevgi Soysal, Bir Düğün Gecesi (A Wedding Night by Adalet Ağaoğlu and Yarın Yarın (Tomorrow Tomorrow by Pınar Kür. Türkiye’de, 1970 ve 1980 yılları arasında, siyasi sebeplerle meydana gelen şiddet olaylarında değişik kaynaklara göre sağ ve sol görüşlü 5.000 dolayında vatan evladının hayatını kaybettiği tahmin edilmektedir. 12 Mart 1971 askeri müdahalesinin öncesi ve sonrasında

    15. FSA Panel on Di etetic Products, Nutrition and Allergie s (NDA); Scientific Opinion on the substantiation of a health claim related to Vitis vinifera L. seeds extract and “helps to drain the body in case of water accumulation” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim...... related to Vitis vinifera L. seeds extract and “helps to drain the body in case of water accumulation”. The Panel considers that the food constituent which is the subject of the health claim is sufficiently characterised. The claimed effect proposed by the applicant is “helps to drain the body in case......” was a beneficial physiological effect in the context of “a normal venous circulation in the legs”. The applicant acknowledged that this claim referred to the same physiological function of the body as another health claim application on Vitis vinifera L. seeds extract and maintenance of normal venous blood flow...

    16. Challenges of Non-Destructive Assay Waste Measurement

      International Nuclear Information System (INIS)

      Shull, A.H.

      2003-01-01

      Historically, the Savannah River Site (SRS) routinely produced special nuclear material (SNM), which provided stable measurement conditions for the non-destructive assay (NDA) methods. However, the main mission of SRS has changed from the production of SNM to the processing of waste and material stabilization. Currently, the purpose of processing is to recover the SNM from the waste and stabilization materials, much of which is from other DOE facilities. These missions are usually of a short duration, but require non-destructive assay (NDA) accountability measurements on materials of varying composition and geometric configuration. These missions usually have cost and time constraints, which sometimes require re-application of existing NDA methods to waste measurements. Usually, each new material or re-application of the NDA method to a different SNM campaign requires new standards and timely re-calibration of the method. These constraints provide numerous challenges for the NDA methods, particularly in the area of measurement uncertainty. This paper will discuss the challenges of these situations, mainly from a measurement and statistical point of view and provide some possible solutions to the problems encountered. Specific examples will be discussed for the segmented gamma scanner (SGS), neutron multiplicity counter (NMC) and passive neutron coincidence counter (PNCC), which are some of the most common NDA instruments at SRS

    17. A Review of the Effect of Processing Variables on the Fabrication of Electro spun Nano fibers for Drug Delivery Applications

      International Nuclear Information System (INIS)

      Pillay, V.; Dott, C.; Choonara, Y.E.; Tyagi, Ch.; Tomar, L.; Kumar, P.; Toit, L.C.D.; Ndesendo, V.M.K.

      2013-01-01

      Electro spinning is a fast emerging technique for producing ultrafine fibers by utilizing electrostatic repulsive forces. The technique has gathered much attention due to the emergence of nano technology that sparked worldwide research interest in nano materials for their preparation and application in biomedicine and drug delivery. Electro spinning is a simple, adaptable, cost-effective, and versatile technique for producing nano fibers. For effective and efficient use of the technique, several processing parameters need to be optimized for fabricating polymeric nano fibers. The nano fiber morphology, size, porosity, surface area, and topography can be refined by varying these parameters. Such flexibility and diversity in nano fiber fabrication by electro spinning has broadened the horizons for widespread application of nano fibers in the areas of drug and gene delivery, wound dressing, and tissue engineering. Drug-loaded electro spun nano fibers have been used in implants, transdermal systems, wound dressings, and as devices for aiding the prevention of post surgical abdominal adhesions and infection. They show great promise for use in drug delivery provided that one can confidently control the processing variables during fabrication. This paper provides a concise incursion into the application of electro spun nano fibers in drug delivery and cites pertinent processing parameters that may influence the performance of the nano fibers when applied to drug delivery.

    18. Esrâr Dede Divanı’nda Renkler Colours In Dıvan Of Esrâr Dede

      Directory of Open Access Journals (Sweden)

      Mahmut KAPLAN

      2013-03-01

      compliance with their frequency of usage in the work.The article has been completed with a general evaluation. Esrâr Dede, klasik şiirimizin önemli simalarından biridir. Mevlevîliğe intisap ettikten sonra şiire başlamış, önemli eserler meydana getirmiştir. Şeyh Galib’in dostluğunu kazanmıştır. Şairin divanı dışında tezkiresi ve lügati bulunmaktadır. Esrar Dede, duygu ve düşüncelerini anlatmak için renk ifade eden kelimeleri sık kullanmıştır. Renk kelimeleri kültürel mirasın da önemli taşıyıcılarıdır. Varlıkları tasvir ve tarifte kullanılan renkler toplumun bazı metinlerde sembolik anlamlar da kazanır. Türkçede bazı renklerin yön bildirdiği bilinmektedir. Renkler bazen duyguları anlatmak için kullanılır, kişinin ruh hallerini ifade ederler. Tabiat manzaralarını tasvir etmek için renkler şairlerin elindeki en önemli araçlardır. Şair, tabiatı renk kelimeleri ile gözler önüne serer, renkler vasıtasıyla duygu ve düşüncelerini sembolik ifadelerle dile getirir. Kasidelerin nesiplerinde yapılan tasvirlerde renklerin önemli görevleri vardır. Çoğu gazelleri âşıkane olan Esrar Dede de duygu ve düşüncelerini anlatmak için renk sıfatlarına başvurmuştur. Esrar Dede Divanı’nda özellikle siyah ve kırmızı hâkim renkler olarak karşımıza çıkmaktadır. Bu renkler varlıkları tasvir etmek ve tasavvufî bir takım durumları anlatmak için kullanılmıştır. Kara, genel olarak gece, saç ve karanlık tasvirlerinde karşımıza çıkar. Ayrıca kara baht, talihsizlik gibi durumları tasvir etmede bu renge başvurulur. Kırmızı, gül, şafak, kan, dudak tasvirlerinde karşımıza çıkar. Bu iki temel renk dışında beyaz, sarı, yeşil ve tasavvufî durumları ifade eden renksizlik, bî-renklik şairin kullandığı renkler arasında yer almıştır. Esrar Dede’nin bir Mevlevî olduğu göz önüne alındığında renklerin onun şiirinde ne kadar önemli olduğu anlaşılır. Bu

    19. Innovative Applications of In Situ Gamma Spectroscopy for Non-destructive Assay of Transuranic Wastes

      International Nuclear Information System (INIS)

      Watters, D.J.; Weismann, J.J.; Duke, S.J.; Nicosia, W.C.

      2009-01-01

      Cabrera Services (CABRERA), under contract to National Security Technologies, LLC (NSTec), supported the transuranic (TRU) waste reduction initiative at the Radioactive Waste Management Complex of the Nevada Test Site (NTS). CABRERA developed advanced NDA techniques for oversized boxes (OSB) and drums using in situ gamma spectroscopy during several phases of the project. A more thorough characterization method was employed during the planning phase of the project to better understand the TRU content and distribution within each container, while a comprehensive NDA program was designed and implemented during the intrusive phase that guided waste segregation and re-packaging of both TRU and low-level wastes (LLW). NSTec took receipt of 58 oversized boxes of suspect TRU waste from Lawrence Livermore National Lab (LLNL). TRU waste is defined as greater than 3.7 kilobecquerels per gram [kBq/g] (100 nanocuries (nCi)/g) activity from alpha-emitting radionuclides with atomic number greater than 92 having a half-life greater than 20 years. Each box was custom-made to house a variety of suspect TRU wastes resulting from years of weapons program research, development, and testing. Since their arrival at NTS, the boxes have undergone several iterations of non-destructive assay (NDA) in preparation for the comprehensive repackaging effort. NDA has included two rounds of in situ gamma spectroscopy and real-time radiography (RTR) scans that were videotaped. Contents have been confirmed to include glove boxes, HEPA filters and their housings, and assorted process equipment and piping. TRU content was determined via directly measuring plutonium-239 (Pu-239), americium-241 (Am-241), and other radionuclides, while adding calculated results for non-measurable nuclides using reliable scaling factors developed from acceptable knowledge (AK). Advantages of CABRERA's NDA methods included: - More NDA information is available in the same amount of counting time, allowing NSTec to make more

    20. Peripheral Applications of Drug-Coated Balloons: Past, Present and Future

      Energy Technology Data Exchange (ETDEWEB)

      Krokidis, Miltiadis, E-mail: mkrokidis@hotmail.com; Spiliopoulos, Stavros, E-mail: stavspiliop@upatras.gr; Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Sabharwal, Tarun, E-mail: tarun_sabharwal@yahoo.co.uk [Guy' s and St. Thomas' Hospitals, NHS Foundation Trust, Department of Radiology (United Kingdom)

      2013-04-15

      Drug-coated balloon (DCB) technologies represent the latest and hottest development in the field of endovascular treatment of peripheral arterial disease. Initial experience with paclitaxel-coated balloon use in the femoral artery has demonstrated lower mid-term restenosis and superior mid-term clinical outcomes in terms of improved wound healing and reduced repeat angioplasty rates compared with standard balloon angioplasty. Many companies are presently developing and/or improving DCB catheters and therefore ongoing, technical improvements of the already existing platforms, new drugs, and innovative carriers are expected. The ongoing basic research studies and various multicenter randomized, controlled trials that are currently in progress will offer valuable scientific insights regarding the long-term effectiveness and other crucial issues, such as efficacy in various vascular beds, optimal balloon dosage, and post angioplasty antiplatelet therapy. Future applications of these devices also could include in-stent restenosis, anastomotic stenosis of surgical bypass, and benign stenoses of the central venous system. The authors envision that DCB angioplasty will evolve to a major paradigm shift in the endovascular treatment of occlusive vascular diseases.

    1. Peripheral Applications of Drug-Coated Balloons: Past, Present and Future

      International Nuclear Information System (INIS)

      Krokidis, Miltiadis; Spiliopoulos, Stavros; Katsanos, Konstantinos; Sabharwal, Tarun

      2013-01-01

      Drug-coated balloon (DCB) technologies represent the latest and hottest development in the field of endovascular treatment of peripheral arterial disease. Initial experience with paclitaxel-coated balloon use in the femoral artery has demonstrated lower mid-term restenosis and superior mid-term clinical outcomes in terms of improved wound healing and reduced repeat angioplasty rates compared with standard balloon angioplasty. Many companies are presently developing and/or improving DCB catheters and therefore ongoing, technical improvements of the already existing platforms, new drugs, and innovative carriers are expected. The ongoing basic research studies and various multicenter randomized, controlled trials that are currently in progress will offer valuable scientific insights regarding the long-term effectiveness and other crucial issues, such as efficacy in various vascular beds, optimal balloon dosage, and post angioplasty antiplatelet therapy. Future applications of these devices also could include in-stent restenosis, anastomotic stenosis of surgical bypass, and benign stenoses of the central venous system. The authors envision that DCB angioplasty will evolve to a major paradigm shift in the endovascular treatment of occlusive vascular diseases.

    2. Albumin and its application in drug delivery.

      Science.gov (United States)

      Sleep, Darrell

      2015-05-01

      Rapid clearance of drugs from the body results in short therapeutic half-life and is an integral property of many protein and peptide-based drugs. To maintain the desired therapeutic effect patients are required to administer higher doses more frequently, which is inconvenient and risks undesirable side effects. Drug delivery technologies aim to minimise the number of administrations and dose-related toxicity while maximising therapeutic efficacy. This review describes albumin's inherent biochemical and biophysical properties, which make it an attractive drug delivery platform and the developmental status of drugs that are associated, conjugated or genetically fused with albumin. Albumin interacts with a number of cell surface receptors including gp18, gp30, gp60, FcRn, cubilin and megalin. The importance of albumin's interaction with the FcRn receptor, the basis for albumin's long circulatory half-life, is described, as are engineered albumins with improved pharmacokinetics. Albumin naturally accumulates at tumours and sites of inflammation, a characteristic which can be augmented by the addition of targeting ligands. The development of albumin drug conjugates which reply upon this property is described. Albumin's inherent biochemical and biophysical properties make it an ideal drug delivery platform. Recent advances in our understanding of albumin physiology and the improvement in albumin-based therapies strongly suggest that albumin-based therapies have a significant advantage over alternative technologies in terms of half-life, stability, versatility, safety and ease of manufacture. Given the importance of the albumin:FcRn interaction, the interpretation of the pharmacokinetic and pharmacodynamic profiles of albumin-based therapeutics with disturbed albumin:FcRn interaction may have to be reassessed. The FcRn receptor has additional functionality, especially in relation to immunology, antigen presentation and delivery of proteins across mucosal membranes

    3. Applications and limitations of lipid nanoparticles in dermal and transdermal drug delivery via the follicular route.

      Science.gov (United States)

      Lauterbach, Andreas; Müller-Goymann, Christel C

      2015-11-01

      Lipid nanoparticles (LN) such as solid lipid nanoparticles (SLN) and nanolipid carriers (NLC) feature several claimed benefits for topical drug therapy including biocompatible ingredients, drug release modification, adhesion to the skin, and film formation with subsequent hydration of the superficial skin layers. However, penetration and permeation into and across deeper skin layers are restricted due to the barrier function of the stratum corneum (SC). As different kinds of nanoparticles provide the potential for penetration into hair follicles (HF) LN are applicable drug delivery systems (DDS) for this route in order to enhance the dermal and transdermal bioavailability of active pharmaceutical ingredients (API). Therefore, this review addresses the HF as application site, published formulations of LN which showed follicular penetration (FP), and characterization methods in order to identify and quantify the accumulation of API delivered by the LN in the HF. Since LN are based on lipids that appear in human sebum which is the predominant medium in HF an increased localization of the colloidal carriers as well as a promoted drug release may be assumed. Therefore, sebum-like lipid material and a size of less or equal 640 nm are appropriate specifications for FP of particulate formulations. Copyright © 2015 Elsevier B.V. All rights reserved.

    4. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

      Science.gov (United States)

      Zajdel, Justyna; Zajdel, Radosław

      2013-01-01

      Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

    5. Application of methyl methacrylate copolymers to the development of transdermal or loco-regional drug delivery systems.

      Science.gov (United States)

      Cilurzo, Francesco; Selmin, Francesca; Gennari, Chiara G M; Montanari, Luisa; Minghetti, Paola

      2014-07-01

      Methyl methacrylate copolymers (Eudragit®) have been exploited to develop transdermal patches, medicated plasters (hereinafter patches) and, more recently, film-forming sprays, microsponges and nanoparticles intended to be applied on the skin. The article reviews the information regarding the application of Eudragits in the design and development of these dosage forms focusing on the impact of formulative variables on the skin drug penetration and the patch adhesive properties. Eudragits combined with a large amount of plasticizers are used to design the pressure-sensitive adhesives, specialized materials used in the patch development. They have to assure the drug skin penetration and the contact with the skin. Most of the studies mainly deal with the former aspect. The authors used a Eudragit type opportunely plasticized to merely investigate the in vitro or in vivo skin permeability of a loaded drug. However, the summa of these data evidenced that a strict connection between the matrix hydrophilicity and drug penetration probably exists. The criticisms of adhesion are addressed in a limited number of papers reporting data on technological properties, namely tack, shear adhesion and peel adhesion, while the structural data of the Eudragit adhesives, rheology and surface free energy are not described, excepting the case of Eudragit E. Among other applications, micro- and nanosystems exploiting the ionizable nature of some Eudragits can offer novel opportunities to develop pH-sensitive drug delivery systems suitable for triggering its release onto the skin.

    6. Legal Responsibility of Doctor Regarding off-label Drug Applications

      Directory of Open Access Journals (Sweden)

      Erdal Yüzbaşıoğlu

      2012-03-01

      Full Text Available The use of off-label medication, which has been frequently applied in oncology, also started to be used in ophthalmology recently; thus, the legal problems that the doctors can encounter more often come up to be a topic of discussion. According to the drug administration guidelines released by the Ministry of Health, off-label medication depends on certain conditions, and applications other than these will be accepted as an experiment on humans according to the law No 5237 of the Turkish Criminal Code (TCC. The aim of this study was to clarify this issue in accordance with the justification of TCC/90. (Turk J Ophthalmol 2012; 42: 135-8

    7. Dendrimers as tunable vectors of drug delivery systems and biomedical and ocular applications

      Science.gov (United States)

      Kalomiraki, Marina; Thermos, Kyriaki; Chaniotakis, Nikos A

      2016-01-01

      Dendrimers are large polymeric structures with nanosize dimensions (1–10 nm) and unique physicochemical properties. The major advantage of dendrimers compared with linear polymers is their spherical-shaped structure. During synthesis, the size and shape of the dendrimer can be customized and controlled, so the finished macromolecule will have a specific “architecture” and terminal groups. These characteristics will determine its suitability for drug delivery, diagnostic imaging, and as a genetic material carrier. This review will focus initially on the unique properties of dendrimers and their use in biomedical applications, as antibacterial, antitumor, and diagnostic agents. Subsequently, emphasis will be given to their use in drug delivery for ocular diseases. PMID:26730187

    8. Application of rotational atherectomy in the drug-eluting stent era

      Science.gov (United States)

      Chen, Chun-Chi; Hsieh, I-Chang

      2013-01-01

      Rotational atherectomy (RA) was introduced in the interventional arena in 1988 as a dedicated device for calcified lesions. Due to the complexity of the technique, the development of alternative methods such as the cutting balloon procedure, and the high restenosis rate of subsequent bare metal stenting in long lesions, its use had later declined. However, with the increasing use of drug-eluting stents (DES) and the aggressive treatment of longer lesions, the number of procedure performed with RA has increased significantly again in recent years. In this article, we reviewed the application of RA in DES era. PMID:24133506

    9. Application of safeguards technology in DOE's environmental restoration program

      International Nuclear Information System (INIS)

      Eccleston, G.W.; Baker, M.P.; Hansen, W.R.; Lucas, M.C.; Markin, J.T.; Phillips, J.R.

      1990-01-01

      During the last two decades, the Department of Energy's Office of Safeguards and Security (DOE/OSS) has supported the research and development of safeguards systems analysis methodologies and nondestructive assay (NDS) technology for characterizing, monitoring, and accounting nuclear materials. This paper discusses methodologies and NDA instrumentation developed by the DOE/OSS program that could be applied in the Environmental Restoration Program. NDA instrumentation could be used for field measurements during site characterization and to monitor nuclear materials, heavy metals, and other hazardous materials during site remediation. Systems methodologies can minimize the expenditure of resources and help specify appropriate combinations of NDA instrumentation and chemical analyses to characterize a variety of materials quickly and reduce personnel exposure in hazardous environments. A training program is available to teach fundamental and advanced principles and approaches to characterize and quantify nuclear materials properly and to organize and analyze measurement information for decision making. The ability to characterize the overall volume and distribution of materials at a waste site is difficult because of the inhomogeneous distribution of materials, the requirement for extreme sensitivity, and the lack of resources to collect and chemically analyze a sufficient number of samples. Using a systems study approach based on statistical sampling, the resources necessary to characterize a site can be enhanced by appropriately combining in situ and field NDA measurements with laboratory analyses. 35 refs., 1 figs., 2 tabs

    10. Screening applications in drug discovery based on microfluidic technology

      Science.gov (United States)

      Eribol, P.; Uguz, A. K.; Ulgen, K. O.

      2016-01-01

      Microfluidics has been the focus of interest for the last two decades for all the advantages such as low chemical consumption, reduced analysis time, high throughput, better control of mass and heat transfer, downsizing a bench-top laboratory to a chip, i.e., lab-on-a-chip, and many others it has offered. Microfluidic technology quickly found applications in the pharmaceutical industry, which demands working with leading edge scientific and technological breakthroughs, as drug screening and commercialization are very long and expensive processes and require many tests due to unpredictable results. This review paper is on drug candidate screening methods with microfluidic technology and focuses specifically on fabrication techniques and materials for the microchip, types of flow such as continuous or discrete and their advantages, determination of kinetic parameters and their comparison with conventional systems, assessment of toxicities and cytotoxicities, concentration generations for high throughput, and the computational methods that were employed. An important conclusion of this review is that even though microfluidic technology has been in this field for around 20 years there is still room for research and development, as this cutting edge technology requires ingenuity to design and find solutions for each individual case. Recent extensions of these microsystems are microengineered organs-on-chips and organ arrays. PMID:26865904

    11. Screening applications in drug discovery based on microfluidic technology.

      Science.gov (United States)

      Eribol, P; Uguz, A K; Ulgen, K O

      2016-01-01

      Microfluidics has been the focus of interest for the last two decades for all the advantages such as low chemical consumption, reduced analysis time, high throughput, better control of mass and heat transfer, downsizing a bench-top laboratory to a chip, i.e., lab-on-a-chip, and many others it has offered. Microfluidic technology quickly found applications in the pharmaceutical industry, which demands working with leading edge scientific and technological breakthroughs, as drug screening and commercialization are very long and expensive processes and require many tests due to unpredictable results. This review paper is on drug candidate screening methods with microfluidic technology and focuses specifically on fabrication techniques and materials for the microchip, types of flow such as continuous or discrete and their advantages, determination of kinetic parameters and their comparison with conventional systems, assessment of toxicities and cytotoxicities, concentration generations for high throughput, and the computational methods that were employed. An important conclusion of this review is that even though microfluidic technology has been in this field for around 20 years there is still room for research and development, as this cutting edge technology requires ingenuity to design and find solutions for each individual case. Recent extensions of these microsystems are microengineered organs-on-chips and organ arrays.

    12. An albumin-oligonucleotide assembly for potential combinatorial drug delivery and half-life extension applications

      DEFF Research Database (Denmark)

      Kuhlmann, Matthias; Hamming, Jonas Bohn Refslund; Voldum, Anders

      2017-01-01

      The long blood circulatory property of human serum albumin, due to engagement with the cellular recycling neonatal Fc receptor (FcRn), is an attractive drug half-life extension enabling technology. This work describes a novel site-specific albumin double-stranded (ds) DNA assembly approach, in wh...... technology platform that offers potential combinatorial drug delivery and half-life extension applications.......The long blood circulatory property of human serum albumin, due to engagement with the cellular recycling neonatal Fc receptor (FcRn), is an attractive drug half-life extension enabling technology. This work describes a novel site-specific albumin double-stranded (ds) DNA assembly approach......, in which the 3' or 5' end maleimide-derivatized oligodeoxynucleotides are conjugated to albumin cysteine at position 34 (cys34) and annealed with complementary strands to allow single site-specific protein modification with functionalized ds oligodeoxynucleotides. Electrophoretic gel shift assays...

    13. Tahsin Ömer’in “Darb-I Mesellerimiz Hakkında Tahlili Tedkikat” Adlı Atasözleri Seçkisi A Selection of Proverbs from Tahsin Ömer’s “Darb-ı Mesellerimiz Hakkında Tahlili Tedkikat”

      Directory of Open Access Journals (Sweden)

      Abdulmuttalip İPEK

      2012-09-01

      Full Text Available Proverbs and idioms include very different matters ranging from the life styles of the societies they belong to to their frames of mind, from standards of judgements to moral insights due to the fact that they are based on lasting observations, experiences and lives of those societies. As a result, they are stereotyped words which are on the position of the soul of all the culture and value world of the nation they belong to. Proverbs, which make a short-cut and efficient expression possible, also reflect the philosophy of a nation. From this point of view, the realization and preservation of these verbal entities are of vital importance. From the time of Diwanu Lugat et-Turk, the oldest known dictionary of Turkish language, to our day, important dictionaries have been authored to preserve and record these verbal entities. Each of these dictionaries are very important resources as regards with Turkish language and culture. This manuscript will mention about an anthology of proverbs. According to the searches and surveys the anthology has been mentioned only in a few articles until today. The booklet “Darb-ı Mesellerimiz Hakkında Tahlili Tedkikat” was written by Tahsin Ömer and was printed in Evkaf Printing House in Şehzadebaşı, İstanbul between 1337 and 1340. The printed copy of the booklet in the library of the University of Toronto with the recording number of PN 6505 T8 035, is translated into Modern Turkish from Ottoman Turkish with an additional short review. As the result of a revisal of about 5000 proverbs used in our country, nearly 200 proverbs were sorted out according to their meanings and Tahsin Ömer says in the two and a half pages of foreword that this 16 pages booklet was written to make people learn and draw some lessons. The most exciting parts of this booklet are that the writer examines the proverbs in moral aspects and presents a sorting method. Another important part is the presented analytical assasments in the

    14. Kanser hastalarında kemoterapinin C-reaktif protein düzeyine ve yaşam kalitesine olan etkileri

      OpenAIRE

      Gürler, Mehmet Yavuz

      2011-01-01

      Giriş ve Amaç: Bir inflamasyon belirteci ve akut faz reaktanı olan C-reaktif protein, karaciğer ve yağ dokusunda üretilen bir beta globulindir. Günümüz pratiğinde pek çok hastalığın tanısını desteklerken bazı hastalıkların ise takibinde ve alevlenmesinde güvenilir bir belirteçtir. Son yıllarda yapılan çalışmalar göstermiş ki kanser hastalarında bakılan serum CRP düzeyi hastalığın yaygınlığı, hastanın yaşam kalitesi, prognozu ve kemoterapiye yanıtı değerlendirmede kullanılabilme...

    15. The application of molecular topology for ulcerative colitis drug discovery.

      Science.gov (United States)

      Bellera, Carolina L; Di Ianni, Mauricio E; Talevi, Alan

      2018-01-01

      Although the therapeutic arsenal against ulcerative colitis has greatly expanded (including the revolutionary advent of biologics), there remain patients who are refractory to current medications while the safety of the available therapeutics could also be improved. Molecular topology provides a theoretic framework for the discovery of new therapeutic agents in a very efficient manner, and its applications in the field of ulcerative colitis have slowly begun to flourish. Areas covered: After discussing the basics of molecular topology, the authors review QSAR models focusing on validated targets for the treatment of ulcerative colitis, entirely or partially based on topological descriptors. Expert opinion: The application of molecular topology to ulcerative colitis drug discovery is still very limited, and many of the existing reports seem to be strictly theoretic, with no experimental validation or practical applications. Interestingly, mechanism-independent models based on phenotypic responses have recently been reported. Such models are in agreement with the recent interest raised by network pharmacology as a potential solution for complex disorders. These and other similar studies applying molecular topology suggest that some therapeutic categories may present a 'topological pattern' that goes beyond a specific mechanism of action.

    16. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs – provision of due diligence in the treatment process

      Science.gov (United States)

      Zajdel, Justyna

      2013-01-01

      Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on “off-label use”. The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug. PMID:24592133

    17. Preparation of bovine serum albumin hollow microparticles by the water-in-oil emulsion solvent diffusion technique for drug delivery applications

      International Nuclear Information System (INIS)

      Baimark, Y.; Srisa-Ard, M.; Srihaman, P.

      2012-01-01

      Biodegradable bovine serum albumin (BSA) hollow microparticles have been prepared by a single step and rapid water-in-oil emulsion solvent diffusion method without any emulsifiers and templates. Aqueous BSA solution and ethyl acetate were used as water and oil phases, respectively. BSA solution was cross-linked with polyethylene glycol diglycidyl ether (PEGDE) before microparticle formation. Methylene blue (MB) was used as a water-soluble model drug to entrap in the microparticle matrix. The non-cross-linked and cross-linked BSA microparticles contained empty core structure with outer smooth surface. Inner surface and matrix of hollow microparticles consisted void structure. Drug loading did not affect the microparticle morphology. Cumulative drug released from microparticles was decreased steadily as decreasing of MB ratio and increasing of PEGDE ratio. The BSA hollow microparticles may have potential application in controlled release drug delivery application. (author)

    18. Image-guided drug delivery: preclinical applications and clinical translation

      NARCIS (Netherlands)

      Ojha, Tarun; Rizzo, Larissa; Storm, Gerrit; Kiessling, Fabian; Lammers, Twan Gerardus Gertudis Maria

      2015-01-01

      Image-guided drug delivery refers to the combination of drug targeting and imaging. Preclinically, image-guided drug delivery can be used for several different purposes, including for monitoring biodistribution, target site accumulation, off-target localization, drug release and drug efficacy.

    19. Seyyid Vehbi'nin Divanında Yer Almayan Bir Kasidesi The Kaside That Doesn’t Take Place In Divan Of Seyyid Vehbi

      Directory of Open Access Journals (Sweden)

      Haluk GÖKALP

      2013-03-01

      Full Text Available Perodicals include kinds of poems. In addition they comprise artistic and cultural accumulation when they were written. Pastiche collections give knowledge abaut pastiche tradition and interactions between poets. Poem notebooks which can collect diffrent subjects contribute to history of literatüre. So, pastiche collections or other collections are one of the main source of classical poetry. Contributions of periodicals to classical school of poetry investigating, may be collected with three groups. Firsh of all, periodicals reflect the plcasure of poem when they were written and poems which were approued can be determined. Second one, they contribute to recognition of poets who weren’t mentioned in history of literature. Third one, investigetors can benefit from periodicals for poems which weren’t mentioned in poet’s divan which include their poems. By this way, investigators can collect all poems of poet. İn this study, we evalvated the contributions of periodicals to classical poetry investigators. And than we are going to publish Seyyid Vehbi’s kaside in “Sıhhatname ve Sur-ı Hıtana Müteallik Kasaid” which was found from Topkapı Palace Library. With this study, Seyyid Vehbi’s poem which weren’t mentioned in other 31 copy is going to be presented to investigator’s advantage. Şiir mecmuaları çeşitli şiirleri derlemekle birlikte yazıldığı devrin sanat ve kültür birikimini de bir araya getirirler. Nazire mecmuaları nazire geleneğini ve şairler arası etkileşimi örnekleriyle gözler önüne sererken, farklı konular etrafında toplanan ya da -tamamen okuyucunun zevkine göre gelişigüzel toplanan- şiir defterleri edebiyat tarihini bir bütünlük içinde görmemize olumlu katkılar sağlar. Bu nedenle nazire mecmuaları ya da diğer şiir mecmuaları, divan şiiri araştırmalarının başlıca kaynaklarındandır. Genel olarak baktığımızda mecmuaların divan edebiyatı araştırmalarına katk

    20. Mathematical description of drug-target interactions: application to biologics that bind to targets with two binding sites.

      Science.gov (United States)

      Gibiansky, Leonid; Gibiansky, Ekaterina

      2018-02-01

      The emerging discipline of mathematical pharmacology occupies the space between advanced pharmacometrics and systems biology. A characteristic feature of the approach is application of advance mathematical methods to study the behavior of biological systems as described by mathematical (most often differential) equations. One of the early application of mathematical pharmacology (that was not called this name at the time) was formulation and investigation of the target-mediated drug disposition (TMDD) model and its approximations. The model was shown to be remarkably successful, not only in describing the observed data for drug-target interactions, but also in advancing the qualitative and quantitative understanding of those interactions and their role in pharmacokinetic and pharmacodynamic properties of biologics. The TMDD model in its original formulation describes the interaction of the drug that has one binding site with the target that also has only one binding site. Following the framework developed earlier for drugs with one-to-one binding, this work aims to describe a rigorous approach for working with similar systems and to apply it to drugs that bind to targets with two binding sites. The quasi-steady-state, quasi-equilibrium, irreversible binding, and Michaelis-Menten approximations of the model are also derived. These equations can be used, in particular, to predict concentrations of the partially bound target (RC). This could be clinically important if RC remains active and has slow internalization rate. In this case, introduction of the drug aimed to suppress target activity may lead to the opposite effect due to RC accumulation.

    1. [Development and effectiveness of a drug dosage calculation training program using cognitive loading theory based on smartphone application].

      Science.gov (United States)

      Kim, Myoung Soo; Park, Jung Ha; Park, Kyung Yeon

      2012-10-01

      This study was done to develop and evaluate a drug dosage calculation training program using cognitive loading theory based on a smartphone application. Calculation ability, dosage calculation related self-efficacy and anxiety were measured. A nonequivalent control group design was used. Smartphone application and a handout for self-study were developed and administered to the experimental group and only a handout was provided for control group. Intervention period was 4 weeks. Data were analyzed using descriptive analysis, χ²-test, t-test, and ANCOVA with the SPSS 18.0. The experimental group showed more 'self-efficacy for drug dosage calculation' than the control group (t=3.82, psmartphone application is effective in improving dosage calculation related self-efficacy and calculation ability. Further study should be done to develop additional interventions for reducing anxiety.

    2. Pnömatik Ekim Makinalarında Farklı Tip Dağıtma Başlıkları, Hava Hızı ve Gübreleme Normunun Akış Düzgünlüğüne Etkisi / The Effects of Distributor Head Types, Air Velocity and Fertilizing Rate on Flow Evenness in Pneumatic Seed Drills

      OpenAIRE

      Güler, İbrahim Ethem; Uygan, Fatih

      2011-01-01

      ÖZET : Bu araştırma pnömatik tahıl ekim makinalarında kullanılan farklı tip dağıtma başlıklarında, hava hızının ve gübrelemenormunun akış düzgünlüğüne etkisini belirlemek için yapılmıştır. Araştırmada üç farklı tip dağıtma başlığı (T, Huni ve Y), üç farklıhava hızında (26, 31, 36 m/s) denenmiştir. Denemelerde Diamonyum fosfat (DAP) ve Triple süper fosfat (TSP) gübrelerikullanılmıştır. Gübreleme normları 12, 16 ve...

    3. gPKPDSim: a SimBiology®-based GUI application for PKPD modeling in drug development.

      Science.gov (United States)

      Hosseini, Iraj; Gajjala, Anita; Bumbaca Yadav, Daniela; Sukumaran, Siddharth; Ramanujan, Saroja; Paxson, Ricardo; Gadkar, Kapil

      2018-04-01

      Modeling and simulation (M&S) is increasingly used in drug development to characterize pharmacokinetic-pharmacodynamic (PKPD) relationships and support various efforts such as target feasibility assessment, molecule selection, human PK projection, and preclinical and clinical dose and schedule determination. While model development typically require mathematical modeling expertise, model exploration and simulations could in many cases be performed by scientists in various disciplines to support the design, analysis and interpretation of experimental studies. To this end, we have developed a versatile graphical user interface (GUI) application to enable easy use of any model constructed in SimBiology ® to execute various common PKPD analyses. The MATLAB ® -based GUI application, called gPKPDSim, has a single screen interface and provides functionalities including simulation, data fitting (parameter estimation), population simulation (exploring the impact of parameter variability on the outputs of interest), and non-compartmental PK analysis. Further, gPKPDSim is a user-friendly tool with capabilities including interactive visualization, exporting of results and generation of presentation-ready figures. gPKPDSim was designed primarily for use in preclinical and translational drug development, although broader applications exist. gPKPDSim is a MATLAB ® -based open-source application and is publicly available to download from MATLAB ® Central™. We illustrate the use and features of gPKPDSim using multiple PKPD models to demonstrate the wide applications of this tool in pharmaceutical sciences. Overall, gPKPDSim provides an integrated, multi-purpose user-friendly GUI application to enable efficient use of PKPD models by scientists from various disciplines, regardless of their modeling expertise.

    4. Chimeric mice with humanized liver: Application in drug metabolism and pharmacokinetics studies for drug discovery.

      Science.gov (United States)

      Naritomi, Yoichi; Sanoh, Seigo; Ohta, Shigeru

      2018-02-01

      Predicting human drug metabolism and pharmacokinetics (PK) is key to drug discovery. In particular, it is important to predict human PK, metabolite profiles and drug-drug interactions (DDIs). Various methods have been used for such predictions, including in vitro metabolic studies using human biological samples, such as hepatic microsomes and hepatocytes, and in vivo studies using experimental animals. However, prediction studies using these methods are often inconclusive due to discrepancies between in vitro and in vivo results, and interspecies differences in drug metabolism. Further, the prediction methods have changed from qualitative to quantitative to solve these issues. Chimeric mice with humanized liver have been developed, in which mouse liver cells are mostly replaced with human hepatocytes. Since human drug metabolizing enzymes are expressed in the liver of these mice, they are regarded as suitable models for mimicking the drug metabolism and PK observed in humans; therefore, these mice are useful for predicting human drug metabolism and PK. In this review, we discuss the current state, issues, and future directions of predicting human drug metabolism and PK using chimeric mice with humanized liver in drug discovery. Copyright © 2017 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

    5. Öğütülmüş Ayçiçek Tohumlarında Enzim Muamelesiyle Yağ Üretiminin Arttırılması

      Directory of Open Access Journals (Sweden)

      Mariyana Perifanova-Nemska

      2015-02-01

      Full Text Available Öğütülmüş ayçiçek tohumları daha fazla yağ elde etmek amacı ile sellülaz, asit ve baz karakterli proteinaz ve pektinaz enzimleri ile muamele edilmiştir. İncelenen preparatlar arasında sellülaz (selobranin enzimi uygulanan tohumlar en yüksek yağ verimini göstermişlerdir.

    6. Tagatose, a new antidiabetic and obesity control drug.

      Science.gov (United States)

      Lu, Y; Levin, G V; Donner, T W

      2008-02-01

      A potentially important new drug for treating type 2 diabetes, tagatose, is now in phase 3 clinical trial. The history, development, additional health benefits, mechanisms of action and the potential for the drug are presented in context with a review of the rapidly growing epidemic of type 2 diabetes and treatments for it. An epimer of fructose, the natural hexose tagatose was originally developed by Spherix Incorporated (formerly Biospherics Inc.) as a low-calorie sugar substitute. Only 20% of orally ingested tagatose is fully metabolized, principally in the liver, following a metabolic pathway identical to that of fructose. Following a decade of studies, tagatose became generally recognized as safe for use in foods and beverages under US FDA regulation. The simple sugar is commercially produced by isomerization of galactose, which is prepared from lactose. Early human studies suggested tagatose as a potential antidiabetic drug through its beneficial effects on postprandial hyperglycaemia and hyperinsulinaemia. A subsequent 14-month trial confirmed its potential for treating type 2 diabetes, and tagatose showed promise for inducing weight loss and raising high-density lipoprotein cholesterol, both important to the control of diabetes and constituting benefits independent of the disease. Furthermore, tagatose was shown to be an antioxidant and a prebiotic, both properties cited in the maintenance and promotion of health. No current therapies for type 2 diabetes provide these multiple health benefits. The predominant side effects of tagatose are gastrointestinal disturbances associated with excessive consumption, generally accommodated within 1- to 2-week period. The health and use potentials for tagatose (branded Naturlose((R)) for this use) are given with respect to current type 2 diabetes drugs and markets. Under an FDA-affirmed protocol, Spherix is currently conducting a phase 3 trial to evaluate a placebo-subtracted treatment effect based on a decrease in Hb

    7. Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm.

      Science.gov (United States)

      Kesisoglou, Filippos; Mitra, Amitava

      2015-09-01

      Physiologically based absorption models can be an important tool in understanding product performance and hence implementation of Quality by Design (QbD) in drug product development. In this report, we show several case studies to demonstrate the potential application of absorption modeling in rational design of drug product under the QbD paradigm. The examples include application of absorption modeling—(1) prior to first-in-human studies to guide development of a formulation with minimal sensitivity to higher gastric pH and hence reduced interaction when co-administered with PPIs and/or H2RAs, (2) design of a controlled release formulation with optimal release rate to meet trough plasma concentrations and enable QD dosing, (3) understanding the impact of API particle size distribution on tablet bioavailability and guide formulation design in late-stage development, (4) assess impact of API phase change on product performance to guide specification setting, and (5) investigate the effect of dissolution rate changes on formulation bioperformance and enable appropriate specification setting. These case studies are meant to highlight the utility of physiologically based absorption modeling in gaining a thorough understanding of the product performance and the critical factors impacting performance to drive design of a robust drug product that would deliver the optimal benefit to the patients.

    8. Fragment-based drug discovery and its application to challenging drug targets.

      Science.gov (United States)

      Price, Amanda J; Howard, Steven; Cons, Benjamin D

      2017-11-08

      Fragment-based drug discovery (FBDD) is a technique for identifying low molecular weight chemical starting points for drug discovery. Since its inception 20 years ago, FBDD has grown in popularity to the point where it is now an established technique in industry and academia. The approach involves the biophysical screening of proteins against collections of low molecular weight compounds (fragments). Although fragments bind to proteins with relatively low affinity, they form efficient, high quality binding interactions with the protein architecture as they have to overcome a significant entropy barrier to bind. Of the biophysical methods available for fragment screening, X-ray protein crystallography is one of the most sensitive and least prone to false positives. It also provides detailed structural information of the protein-fragment complex at the atomic level. Fragment-based screening using X-ray crystallography is therefore an efficient method for identifying binding hotspots on proteins, which can then be exploited by chemists and biologists for the discovery of new drugs. The use of FBDD is illustrated here with a recently published case study of a drug discovery programme targeting the challenging protein-protein interaction Kelch-like ECH-associated protein 1:nuclear factor erythroid 2-related factor 2. © 2017 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

    9. 1911-1918 Yılları Arasında Türk Yurdu Dergisine Konu Olan Bazı Tartışma ve Polemikler / Some Polemics and Discussions which were Subjected In Turk Yurdu Magazine Between 1911-1918

      Directory of Open Access Journals (Sweden)

      Ümmet Erkan

      2016-01-01

      Bazı Tartışma ve Polemikler  Öz Türk Yurdu Dergisi 1911 yılında yayın hayatına başlamış, Türk milliyetçiliinin en uzun soluklu yayın organıdır. Rusya Türklerinin öncülük ettiği dergide Türklüğün her alanda yükselmesi amaçlanmıştır. Bu makalede Türk Yurdu dergisinin 1911-1918 yılları arasındaki sayılarından yola çıkılarak dergideki bazı kalem tartışmaları, mektuplar ve onlara verilen cevaplar incelenecektir. Bu kalem tartışmalarında Türkçenin sadeleştirilmesinden ne anlaşılması gerektiği ve sınırları, eğitimde ideal eksikliği, eğitim dilinin Türkçe olması ve azınlık okullarının Osmanlı sosyal bünyesine verdiği zararlar, Tanzimatçı reform programının başarılı olup olmadığı ve nedenleri, milli kimliğin dini aidiyete zarar verip vermeyeceği konuları ele alınacaktır. Türk Yurdu dergisi yazarları ile dönemin diğer önemli entelektüellerinin çeşitli gazete ve dergilerde dâhil olduğu bu kalem tartışmaları zengin bir muhteva kazanmıştır. Bu tartışmalar dönemin entelektüel fikir hareketleri ve siyasi akımlar hakkında önemli bilgiler içermektedir. Bu araştırma, yapılan tartışma ve polemiklerin hangi konular etrafında yoğunlaştığını ve Türk Yurdu dergisinin bu tartışma ve polemiklerde ne tür bir yöntem izlediğini ortaya koymaktadır.

    10. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

      Science.gov (United States)

      2012-10-25

      ..., U.S. postal money order, or wire transfer. FDA has partnered with the U.S. Department of the... money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be...

    11. Short-peptide-based molecular hydrogels: novel gelation strategies and applications for tissue engineering and drug delivery

      Science.gov (United States)

      Wang, Huaimin; Yang, Zhimou

      2012-08-01

      Molecular hydrogels hold big potential for tissue engineering and controlled drug delivery. Our lab focuses on short-peptide-based molecular hydrogels formed by biocompatible methods and their applications in tissue engineering (especially, 3D cell culture) and controlled drug delivery. This feature article firstly describes our recent progresses of the development of novel methods to form hydrogels, including the strategy of disulfide bond reduction and assistance with specific protein-peptide interactions. We then introduce the applications of our hydrogels in fields of controlled stem cell differentiation, cell culture, surface modifications of polyester materials by molecular self-assembly, and anti-degradation of recombinant complex proteins. A novel molecular hydrogel system of hydrophobic compounds that are only formed by hydrolysis processes was also included in this article. The hydrogels of hydrophobic compounds, especially those of hydrophobic therapeutic agents, may be developed into a carrier-free delivery system for long term delivery of therapeutic agents. With the efforts in this field, we believe that molecular hydrogels formed by short peptides and hydrophobic therapeutic agents can be practically applied for 3D cell culture and long term drug delivery in near future, respectively.

    12. Preclinical experimental models of drug metabolism and disposition in drug discovery and development

      Directory of Open Access Journals (Sweden)

      Donglu Zhang

      2012-12-01

      Full Text Available Drug discovery and development involve the utilization of in vitro and in vivo experimental models. Different models, ranging from test tube experiments to cell cultures, animals, healthy human subjects, and even small numbers of patients that are involved in clinical trials, are used at different stages of drug discovery and development for determination of efficacy and safety. The proper selection and applications of correct models, as well as appropriate data interpretation, are critically important in decision making and successful advancement of drug candidates. In this review, we discuss strategies in the applications of both in vitro and in vivo experimental models of drug metabolism and disposition.

    13. Synthesis and applications of radiolabelled drugs in pharmaceutical development

      International Nuclear Information System (INIS)

      Landvatter, S.W.; Heys, J.R.; Garner, K.T.; Mack, J.F.; Senderoff, S.G.; Shu, A.Y.; Villani, A.J.; Saunders, D.

      1994-01-01

      Radiolabelled drugs play a vital role in the development of new pharmaceuticals including application in drug discovery, pre-clinical development and clinical development. The synthesis of these pharmaceuticals in tritium or carbon-14 labelled form poses many challenges for the synthetic organic chemist. The actual choice of synthetic route must take into account the small scale, limited choice and high cost of labelled precursors, and the positioning of the label into a metabolically stable position. There are, however, a number of synthetic strategies available for overcoming these constraints. Although in some C-14 syntheses the requisite labelled raw material can be purchased and the existing synthesis adapted for labelling, frequently the synthetic challenge is the synthesis of a structurally simple, yet commercially unavailable, labelled precursor (e.g., γ-butyrolactone-[2- 14 C], cyclohexanone-[ 3 H], CuCN-[ 14 C], 2-furancarboxaldehyde-[ 14 C]). Another useful strategy in C-14 synthesis is the conversion of an advanced intermediate, or perhaps the unlabelled product itself, into a precursor which can then be reconverted into the labelled version of the intermediate. Occasionally, a new total synthesis must be developed. In addition to these strategies, tritium labelling can uniquely take advantage of exchange labelling techniques, synthesis and reduction of unsaturated precursors, or tritium-halogen replacement reactions. Examples of these strategies and use of the labelled products are discussed

    14. Kefir Kültürünün Beyaz Peynir Yapımında Kullanılması Üzerine bir Araştırma

      Directory of Open Access Journals (Sweden)

      Hasan Yaygın

      2015-02-01

      Full Text Available Beyaz peynir yapımında kullanılacak saf kültürde yer alması gereken mikroorganizmaları saptamak amacı ile bazı çalışmalar yapılmıştır. Araştırıcıların çoğunluğu saf kültürde S. lactis, S. cremoris ve L. casei’ nin bulunması gerektiğini belirtmişlerdir. Bu çalışmada beyaz peynir yapımında saf kültür olarak kefir kültürü kullanılmıştır. Kefir kültüründe söz konusu bakterilerle beraber bazı maya ve bakteriler de bulunmaktadır. Araştırma sonuçları kefir kültürü katılan sütten yapılan beyaz peynirde asitlik gelişiminin istenilen düzeyde olduğu; tat ve aroma ile yapının tüketiciler tarafından beğenildiğini ortaya çıkarmıştır.

    15. Illicit drugs and pharmaceuticals in the environment--forensic applications of environmental data. Part 1: Estimation of the usage of drugs in local communities.

      Science.gov (United States)

      Kasprzyk-Hordern, Barbara; Dinsdale, Richard M; Guwy, Alan J

      2009-06-01

      Pharmaceuticals and recently also illicit drugs have been recognised as emerging environmental contaminants due to their potential environmental impact: frequent occurrence, persistence and risk to aquatic life and humans. This manuscript is part one of the two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. An attempt to use wastewater data is made in order to verify patterns of the usage of drugs (in particular illicit) in local communities. The average usage of cocaine in South Wales was estimated at 0.9 g day(-1) 1000 people(-1), which equals 1 tonne of this drug used or disposed of to sewage annually in Wales. The calculated usage of amphetamine denoted 2.5 g day(-1) 1000 people(-1) and is suspected to be an overestimate. Because no analysis of enantiomers of amphetamine was undertaken, no distinction between amphetamine's legal and illicit usage could be made.

    16. Application of PK/PD Modeling in Veterinary Field: Dose Optimization and Drug Resistance Prediction

      Directory of Open Access Journals (Sweden)

      Ijaz Ahmad

      2016-01-01

      Full Text Available Among veterinary drugs, antibiotics are frequently used. The true mean of antibiotic treatment is to administer dose of drug that will have enough high possibility of attaining the preferred curative effect, with adequately low chance of concentration associated toxicity. Rising of antibacterial resistance and lack of novel antibiotic is a global crisis; therefore there is an urgent need to overcome this problem. Inappropriate antibiotic selection, group treatment, and suboptimal dosing are mostly responsible for the mentioned problem. One approach to minimizing the antibacterial resistance is to optimize the dosage regimen. PK/PD model is important realm to be used for that purpose from several years. PK/PD model describes the relationship between drug potency, microorganism exposed to drug, and the effect observed. Proper use of the most modern PK/PD modeling approaches in veterinary medicine can optimize the dosage for patient, which in turn reduce toxicity and reduce the emergence of resistance. The aim of this review is to look at the existing state and application of PK/PD in veterinary medicine based on in vitro, in vivo, healthy, and disease model.

    17. Kıl Keçi ve Saanen x Kıl Keçi Melezlerinin (F1, G1, Üretici Şartlarında Döl Verim Özellikleri Bakımından Karşılaştırılması

      Directory of Open Access Journals (Sweden)

      Hilal Tozlu Çelik

      2014-11-01

      Full Text Available Bu araştırma, Amasya ili Sarılar köyünde (40°54'23"N, 35°08'dk5"E özel bir işletmede 2011-2012 yılları arasında yetiştirilen Saanen x Kıl keçi melezleri (F1, G1 ve Kıl keçilerinde döl verimi özelliklerini tespit etmek ve bu özellikler üzerine genotip ve yıl faktörlerinin etkisini ortaya koymak amacıyla yapılmıştır. Araştırmada döl verim özelliklerinden 2011 yılı için sadece ikiz doğuran keçi oranı bakımından genotipler arasında istatistiki farklılık belirlenmiştir. İkiz doğuran keçi oranı Kıl keçilerle, F1 melezlerinde benzer bulunmuş ve G1 melezlerinde ise her iki genotipten farklı bulunmuştur. 2012 yılında genotipler arasında kısır kalan keçi, ikiz doğuran keçi ve ölü doğum yapan keçi oranı bakımından istatistiki farklılıklar olduğu tespit edilmiştir. Kısırlık oranının, Saanen x Kıl keçi F1, G1 melezlerinde Kıl keçilerinden daha yüksek olduğu belirlenmiştir. İkiz doğuran keçi oranı F1 genotipinde yüksek, G1 genotipinde ve Kıl keçilerinde benzer bulunmuştur.

    18. Virosome, a hybrid vehicle for efficient and safe drug delivery and its emerging application in cancer treatment.

      Science.gov (United States)

      Liu, Hanqing; Tu, Zhigang; Feng, Fan; Shi, Haifeng; Chen, Keping; Xu, Ximing

      2015-06-01

      A virosome is an innovative hybrid drug delivery system with advantages of both viral and non-viral vectors. Studies have shown that a virosome can carry various biologically active molecules, such as nucleic acids, peptides, proteins and small organic molecules. Targeted drug delivery using virosome-based systems can be achieved through surface modifications of virosomes. A number of virosome-based prophylactic and therapeutic products with high safety profiles are currently available in the market. Cancer treatment is a big battlefield for virosome-based drug delivery systems. This review provides an overview of the general concept, preparation procedures, working mechanisms, preclinical studies and clinical applications of virosomes in cancer treatment.

    19. Supply and demand: application of Lean Six Sigma methods to improve drug round efficiency and release nursing time.

      Science.gov (United States)

      Kieran, Maríosa; Cleary, Mary; De Brún, Aoife; Igoe, Aileen

      2017-10-01

      To improve efficiency, reduce interruptions and reduce the time taken to complete oral drug rounds. Lean Six Sigma methods were applied to improve drug round efficiency using a pre- and post-intervention design. A 20-bed orthopaedic ward in a large teaching hospital in Ireland. Pharmacy, nursing and quality improvement staff. A multifaceted intervention was designed which included changes in processes related to drug trolley organization and drug supply planning. A communications campaign aimed at reducing interruptions during nurse-led during rounds was also developed and implemented. Average number of interruptions, average drug round time and variation in time taken to complete drug round. At baseline, the oral drug round took an average of 125 min. Following application of Lean Six Sigma methods, the average drug round time decreased by 51 min. The average number of interruptions per drug round reduced from an average of 12 at baseline to 11 following intervention, with a 75% reduction in drug supply interruptions. Lean Six Sigma methodology was successfully employed to reduce interruptions and to reduce time taken to complete the oral drug round. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

    20. Emirhan Yeniki’nin “Bir Saatliğine” Hikâyesi Ve Tatar Edebiyatında Savaşın İzleri “For One Hour” Story Of Emirhan Yeniki And The Effects Of War In Tatar Literature

      Directory of Open Access Journals (Sweden)

      Alsu KAMALİEVA

      2013-03-01

      Full Text Available War offers a variety of themes for artists with the tragedies it embodies. The war theme is one of the most challenging themes of literary works. Wars that have been experienced throughout the history of humanity have been worked in various literary genres in world literatures. “War” has been widely discussed in Tatar Literature as well. This is strongly related to the fact that Tatar society deeply experienced the sufferings of World War II. As it is known, the Tatar people had livedclosely with Soviet people and struggled against the Nazi Germany inthe Second World War by taking sides with Soviet Union. Many Tatarwriters and artists had been in the war in person and experienced theprocess. EmirhanYeniki, whose name has exceeded the borders of hiscountry, is one of those Tatar artists who experienced the war andreflected it successfully. “Bir Saatliğine” (For One Hour is a significantstory by EmirhanYeniki which established a place for itself in TatarLiterature among the works of war period. In the story, Yeniki tells usabout the Tatar society during the World War II and the meeting of amother with his youngest son of her three children for one hour byenriching the story with psychological analyses. In the “For One Hour”story, we can find about Tatar village life with all its details within thetechnical possibilities of story genre. In addition, the significance of“train”, the means of transportation where the story was set around,among Tatar society is clearly emphasized in the story. Savaş, trajedileriyle, sanatkârlara geniş bir yelpazede tema çeşitliliği verir. Savaş teması, edebi eserlerin de iddialı temalarından biridir. İnsanlık tarihi boyunca yaşanan savaşlar, dünya edebiyatlarında çeşitli edebî türlerde işlenmiştir. Tatar Edebiyatı’nda da savaş teması geniş bir şekilde yer almıştır. Bu durumun ortaya çıkmasında Tatar toplumunun, İkinci Dünya Savaşı’nın bütün acılarını derin

    1. The application of drug delivery system about nanoparticles in nuclear medicine

      International Nuclear Information System (INIS)

      Yao Ning; Wang Rongfu

      2013-01-01

      The development of nuclear medicine relies on the advancement of precise probes at the cellular and molecular levels. Nanoparticle as a new molecular probe, is mainly consists of the targeting groups, imaging groups, the superb biocompatible 'shells' and the modify groups. These nanoparticles have the better image contrast by targeting positioning in the target tissues and cells. At the same time, because of the diversity of the materials and the uniqueness of the structures, the nanoparticles can realize multimodal imaging at molecular level, which complement each other's advantages of different imaging modals. If the treatment groups are joined into the nanoparticles, a new nanoparticles are formed-the theranosis nanoparticles, which have realized the diagnosis and therapy at the molecular level synchronously. In addition, the application of intelligent nanoprobes can achieve the smart control of drug release and reduce the side effects of cancer treatment. Anyhow, the development of this new drug delivery system about nanoparticles has brought about a new breakthrough on the nuclear medicine. (authors)

    2. Fabrication of luminescent hydroxyapatite nanorods through surface-initiated RAFT polymerization: Characterization, biological imaging and drug delivery applications

      Energy Technology Data Exchange (ETDEWEB)

      Heng, Chunning [Shaanxi Key Laboratory of Degradable Biomedical Materials, Shaanxi R& D Center of Biomaterials and Fermentation Engineering, School of Chemical and Engineering, Northwest University, Xi’an, 710069 (China); Department of Chemistry, Nanchang University, 999 Xuefu Avenue, Nanchang 330031 (China); Zheng, Xiaoyan [Shaanxi Key Laboratory of Degradable Biomedical Materials, Shaanxi R& D Center of Biomaterials and Fermentation Engineering, School of Chemical and Engineering, Northwest University, Xi’an, 710069 (China); Liu, Meiying; Xu, Dazhuang; Huang, Hongye; Deng, Fengjie [Department of Chemistry, Nanchang University, 999 Xuefu Avenue, Nanchang 330031 (China); Hui, Junfeng, E-mail: huijunfeng@126.com [Shaanxi Key Laboratory of Degradable Biomedical Materials, Shaanxi R& D Center of Biomaterials and Fermentation Engineering, School of Chemical and Engineering, Northwest University, Xi’an, 710069 (China); Zhang, Xiaoyong, E-mail: xiaoyongzhang1980@gmail.com [Department of Chemistry, Nanchang University, 999 Xuefu Avenue, Nanchang 330031 (China); Wei, Yen, E-mail: weiyen@tsinghua.edu.cn [Department of Chemistry and the Tsinghua Center for Frontier Polymer Research, Tsinghua University, Beijing, 100084 (China)

      2016-11-15

      Highlights: • Hydrophobic hydroxyapatite nanorods were obtained from hydrothermal synthesis. • Surface initiated RAFT polymerization was adopted to surface modification of hydroxyapatite nanorods. • These modified hydroxyapatite nanorods showed high water dispersibility and biocompatibility. • These modified hydroxyapatite nanorods can be used for controlled drug delivery. - Abstract: Hydroxyapatite nanomaterials as an important class of nanomaterials, have been widely applied for different biomedical applications for their excellent biocompatibility, biodegradation potential and low cost. In this work, hydroxyapatite nanorods with uniform size and morphology were prepared through hydrothermal synthesis. The surfaces of these hydroxyapatite nanorods are covered with hydrophobic oleic acid, making them poor dispersibility in aqueous solution and difficult for biomedical applications. To overcome this issue, a simple surface initiated polymerization strategy has been developed via combination of the surface ligand exchange and reversible addition fragmentation chain transfer (RAFT) polymerization. Hydroxyapatite nanorods were first modified with Riboflavin-5-phosphate sodium (RPSSD) via ligand exchange reaction between the phosphate group of RPSSD and oleic acid. Then hydroxyl group of nHAp-RPSSD was used to immobilize chain transfer agent, which was used as the initiator for surface-initiated RAFT polymerization. The nHAp-RPSSD-poly(IA-PEGMA) nanocomposites were characterized by means of {sup 1}H nuclear magnetic resonance, Fourier transform infrared spectroscopy, fluorescence spectroscopy and thermal gravimetric analysis in detailed. The biocompatibility, biological imaging and drug delivery of nHAp-RPSSD-poly(IA-PEGMA) were also investigated. Results showed that nHAp-RPSSD-poly(IA-PEGMA) exhibited excellent water dispersibility, desirable optical properties, good biocompatibility and high drug loading capability, making them promising candidates for

    3. Fabrication of luminescent hydroxyapatite nanorods through surface-initiated RAFT polymerization: Characterization, biological imaging and drug delivery applications

      International Nuclear Information System (INIS)

      Heng, Chunning; Zheng, Xiaoyan; Liu, Meiying; Xu, Dazhuang; Huang, Hongye; Deng, Fengjie; Hui, Junfeng; Zhang, Xiaoyong; Wei, Yen

      2016-01-01

      Highlights: • Hydrophobic hydroxyapatite nanorods were obtained from hydrothermal synthesis. • Surface initiated RAFT polymerization was adopted to surface modification of hydroxyapatite nanorods. • These modified hydroxyapatite nanorods showed high water dispersibility and biocompatibility. • These modified hydroxyapatite nanorods can be used for controlled drug delivery. - Abstract: Hydroxyapatite nanomaterials as an important class of nanomaterials, have been widely applied for different biomedical applications for their excellent biocompatibility, biodegradation potential and low cost. In this work, hydroxyapatite nanorods with uniform size and morphology were prepared through hydrothermal synthesis. The surfaces of these hydroxyapatite nanorods are covered with hydrophobic oleic acid, making them poor dispersibility in aqueous solution and difficult for biomedical applications. To overcome this issue, a simple surface initiated polymerization strategy has been developed via combination of the surface ligand exchange and reversible addition fragmentation chain transfer (RAFT) polymerization. Hydroxyapatite nanorods were first modified with Riboflavin-5-phosphate sodium (RPSSD) via ligand exchange reaction between the phosphate group of RPSSD and oleic acid. Then hydroxyl group of nHAp-RPSSD was used to immobilize chain transfer agent, which was used as the initiator for surface-initiated RAFT polymerization. The nHAp-RPSSD-poly(IA-PEGMA) nanocomposites were characterized by means of "1H nuclear magnetic resonance, Fourier transform infrared spectroscopy, fluorescence spectroscopy and thermal gravimetric analysis in detailed. The biocompatibility, biological imaging and drug delivery of nHAp-RPSSD-poly(IA-PEGMA) were also investigated. Results showed that nHAp-RPSSD-poly(IA-PEGMA) exhibited excellent water dispersibility, desirable optical properties, good biocompatibility and high drug loading capability, making them promising candidates for biological

    4. Türk Yazınından Seçili İki Romanda Göç ve Göçmen Olgusunun Paydaşlık Bağlamında Yansımaları

      Directory of Open Access Journals (Sweden)

      Birkan KARGI

      2017-09-01

      Full Text Available Nazan Bekiroğlu’nun 2012 yılında yayınlanan Nar Ağacı romanı ve Ali Arslan’ın 2003 yılında yayınlanan Ama Sevgi Kalmalı adlı romanda, anlatıcılar kendi köklerini ve kendilerinden önceki kuşakların göç yazgılarının izlerini sürerler. Bu yapıtlarda biri batıdan doğuya, diğeri ise doğudan batıya evlerinden ayrılarak göç etmek zorunda kalan protogonistlerin yaşam öyküleri ele alınmıştır. Nar Ağacı romanında protogonistin göç serüveni İran’ın Tebriz kentinden başlayıp Tiflis, Bakü, Batum ve Trabzon zincirinde gelişirken, Ama Sevgi Kalmalı adlı roman da protogonistin göç serüveni Hannover’in Linden bölgesinden Filistin’e oradan da Anadolu’ya, Egenin Seki köyüne kadar devam eder. Yapıtların arka dokusunu Rus işgali, Birinci Dünya Savaşı, Milli Mücadele ve sonrası oluşturur. Göç serüveninde, göçmenlerin kimlikleri bölünür, parçalanır ve kendilerini yeniden gerçekleştirmek zorunda hissederler. Bu bağlamda Hans’ın Sofiya’ya, Settarhan’ın Zehra’ya olan aşkları protogonistler için varoluşsal bir işlev görür. Aslında her iki yapıttaki protogonistlerin göç nedenlerini, kurulu düzene ‘karşı olma’ ve kendi farklılıklarını ortaya koyma üzerine kuruludur. Derrida’nın da vurguladığı gibi, kimlikler ancak kendi farklılıklarıyla var olabilir ve bir anlamda her kimlik ötekidir. Benzer şekilde Laclau’ya göre de tüm kimliklerin temelinde antagonizma ve dışlanma bulunur. Hans, savaş karşıtı duruşuyla Almanya’da ötekidir. Settarhan ise gelenek ve törelere karşı duruşuyla öteki olmak durumuna düşmüştür. Her ikisi de göç nedeniyle yeniden varlık sorunlarını biçimlendirmeye çalışırlar. Her iki yapıtta da göç, benzer nedenlere dayanmaktadır. Bu benzerlik, batı ve doğu dünyasının karşıtlığında ortaya çıkar. Avrupa’da Aydınlanma anlayışının gelişim sürecinde egemen olan modernite

    5. Nanomedicine: towards development of patient-friendly drug-delivery systems for oncological applications

      Directory of Open Access Journals (Sweden)

      Ranganathan R

      2012-02-01

      Full Text Available Ramya Ranganathan1,*, Shruthilaya Madanmohan1,*, Akila Kesavan1, Ganga Baskar1, Yoganathan Ramia Krishnamoorthy2, Roy Santosham3, D Ponraju4, Suresh Kumar Rayala2, Ganesh Venkatraman1 1Department of Human Genetics, Sri Ramachandra University, Porur, 2Department of Biotechnology, Indian Institute of Technology, Madras, 3Department of Radiology and Imaging Sciences, Sri Ramachandra University, Porur, Chennai, 4Safety Engineering Division, Nuclear and Engineering Safety Group, Indira Gandhi Center for Atomic Research, Kalpakkam, India*Authors contributed equally to this workAbstract: The focus on nanotechnology in cancer treatment and diagnosis has intensified due to the serious side effects caused by anticancer agents as a result of their cytotoxic actions on normal cells. This nonspecific action of chemotherapy has awakened a need for formulations capable of definitive targeting with enhanced tumor-killing. Nanooncology, the application of nanobiotechnology to the management of cancer, is currently the most important area of nanomedicine. Currently several nanomaterial-based drug-delivery systems are in vogue and several others are in various stages of development. Tumor-targeted drug-delivery systems are envisioned as magic bullets for cancer therapy and several groups are working globally for development of robust systems.Keywords: patient-friendly, drug-delivery systems, cancer, nanomedicine

    6. Controlled adsorption and release onto calcium phosphates materials and drug delivery applications

      Directory of Open Access Journals (Sweden)

      Barroug A.

      2013-11-01

      Full Text Available The adsorptive properties of synthetic calcium phosphates analogous to bone mineral were examined with respect to cisplatin and risedronate, two biological active drugs; the uptake and release experiments were carried out under various conditions in order to understand the basic mechanism of interaction. The effect of temperature and solution composition were highlighted and discussed. The adsorption results obtained for the therapeutic agents demonstrated that, depending on the conditions investigated (nature of the sorbent, concentration range, ionic composition, temperature…, the shape of the isotherms is of Freundlich or Langmuir type. The adsorption is described as an ion-exchange process in dilute solutions, while the interaction appears to be reactive for concentrated solutions (dissolution of mineral ions from the apatite substrate and formation of soluble calcium complex and/or precipitation of calcium salts involving sorbate molecules. The information gained on the surface reactivity of calcium phosphate were exploited to associate an antibiotic to calcium phosphate cements for drug delivery applications. The specimens were obtained by combination of calcium phosphate and calcium carbonate powders upon mixing with water. The physicochemical properties of the paste were altered by the drug loading method (in the liquid or solid phase. Thus, a dose-dependent effect was noticed for the paste setting time, hardening and the release process.

    7. Copper-gold nanoparticles: Fabrication, characteristic and application as drug carriers

      Energy Technology Data Exchange (ETDEWEB)

      Woźniak-Budych, Marta J., E-mail: marta.budych@amu.edu.pl; Langer, Krzysztof; Peplińska, Barbara; Przysiecka, Łucja; Jarek, Marcin; Jarzębski, Maciej; Jurga, Stefan

      2016-08-15

      In this investigation, the fabrication of porous core/shell nanostructures consisting of copper (core) and copper-gold nanoalloy (shell) for medical applications is presented. As a core triangular-shaped copper nanoparticles were used. The porous bimetallic nanoshell was prepared via galvanic reaction in the presence of oil-in water emulsion. It was proved that porous nanoalloy layer can be prepared at pH 7 and in the presence 0.1% and 0.5% oil-in water emulsion. The porous structure fabrication was mainly determined by volume fraction of hexadecane to acetone in the oil-in water emulsion and Zeta-potential of emulsion droplets (pH of emulsion). The influence of emulsion droplets size before galvanic reaction on porous structure preparation was negligible. It was found that doxorubicin could be easily introduced and released from porous core/shell nanostructures, due to spontaneous adsorption on the copper-gold nanoporous surface. The in vitro test showed that cytotoxic effect was more prominent once the doxorubicin was adsorbed on the porous copper-gold nanocarriers. It was demonstrated, that doxorubicin-loaded copper-gold nanostructures caused inhibition cell proliferation and viability of cancer cells, in a concentration-dependent manner. The results indicates that presented coper-gold nanocarrier have potential to be used in targeted cancer therapy, due to its porous structure and cytotoxic effect in cancer cells. - Highlights: • Porous copper-gold nanostructure as a cytostatic drug carrier was prepared. • Kinetics and thermodynamics of drug adsorption were studied. • DOX-loaded copper-gold nanoparticles showed a pH-controlled release rate. • DOX-loaded copper-gold NPs caused inhibition cell proliferation of cancer cells. • The Cu-Au NPs could serve as a theranostic platform for biomedical applications.

    8. Common characteristics of open source software development and applicability for drug discovery: a systematic review.

      Science.gov (United States)

      Ardal, Christine; Alstadsæter, Annette; Røttingen, John-Arne

      2011-09-28

      Innovation through an open source model has proven to be successful for software development. This success has led many to speculate if open source can be applied to other industries with similar success. We attempt to provide an understanding of open source software development characteristics for researchers, business leaders and government officials who may be interested in utilizing open source innovation in other contexts and with an emphasis on drug discovery. A systematic review was performed by searching relevant, multidisciplinary databases to extract empirical research regarding the common characteristics and barriers of initiating and maintaining an open source software development project. Common characteristics to open source software development pertinent to open source drug discovery were extracted. The characteristics were then grouped into the areas of participant attraction, management of volunteers, control mechanisms, legal framework and physical constraints. Lastly, their applicability to drug discovery was examined. We believe that the open source model is viable for drug discovery, although it is unlikely that it will exactly follow the form used in software development. Hybrids will likely develop that suit the unique characteristics of drug discovery. We suggest potential motivations for organizations to join an open source drug discovery project. We also examine specific differences between software and medicines, specifically how the need for laboratories and physical goods will impact the model as well as the effect of patents.

    9. Supramolecular Nanostructures Based on Cyclodextrin and Poly(ethylene oxide: Syntheses, Structural Characterizations and Applications for Drug Delivery

      Directory of Open Access Journals (Sweden)

      Yue Zheng

      2016-05-01

      Full Text Available Cyclodextrins (CDs have been extensively studied as drug delivery carriers through host–guest interactions. CD-based poly(pseudorotaxanes, which are composed of one or more CD rings threading on the polymer chain with or without bulky groups (or stoppers, have attracted great interest in the development of supramolecular biomaterials. Poly(ethylene oxide (PEO is a water-soluble, biocompatible polymer. Depending on the molecular weight, PEO can be used as a plasticizer or as a toughening agent. Moreover, the hydrogels of PEO are also extensively studied because of their outstanding characteristics in biological drug delivery systems. These biomaterials based on CD and PEO for controlled drug delivery have received increasing attention in recent years. In this review, we summarize the recent progress in supramolecular architectures, focusing on poly(pseudorotaxanes, vesicles and supramolecular hydrogels based on CDs and PEO for drug delivery. Particular focus will be devoted to the structures and properties of supramolecular copolymers based on these materials as well as their use for the design and synthesis of supramolecular hydrogels. Moreover, the various applications of drug delivery techniques such as drug absorption, controlled release and drug targeting based CD/PEO supramolecular complexes, are also discussed.

    10. A close collaboration of chitosan with lipid colloidal carriers for drug delivery applications.

      Science.gov (United States)

      Bugnicourt, Loïc; Ladavière, Catherine

      2017-06-28

      Chitosan and lipid colloids have separately shown a growing interest in the field of drug delivery applications. Their success is mainly due to their interesting physicochemical behaviors, as well as their biological properties such as bioactivity and biocompatibility. While chitosan is a well-known cationic polysaccharide with the ability to strongly interact with drugs and biological matrices through mainly electrostatic interactions, lipid colloids are carriers particularly recognized for the drug vectorization. In recent years, the combination of both entities has been considered because it offers new systems which gather the advantages of each of them to efficiently deliver various types of bioactive species. The purpose of this review is to describe these associations between chemically-unmodified chitosan chains (solubilized or dispersed) and lipid colloids (as nanoparticles or organized in lipid layers), as well as their potential in the drug delivery area so far. Three assemblies have mainly been reported in the literature: i) lipid nanoparticles (solid lipid nanoparticles or nanostructured lipid carriers) coated with chitosan chains, ii) lipid vesicles covered with chitosan chains, and iii) chitosan chains structured in nanoparticles with a lipid coating. Their elaboration processes, their physicochemical characterization, and their biological studies are detailed and discussed herein. The different bioactive species (drugs and bio(macro)molecules) incorporated in these assemblies, their maximal incorporation efficiency, and their loading capacity are also presented. This review reveals the versatility of these assemblies. Depending on the organization of lipids (i.e., nanoparticles or vesicles) and the state of polymer chains (i.e., solubilized or dispersed under the form of nanoparticles), a large variety of drugs can be successfully incorporated, and various routes of administration can be considered. Copyright © 2017 Elsevier B.V. All rights reserved.

    11. Nâbî'nin Münşeâtında Biyografik Bilgiler Biographical Accounts In Nabi’s Munsheat

      Directory of Open Access Journals (Sweden)

      Halil İbrahim HAKSEVER

      2013-03-01

      Full Text Available An eminent representative of erudite poetry, Nabi is compiled several prosal and poetic works. Born in Edessa, he had been to Istanbul before living for a long time in Aleppo. He turned back toIstanbul and died there at the age of 70. He has been remembered for afamous and wise poet. Among his works, his Munsheaat, whichincludes monobiographical accounts about his life, is a significant book.His letters mostly written to his friends especially in Aleppo gives usbrief accounts and clues about literary aspects of his personality.Analysis of these letter helps us to have knowledge about his relationswith the bureaucracy elites around him and the civil servants on theone hand; his expectations, his appointments, difficult life conditions helived in. In these letters, there are some remarks about the problemsrelated to official institutions of his time, civil unrest in some regions.There are also mention of some of his appointments, official duties,psychological problems he suffered from, his endeavours to send hisworks to the officials and friends. In this article, using the publishedversion of the Munsheat, we will try to quote and analyze some parts ofthese letters. We will also quote and discuss some passages giving usinformation about Nabi, his ideas and observations. Hikemî şiirin büyük temsilcisi Nabî, manzum mensur birçok eserin sahibidir. Urfa’da başlayan hayatı İstanbul’da devam etmiş, çeşitli memuriyetlerde bulunmuş, uzun yıllar Halep’te yaşamıştır.Uzun gurbet hayatından sonra tekrar İstanbul���a dönmüş, yetmiş yaşını aşmış olarak itibarlı, şöhretli, hikmetli bir şair kimliğiyle hayata veda etmiştir.Yazdığı eserler arasında, hayatına dair kendi kaleminden aktarma bilgiler bulunan Münşeatı önemlidir. Daha çok İstanbul dışında -özellikle Halep’te- iken dost ve tanıdıklarına yazdığı çeşitli konulardaki mektupları, Nabi’nin sosyal ve edebî hayatına dair k

    12. İş Hayatında Tükenmişlik Sendromu: Finans ve Muhasebe Çalışanlarının Tükenmişlik Düzeylerinin Belirlenmesine İlişkin Bir Çalışma

      Directory of Open Access Journals (Sweden)

      Elvan OKUTAN

      2013-09-01

      Full Text Available Çalışmanın amacı, KOBİ’lerin Finans ve Mali İşler Departmanı'nda çalışan muhasebe ve finans elemanlarının tükenmişlik düzeyinin belirlenmesi ve tükenmişlik düzeyleri ile demografik özellikleri arasındaki ilişkinin tespit edilmesidir. Araştırma kapsamında uygulanan ankette, Maslach Tükenmişlik ölçeği kullanılmıştır. Elde edilen veriler SPSS 15 kullanılarak frekans değerleri, t-testi ve ANOVA testi yardımıyla analiz edilmiştir. Araştırmadan elde edilen bulgular değerlendirildiğinde genel olarak araştırma kapsamındaki meslek elemanlarının duygusal tükenme düzeylerinin düşük, duyarsızlaşma düzeylerinin normal, kişisel başarı düzeylerinin ise yüksek olduğu saptanmıştır. Bu bağlamda, yapılan araştırma kapsamında muhasebe ve finans çalışanlarının düşük tükenme düzeylerine sahip oldukları ifade edilebilir.

    13. Structural and biological properties of thermosensitive chitosan-graphene hybrid hydrogels for sustained drug delivery applications.

      Science.gov (United States)

      Saeednia, Leyla; Yao, Li; Berndt, Marcus; Cluff, Kim; Asmatulu, Ramazan

      2017-09-01

      Chitosan has the ability to make injectable thermosensitive hydrogels which has been highly investigated for drug delivery applications. The addition of nanoparticles is one way to increase the mechanical strength of thermosensitive chitosan hydrogel and subsequently and control the burst release of drug. Graphene nanoparticles have shown unique mechanical, optical and electrical properties which can be exploited for biomedical applications, especially in drug delivery. This study, have focused on the mechanical properties of a thermosensitive and injectable hybrid chitosan hydrogel incorporated with graphene nanoparticles. Scanning electron microscope (SEM), Fourier transform infrared (FTIR) spectroscopy, Raman spectroscopy, and X-ray diffraction (XRD) have been used for morphological and chemical characterization of graphene infused chitosan hydrogels. The cell viability and cytotoxicity of graphene-contained hydrogels were analyzed using the alamarBlue ® technique. In-vitro methotrexate (MTX) release was investigated from MTX-loaded hybrid hydrogels as well. As a last step, to evaluate their efficiency as a cancer treatment delivery system, an in vitro anti-tumor test was also carried out using MCF-7 breast cancer cell lines. Results confirmed that a thermosensitive chitosan-graphene hybrid hydrogel can be used as a potential breast cancer therapy system for controlled delivery of methotrexate. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 2381-2390, 2017. © 2017 Wiley Periodicals, Inc.

    14. Delice(Olea europea var. oleaster L.) ile zeytin (Olea europea var.sativa) arasında anatomik ve palinojik ayrıcalıklar (The Anatomic And Palynological Differences Between Olea europea var. oleaster L. AND Olea europea var.sativa)

      OpenAIRE

      Kaya, Zafer

      1991-01-01

      Delice(Olea europea var. oleaster L.) ile zeytin (Olea europea var.sativa) arasında anatomik ve palinojik ayrıcalıklar (The Anatomic And Palynological Differences Between Olea europea var. oleaster L. AND Olea europea var.sativa)

    15. Application of gold nanoparticles for improved drug efficiency

      Science.gov (United States)

      Shittu, K. O.; Bankole, M. T.; Abdulkareem, A. S.; Abubakre, O. K.; Ubaka, A. U.

      2017-09-01

      Due to increasing resistance of microorganisms towards current antibiotics, there is a need for new or enhanced antibiotics. Nanotechnology is a technology that enhances the use of gold nanoparticles (AuNP) in area of medical applications, especially as a drug carrier for targeted drug delivery. In this research, AuNPs was synthesized using biological method via bioreduction of Piper guineense aqueous leaf extract on tetra gold chloride, characterized using UV-Vis spectrophometer, DLS, TEM/EDS and FTIR. The synthesized AuNPs was covalently functionalized with polyethylene glycol and encapsulated with Lincomycin and in vitro dissolution methods was used to evaluate the potential performance of the formulated nanodrug. The nanodrug has highest release efficiency at the 9th minutes (23.4 mg ml-1 for 40 °C) and (29.5 mg ml-1 for 60 °C) compared with the non-nanodrug. The antibacterial potential of the nanodrug was seen on the gram-positive bacteria of Staphylococcus aureus and Streptococcus pyogenes with highest inhibitions of 18 mm (at 40 °C) and 16 mm (at 60 °C) for S. aureus, and 16 mm for S. pyogenes (both at 40 °C and 60 °C). The bacteria growth inhibition continued and lasted for 15 min, while that of non-nanodrug lasted for 9 min with lesser growth inhibition compared to the formulated nanodrug. This work shows that the presence of the AuNPs increased the release efficiency of lincomycin even at a lower concentration and also bacteria growth inhibition thereby suggesting the effectiveness of the nanodrug formulation.

    16. Applications of nanoparticle systems in drug delivery technology

      Directory of Open Access Journals (Sweden)

      Syed A.A. Rizvi

      2018-01-01

      Full Text Available The development of nanoparticle-based drug formulations has yielded the opportunities to address and treat challenging diseases. Nanoparticles vary in size but are generally ranging from 100 to 500 nm. Through the manipulation of size, surface characteristics and material used, the nanoparticles can be developed into smart systems, encasing therapeutic and imaging agents as well as bearing stealth property. Further, these systems can deliver drug to specific tissues and provide controlled release therapy. This targeted and sustained drug delivery decreases the drug related toxicity and increase patient’s compliance with less frequent dosing. Nanotechnology has proven beneficial in the treatment of cancer, AIDS and many other disease, also providing advancement in diagnostic testing.

    17. Drug delivery and nanoparticles: Applications and hazards

      Directory of Open Access Journals (Sweden)

      Wim H De Jong

      2008-06-01

      Full Text Available Wim H De Jong1, Paul JA Borm2,31Laboratory for Toxicology, Pathology and Genetics, National Institute for Public Health and the Environment (RIVM, Bilthoven, The Netherlands; 2Zuyd University, Centre of Expertise in Life Sciences, Heerlen, The Netherlands; 3Magnamedics GmbH, Aachen, GermanyAbstract: The use of nanotechnology in medicine and more specifically drug delivery is set to spread rapidly. Currently many substances are under investigation for drug delivery and more specifically for cancer therapy. Interestingly pharmaceutical sciences are using nanoparticles to reduce toxicity and side effects of drugs and up to recently did not realize that carrier systems themselves may impose risks to the patient. The kind of hazards that are introduced by using nanoparticles for drug delivery are beyond that posed by conventional hazards imposed by chemicals in classical delivery matrices. For nanoparticles the knowledge on particle toxicity as obtained in inhalation toxicity shows the way how to investigate the potential hazards of nanoparticles. The toxicology of particulate matter differs from toxicology of substances as the composing chemical(s may or may not be soluble in biological matrices, thus influencing greatly the potential exposure of various internal organs. This may vary from a rather high local exposure in the lungs and a low or neglectable exposure for other organ systems after inhalation. However, absorbed species may also influence the potential toxicity of the inhaled particles. For nanoparticles the situation is different as their size opens the potential for crossing the various biological barriers within the body. From a positive viewpoint, especially the potential to cross the blood brain barrier may open new ways for drug delivery into the brain. In addition, the nanosize also allows for access into the cell and various cellular compartments including the nucleus. A multitude of substances are currently under investigation

    18. Applicability of bioanalysis of multiple analytes in drug discovery and development: review of select case studies including assay development considerations.

      Science.gov (United States)

      Srinivas, Nuggehally R

      2006-05-01

      The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval. Although the bioanalytical procedure(s) originally developed during the discovery stage may not necessarily be fit to support the drug development scenario, they may be suitably modified and validated, as deemed necessary. Several reviews have appeared over the years describing analytical approaches including various techniques, detection systems, automation tools that are available for an effective separation, enhanced selectivity and sensitivity for quantitation of many analytes. The intention of this review is to cover various key areas where analytical method development becomes necessary during different stages of drug discovery research and development process. The key areas covered in this article with relevant case studies include: (a) simultaneous assay for parent compound and metabolites that are purported to display pharmacological activity; (b) bioanalytical procedures for determination of multiple drugs in combating a disease; (c) analytical measurement of chirality aspects in the pharmacokinetics, metabolism and biotransformation investigations; (d) drug monitoring for therapeutic benefits and/or occupational hazard; (e) analysis of drugs from complex and/or less frequently used matrices; (f) analytical determination during in vitro experiments (metabolism and permeability related) and in situ intestinal perfusion experiments; (g) determination of a major metabolite as a surrogate for the parent molecule; (h) analytical approaches for universal determination of CYP450 probe substrates and metabolites; (i) analytical applicability to prodrug evaluations-simultaneous determination of prodrug, parent and metabolites; (j) quantitative determination of parent compound and/or phase II metabolite(s) via direct or indirect approaches; (k) applicability in analysis of multiple compounds in select

    19. Dendrimers in drug delivery and targeting: Drug-dendrimer interactions and toxicity issues

      Directory of Open Access Journals (Sweden)

      Kanika Madaan

      2014-01-01

      Full Text Available Dendrimers are the emerging polymeric architectures that are known for their defined structures, versatility in drug delivery and high functionality whose properties resemble with biomolecules. These nanostructured macromolecules have shown their potential abilities in entrapping and/or conjugating the high molecular weight hydrophilic/hydrophobic entities by host-guest interactions and covalent bonding (prodrug approach respectively. Moreover, high ratio of surface groups to molecular volume has made them a promising synthetic vector for gene delivery. Owing to these properties dendrimers have fascinated the researchers in the development of new drug carriers and they have been implicated in many therapeutic and biomedical applications. Despite of their extensive applications, their use in biological systems is limited due to toxicity issues associated with them. Considering this, the present review has focused on the different strategies of their synthesis, drug delivery and targeting, gene delivery and other biomedical applications, interactions involved in formation of drug-dendrimer complex along with characterization techniques employed for their evaluation, toxicity problems and associated approaches to alleviate their inherent toxicity.

    20. Dendrimers in drug delivery and targeting: Drug-dendrimer interactions and toxicity issues

      Science.gov (United States)

      Madaan, Kanika; Kumar, Sandeep; Poonia, Neelam; Lather, Viney; Pandita, Deepti

      2014-01-01

      Dendrimers are the emerging polymeric architectures that are known for their defined structures, versatility in drug delivery and high functionality whose properties resemble with biomolecules. These nanostructured macromolecules have shown their potential abilities in entrapping and/or conjugating the high molecular weight hydrophilic/hydrophobic entities by host-guest interactions and covalent bonding (prodrug approach) respectively. Moreover, high ratio of surface groups to molecular volume has made them a promising synthetic vector for gene delivery. Owing to these properties dendrimers have fascinated the researchers in the development of new drug carriers and they have been implicated in many therapeutic and biomedical applications. Despite of their extensive applications, their use in biological systems is limited due to toxicity issues associated with them. Considering this, the present review has focused on the different strategies of their synthesis, drug delivery and targeting, gene delivery and other biomedical applications, interactions involved in formation of drug-dendrimer complex along with characterization techniques employed for their evaluation, toxicity problems and associated approaches to alleviate their inherent toxicity. PMID:25035633

    1. Nanomaterials potentiating standard chemotherapy drugs' effect

      Science.gov (United States)

      Kazantsev, S. O.; Korovin, M. S.

      2017-09-01

      Application of antitumor chemotherapeutic drugs is hindered by a number of barriers, multidrug resistance that makes effective drug deposition inside cancer cells difficult is among them. Recent research shows that potential efficiency of anticancer drugs can be increased with nanoparticles. This review is devoted to the application of nanoparticles for cancer treatment. Various types of nanoparticles currently used in medicine are reviewed. The nanoparticles that have been used for cancer therapy and targeted drug delivery to damaged sites of organism are described. Also, the possibility of nanoparticles application for cancer diagnosis that could help early detection of tumors is discussed. Our investigations of antitumor activity of low-dimensional nanostructures based on aluminum oxides and hydroxides are briefly reviewed.

    2. Yazma Eğitimi Alanında Yapılan Akademik Çalışmaların Eğilimleri (2010 - 2014 Yılları

      Directory of Open Access Journals (Sweden)

      Mehmet TOK

      2015-10-01

      Full Text Available Yazma becerisinin birçok bilişsel işlemleri içerisinde barındırması, süreç içermesi, öğrencinin psikolojik durumu, motivasyon ve tutumu, öğretmenlerin yazma alanındaki konumu vb. unsurlar yazma alanında birçok sorunun yaşanmasını beraberinde getirmektedir. Bu nedenle, alan yazında yer alan birçok çalışmada, yazma sorunları doğrudan ele alınmış ya da sıkça bu sorunlara değinilmiştir. Yazma alanındaki sorunların çok olması, alanda yapılan çalışmaların önemini bir kat daha arttırmıştır. Bu çalışmada, yazma eğitimi konusunda 2010-2014 yılları arasında yapılan 126 yüksek lisans, 38 doktora tezinin yanı sıra düzenli bir şekilde yayınlanan 16 ulusal ve uluslararası bilimsel dergide yer alan 127 makale taranmıştır. Ele alınan akademik çalışmalar; hedef kitle, ilişkili olduğu alan, kullanılan yöntem ve yazma eğitimindeki eğilimleri bakımından değerlendirilmiştir. Araştırmada meta-analiz yöntemi kullanılmıştır. Yapılan araştırmalarda hedef kitle bakımından en fazla ortaokul öğrencilerinin seçildiği, yazmanın daha çok okuma ve ilk okuma ile ilişkilendirilerek ele alındığı, yöntem olarak nicel araştırmaların (f=152 nitel araştırmalardan (f=114 daha çok tercih edildiği görülmüştür. En çok kullanılan yöntem tarama modeli olurken doktora tezlerinde deneysel çalışmalar ön plana çıkmıştır. Yazma araştırmaları incelendiğinde araştırmacı eğilimlerinin, yazma yöntemleri ve farklı türlerde metin yazmaya yönelik olduğu görülmüştür.

    3. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study.

      Science.gov (United States)

      Hon, Chun-Yip; Chua, Prescillia Ps; Danyluk, Quinn; Astrakianakis, George

      2014-06-01

      Occupational exposure to antineoplastic drugs has been documented to result in various adverse health effects. Despite the implementation of control measures to minimize exposure, detectable levels of drug residual are still found on hospital work surfaces. Cleaning these surfaces is considered as one means to minimize the exposure potential. However, there are no consistent guiding principles related to cleaning of contaminated surfaces resulting in hospitals to adopt varying practices. As such, this pilot study sought to evaluate current cleaning protocols and identify those factors that were most effective in reducing contamination on drug preparation surfaces. Three cleaning variables were examined: (1) type of cleaning agent (CaviCide®, Phenokil II™, bleach and chlorhexidine), (2) application method of cleaning agent (directly onto surface or indirectly onto a wipe) and (3) use of isopropyl alcohol after cleaning agent application. Known concentrations of antineoplastic drugs (either methotrexate or cyclophosphamide) were placed on a stainless steel swatch and then, systematically, each of the three cleaning variables was tested. Surface wipes were collected and quantified using high-performance liquid chromatography-tandem mass spectrometry to determine the percent residual of drug remaining (with 100% being complete elimination of the drug). No one single cleaning agent proved to be effective in completely eliminating all drug contamination. The method of application had minimal effect on the amount of drug residual. In general, application of isopropyl alcohol after the use of cleaning agent further reduced the level of drug contamination although measureable levels of drug were still found in some cases.

    4. Using ChEMBL web services for building applications and data processing workflows relevant to drug discovery.

      Science.gov (United States)

      Nowotka, Michał M; Gaulton, Anna; Mendez, David; Bento, A Patricia; Hersey, Anne; Leach, Andrew

      2017-08-01

      ChEMBL is a manually curated database of bioactivity data on small drug-like molecules, used by drug discovery scientists. Among many access methods, a REST API provides programmatic access, allowing the remote retrieval of ChEMBL data and its integration into other applications. This approach allows scientists to move from a world where they go to the ChEMBL web site to search for relevant data, to one where ChEMBL data can be simply integrated into their everyday tools and work environment. Areas covered: This review highlights some of the audiences who may benefit from using the ChEMBL API, and the goals they can address, through the description of several use cases. The examples cover a team communication tool (Slack), a data analytics platform (KNIME), batch job management software (Luigi) and Rich Internet Applications. Expert opinion: The advent of web technologies, cloud computing and micro services oriented architectures have made REST APIs an essential ingredient of modern software development models. The widespread availability of tools consuming RESTful resources have made them useful for many groups of users. The ChEMBL API is a valuable resource of drug discovery bioactivity data for professional chemists, chemistry students, data scientists, scientific and web developers.

    5. İşitme Kayıplı Çocuğu Olan Bir Annenin Etkileşim Davranışlarının Aile Eğitimi Bağlamında İncelenmesi

      Directory of Open Access Journals (Sweden)

      Emel Ertürk Mustul

      2016-04-01

      Full Text Available Bu eylem araştırmasında çok ileri dereceli işitme kayıplı çocuğu olan işiten bir annenin etkileşim davranışları ve bu davranışlarının desteklenme biçiminin aile eğitimi bağlamında incelenmesi amaçlanmıştır. Araştırmanın verileri aile eğitimi video kayıtları, anneyle yapılan görüşmeler, yazarlar arasında yapılan aile eğitimi değerlendirmeleri ile geçerlik güvenirlik toplantılarında alınan ses kayıtları, aile eğitimi seans planları ve araştırmacı günlükleriyle toplanmıştır. Toplam sekiz aile eğitimi yapılmıştır ve annenin etkileşim davranışlarını incelemek amacıyla ikinci, dördüncü, altıncı ve sekizinci aile eğitimlerinde yer alan on dakikalık anne-çocuk etkileşimi bölümleri temsili video kaydı olarak belirlenmiş ve tümevarım analizi uygulanmıştır. Analiz sonucunda beş etkileşim davranışı belirlenmiĢ ve bu davranışlar iki tema altında toplanmıştır. Annenin etkileşim davranışları bu davranış tanımları altında incelenmiş, davranışların görülme sıklığına bakılmış ve bu davranışları desteklemeye dair eylem planları geliştirilmiştir. Araştırmanın bulguları annenin etkileşimi destekleyen davranışlarının arttığını, etkileşimi olumsuz etkileyen davranışlarının da azaldığını göstermiştir. Araştırma sonuçlarını genellemek mümkün olmasa da elde edilen bulguların etkileşime odaklanan aile eğitimi programının bu anne-çocuk çifti için işlediğini ve erken çocukluk dönemi boyunca aile eğitiminin devam etmesi gerektiğini gösterdiği ileri sürülebilir. The main purpose of this action research was to examine the interactive behaviour of a mother who has a child with a hearing loss and the way these skills were supported in the context of parent guidance process. The data were collected by the video recordings of the parent guidance sessions, audio recordings of session evaluation meetings among

    6. Uşak İli Buğday Ekim Alanlarında Süne, [Eurygaster spp. (Hemiptera: Scutelleridae] Yumurtalarının Parazitlenme Oranları ile Buğday Tanelerindeki Emgi Oranları Arasındaki İlişkinin Belirlenmesi

      Directory of Open Access Journals (Sweden)

      Erdal ZENGİN

      2017-06-01

      Full Text Available Bu çalışma, 2015-2016 yıllarında Uşak iline bağlı 10 köydeki Süne yumurtalarının parazitlenme oranlarının ve emgili tane sayılarının belirlenmesi ile bu oranlar arasındaki ilişkinin tespit edilmesi amacıyla yapılmıştır. Araştırma sonuçlarına göre, 2015 ve 2016 yıllarındaki en yüksek Süne yumurtası parazitlenme oranı ve emgili tane sayıları sırasıyla %95.4-%1.60, %90.7-%1.05 olarak bulunmuştur. Köylerde yapılan arazi çalışmaları sonucunda elde edilen oranlara çoklu karşılaştırma testi uygulanarak köyler arasındaki farklılıklar belirlenmiştir.  Parazitlenme oranı ile emgili tane sayısı arasında bir ilişkinin olup olmadığını belirlemek için her iki yıl verileri üzerinde yapılan regresyon analizi sonucunda, bu iki değişken arasında doğrusal bir ilişkinin olduğu tespit edilmiştir.

    7. Micelle-like nanoassemblies based on polymer-drug conjugates as an emerging platform for drug delivery.

      Science.gov (United States)

      Liu, Zhihong; Wang, Yutao; Zhang, Na

      2012-07-01

      During the past decades, polymer-drug conjugates are one of the hottest topics in novel drug development fields. Amphiphilic polymer-drug conjugates in aqueous solution could form micelles or micelle-like nanoassemblies. Compared with polymer-drug conjugates and the micelles into which drugs are physically entrapped, micelles or micelle-like nanoassemblies based on polymer-drug conjugates bring several additional advantages, including increased drug-loading capacity, enhanced intracellular uptake, reduced systemic toxicity, and improved therapeutic efficacy. This review focuses on recent progress achieved in the research field of micelles or micelle-like nanoassemblies based on polymer-drug conjugates. Firstly, properties of polymers, drugs, and linkers which could be used to build polymer-drug conjugate micelles or micelle-like nanoassemblies are summarized. Then, the characterization methods are described. Finally, the drug-targeting mechanisms are discussed. Micelles or micelle-like nanoassemblies based on polymer-drug conjugates as an emerging platform have the potential to achieve medical treatments with enhanced therapeutic effect. The application of micelles or micelle-like nanoassemblies based on polymer-drug conjugates may give new life to old active compounds abandoned due to their low solubility problems. For clinical application, there is a need to further optimize the properties of the polymer, drug, and linker.

    8. Food and Drug Administration Drug Approval Process: A History and Overview.

      Science.gov (United States)

      Williams, Christopher Ty

      2016-03-01

      In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively. Copyright © 2016 Elsevier Inc. All rights reserved.

    9. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

      OpenAIRE

      Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

      2017-01-01

      Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

    10. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient

      DEFF Research Database (Denmark)

      Tetens, Inge; Poulsen, Morten

      2014-01-01

      Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on an extension of use for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)-rich algal oil from Schizochytrium sp. as a novel food...... population, excluding pregnant and lactating women. In a previous opinion on the Tolerable Upper Intake Level of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults. Based...... ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is already authorised for use in a range of foodstuffs at specified maximum levels. The applicant requests an extension of use of the NFI in food supplements up to a maximum DHA and EPA content of 3 g per daily dose for the adult...

    11. Electrospun polymeric nanofibers for transdermal drug delivery

      Directory of Open Access Journals (Sweden)

      Mahya Rahmani

      2017-04-01

      Full Text Available Conventional transdermal drug delivery systems (TDDS have been designed for drug delivery through the skin. These systems use the permeability property of stratum corneum, the outermost surface layer of the skin. Applying polymeric micro and nanofibers in drug delivery has recently attracted great attention and the electrospinning technique is the preferred method for polymeric micro-nanofibers fabrication with a great potential for drug delivery. More studies in the field of nanofibers containing drug are divided two categories: first, preparation and characterization of nanofibers containing drug and second, investigation of their therapeutic applications. Drugs used in electrospun nanofibers can be categorized into three main groups, including antibiotics and antimicrobial agents, anti-inflammatory agents and vitamins with therapeutic applications. In this paper, we review the application of electrospun polymeric scaffolds in TDDS and also introduce several pharmaceutical and therapeutic agents which have been used in polymer nanofibrous patches.

    12. Microneedles as Enhancer of Drug Absorption Through the Skin and Applications in Medicine and Cosmetology.

      Science.gov (United States)

      Serrano-Castañeda, Pablo; Escobar-Chavez, Jose Juan; Rodriguez-Cruz, Isabel Marlen; Melgoza, Luz Maria; Martinez-Hernandez, Jessica

      2018-01-01

      The microneedles technology has found applications in many health-related fields. For example, their application in drugs and vaccines delivery as well, as the determination of biomarkers, has been reported. They also have a place in the dermatology and cosmetic areas such as the treatment of wounds from burns, scars, acne, depigmentation, and alopecia will be shown. Microneedles are used in therapeutic applications and are manufactured using materials such as metal (steel, titanium, nickel), polymer (oly-glycolic acid (PGA), poly-lactide-co-glycolide acid (PLGA), poly-L-lactic acid (PLA), chitosan), glass, silicon, ceramic, carbohydrates (trehalose, sucrose, mannitol). Examples of application of microneedles and their advantages and disadvantages are discussed. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

    13. Core-shell designs of photoluminescent nanodiamonds with porous silica coatings for bioimaging and drug delivery II: application.

      Science.gov (United States)

      Prabhakar, Neeraj; Näreoja, Tuomas; von Haartman, Eva; Karaman, Didem Şen; Jiang, Hua; Koho, Sami; Dolenko, Tatiana A; Hänninen, Pekka E; Vlasov, Denis I; Ralchenko, Victor G; Hosomi, Satoru; Vlasov, Igor I; Sahlgren, Cecilia; Rosenholm, Jessica M

      2013-05-07

      Recent advances within materials science and its interdisciplinary applications in biomedicine have emphasized the potential of using a single multifunctional composite material for concurrent drug delivery and biomedical imaging. Here we present a novel composite material consisting of a photoluminescent nanodiamond (ND) core with a porous silica (SiO2) shell. This novel multifunctional probe serves as an alternative nanomaterial to address the existing problems with delivery and subsequent tracing of the particles. Whereas the unique optical properties of ND allows for long-term live cell imaging and tracking of cellular processes, mesoporous silica nanoparticles (MSNs) have proven to be efficient drug carriers. The advantages of both ND and MSNs were hereby integrated in the new composite material, ND@MSN. The optical properties provided by the ND core rendered the nanocomposite suitable for microscopy imaging in fluorescence and reflectance mode, as well as super-resolution microscopy as a STED label; whereas the porous silica coating provided efficient intracellular delivery capacity, especially in surface-functionalized form. This study serves as a demonstration how this novel nanomaterial can be exploited for both bioimaging and drug delivery for future theranostic applications.

    14. Almanya'da sığır ve dana eti piyasa düzeni ve Türkiye için sığır eti pazarlamasında model oluşturabilme olanakları üzerine bir araştırma

      OpenAIRE

      KILIÇ, Sevinç

      2006-01-01

      Almanya'da Sığır ve Dana Eti Piyasa Düzeni ve Türkiye İçin Sığır Eti PazarlamasındaModel Oluşturabilme Olanakları Üzerine Bir AraştırmaBu araştırmada Avrupa Birliği Ortak Tarım Politikası kapsamında Sığır ve Dana Eti OrtakPiyasa Düzeni'nde uygulanmış ve uygulanmakta olan politikalar, Almanya'nın kasaplıkhayvan ve et piyasa yapısı ile ilgili düzenlemeleri, Almanya'da kasaplık hayvan ve etpazarlamasının tarihsel gelişimi detaylı olarak incelenmiştir.Türkiye'de 2001-2004 yıl...

    15. The application of ATR-FTIR spectroscopy and multivariate data analysis to study drug crystallisation in the stratum corneum.

      Science.gov (United States)

      Goh, Choon Fu; Craig, Duncan Q M; Hadgraft, Jonathan; Lane, Majella E

      2017-02-01

      Drug permeation through the intercellular lipids, which pack around and between corneocytes, may be enhanced by increasing the thermodynamic activity of the active in a formulation. However, this may also result in unwanted drug crystallisation on and in the skin. In this work, we explore the combination of ATR-FTIR spectroscopy and multivariate data analysis to study drug crystallisation in the skin. Ex vivo permeation studies of saturated solutions of diclofenac sodium (DF Na) in two vehicles, propylene glycol (PG) and dimethyl sulphoxide (DMSO), were carried out in porcine ear skin. Tape stripping and ATR-FTIR spectroscopy were conducted simultaneously to collect spectral data as a function of skin depth. Multivariate data analysis was applied to visualise and categorise the spectral data in the region of interest (1700-1500cm -1 ) containing the carboxylate (COO - ) asymmetric stretching vibrations of DF Na. Spectral data showed the redshifts of the COO - asymmetric stretching vibrations for DF Na in the solution compared with solid drug. Similar shifts were evident following application of saturated solutions of DF Na to porcine skin samples. Multivariate data analysis categorised the spectral data based on the spectral differences and drug crystallisation was found to be confined to the upper layers of the skin. This proof-of-concept study highlights the utility of ATR-FTIR spectroscopy in combination with multivariate data analysis as a simple and rapid approach in the investigation of drug deposition in the skin. The approach described here will be extended to the study of other actives for topical application to the skin. Copyright © 2016 Elsevier B.V. All rights reserved.

    16. Synthesis and evaluation of functional alginate hydrogels based on click chemistry for drug delivery applications.

      Science.gov (United States)

      García-Astrain, Clara; Avérous, Luc

      2018-06-15

      Environment-sensitive alginate-based hydrogels for drug delivery applications are receiving increasing attention. However, most work in this field involves traditional cross-linking strategies which led to hydrogels with poor long-term stability. Herein, a series of chemically cross-linked alginate hydrogels was synthesized via click chemistry using Diels-Alder reaction by reacting furan-modified alginate and bifunctional cross-linkers. Alginate was successfully functionalized with furfurylamine. Then, 3D architectures were synthesized with water-soluble bismaleimides. Different substitution degrees were achieved in order to study the effect of alginate modification and the cross-linking extent over the behaviour of the hydrogels. The ensuing hydrogels were analysed in terms of microstructure, swelling, structure modification and rheological behaviour. The materials response to external stimuli such as pH was also investigated, revealing a pulsatile behaviour in a large pH range (1-13) and a clear pH-dependent swelling. Finally, vanillin release studies were conducted to demonstrate the potential of these biobased materials for drug delivery applications. Copyright © 2018 Elsevier Ltd. All rights reserved.

    17. Asetonitril-Su İkili Karışımlarında Piroksikam ve Tenoksikam'ın Potansiyometrik pKa Tayini

      OpenAIRE

      Çubuk Demiralay, Ebru; Yılmaz, Hülya

      2012-01-01

      İyonlaşma sabiti (pKa) çözünebilirlik sınırlaması olmaksızın doğru tahmin edilebilen parametrelerden birisidir. Sunulan bu çalışmada, piroksikam ve tenoksikamın asit- baz davranışı çalışılmıştır. Potansiyometrik metot kullanılarak, piroksikam ve tenoksikamın pKa değerleri asetonitril-su ikili karışımlarının farklı yüzdelerinde tayin edilmiştir (asetonitril içeriği hacimce % 30 ile 45 arasında). Bu bileşiklerin sudaki pKa değerleri mol kesri ve Yasuda-Shedlovsky eşitlikleri kullanarak hesaplan...

    18. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on Dietary Reference Values for chromium

      DEFF Research Database (Denmark)

      Tetens, Inge

      2014-01-01

      parenteral nutrition was considered to be the most convincing, but overall data do not provide sufficient information on the reversibility of the possible deficiencies and the nature of any dose–response curve in order to identify a dietary requirement for humans. The Panel concludes that no Average......Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) considered the evidence for setting Dietary Reference Values for chromium. Trivalent chromium (Cr(III)) has been postulated to be necessary for the efficacy of insulin in regulating...... models have not produced consistent results, and that there is no evidence of essentiality of Cr(III) in animal nutrition. Evaluating the possibility of Cr(III) as an essential element for humans, the evidence from reported improvements associated with chromium supplementation in patients on total...

    19. Design of Hybrid Gels Based on Gellan-Cholesterol Derivative and P90G Liposomes for Drug Depot Applications

      Directory of Open Access Journals (Sweden)

      Nicole Zoratto

      2017-05-01

      Full Text Available Gels are extensively studied in the drug delivery field because of their potential benefits in therapeutics. Depot gel systems fall in this area, and the interest in their development has been focused on long-lasting, biocompatible, and resorbable delivery devices. The present work describes a new class of hybrid gels that stem from the interaction between liposomes based on P90G phospholipid and the cholesterol derivative of the polysaccharide gellan. The mechanical properties of these gels and the delivery profiles of the anti-inflammatory model drug diclofenac embedded in such systems confirmed the suitability of these hybrid gels as a good candidate for drug depot applications.

    20. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

      Science.gov (United States)

      2010-05-05

      ... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

    1. Transuranic and Low-Level Boxed Waste Form Nondestructive Assay Technology Overview and Assessment

      International Nuclear Information System (INIS)

      Becker, G.; Connolly, M.; McIlwain, M.

      1999-01-01

      The Mixed Waste Focus Area (MWFA) identified the need to perform an assessment of the functionality and performance of existing nondestructive assay (NDA) techniques relative to the low-level and transuranic waste inventory packaged in large-volume box-type containers. The primary objectives of this assessment were to: (1) determine the capability of existing boxed waste form NDA technology to comply with applicable waste radiological characterization requirements, (2) determine deficiencies associated with existing boxed waste assay technology implementation strategies, and (3) recommend a path forward for future technology development activities, if required. Based on this assessment, it is recommended that a boxed waste NDA development and demonstration project that expands the existing boxed waste NDA capability to accommodate the indicated deficiency set be implemented. To ensure that technology will be commercially available in a timely fashion, it is recommended this development and demonstration project be directed to the private sector. It is further recommended that the box NDA technology be of an innovative design incorporating sufficient NDA modalities, e.g., passive neutron, gamma, etc., to address the majority of the boxed waste inventory. The overall design should be modular such that subsets of the overall NDA system can be combined in optimal configurations tailored to differing waste types

    2. Core-shell designs of photoluminescent nanodiamonds with porous silica coatings for bioimaging and drug delivery, II : Application

      NARCIS (Netherlands)

      Prabhakar, N.; Näreoja, T.; Haartman, Von E.; Karaman, D.S.; Jiang, H.; Koho, S.; Dolenko, T.A.; Hänninen, P.E.; Vlasov, D.I.; Ralchenko, V.G.; Hosomi, S.; Vlasov, I.I.; Sahlgren, C.M.; Rosenholm, J.M.

      2013-01-01

      Recent advances within materials science and its interdisciplinary applications in biomedicine have emphasized the potential of using a single multifunctional composite material for concurrent drug delivery and biomedical imaging. Here we present a novel composite material consisting of a

    3. Frequency-controlled wireless shape memory polymer microactuator for drug delivery application.

      Science.gov (United States)

      Zainal, M A; Ahmad, A; Mohamed Ali, M S

      2017-03-01

      This paper reports the wireless Shape-Memory-Polymer actuator operated by external radio frequency magnetic fields and its application in a drug delivery device. The actuator is driven by a frequency-sensitive wireless resonant heater which is bonded directly to the Shape-Memory-Polymer and is activated only when the field frequency is tuned to the resonant frequency of heater. The heater is fabricated using a double-sided Cu-clad Polyimide with much simpler fabrication steps compared to previously reported methods. The actuation range of 140 μm as the tip opening distance is achieved at device temperature 44 °C in 30 s using 0.05 W RF power. A repeatability test shows that the actuator's average maximum displacement is 110 μm and standard deviation of 12 μm. An experiment is conducted to demonstrate drug release with 5 μL of an acidic solution loaded in the reservoir and the device is immersed in DI water. The actuator is successfully operated in water through wireless activation. The acidic solution is released and diffused in water with an average release rate of 0.172 μL/min.

    4. Mass Spectrometry for Research and Application in Therapeutic Drug Monitoring or Clinical and Forensic Toxicology.

      Science.gov (United States)

      Maurer, Hans H

      2018-04-30

      This paper reviews current applications of various hyphenated low- and high-resolution mass spectrometry techniques in the field of therapeutic drug monitoring and clinical/forensic toxicology in both research and practice. They cover gas chromatography, liquid chromatography, matrix-assisted laser desorption ionization, or paper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap mass analyzers.

    5. Recent progress in the synthesis of poly(organo)phosphazenes and their applications in tissue engineering and drug delivery

      Science.gov (United States)

      Khan, R. U.; Wang, L.; Yu, H.; Zain-ul-Abdin; Akram, M.; Wu, J.; Haroon, M.; Ullah, R. S.; Deng, Zh; Xia, X.

      2018-02-01

      It is a highly desirable goal of researchers to develop effective biomaterials with minimum recovery time and affordable treatment expense for tissue engineering and drug delivery. In this scenario, numerous synthetic and natural polymers have been used. Among those synthetic polymers, polyorganophosphazenes (POPs) have got much attention as highly promising candidates for applications in tissue engineering and drug delivery. Polyorganophosphazenes are hybrid polymers containing inorganic backbone consisting of alternating nitrogen and phosphorus atoms with two organic side groups. POPs possess a wide range of unique properties, i.e., synthetic flexibility, biocompatibility, osteocompatibility, osteoinductivity, sustainability and degradability into harmless end products with predictable degradation rate and adjustable mechanical strength. Moreover, their tunable hydrophilic/hydrophobic and stimuli responsive properties add extra points to their use in biomedical applications. In addition, their various polymeric forms, i.e., microspheres, nano/microfibres, micelles, membranes, polymersomes, hydrogels and nano-conjugate linear polymers provide different carriers to efficiently deliver various hydrophilic/hydrophobic therapeutic agents both in vitro and in vivo. This review focuses on the most recent progress that has been made in the synthesis and applications of POPs in tissue engineering and their different polymeric forms used for drug delivery. Moreover, we have also summarized the effect of different side groups on the overall efficiency of POPs. The bibliography includes 239 references.

    6. Species differences in drug glucuronidation: Humanized UDP-glucuronosyltransferase 1 mice and their application for predicting drug glucuronidation and drug-induced toxicity in humans.

      Science.gov (United States)

      Fujiwara, Ryoichi; Yoda, Emiko; Tukey, Robert H

      2018-02-01

      More than 20% of clinically used drugs are glucuronidated by a microsomal enzyme UDP-glucuronosyltransferase (UGT). Inhibition or induction of UGT can result in an increase or decrease in blood drug concentration. To avoid drug-drug interactions and adverse drug reactions in individuals, therefore, it is important to understand whether UGTs are involved in metabolism of drugs and drug candidates. While most of glucuronides are inactive metabolites, acyl-glucuronides that are formed from compounds with a carboxylic acid group can be highly toxic. Animals such as mice and rats are widely used to predict drug metabolism and drug-induced toxicity in humans. However, there are marked species differences in the expression and function of drug-metabolizing enzymes including UGTs. To overcome the species differences, mice in which certain drug-metabolizing enzymes are humanized have been recently developed. Humanized UGT1 (hUGT1) mice were created in 2010 by crossing Ugt1-null mice with human UGT1 transgenic mice in a C57BL/6 background. hUGT1 mice can be promising tools to predict human drug glucuronidation and acyl-glucuronide-associated toxicity. In this review article, studies of drug metabolism and toxicity in the hUGT1 mice are summarized. We further discuss research and strategic directions to advance the understanding of drug glucuronidation in humans. Copyright © 2017 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

    7. Chiron Vision files FDA application to market intraocular implant for CMV retinitis. Food and Drug Administration.

      Science.gov (United States)

      1995-07-01

      Chiron Corporation and Hoffman-LaRoche announced a filing of a New Drug Application with the Food and Drug Administration (FDA) to market Vitrasert, its intraocular implant which delivers ganciclovir directly to the eye for treatment of CMV retinitis. Clinical trials show that Vitrasert offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV retinitis in the treated eye. One study reported that the median time to progression of CMV retinitis was 186 days for eyes receiving Vitrasert compared to 72 days for eyes receiving intravenous ganciclovir therapy. Chiron's intraocular implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug into the eye for up to eight months. Two additional trials are underway. For further information contact the Professional Services Group at Chiron Corporation at (800) 244-7668, select 2.

    8. A Novel Adaptive Modulation Based on Nondata-Aided Error Vector Magnitude in Non-Line-Of-Sight Condition of Wireless Sensor Network.

      Science.gov (United States)

      Yang, Fan; Zeng, Xiaoping; Mao, Haiwei; Jian, Xin; Tan, Xiaoheng; Du, Derong

      2018-01-15

      The high demand for multimedia applications in environmental monitoring, invasion detection, and disaster aid has led to the rise of wireless sensor network (WSN). With the increase of reliability and diversity of information streams, the higher requirements on throughput and quality of service (QoS) have been put forward in data transmission between two sensor nodes. However, lower spectral efficiency becomes a bottleneck in non-line-of-sight (NLOS) transmission of WSN. This paper proposes a novel nondata-aided error vector magnitude based adaptive modulation (NDA-EVM-AM) to solve the problem. NDA-EVM is considered as a new metric to evaluate the quality of NLOS link for adaptive modulation in WSN. By modeling the NLOS scenario as the η - μ fading channel, a closed-form expression for the NDA-EVM of multilevel quadrature amplitude modulation (MQAM) signals over the η - μ fading channel is derived, and the relationship between SER and NDA-EVM is also formulated. Based on these results, NDA-EVM state machine is designed for adaptation strategy. The algorithmic complexity of NDA-EVM-AM is analyzed and the outage capacity of NDA-EVM-AM in an NLOS scenario is also given. The performances of NDA-EVM-AM are compared by simulation, and the results show that NDA-EVM-AM is an effective technique to be used in the NLOS scenarios of WSN. This technique can accurately reflect the channel variations and efficiently adjust modulation order to better match the channel conditions, hence, obtaining better performance in average spectral efficiency.

    9. Synthesis, characterization and applications of nanostructural ...

      Indian Academy of Sciences (India)

      various methods [4] like coagulation and precipitation process (named as Nalgo- nda technique) ... cially available metal oxides like activated alumina, magnesia and other materials .... Nanomaterials NANO-2005, July 13–15, 2005 (Mepco.

    10. Application of ion mobility spectrometer for rapid drug detection

      International Nuclear Information System (INIS)

      Zhu Xuemei; Zheng Jian; Lv Yongjie; Chen Yangqin

      2007-01-01

      A 63 Ni source-based high resolution ion mobility spectrometer (IMS) was developed and applied to drug detection. The drugs included opium, morphine, heroin, methamphetamine, MDMA, MDEA, ketamine and cannabis. Their ion mobility spectra were acquired, ion types were derived and reduced mobilities were calculated, which are in good agreement with the data reported in literatures. The results indicate that the IMS can detect effectively a variety of drugs, especially for the amphetamine derivatives. And the reduced mobility standard database of drugs was established. (authors)

    11. Application of ion mobility spectrometer for rapid drug detection

      Energy Technology Data Exchange (ETDEWEB)

      Xuemei, Zhu; Jian, Zheng [The Third Research Inst. of Ministry of Public Security, Shanghai (China); Yongjie, Lv; Yangqin, Chen [Department of Physics, Key Laboratory of Optical and Magnetic Resonance Spectroscopy, East China Normal Univ., Shanghai (China)

      2007-10-15

      A {sup 63}Ni source-based high resolution ion mobility spectrometer (IMS) was developed and applied to drug detection. The drugs included opium, morphine, heroin, methamphetamine, MDMA, MDEA, ketamine and cannabis. Their ion mobility spectra were acquired, ion types were derived and reduced mobilities were calculated, which are in good agreement with the data reported in literatures. The results indicate that the IMS can detect effectively a variety of drugs, especially for the amphetamine derivatives. And the reduced mobility standard database of drugs was established. (authors)

    12. Ölçüm Öncesi Dinlenme Süresinin ve Dinlenme Esnasında Konuşmanın İndirekt Kan Basıncı Ölçüm Değeri Üzerine Etkisi

      OpenAIRE

      BAYRAKTAR, DUYGU; KHORSHTD, LEYLA

      2018-01-01

      Başlık:Ölçüm Öncesi Dinlenme Süresinin ve DinlenmeEsnasında Konuşmanın İndirekt Kan Basıncı Ölçüm Değeri Üzerine EtkisiTitle:Özet:            Amaç: Buaraştırma, indirekt arteriyel kan basıncı ölçerken bireyin dinlenme süresininve dinlenme esnasında konuşmanın ölçüm değeri üzerine etkisini incelemekamacıyla yapılmıştır.Gereç-Yöntem:Örneklemini, bir üniversite hastanesinin İç Hastalıkları Polikliniği’nebaşvuran 18 yaşın üzerinde olan, 60 normotansif ve 60 hipertansif bireyleroluşturmuştur. Veri...

    13. Muhasebe Meslek Mensuplarında Tükenmişlik Sendromu Üzerine Bir Araştırma

      OpenAIRE

      DOĞAN, Prof. Dr. Zeki; NAZLIOĞLU, Elif Hilal

      2010-01-01

      Bu çalışmanın amacı, muhasebe meslek mensuplarının tükenmişlik sendromu yaşayıp-yaşamadıklarını incelemek ve eğer yaşıyorlarsa bunun boyutunu araştırmaktır. Bunun için Kayseri ilinde faaliyet gösteren muhasebe meslek mensuplarının tükenmişlik düzeylerinin ölçümüne ve tükenmişliğin alt boyutlarında nedensellik ilişkilerinin yönünün tespitine ilişkin bir anket çalışması yapılmıştır. Elde edilen verilerden hareketle ilk olarak Maslach Tükenmişlik Ölçeği hesaplanmış ve daha sonra nedensellik test...

    14. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on the substantiation of a health claim related to beta-palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

      DEFF Research Database (Denmark)

      Tetens, Inge

      2014-01-01

      Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked...... to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial...... physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool...

    15. GlyEFSA NDA Panel (EFSA Panel on Dietetic Product s, Nutrition and Allergies), 20 13 . Scientific Opinion on the substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after stren uous exercise pursuant to Article 13(5) of Regulation

      DEFF Research Database (Denmark)

      Tetens, Inge

      Following an application from Aptonia, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific...... substantiation of a health claim related to glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise. The food constituent, glycaemic carbohydrates, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. Recovery...... to the recovery of normal skeletal muscle function (contraction), the Panel concludes that a cause and effect relationship has been established between the consumption of glycaemic carbohydrates and recovery of normal muscle function (contraction) after strenuous exercise....

    16. Stable isotope-resolved metabolomics and applications for drug development

      Science.gov (United States)

      Fan, Teresa W-M.; Lorkiewicz, Pawel; Sellers, Katherine; Moseley, Hunter N.B.; Higashi, Richard M.; Lane, Andrew N.

      2012-01-01

      Advances in analytical methodologies, principally nuclear magnetic resonance spectroscopy (NMR) and mass spectrometry (MS), during the last decade have made large-scale analysis of the human metabolome a reality. This is leading to the reawakening of the importance of metabolism in human diseases, particularly cancer. The metabolome is the functional readout of the genome, functional genome, and proteome; it is also an integral partner in molecular regulations for homeostasis. The interrogation of the metabolome, or metabolomics, is now being applied to numerous diseases, largely by metabolite profiling for biomarker discovery, but also in pharmacology and therapeutics. Recent advances in stable isotope tracer-based metabolomic approaches enable unambiguous tracking of individual atoms through compartmentalized metabolic networks directly in human subjects, which promises to decipher the complexity of the human metabolome at an unprecedented pace. This knowledge will revolutionize our understanding of complex human diseases, clinical diagnostics, as well as individualized therapeutics and drug response. In this review, we focus on the use of stable isotope tracers with metabolomics technologies for understanding metabolic network dynamics in both model systems and in clinical applications. Atom-resolved isotope tracing via the two major analytical platforms, NMR and MS, has the power to determine novel metabolic reprogramming in diseases, discover new drug targets, and facilitates ADME studies. We also illustrate new metabolic tracer-based imaging technologies, which enable direct visualization of metabolic processes in vivo. We further outline current practices and future requirements for biochemoinformatics development, which is an integral part of translating stable isotope-resolved metabolomics into clinical reality. PMID:22212615

    17. Development and optimization of methotrexate-loaded lipid-polymer hybrid nanoparticles for controlled drug delivery applications.

      Science.gov (United States)

      Tahir, Nayab; Madni, Asadullah; Balasubramanian, Vimalkumar; Rehman, Mubashar; Correia, Alexandra; Kashif, Prince Muhammad; Mäkilä, Ermei; Salonen, Jarno; Santos, Hélder A

      2017-11-25

      Lipid-polymer hybrid nanoparticles (LPHNPs) are emerging platforms for drug delivery applications. In the present study, methotrexate loaded LPHNPs consisted of PLGA and Lipoid S100 were fabricated by employing a single-step modified nanoprecipitation method combined with self-assembly. A three factor, three level Box Behnken design using Design-Expert ® software was employed to access the influence of three independent variables on the particle size, drug entrapment and percent drug release. The optimized formulation was selected through numeric optimization approach. The results were supported with the ANOVA analysis, regression equations and response surface plots. Transmission electron microscope images indicated the nanosized and spherical shape of the LPHNPs with fair size distribution. The nanoparticles ranged from 176 to 308nm, which increased with increased polymer concentration. The increase in polymer and lipid concentration also increased the drug entrapment efficiency. The in vitro drug release was in range 70.34-91.95% and the release mechanism follow the Higuchi model (R 2 =0.9888) and Fickian diffusion (n<0.5). The in vitro cytotoxicity assay and confocal microscopy of the optimized formulation demonstrate the good safety and better internalization of the LPHNPs. The cell antiproliferation showed the spatial and controlled action of the nanoformulation as compared to the plain drug solution. The results suggest that LPHNPs can be a promising delivery system envisioned to safe, stable and potentially controlled delivery of methotrexate to the cancer cells to achieve better therapeutic outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

    18. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

      Science.gov (United States)

      2010-06-21

      ...] Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension AGENCY... Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable... of NOROCILLIN (penicillin G procaine) Injectable Suspension by intramuscular injection in cattle...

    19. Application of Model Animals in the Study of Drug Toxicology

      Science.gov (United States)

      Song, Yagang; Miao, Mingsan

      2018-01-01

      Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

    20. Dendrimers as tunable vectors of drug delivery systems and biomedical and ocular applications

      Directory of Open Access Journals (Sweden)

      Kalomiraki M

      2015-12-01

      Full Text Available Marina Kalomiraki,1 Kyriaki Thermos,2 Nikos A Chaniotakis1 1Laboratory of Analytical Chemistry, Department of Chemistry, 2Department of Pharmacology, School of Medicine, University of Crete Voutes, Heraklion, Greece Abstract: Dendrimers are large polymeric structures with nanosize dimensions (1–10 nm and unique physicochemical properties. The major advantage of dendrimers compared with linear polymers is their spherical-shaped structure. During synthesis, the size and shape of the dendrimer can be customized and controlled, so the finished macromolecule will have a specific “architecture” and terminal groups. These characteristics will determine its suitability for drug delivery, diagnostic imaging, and as a genetic material carrier. This review will focus initially on the unique properties of dendrimers and their use in biomedical applications, as antibacterial, antitumor, and diagnostic agents. Subsequently, emphasis will be given to their use in drug delivery for ocular diseases. Keywords: nanoparticles, ocular diseases, encapsulation, macromolecule, diagnostic agent