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Sample records for bulk drug industry

  1. Toxicity Evaluation of Through Fish Bioassay Raw Bulk Drug Industry Wastewater After Electrochemical Treatment

    Directory of Open Access Journals (Sweden)

    S Satyanarayan

    2011-10-01

    Full Text Available Considering the high pollution potential that the synthetic Bulk Drug industry Wastewater (BDW possesses due to the presence of variety of refractory organics, toxicity evaluation is of prime importance in assessing the efficiency of the applied wastewater treatment system and in establishing the discharge standards. Therefore, in this study the toxic effects of high strength bulk drug industry wastewater before and after electrochemical treatment on common fish Lebistes reticulatus-(peter were studied under laboratory conditions. Results indicated that wastewater being very strong in terms of color, COD and BOD is found to be very toxic to the studied fish. The LC50 values for raw wastewater and after electrochemical treatment with carbon and aluminium electrodes for 24, 48, 72 and 96 hours ranged between, 2.5-3.6%, 6.8-8.0%, 5.0-5.8% respectively. Carbon electrode showed marginally better removals for toxicity than aluminium electrode. It was evident from the studies that electrochemical treatment reduces toxicity in proportion to the removal efficiency shown by both the electrodes. The reduction in toxicity after treatment indicates the intermediates generated are not toxic than the parent compounds. Furthermore, as the electrochemical treatment did not result in achieving disposal standards it could be used only as a pre-treatment and the wastewater needs further secondary treatment before final disposal.

  2. Anaerobic treatment of wastewater with high suspended solids from a bulk drug industry using fixed film reactor (AFFR).

    Science.gov (United States)

    Gangagni Rao, A; Venkata Naidu, G; Krishna Prasad, K; Chandrasekhar Rao, N; Venkata Mohan, S; Jetty, Annapurna; Sarma, P N

    2005-01-01

    Studies were carried out on the treatment of wastewater from a bulk drug industry using an anaerobic fixed film reactor (AFFR) designed and fabricated in the laboratory. The chemical oxygen demand (COD) and total dissolved solids (TDS) of the wastewater were found to be very high with low biochemical oxygen demand (BOD) to COD ratio and high total suspended solid (TSS) concentration. Acclimatization of seed consortia and startup of the reactor was carried out by directly using the wastewater, which resulted in reducing the period of startup to 30 days. The reactor was studied at different organic loading rates (OLR) and it was found that the optimum OLR was 10 kg COD/m(3)/day. The wastewater under investigation, which had a considerable quantity of SS, was treated anaerobically without any pretreatment. COD and BOD of the reactor outlet wastewater were monitored and at steady state and optimum OLR 60-70% of COD and 80-90% of BOD were removed. The reactor was subjected to organic shock loads at two different OLR and the reaction could withstand the shocks and performance could be restored to normalcy at that OLR. The results obtained indicated that AFFR could be used efficiently for the treatment of wastewater from a bulk drug industry having high COD, TDS and TSS.

  3. 78 FR 72841 - List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That...

    Science.gov (United States)

    2013-12-04

    ... Used in Pharmacy Compounding; Bulk Drug Substances That May Be Used To Compound Drug Products in... Administration (FDA or Agency) is withdrawing the proposed rule to list bulk drug substances used in pharmacy... Pharmacopoeia chapter on pharmacy compounding; (II) if such a monograph does not exist, are drug substances that...

  4. New Zealand's drug development industry.

    Science.gov (United States)

    Lockhart, Michelle Marie; Babar, Zaheer-Ud-Din; Carswell, Christopher; Garg, Sanjay

    2013-09-13

    The pharmaceutical industry's profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ) from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ's clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ's clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support.

  5. Development of Bulk Nanocrystalline Cemented Tungsten Carbide for Industrial Applicaitons

    Energy Technology Data Exchange (ETDEWEB)

    Z. Zak Fang, H. Y. Sohn

    2009-03-10

    This report contains detailed information of the research program entitled "Development of Bulk Nanocrystalline Cemented Tungsten Carbide Materials for Industrial Applications". The report include the processes that were developed for producing nanosized WC/Co composite powders, and an ultrahigh pressure rapid hot consolidation process for sintering of nanosized powders. The mechanical properties of consolidated materials using the nanosized powders are also reported.

  6. Drug Information Residency Rotation with Pharmaceutical Industry.

    Science.gov (United States)

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  7. Drug Information Residency Rotation with Pharmaceutical Industry.

    Science.gov (United States)

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  8. China's bulk shipping industry overview

    Energy Technology Data Exchange (ETDEWEB)

    Li, Z. [China National Chartering Corp., Sinochart (China)

    2002-07-01

    A set of 20 slides/overheads (file LiZhen.ppt) in Chinese and English outlines the talk under the headings: recent development in marine shipping governance; trends and characteristics of international trade of China's main bulk cargo; China's bulk cargo fleet; and the development of China National Chartering Corp, SINOCHART. Four pages of text in English reports the talk.

  9. Energy-Efficient Devices for Transporting and Feeding Bulk Materials in the Construction Industry

    Directory of Open Access Journals (Sweden)

    Ishkov Alexander

    2016-01-01

    Full Text Available Only in the construction industry millions of tons of bulk materials that need to be transported to the place of processing, storing and evenly or dosed feeding are recycled annually. Decreasing the costs of these processes will significantly reduce the cost of the finished product. The article presents a review of studies conducted in the field of storage, transport and feed bulk materials, and it describes the innovative design of energy-efficient disc vibrating feeder bulk materials.

  10. New Zealand’s Drug Development Industry

    Directory of Open Access Journals (Sweden)

    Christopher Carswell

    2013-09-01

    Full Text Available The pharmaceutical industry’s profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ’s clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ’s clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support.

  11. Producing Bio-Based Bulk Chemicals Using Industrial Biotechnology Saves Energy and Combats Climate Change

    NARCIS (Netherlands)

    Hermann, B.G.|info:eu-repo/dai/nl/304837415; Blok, K.|info:eu-repo/dai/nl/07170275X; Patel, M.K.|info:eu-repo/dai/nl/18988097X

    2007-01-01

    The production of bulk chemicals from biomass can make a significant contribution to solving two of the most urgent environmental problems: climate change and depletion of fossil energy. We analyzed current and future technology routes leading to 15 bulk chemicals using industrial biotechnology and

  12. Producing Bio-Based Bulk Chemicals Using Industrial Biotechnology Saves Energy and Combats Climate Change

    NARCIS (Netherlands)

    Hermann, B.G.; Blok, K.; Patel, M.K.

    2007-01-01

    The production of bulk chemicals from biomass can make a significant contribution to solving two of the most urgent environmental problems: climate change and depletion of fossil energy. We analyzed current and future technology routes leading to 15 bulk chemicals using industrial biotechnology and

  13. Bulk forming of industrial micro components in conventional metals and bulk metallic glasses

    DEFF Research Database (Denmark)

    Arentoft, Mogens; Paldan, Nikolas Aulin; Eriksen, Rasmus Solmer;

    2007-01-01

    For production of micro components in large numbers, forging is an interesting and challenging process. The conventional metals like silver, steel and aluminum often require multi-step processes, but high productivity and increased strength justify the investment. As an alternative, bulk metallic...... glasses will at elevated temperatures behave like a highly viscous liquid, which can easily form even complicated geometries in 1 step. The strengths and limitations of forming the 2 materials are analyzed for a micro 3D component in a silver alloy and an Mg-Cu-Y BMG. ©2007 American Institute of Physics...

  14. Industrial natural product chemistry for drug discovery and development.

    Science.gov (United States)

    Bauer, Armin; Brönstrup, Mark

    2014-01-01

    Covering: up to March 2013. In addition to their prominent role in basic biological and chemical research, natural products are a rich source of commercial products for the pharmaceutical and other industries. Industrial natural product chemistry is of fundamental importance for successful product development, as the vast majority (ca. 80%) of commercial drugs derived from natural products require synthetic efforts, either to enable economical access to bulk material, and/or to optimize drug properties through structural modifications. This review aims to illustrate issues on the pathway from lead to product, and how they have been successfully addressed by modern natural product chemistry. It is focused on natural products of current relevance that are, or are intended to be, used as pharmaceuticals.

  15. Interactions between physicians and drug industry

    Directory of Open Access Journals (Sweden)

    Begul Yagci Kupeli

    2016-12-01

    Full Text Available Ethical issues involving drug industry physician relationship have resulted in an ongoing debate about its appropriateness for many years in medical World. The most familiar marketing strategies of drug companies include individual gifts for physicians and sponsorship for educational and social activities. This interaction begins during medical school years of doctors and types of interactions are modified according to factors such as physician's position, title and number of patients. Although data reveal the opposite, most doctors deny or underestimate the influence of drug companies on their drug prescription. Both sides have common interests such as effective drug usage and observation, conduction of creative scientific studies. However, they have conflict of interests in some aspects. Physicians mostly care about patients' well-being and scientific improvement while drug companies are mostly involved in commercial benefit. Furthermore, some of the marketing strategies may have significant consequences on health of society such as rising drug costs, wrong or excessive usage of drugs. Regulations and guidelines have been designed in order to overcome these issues. However, the most important role in modelling of physician-drug industry interaction belongs to physicians. [Cukurova Med J 2016; 41(4.000: 777-781

  16. Drug-induced liver injury and drug development: industry perspective.

    Science.gov (United States)

    Regev, Arie

    2014-05-01

    Despite intensive ongoing research, drug-induced live injury (DILI) remains a serious issue for care providers and patients, and has been a major cause of drug withdrawal and non-approval by regulatory authorities in the past 50 years. Consequently, DILI remains a major concern for the pharmaceutical industry and a leading cause for attrition during drug development. In most instances, severe DILI is an uncommon idiosyncratic reaction, which typically does not present during preclinical phases or early clinical phases of drug development. In the majority of cases, drugs that caused severe DILI in humans have not shown clear and consistent hepatotoxic signals in preclinical assessment including animal studies, cell cultures, or other methods. Despite intensive efforts to develop better biomarkers that would help in predicting DILI risk in earlier phases of drug development, such biomarkers are currently not supported by sufficient evidence and are not yet available for routine use by drug makers. Due to the lack of effective and accurate methods for prediction of idiosyncratic DILI during preclinical phases of drug development, different drug makers have adopted different approaches, which are often not supported by strong systematic evidence. Based on growing experience, it is becoming increasingly evident that milder forms of liver injury occurring during clinical development, when assessed correctly, may significantly enhance our ability to predict the drug's potential to cause more severe liver injury postmarketing. Strategies based on this concept have been adopted by many drug makers, and are being increasingly implemented during drug development. Meticulous causality assessment of individual hepatic cases and adherence to strict hepatic discontinuation rules are critical components of this approach and have to rely on thorough clinical evaluation and occasionally on assessment by liver experts experienced with DILI and drug development.

  17. Price Formation of Dry Bulk Carriers in the Chinese Shipbuilding Industry

    DEFF Research Database (Denmark)

    JIANG, Liping

    In this paper we present, for the first time, the price formation of China’s dry bulk carrier using vessel prices quoted by major Chinese shipyards in actual shipbuilding orders. This allows us to investigate the relationship of price and determinants in the Chinese shipbuilding industry by inclu...

  18. Characterization of a novel impurity in bulk drug of lisinopril by multidimensional NMR technique

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    During the routine impurity profile of lisinopril bulk drug by HPLC (high-performance liquid chromatography), a potential impurity was detected. Using multidimensional NMR (nuclear magnetic resonance) technique, the trace-level impurity was unambiguously identified to be 2-(-2-oxo-azocan-3-ylamino)-4-phenyl-butyric acid after isolation from lisinopril bulk drug by semi-preparative HPLC. Formation of the impurity was also discussed. To our knowledge, this is a novel impurity and not reported elsewhere.

  19. Academia-industry partnerships in drug discovery.

    Science.gov (United States)

    Dalrymple, Michael; Taylor, Debbie; Kettleborough, Catherine; Bryans, Justin; Solari, Roberto

    2006-06-01

    The movement of ideas and innovation from academia into the world of business has a long and fruitful history. Ironically, it might be argued that the recent pressure put on universities and basic research organisations to protect and exploit their intellectual property has, in many ways, created a less conducive environment to successful commercialisation than existed 30 years ago. This movement has been concurrent with the drift of the Pharmaceutical industry towards a more risk-averse R&D strategy in which it has increasingly concentrated its resources on a reductionist drug discovery process and later stage clinical development. In effect, these two strategies have created a discontinuity between academic scientific output and industry at a time when academia as a source of innovation is perhaps more important to industry than ever.

  20. Price Formation of Dry Bulk Carriers in the Chinese Shipbuilding Industry

    DEFF Research Database (Denmark)

    JIANG, Liping

    In this paper we present, for the first time, the price formation of China’s dry bulk carrier using vessel prices quoted by major Chinese shipyards in actual shipbuilding orders. This allows us to investigate the relationship of price and determinants in the Chinese shipbuilding industry...... by including generic market factors as well as Chinese elements. The analysis, employing Principal Component Regression (PCR) approach, indicates that the time charter rate has the most significantly positive impact. While increases in other four factors, namely shipbuilding cost, price cost margin...... to investigate what would happen to the Chinese dry bulk carrier prices under changes of time charter rate and shipbuilding cost. This paper has implications for the Chinese shipyards, shipbuilding industry customers and industry policy makers....

  1. Producing bio-based bulk chemicals using industrial biotechnology saves energy and combats climate change.

    Science.gov (United States)

    Hermann, B G; Blok, K; Patel, M K

    2007-11-15

    The production of bulk chemicals from biomass can make a significant contribution to solving two of the most urgent environmental problems: climate change and depletion of fossil energy. We analyzed current and future technology routes leading to 15 bulk chemicals using industrial biotechnology and calculated their CO2 emissions and fossil energy use. Savings of more than 100% in non-renewable energy use and greenhouse gas emissions are already possible with current state of the art biotechnology. Substantial further savings are possible for the future by improved fermentation and downstream processing. Worldwide CO2 savings in the range of 500-1000 million tons per year are possible using future technology. Industrial biotechnology hence offers excellent opportunities for mitigating greenhouse gas emissions and decreasing dependence on fossil energy sources and therefore has the potential to make inroads into the existing chemical industry.

  2. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug... the availability of a guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and... generic drug review, FDA is recommending that the generic drug industry follow the approach in...

  3. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug... availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and... of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and...

  4. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Science.gov (United States)

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Abbreviated New Drug Applications...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry...) guidance for industry ``Q3B(R) Impurities in New Drug Products,'' which was announced in August 2006....

  5. 76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

    Science.gov (United States)

    2011-08-02

    ...: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord... for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated... the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational...

  6. Limited bacterial diversity within a treatment plant receiving antibiotic containing waste from bulk drug production

    NARCIS (Netherlands)

    Marathe, Nachiket P.; Shetty, Sudarshan A.; Shouche, Yogesh S.; Larsson, D.G.J.

    2016-01-01

    Biological treatment of waste water from bulk drug production, contaminated with high levels of fluoroquinolone antibiotics, can lead to massive enrichment of antibiotic resistant bacteria, resistance genes and associated mobile elements, as previously shown. Such strong selection may be boosted

  7. Stability-indicating HPTLC determination of ambroxol hydrochloride in bulk drug and pharmaceutical dosage form.

    Science.gov (United States)

    Jain, P S

    2010-01-01

    A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for the analysis of ambroxol hydrochloride both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of methanol-triethylamine (4:6 v/v). The system was found to give a compact spot for ambroxol hydrochloride (R(f) value of 0.53 +/- 0.02). Densitometric analysis of ambroxol hydrochloride was carried out in the absorbance mode at 254 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r(2) = 0.9966 +/- 0.0013 with respect to peak area in the concentration range 100-1000 ng/spot. The mean value +/- standard deviation of slope and intercept were 164.85 +/- 0.72 and 1168.3 +/- 8.26 with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 10 and 30 ng/spot, respectively. Ambroxol hydrochloride was subjected to oxidation and thermal degradation. The drug undergoes degradation under oxidation and heat conditions. This indicates that the drug is susceptible to oxidation and heat. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of said drug. Stability indicating of new chemical entities is an important part for the drug development of ambroxol hydrochloride and for its estimation in plasma and other biological fluids; the novel Statistical analysis proves that the method is repeatable and selective for the analysis of ambroxol hydrochloride as bulk drug and in pharmaceutical formulations. The proposed developed HPTLC method can be applied for identification and quantitative determination of ambroxol hydrochloride in bulk drug and dosage forms. This work is to determine the purity of the drug available from the various sources by detecting

  8. The Feasibility of Bulk Crystallization as an Industrial Purification and Production Technique for Proteins

    Science.gov (United States)

    Judge, Russell A.; Forsythe, Elizabeth L.; Johns, Michael R.; Pusey, Marc L.; White, Edward T.

    1998-01-01

    Bulk crystallization in stirred vessels is used industrially for the recovery and purification of many inorganic and organic materials. Although much has been written on the crystallization of proteins for X-ray diffraction analysis, very little has been reported on the application of bulk crystallization in stirred vessels. In this study, a 1-liter, seeded, stirred, batch crystallizer was used with ovalbumin as a model protein to test the feasibility of this crystallization method as a recovery and purification process for proteins. Results were obtained for ovalbumin solubility, nucleation thresholds, crystal breakage and crystal growth kinetics in bulk solution under a range of operating conditions of pH and ammonium sulphate concentration (Judge et al., 1996). Experiments were also performed to determine the degree of purification that can be achieved by the crystallization of ovalbumin from a mixture of proteins. The effect of the presence of these proteins upon the ovalbumin crystal growth kinetics was also investigated (Judge et al., 1995). All of these aspects are essential for the design of bulk crystallization processes which have not previously been reported for proteins. Results from a second study that investigated the effect of structurally different proteins on the solubility, crystal growth rates and crystal purity of chicken egg white lysozyme are also presented (Judge et al., 1997). In this case face growth rates were measured using lysozyme purified by liquid chromatography and the effect of the addition of specific protein impurities were observed on the (110) and (101) crystal faces. In these two studies the results are presented to show the feasibility and purifying ability of crystallization as a production process for proteins.

  9. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Science.gov (United States)

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... draft guidance for industry entitled ``Investigational New Drug Applications (INDs)--Determining...

  10. Determination of prilocaine HCl in bulk drug and pharmaceutical formulation by GC-NPD method

    Directory of Open Access Journals (Sweden)

    Atila Alptug

    2013-01-01

    Full Text Available The novel analytical method was developed and validated for determination of prilocaine HCl in bulk drug and pharmaceutical formulation by gas chromatography-nitrogen phosphorus detection (GC-NPD. The chromatographic separation was performed using a HP-5MS column. The calibration curve was linear over the concentration range of 40-1000 ng ml-1 with a correlation coefficient of 0.9998. The limits of detection (LOD and quantification (LOQ of method were 10 ng ml-1 and 35 ng ml-1, respectively. The within-day and between-day precision, expressed as the percent relative standard deviation (RSD% was less than 5.0%, and accuracy (percent relative error was better than 4.0%. The developed method can be directly and easily applied for determination of prilocaine HCl in bulk drug and pharmaceutical formulation using internal standard methodology.

  11. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of...

  12. Spectrophotometric Determination of drugs in bulk and pharmaceutical dosage forms by using Tetracyanoethylene

    Directory of Open Access Journals (Sweden)

    Bathini.Srinivas

    2015-06-01

    Full Text Available A selective ,sensitive ,accurate UV-Visible spectrophotometric methods have been developed for the estimation of drugs viz.,Diflunisal (DFL,Febuxostat(FBT,Metaxalone(MTX,Fexofenadine methyl ester(FME and Linezolid(LZD in bulk and their pharmaceutical dosage forms using Tetracyanoethylene (TCNE as analytical reagent. These method are based on the formation of charge transfer complexes of drugs as n-electron donor with TCNE as π-acceptor .The selected drugs turned the colorless solution of TCNE in Acetonytrile to yellow and exhibited a doublet at 400 & 420nm due to the formation of Complex of drugs with TCNE.Under the optimized experimental conditions ,Beer, s law is obeyed over the concentration ranges of 10-50 μg/ml ,5- 25 μg/ml,15-75 μg/ml,5-25 μg/ml and 5-25 μg/ml for DFL,FBT,MTX,FME and LZD respectively. The effect of reagent concentrations, polarity of solvents and effect of reaction time have been studied and optimized. These methods have been validated in terms of ICH guidelines and applied to the quantification of selected drugs in bulk and dosage forms.

  13. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Science.gov (United States)

    2013-05-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Contract Manufacturing... guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This... draft guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality...

  14. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Science.gov (United States)

    2012-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  15. One-step bulk preparation of calcium carbonate nanotubes and its application in anticancer drug delivery.

    Science.gov (United States)

    Tang, Jing; Sun, Dong-Mei; Qian, Wen-Yu; Zhu, Rong-Rong; Sun, Xiao-Yu; Wang, Wen-Rui; Li, Kun; Wang, Shi-Long

    2012-06-01

    Bulk fabrication of ordered hollow structural particles (HSPs) with large surface area and high biocompatibility simultaneously is critical for the practical application of HSPs in biosensing and drug delivery. In this article, we describe a smart approach for batch synthesis of calcium carbonate nanotubes (CCNTs) based on supported liquid membrane (SLM) with large surface area, excellent structural stability, prominent biocompatibility, and acid degradability. The products were characterized by transmission electron micrograph, X-ray diffraction, Fourier transform infrared spectra, UV-vis spectroscopy, zeta potential, and particle size distribution. The results showed that the tube-like structure facilitated podophyllotoxin (PPT) diffusion into the cavity of hollow structure, and the drug loading and encapsulation efficiency of CCNTs for PPT are as high as 38.5 and 64.4 wt.%, respectively. In vitro drug release study showed that PPT was released from the CCNTs in a pH-controlled and time-dependent manner. The treatment of HEK 293T and SGC 7901 cells demonstrated that PPT-loaded CCNTs were less toxic to normal cells and more effective in antitumor potency compared with free drugs. In addition, PPT-loaded CCNTs also enhanced the apoptotic process on tumor cells compared with the free drugs. This study not only provides a new kind of biocompatible and pH-sensitive nanomaterial as the feasible drug container and carrier but more importantly establishes a facile approach to synthesize novel hollow structural particles on a large scale based on SLM technology.

  16. An Assessment of Drug Testing within the Construction Industry.

    Science.gov (United States)

    Gerber, Jonathan K.; Yacoubian, George S., Jr.

    2002-01-01

    Investigates the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors within the construction industry. Analyses indicate that companies with drug-testing programs experienced a 51 percent reduction in incident rates within two years of implementation.…

  17. Stability-indicating HPTLC determination of imatinib mesylate in bulk drug and pharmaceutical dosage form.

    Science.gov (United States)

    Vadera, N; Subramanian, G; Musmade, P

    2007-01-17

    A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of imatinib mesylate both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform:methanol (6:4, v/v). The system was found to give compact spot for imatinib mesylate (R(f) value of 0.53+/-0.02). Densitometric analysis of imatinib mesylate was carried out in the absorbance mode at 276 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r(2)=0.9966+/-0.0013 with respect to peak area in the concentration range 100-1000 ng per spot. The mean value+/-S.D. of slope and intercept were 164.85+/-0.72 and 1168.3+/-8.26 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 10 and 30 ng per spot, respectively. Imatinib mesylate was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of imatinib mesylate in bulk drug and dosage forms.

  18. Stability-Indicating HPTLC Determination of Imatinib Mesylate in Bulk Drug and Pharmaceutical Dosage

    Science.gov (United States)

    Musmade, P.; Vadera, N.; Subramanian, G.

    A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of imatinib mesylate both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform:methanol (6:4, v/v). The system was found to give compact spot for imatinib mesylate (R f value of 0.53 ± 0.02). Densitometric analysis of imatinib mesylate was carried out in the absorbance mode at 276 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r 2 = 0.9966 ± 0.0013 with respect to peak area in the concentration range 100-1,000 ng per spot. The mean value ± SD of slope and intercept were 164.85 ± 0.72 and 1168.3 ± 8.26, respectively, with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 10 and 30 ng per spot, respectively. Imatinib mesylate was subjected to acid and alkali hydrolysis, and oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation, and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation, and heat. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of the said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of imatinib mesylate in bulk drug and dosage forms.

  19. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food... guidances to industry on ``Bioavailability and Bioequivalence Studies for Orally Administered Drug...

  20. Drug discovery in pharmaceutical industry: productivity challenges and trends.

    Science.gov (United States)

    Khanna, Ish

    2012-10-01

    Low productivity, rising R&D costs, dissipating proprietary products and dwindling pipelines are driving the pharmaceutical industry to unprecedented challenges and scrutiny. In this article I reflect on the current status of the pharmaceutical industry and reasons for continued low productivity. An emerging 'symbiotic model of innovation', that addresses underlying issues in drug failure and attempts to narrow gaps in current drug discovery processes, is discussed to boost productivity. The model emphasizes partnerships in innovation to deliver quality products in a cost-effective system. I also discuss diverse options to build a balanced research portfolio with higher potential for persistent delivery of drug molecules.

  1. A validated HPLC stability-indicating method for the determination of diacerhein in bulk drug substance.

    Science.gov (United States)

    Giannellini, Valerio; Salvatore, Francesco; Bartolucci, Gianluca; Coran, Silvia A; Bambagiotti-Alberti, Massimo

    2005-09-15

    A novel stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the assay of diacerhein in bulk forms. Diacerhein was found to degrade in alkaline and acidic conditions and also under oxidative stress. The drug was stable to dry heat and in presence of light. Resolution of drug, its potential impurities and degradation products were achieved on a RP18 (endcapped) column utilizing 0.1 M phosphoric acid and methanol (40:60, v/v) as eluent at the detection wavelength of 254 nm. The validation studies were carried out fulfilling International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intermediate precision), accurate and robust.

  2. Drug packaging in 2015: risky industry choices and lax regulation.

    Science.gov (United States)

    2016-06-01

    Prescrire examined the packaging quality of 240 drugs in 2015. No new advances were identified, but drug packaging continues to expose patients to a variety of dangers. Some past advances persist: for example, INNs are often more legible, and recent patient leaflets tend to be clearer and more informative. But these measures are not applied to all drugs, and are rarely applied retroactively to older drugs. The overall picture in 2015 is that many drugs are difficult to identify, risky or downright dangerous to prepare, or supplied with patient leaflets that fail to correctly inform patients about their medication. And measures to prevent drug poisoning in children need to be completely rethought. It is high time for regulators and policy makers to take the issue of drug packaging seriously, so blatant are the signs of their failure to do so: the increasing use of bulk bottles for new drugs; failure to implement guidelines on safe drug packaging (unit-dose presentations, appropriate dosing devices, etc.); and expanding umbrella brands which, given the dangers they pose to patients, should be banned instead. All things considered, healthcare professionals and patients must remain vigilant and report any dangers they identify. A major European initiative on drug packaging is becoming increasingly necessary.

  3. Closing the drug lag for new drug submission and review in Japan: An industry perspective.

    Science.gov (United States)

    Poirier, A F

    2015-11-01

    Previous publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs.

  4. A treatment plant receiving waste water from multiple bulk drug manufacturers is a reservoir for highly multi-drug resistant integron-bearing bacteria.

    Directory of Open Access Journals (Sweden)

    Nachiket P Marathe

    Full Text Available The arenas and detailed mechanisms for transfer of antibiotic resistance genes between environmental bacteria and pathogens are largely unclear. Selection pressures from antibiotics in situations where environmental bacteria and human pathogens meet are expected to increase the risks for such gene transfer events. We hypothesize that waste-water treatment plants (WWTPs serving antibiotic manufacturing industries may provide such spawning grounds, given the high bacterial densities present there together with exceptionally strong and persistent selection pressures from the antibiotic-contaminated waste. Previous analyses of effluent from an Indian industrial WWTP that processes waste from bulk drug production revealed the presence of a range of drugs, including broad spectrum antibiotics at extremely high concentrations (mg/L range. In this study, we have characterized the antibiotic resistance profiles of 93 bacterial strains sampled at different stages of the treatment process from the WWTP against 39 antibiotics belonging to 12 different classes. A large majority (86% of the strains were resistant to 20 or more antibiotics. Although there were no classically-recognized human pathogens among the 93 isolated strains, opportunistic pathogens such as Ochrobactrum intermedium, Providencia rettgeri, vancomycin resistant Enterococci (VRE, Aerococcus sp. and Citrobacter freundii were found to be highly resistant. One of the O. intermedium strains (ER1 was resistant to 36 antibiotics, while P. rettgeri (OSR3 was resistant to 35 antibiotics. Class 1 and 2 integrons were detected in 74/93 (80% strains each, and 88/93 (95% strains harbored at least one type of integron. The qPCR analysis of community DNA also showed an unprecedented high prevalence of integrons, suggesting that the bacteria living under such high selective pressure have an appreciable potential for genetic exchange of resistance genes via mobile gene cassettes. The present study provides

  5. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information... Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and...

  6. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Science.gov (United States)

    2012-04-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under... guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; FDA and...

  7. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    Science.gov (United States)

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision.

  8. Roles of Co element in Fe-based bulk metallic glasses utilizing industrial FeB alloy as raw material

    Directory of Open Access Journals (Sweden)

    Shouyuan Wang

    2017-08-01

    Full Text Available A series of Fe-based bulk metallic glasses were fabricated by a conventional copper mold casting method using a kind of Fe-B industrial raw alloy. It is found that Fe-B-Y-Nb bulk metallic glass with 3 at% of Co addition possesses the best glass forming ability, thermal stability, hardness, magnetic property and anti-corrosion property. The hardness test result indicates a synchronically trend with glass-forming ability parameters. The excellent glass-forming ability and a combination of good mechanical and functional properties suggest that the alloys in this work might be good candidates for commercial use.

  9. Characterization of impurities in the bulk drug lisinopril by liquid chromatography/ion trap spectrometry

    Institute of Scientific and Technical Information of China (English)

    Pei-xi ZHU; Dan-hun WANG; Cui-rong SUN; Zhi-quan SHEN

    2008-01-01

    Two trace impurities in the bulk drug lisinopril were detected by means of high-performance liquid chromatography coupled with mass spectrometry (HPLC/MS) with a simple and sensitive method suitable for HPLC/MSn analysis.The frag-mentation behavior of lisinopril and the impurities was investigated,and two unknown impurities were elucidated as 2-(6-amino-1-(1-earboxyethylamino)-1-oxohexan-2-ylamino)-4-phenylbutanoic acid and 6-amino-2-(1-carboxy-3-phenylpro-pylamino)-hexanoic acid on the basis of the multi-stage mass spectrometry and exact mass evidence.The proposed structures of the two unknown impurities were further confirmed by nuclear magnetic resonance (NMR) experiments after preparative isola-tion.

  10. Spectrophotometric quantitation of metformin in bulk drug and pharmaceutical formulations using multivariate technique

    Directory of Open Access Journals (Sweden)

    Arayne M

    2009-01-01

    Full Text Available A sensitive and accurate UV spectrophotometric method with multivariate calibration technique for the determination of metformin hydrochloride in bulk drug and different pharmaceutical formulations has been described. This technique is based on the use of the linear regression equations by using relationship between concentration and absorbance at five different wavelength. The results were treated statistically and were found highly accurate, precise and reproducible. The method is accurate, precise (% recovery 102.50΁0.063, CV≤0.56, r =0.997 and linear within the range 1-10 mg/ml. There was no interference from the excipients i.e Povidone K 30, magnesium stearate, lactose and hydroxypropylmethylcellulose. This statistical approach gives optimum results for the eliminating fluctuations coming from instrumental or experimental conditions.

  11. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application; Availability... the availability of a draft guidance for industry and researchers entitled ``The Radioactive...

  12. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... products developed as drug-device combination products. This guidance revises the guidance for...

  13. RP-HPLC Method for the Determination of Cinitapride in the Presence of its Degradation Products in Bulk Drug

    Directory of Open Access Journals (Sweden)

    S. M. N. Roy

    2010-01-01

    Full Text Available A reverse phase HPLC method is described for the determination of cinitapride hydrogen tartrate in the presence of its degradation products in bulk drug. A drug was subjected to all stress conditions such as reduction, oxidation acidic and alkaline medium. Chromatography was recorded on an Intersil ODS-3 column using mixture of acetonitrile and phosphate buffer, pH adjusted to 6.7 in the ratio (70:30 v/v as the mobile phase at the rate of 1.0 mL/min with detection at 260 nm. Glimepride was used as internal standard. The retention time of drug cinitapride was 3.8 min and glimepride an internal standard was 2.5 minute. The drug was found to degrade extensively in reduction conditions and mild degradation in the presence of in alkaline, acidic and oxidative but the drug was stable in thermal stress. The method was validated by determining its specificity, linearity, precision and accuracy. The developed method with good separation of all degradation products from drug could be successfully applied for the determination of cinitapride in the presence of its degradation products in the bulk drug. The proposed method is simple, fast, accurate and precise and hence applied for routine quality control of cinitapride in bulk drug. It can be used for analysis of samples during stability testing.

  14. A comparative study between the fluxes of trace elements in bulk atmospheric deposition at industrial, urban, traffic, and rural sites.

    Science.gov (United States)

    Fernández-Olmo, I; Puente, M; Irabien, A

    2015-09-01

    The input of trace elements via atmospheric deposition towards industrial, urban, traffic, and rural areas is quite different and depends on the intensity of the anthropogenic activity. A comparative study between the element deposition fluxes in four sampling sites (industrial, urban, traffic, and rural) of the Cantabria region (northern Spain) has been performed. Sampling was carried out monthly using a bulk (funnel bottle) sampler. The trace elements, As, Cd, Cr, Cu, Mn, Mo, Ni, Pb, Ti, Zn, and V, were determined in the water soluble and insoluble fractions of bulk deposition samples. The element deposition fluxes at the rural, urban, and traffic sites followed a similar order (Zn > Mn> > Cu ≈ Ti > Pb > V ≈ Cr > Ni> > As ≈ Mo > Cd). The most enriched elements were Cd, Zn, and Cu, while V, Ni, and Cr were less enriched. An extremely high deposition of Mn was found at the industrial site, leading to high enrichment factor values, resulting from the presence of a ferro-manganese/silico-manganese production plant in the vicinity of the sampling site. Important differences were found in the element solubilities in the studied sites; the element solubilities were higher at the traffic and rural sites, and lower at the urban and industrial sites. For all sites, Zn and Cd were the most soluble elements, whereas Cr and Ti were less soluble. The inter-site correlation coefficients for each element were calculated to assess the differences between the sites. The rural and traffic sites showed some similarities in the sources of trace elements; however, the sources of these elements at the industrial and rural sites were quite different. Additionally, the element fluxes measured in the insoluble fraction of the bulk atmospheric deposition exhibited a good correlation with the daily traffic volume at the traffic site.

  15. Industry perspectives on market access of innovative drugs

    Directory of Open Access Journals (Sweden)

    Kim ePauwels

    2016-06-01

    Full Text Available This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on patient reported outcomes and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.

  16. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Science.gov (United States)

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Antibacterial Drug Products: Use of.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... of the draft guidance for industry entitled ``Antibacterial Drug Products: Use of...

  17. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this....regulations.gov . To receive ``Guidance for Industry and Food and Drug Administration Staff; Blood...

  18. Removal of the nonconformities in the drug boxes packaging industry

    Directory of Open Access Journals (Sweden)

    Bălan Emilia

    2017-01-01

    Full Text Available The paper presents the specific quality aspects of cardboard drug boxes (folding boxes used as packaging in pharmaceutical industry. The types of defects and nonconformities that occur during offset printing and finishing of the packaging products are being identified and analyzed, such as: differences in color printing, scratches on the printed sheets, cracks during creasing, unparalleled gluing in respect to the closing flaps, ungluing, successive drug boxes stick to each other. The paper also focuses on aspects regarding the nonconformities removal of the drug boxes by establishing a control plan and preventive and corrective methods applicable in different technological stages of the production flow. Monitoring and analyzing activities for quality improvement of the drug boxes, in accordance with the quality specifications required by customers were performed for 20 months on a production line with Heidelberg machines. Nonconformities considered in this paper are also encountered in advertising printing.

  19. Drug development: how academia, industry and authorities interact.

    Science.gov (United States)

    Garattini, Silvio; Perico, Norberto

    2014-10-01

    Unfortunately, abundant examples could be given of pitfalls in the current drug development paradigm-including in the design, conduct and evaluation of phase III clinical trials. This article discusses issues of particular relevance to clinical trials in nephrology, including the inappropriate use of placebo, publication of reports that emphasize potential treatment benefits over adverse reactions, the sometimes dubious impartiality of independent guidelines, and inadequate recruitment of elderly patients. This Perspectives article aims to highlight and summarize the flaws in the current drug development process, while suggesting a way forward that equally satisfies the requirements of academia, patients and the pharmaceutical industry. We suggest improvements to the drug development process and related legislation that intend to balance public needs with commercial aims and ensure effective drug evaluation by regulatory authorities.

  20. Herbal drug regulation and commercialization: an Indian industry perspective.

    Science.gov (United States)

    Sahoo, Niharika; Manchikanti, Padmavati

    2013-12-01

    To assess the constraints for Indian herbal drug industry with respect to manufacturing and commercialization of herbal medicines. A questionnaire-based survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from 150 companies by email, telephone, and in-person interviews from June 2009 to August 2010 and were analyzed to draw appropriate conclusions. The survey result showed that differing regulatory requirements and the limited market in foreign countries are the major hindrances for exporting. Standardization and quality control of raw materials and herbal formulations emerged as the major challenge for Indian herbal drug manufacturing firms. Insufficient regulatory guidelines, particularly guidelines for good manufacturing practices; nonimplementation of good agricultural and collection practices; and weak implementation of the Drugs and Cosmetics Act of 1940 are considered major drawbacks for the Indian herbal industry. Proper implementation of the Drugs and Cosmetics Act of 1940, development of more elaborate guidelines on quality control aspects, and development of marker-based standards are needed to produce safe and effective herbal medicines in India. Because evidence-based studies are becoming increasingly essential for establishing the safety and efficacy of herbal products in the domestic and export market, more focus should be placed on scientific and technological advancement in the field of herbal medicine. Regulatory harmonization becomes essential to mitigate the delays in commercialization across countries.

  1. Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs.

    Science.gov (United States)

    Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven

    2016-01-01

    Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs- Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers- A well-considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in assessment and appraisal at national and European level in order to coordinate the views of different stakeholders and allow efficient resource allocation This study presents industry perspectives on the challenges related to market access of innovative drugs in general and oncology drugs in specific. Fifteen interviews were conducted with representatives of pharmaceutical companies and industry associations. Interviewees call for a broader recognition of value within the assessment and appraisal of drugs. According to interviewees, focus on value is jeopardized by the lack of a common value definition across Europe, poor availability and validity of value measures and cost-saving measures such as external reference price setting and cost-effectiveness analysis at the side of the payers. Centralized assessment of relative-effectiveness at European level would provide a common value estimate across member states, independent of financial drivers. Empirical evidence on PRO and societal preferences is however essential in the development of a value definition. Furthermore, value-based pricing would imply a dynamic approach where the price is differentiated across indications and across the lifecycle of the drug, especially in fields such as oncology. Financial drivers however also threat the application of value-based pricing at the side of the industry, making value-based profitability a more appropriate term.

  2. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Assessment of Abuse Potential... and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... availability of a draft guidance for industry entitled ``Assessment of Abuse Potential of Drugs.'' Under...

  3. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Science.gov (United States)

    2013-05-09

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 312 Draft Guidance for Industry on Charging for... Investigational Drugs Under an IND--Qs & As.'' This guidance is intended to provide information for industry... for industry entitled ``Charging for Investigational Drugs Under an IND--Qs & As.'' In 2009,...

  4. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Science.gov (United States)

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... appropriate for them to use a drug product. The guidance provides recommendations to industry involved...

  5. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Science.gov (United States)

    2011-09-29

    ... HUMAN SERVICES Food and Drug Administration (Formerly 2004D-0027) Guidance for Industry on Time and... a guidance for industry entitled ``Time and Extent Applications for Nonprescription Drug Products... in 21 CFR part 25 and the guidance for industry entitled ``Environmental Assessment of Human Drug...

  6. An industry statistician's perspective on PHC drug development.

    Science.gov (United States)

    Fridlyand, Jane; Yeh, Ru-Fang; Mackey, Howard; Bengtsson, Thomas; Delmar, Paul; Spaniolo, Greg; Lieberman, Grazyna

    2013-11-01

    In the past decade, the cost of drug development has increased significantly. The estimates vary widely but frequently quoted numbers are staggering-it takes 10-15 years and billions of dollars to bring a drug to patients. To a large extent this is due to many long, expensive and ultimately unsuccessful drug trials. While one approach to combat the low yield on investment could be to continue searching for new blockbusters, an alternative method would lead us to focus on testing new targeted treatments that have a strong underlying scientific rationale and are more likely to provide enhanced clinical benefit in population subsets defined by molecular diagnostics. Development of these new treatments, however, cannot follow the usual established path; new strategies and approaches are required for the co-development of novel therapeutics and the diagnostic. In this paper we will review, from the point of view of industry, the approaches to, and challenges of drug development strategies incorporating predictive biomarkers into clinical programs. We will outline the basic concepts behind co-development with predictive biomarkers and summarize the current regulatory paradigm. We will present guiding principles of personalized health care (PHC) development and review the statistical, strategic, regulatory and operational challenges that statisticians regularly encounter on development programs with a PHC component. Some practical recommendations for team statisticians involved in PHC drug development are included. The majority of the examples and recommendations are drawn from oncology but broader concepts apply across all therapeutic areas.

  7. Recombinant drug development, regulation, and commercialization: an Indian industry perspective.

    Science.gov (United States)

    Sahoo, Niharika; Manchikanti, Padmavati

    2011-04-01

    The Indian biopharmaceutical sector comprises nearly 40 companies that manufacture and/or market 14 recombinant drugs that account for nearly 50 products. Among these, 22 companies have manufacturing facilities in India. The aim of the present study was to analyze the patenting trends, commercialization, and regulatory system for biopharmaceuticals in India. Representatives from 19 such biopharmaceutical companies were interviewed on aspects related to regulatory compliance, manufacturing, commercialization, and innovation in order to understand the challenges faced by them in the current regulatory and patent system. The study revealed that 94% of the companies have filed patents and 52% are developing new biologic entities in areas such as diabetes mellitus, cancer, and congestive heart diseases. Forty-two percent of the companies consider delays in regulatory approval to be a major constraint for biopharmaceutical industry development. Almost all are of the opinion that uniform guidelines across countries would help to prevent delays in the commercialization of products. A high proportion of representatives of the biopharmaceutical industry in India identified that elaboration of regulatory guidelines, defined submission requirements, and drug approval timelines are vital to the growth of the biopharmaceutical industry. © 2011 Adis Data Information BV. All rights reserved.

  8. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Science.gov (United States)

    2011-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j)...

  9. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian...

  10. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device...

  11. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Science.gov (United States)

    2011-12-20

    ... Drug Administration (FDA) is announcing the availability of the guidance entitled ``Enforcement Policy... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and...

  12. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Science.gov (United States)

    2013-06-17

    ... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood... for Industry and FDA Staff: ] Investigational New Drug Applications for Minimally Manipulated... Investigational New Drug Application (IND) for certain hematopoietic progenitor cells from...

  13. A validated RP-HPLC method for the determination of mosapride citrate in bulk drug samples and pharmaceutical formulations.

    Science.gov (United States)

    Krishnaiah, Y S R; Murthy, T K; Sankar, D G; Satyanarayana, V

    2002-12-01

    Mosapride citrate, a selective serotonin 5-HT4 agonist, is a novel and potent gastroprokinetic drug. So far no assay procedure has been reported for the estimation of this drug either in bulk drug samples, pharmaceutical formulations or in biological samples. A rapid and sensitive high-performance liquid chromatographic method was developed for the estimation of mosapride citrate in bulk drug samples and pharmaceutical dosage forms. Risperidone was used as an internal standard (ISD). A HPLC system consisting of gradient pump, reverse phase C-18 analytical column, a variable UV-visible detector set at 274 nm and an integrator was used. The mobile phase consisted of acetonitrile: 0.02 M potassium dihydrogen phosphate buffer (pH adjusted to 4.0 with o-phosphoric acid) in the ratio of 50:50 (v/v), and was pumped at 1 ml/min at 40 degrees C. The drug and ISD were eluted at 8.10 and 2.27 min, respectively. The peak drug/ISD area ratio versus drug concentration relationship was linear (r = 0.9998). The method was validated for its linearity, precision and accuracy. The calibration curve was linear in the range of 0.5 to 30 micrograms/ml. The lower detection limit was found to be 0.23 microgram/ml. The intra- and inter-day variation was found to be less than 1% showing high precision of the assay method. The mean recovery of the drug from the solutions containing 2, 4 or 10 micrograms/ml was 101.55 +/- 0.97% indicating high accuracy of the proposed HPLC method.

  14. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Science.gov (United States)

    2011-06-21

    ... HUMAN SERVICES Food and Drug Administration Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs and Devices and Additional Product Classification...(h) of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS....

  15. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  16. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Science.gov (United States)

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... provide recommendations to industry on the design of self- selection studies for nonprescription...

  17. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Complicated Intra-Abdominal... guidance for industry entitled ``Complicated Intra-Abdominal Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for...

  18. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  19. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  20. 77 FR 35689 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Science.gov (United States)

    2012-06-14

    ... Evaluation of Drugs for Treatment; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment...

  1. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Science.gov (United States)

    2013-02-26

    ..., Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators..., Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to... governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the...

  2. The role of modern biology and medicine in drug development in academia and industry.

    Science.gov (United States)

    Blake, Charles A; Barker, Kenneth L; Sobel, Burton E

    2006-12-01

    This symposium addresses careers in drug development in industry; the performance of translational research by academia, industry, and both; and numerous factors pertinent to alliances essential to drug discovery and development. Drug development is a complex process that regularly involves effective collaborations between academic and physician scientists and industry. There are specific occupational factors affecting recruitment of scientists and physicians in drug development programs in industry; ideal backgrounds for successful applicants for positions in industry in drug development; ethical and regulatory considerations particularly germane to the performance of scientists and physicians in drug development programs in industry and at universities; and particular gratifications available to scientists in industry working on drug development. Both similarities and differences characterize the performance of translational research in industry compared with academia. In industry, logistic, operational, and scientific oversight is complex, especially because it often involves relationships with clinical enterprises outside of the corporation. The process is long and arduous from formulation of a good idea in discovery to acceptance of a novel drug in the marketplace. Collaborations and partnerships by industry often involving academia and confrontation of multiple issues are pivotal.

  3. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Science.gov (United States)

    2013-09-20

    ... entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.'' Endocrine disruptors are... its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Endocrine...

  4. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Acute Bacterial Sinusitis... entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' This guidance addresses FDA's... an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes the...

  5. 76 FR 26307 - Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug...

    Science.gov (United States)

    2011-05-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Submission of Summary Bioequivalence Data for Abbreviated New...

  6. Determination of the antibiotic drug pefloxacin in bulk form, tablets and human serum using square wave cathodic adsorptive stripping voltammetry.

    Science.gov (United States)

    Beltagi, A M

    2003-04-10

    A simple, rapid, reliable and fully validated square wave cathodic adsorptive stripping voltammetric procedure has been developed for the determination of the antibiotic pefloxacin drug in bulk form, tablets and human serum, based on its electrochemical reduction at a hanging mercury drop electrode. The Britton-Robinson buffer of pH 7.0 was found to be reasonable as a supporting electrolyte for assay of the drug. Pefloxacin drug, at the optimized conditions, showed a single 2-electron well-defined peak at -1.07 V (versus Ag/AgCl/KCl(s)) using an accumulation potential of -0.40 V. This peak may be attributed to the reduction of the C=O group. A mean recovery of 99.54%+/-0.23 and a detection limit of 1.65 x 10(-10) M pefloxacin were achieved. After being validated, the proposed procedure was successfully applied for the determination of the drug in tablets and human serum with mean recoveries of 99.57+/-0.48 and 98.55+/-0.78%, respectively. A detection limit of 4.50 x 10(-10) M was achieved for the determination of the drug in human serum. Results of the proposed procedure were comparable with those obtained by reported methods.

  7. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  8. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for...

  9. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Science.gov (United States)

    2011-07-21

    ... HUMAN SERVICES Food and Drug Administration 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 Administration (FDA) is announcing the availability of the...

  10. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Science.gov (United States)

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance...

  11. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  12. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Science.gov (United States)

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  13. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Science.gov (United States)

    2012-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  14. Development and validation of a HPTLC method for estimation of duloxetine hydrochloride in bulk drug and in tablet dosage form

    Directory of Open Access Journals (Sweden)

    Dhaneshwar Suneela

    2008-01-01

    Full Text Available Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11±0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot, precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46-1.59%, accuracy (98.72±0.20 and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation.

  15. Extractive Spectrophotometric Methods for the Determination of Zolmitriptan in Bulk Drug and Pharmaceutical Formulation Using Bromocresol Green

    Science.gov (United States)

    Prashanth, K. N.; Swamy, N.; Basavaiah, K.

    2013-11-01

    Considering the basic property of zolmitriptan (ZMT) to generate ion-pairs with sulfonephthalein dyes two methods have been developed for its assay in bulk drug and dosage form. The first method (method A) is based on the formation of a colored ion-pair complex (1:1 drug:dye) of ZMT with bromocresol green (BCG) at pH 4.20 ± 0.01 and extraction of the complex into chloroform followed by measurement of the yellow ion-pair complex at 435 nm. In the second method (method B), the drug-dye ion-pair complex was treated with ethanolic potassium hydroxide in ethanolic medium and the resulting base form of the dye was measured at 630 nm. Beer's law was obeyed in the concentration range of 0.8-18.0 and 0.08-1.4 μg/ml for method A and B, respectively, and the corresponding molar absorptivity values were 1.50ṡ104 and 1.52ṡ105 l/(molṡcm). The Sandell sensitivity values were 0.0191 and 0.0019 μg/cm2 for method A and method B, respectively. The stoichiometry of the ion-pair complex formed between the drug and dye (1:1) was determined by Job's continuous variation method and the stability constant of the complex was also calculated. The proposed method was successfully extended to dosage form (tablets).

  16. Simultaneous Estimation of Fluoxetine HCl and Olanzapine in Bulk Drug and Pharmaceutical Formulation by Using UV-Visible Spectroscopy Method

    Directory of Open Access Journals (Sweden)

    Rubesh kumar S

    2011-01-01

    Full Text Available Present work is to carry out an analytical method development and validation of Fluoxetine HCl (FLU and Olanzapine (OLZ in bulk drug and pharmaceutical dosage form. The developed method is based upon simultaneous equations (Vierodt’s method by using UV/Visible spectroscopy. Both drugs come in the categories of anti- depressant and anti-psychotic agent. The developed method can be used for the simultaneous estimation of FLU and OLZ in pharmaceutical dosage form without separating from each other or from the excipients. Primarily the λ max of Fluoxetine HCl (FLU and Olanzapine (OLZ was determined as 226 and 258 nm respectively. The suggested method is validated by using ICH validation parameters like accuracy, precession, linearity and LOD and LOQ respectively. Accuracy study showed percentage recovery in the range of 97-102% w/w respectively. Precision studies were carried out for 6 successive absorbance and studied for their percentage relative standard deviation (%RSD was < 2%, LOD and LOQ was studied and the limit of detection and limit of quantification were found to be was 1-100 µg/ml for Olanzapine and Fluoxetine HCl, the slope of interception Y=0.23x6+0.054 (R2 0.993 and Y=0.222x6-0.014 (R 2 0.995 respectively. Relative standard deviation for Fluoxetine hydrochloride and Olanzapine were 0.4904 and 0.53969, the co-relation coefficient were 0.997 and 0.825 respectively. This procedure was applied successfully for the analysis of FLU and OLZ in bulk drug and Pharmaceutical preparations.

  17. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in... draft guidance entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of...

  18. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees...

  19. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size of Beads in Drug... industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides... guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft...

  20. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and... generic drugs to the public and reduce costs to industry, requires that generic drug facilities,...

  1. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Science.gov (United States)

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs for.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... guidance for industry entitled ``Influenza: Development of Drugs for Treatment and/or...

  2. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-09-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... a draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and... delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables...

  3. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  4. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Science.gov (United States)

    2013-09-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  5. HPTLC determination of artesunate as bulk drug and in pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    Agarwal S

    2007-01-01

    Full Text Available A new, simple, rapid, accurate and precise HPTLC method has been developed for the estimation of artesunate in bulk and pharmaceutical formulations. The study employs silica gel F 254 as stationary phase on aluminium foil and mobile phase comprising toluene: ethyl acetate: acetic acid (2:8:0.2. Vanillin (1% in sulphuric acid (5% in ethanolic solution gave prominent well-resolved pink colour spot for artesunate, which was stable for more than a day. The densitometric analysis was carried out in the absorbance mode at 520 nm and symmetrical, well-resolved, well-defined peaks were obtained. The Rf value for artesunate was found to be 0.44. The linear detector response for artesunate was observed between 100-600 ng per spot and the calibration plots showed good linear relationship with coefficient of regression, r= 0.9989 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 30 ng/spot and 90 ng/spot, respectively. The recovery study was carried out by standard addition method and the recovery was found to be 99.89±1.006. Recovery from tablets was 98.88 (±0.55 and from injection, it was 98.83 (±0.60 of the labeled amount.

  6. A Newly Improved Modified Method Development and Validation of Bromofenac Sodium Sesquihydrate in Bulk Drug Manufacturing

    Directory of Open Access Journals (Sweden)

    Sunil Kumar Yelamanchi V

    2016-10-01

    Full Text Available The main objective of this study was to develop a simple, efficient, specific, precise and accurate newly improved modified Reverse Phase High Performance Liquid Chromatographic Purity (or Related substance method for bromofenac sodium sesquihydrate active pharmaceuticals ingredient dosage form. Validation of analytical method is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled as per ICH, USP, BP or any other suitable regulatory guidelines. The Reverse Phase High Performance Liquid Chromatographic Gradient method was developed by utilizing Waters Symmetry C8, 150x4.6mm, 3.5µm on Waters 2487 series Liquid Chromatograph. The retention time of bromofenac sodium sesquihydrate was found to be 5.973minutes. Considering all the results of validation parameters simplicity of the method and the cost effectiveness of the overall procedure, it is possible to conclude that the developed method can be suitable for the regular quality control determination of bromofenac sodium sesquihydrate in bulk as well as pharmaceutical dosage form.The developed Reverse Phase High Performance Liquid Chromatographic Purity (or Related substance method for bromofenac sodium sesquihydrate active pharmaceuticals ingredient method was validated with respect to System Suitability , linearity, , precision ,Range, Ruggedness, Test Solution and Mobile phase stability ,Robustness..

  7. Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations

    Directory of Open Access Journals (Sweden)

    Zarna R. Dedania

    2011-01-01

    Full Text Available The objective of the current study was to develop a validated stability-indicating assay method (SIAM for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d. using a mobile phase containing methanol: acetonitrile (80 : 20, v/v at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be 3.35±0.01. The method was linear over the concentration range of 10–60 μg/mL(2=0.998 with a limit of detection and quantitation of 1.79 and 5.44 μg/mL, respectively. The method has the requisite accuracy, specificity, sensitivity, and precision to assay risperidone in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of Risperidone, and the assay is thus stability indicating.

  8. Stability-indicating high performance thin layer chromatography determination of Paroxetine hydrochloride in bulk drug and pharmaceutical formulations.

    Science.gov (United States)

    Venkatachalam, A; Chatterjee, Vidya S

    2007-08-29

    A simple selective precise and stability-indicating high performance thin layer chromatographic method of analysis of Paroxetine hydrochloride both as a bulk drug and in formulations was developed and validated. The method employed TLC (Thin Layer Chromatography) aluminum precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of butanol:acetic acid:water (8:2:0.5, v/v/v). This system was found to give compact spots for Paroxetine HCl (Rf, retardation factor, value-0.48+/-0.02). Paroxteine HCl was subjected to acid and alkali hydrolysis, oxidation and photodegradation, where the degraded product was well separated from the pure drug. Densitometric analysis of Paroxetine hydrochloride was carried out in the absorbance mode at 295 nm. The linear regression analysis data for the calibration spots showed good relationship with (regression) r2 = 0.9903 in the amount range of 300-1500 ng (nanogram) per spot. The mean value of co-relation co-efficient, slope and intercept were 0.9903+/-0.001, 5.38+/-0.058 and 182.5+/-2.16 respectively. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 50 and 150 ng, respectively. The drug does not undergo degradation with oxidation, but gets affected in acidic and alkaline conditions. The acid and alkali degradation showed extra peaks at 0.4 and 0.08 Rf, respectively. This indicates that the drug is susceptible to acidic and alkaline medium. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one.

  9. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses FDA's current......

  10. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Science.gov (United States)

    2011-07-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  11. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation);...

  12. 75 FR 70011 - Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug...

    Science.gov (United States)

    2010-11-16

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13; Availability AGENCY: Food and Drug...

  13. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... Doc No: 2011-30149] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in...: The Food and Drug Administration (FDA) is announcing the availability of draft guidance for...

  14. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Science.gov (United States)

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  15. Mathematical modeling of degradation for bulk-erosive polymers: applications in tissue engineering scaffolds and drug delivery systems.

    Science.gov (United States)

    Chen, Yuhang; Zhou, Shiwei; Li, Qing

    2011-03-01

    The degradation of polymeric biomaterials, which are widely exploited in tissue engineering and drug delivery systems, has drawn significant attention in recent years. This paper aims to develop a mathematical model that combines stochastic hydrolysis and mass transport to simulate the polymeric degradation and erosion process. The hydrolysis reaction is modeled in a discrete fashion by a fundamental stochastic process and an additional autocatalytic effect induced by the local carboxylic acid concentration in terms of the continuous diffusion equation. Illustrative examples of microparticles and tissue scaffolds demonstrate the applicability of the model. It is found that diffusive transport plays a critical role in determining the degradation pathway, whilst autocatalysis makes the degradation size dependent. The modeling results show good agreement with experimental data in the literature, in which the hydrolysis rate, polymer architecture and matrix size actually work together to determine the characteristics of the degradation and erosion processes of bulk-erosive polymer devices. The proposed degradation model exhibits great potential for the design optimization of drug carriers and tissue scaffolds.

  16. Stability Indicating HPLC Method for Estimation of S-amlodipine besylate and Nebivolol hydrochloride in Bulk Drugs and Marketed Formulation

    Directory of Open Access Journals (Sweden)

    G.V.S Kumar

    2012-10-01

    Full Text Available A simple, precise and stability indicating reversed phase liquid chromatographic method was developed and validated for estimation of s-amlodipine besylate and nebivolol hydrochloride in bulk drug and marketed formulation. The separation was achieved on Zorbax C8 G (250mm x 4.6mm, 5µm analytical column with mobile phase comprising of 0.05M Potassium di hydrogen phosphate: Acetonitrile (pH 3.0 (60:40v/v at isocratic flow of 1.0ml/min with UV detection at 269 nm. The retention times of s-amlodipine besylate and nebivolol hydrochloride was found to be 5.2 and 6.8 minutes respectively. The method was successfully validated in accordance to ICH guidelines for accuracy, precision, specificity, linearity, ruggedness and robustness. The linear regression analysis data for calibration plots showed good linear relationship in the concentration range 0.125-0.375μg/mL for s-amlodipine besylate and 0.25-0.75 for nebivolol hydrochloride. The drugs were exposed to acidic, basic, oxidation, thermal and photolytic stress degradation conditions. The resultant stressed samples were analyzed by the proposed method and was established to provide high resolution among the degradation products and the analytes. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time and the peak purity of analyte peaks in the stressed samples was confirmed by photodiode array detector. The method could effectively separate the drug from its degradation product; it can be employed as a stability- indicating one.

  17. Stability indicating RP-HPLC method for the estimation of Decitabine in bulk drug and lipid based Nanoparticles

    Directory of Open Access Journals (Sweden)

    Yub Raj Neupane

    2014-07-01

    Full Text Available The aim of our present work was to develop and validate a reverse phase high-performance liquid chromatography (RP-HPLC method for the determination of Decitabine (DCB. The developed method was further applied to observe the degradation of DCB under various stress conditions. Methods: Chromatographic separation was achieved on C18, 250 × 4.6 mm, particle size 5 μm, Agilent column, using ammonium acetate (0.01M as mobile phase with flow rate of 1mL/min and injection volume was 20 μL. Quantification was carried out with UV detector at 230 nm with a linear calibration curve in the concentration range of 10–100 μg/mL based on peak area. Thus, developed method was validated for linearity, accuracy, precision, and robustness. Results: Linearity was found to be in the range between 10–100 μg/mL with a significantly higher value of correlation coefficient r2 = 0.9994. The limits of detection (LOD and the limits of quantification (LOQ were found to be 1.92μg/mL and 5.82 μg/mL respectively. Moreover, validated method was applied to study the degradation profile of DCB under various stress degradation conditions. Examination of different stress conditions on degradation of DCB showed that its degradation was highly susceptible to oxidative condition as 31.24% of drug was degraded. In acidic and alkaline conditions, the drug was degraded by 21.03% and 12.16% respectively, while thermal and photolytic condition causes least degradation, i.e. 0.21% and 0.3% respectively. Conclusion: The proposed method was found to be sensitive, specific and was successfully applied for the estimation of DCB in bulk drug, and lipid based nanoparticles.

  18. Stability-Indicating RP-HPLC Method for Determination of Guanfacine Hydrochloride in Bulk Drugs and in Pharmaceutical Dosage Form

    Directory of Open Access Journals (Sweden)

    Vinod K. Ahirrao

    2011-04-01

    Full Text Available A novel stability-indicating RP-HPLC method was developed and validated for quantitative determination of guanfacine hydrochloride in bulk drug and in pharmaceutical dosage form. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using Apollo, C18 (250mm x 4.6mm, 5µm column with mobile phase of 50mM Ammonium acetate (volatile buffer and acetonitrile (65:35, v/v. UV detection has been done at wavelength 220 nm. The guanfacine hydrochloride was subjected to the stress conditions of hydrolysis (acid, base, oxidation, photolysis and thermal degradation. The stressed samples were analyzed by the proposed method. The analyte peak shape was excellent. The described method shows excellent linearity over a range of 30 – 450 µg/mL. The correlation coefficient for guanfacine hydrochloride was 0.999. The limit of detection for Guanfacine hydrochloride is 0.011 µg/mL and the limit of quantification is 0.038 µg/mL respectively.Degradation was observed for guanfacine hydrochloride in base, thermal and in 30% H2O2 conditions. The drug was found to be stable in the other stress conditions attempted. The degradation products were well resolved from main peak. The percentage recovery of guanfacine hydrochloride was ranged from (99.2% to 100.5% in pharmaceutical dosage form. The developed method was validated with respect to the linearity, accuracy (recovery, precision, specificity and robustness. The forced degradation studies prove the stability indicating power of the method.

  19. 77 FR 32124 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Science.gov (United States)

    2012-05-31

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Irritable Bowel Syndrome--Clinical.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... intended to assist the pharmaceutical industry and investigators who are developing drugs for the...

  20. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Science.gov (United States)

    2010-09-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Small Entities Compliance Guide... Animal Drugs for Minor Uses or Minor Species.'' This small entities compliance guide (SECG) aids industry... Animal Drugs for Minor Uses or Minor Species.'' This SECG aids industry in complying with...

  1. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Science.gov (United States)

    2011-09-27

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on User Fee Waivers, Reductions, and... industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This... a guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and...

  2. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Science.gov (United States)

    2012-04-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g... for single copies of the guidance document entitled ``Guidance for Industry and Food and...

  3. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Science.gov (United States)

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Expedited Programs for... guidance for industry entitled ``Expedited Programs for Serious Conditions--Drugs and Biologics.'' The... for industry entitled ``Expedited Programs for Serious Conditions--Drugs and Biologics.'' This...

  4. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  5. Adaptation of Color Reactions for Spectrophotometric Determination of Pitavastatin Calcium in Bulk Drugs and in Pharmaceutical Formulations

    Directory of Open Access Journals (Sweden)

    Marothu Vamsi Krishna

    2007-01-01

    Full Text Available Three simple, sensitive and cost effective Spectrophotometric methods are described for the determination of pitavastatin calcium (PST in bulk drugs and in pharmaceutical formulations. These methods are based on the oxidation of PST by ferric chloride in presence of o-phenanthroline (Method A or 2, 2’ bipyridyl (Method B or potassium ferricyanide (Method C. The colored complex formed was measured at 510, 530 and 755 nm for method A, B and C respectively against the reagent blank prepared in the same manner. The optimum experimental parameters for the color production are selected. Beer’s law is valid with in a concentration range of 4-20 μg mL-1 for method A, 7.5-37.5 μg mL-1 for method B and 5 -25 μg mL-1 for method C. For more accurate results, ringbom optimum concentration ranges are 5-18 μg mL-1 for method A , 8.5-35.5 μg mL-1 for method B and 6.0-23.0 μg mL-1 for method C. The molar absorptivities are 3.55x104, 2.10x104 and 3.10x104 L mol-1 cm-1. Where as sandell sensitivities are 0.024, 0.041 and 0.028 μg cm-22 for method A, B and C respectively. The mean percentage recoveries are 99.95 for method A, 101.35 for method B and 100.33 for method C. The developed methods were applied for the determination of PST in bulk powder and in the pharmaceutical formulations without any interference from tablet excipients.

  6. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Science.gov (United States)

    2011-06-22

    ... Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low... document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)...

  7. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ... INFORMATION: I. Background This draft guidance recommends studies for establishing the performance... Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the...

  8. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Science.gov (United States)

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION... industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

  9. 78 FR 63220 - Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for...

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs...

  10. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  11. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2012-02-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry...

  12. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... March 19, 2012 Part II Department of Health and Human Services Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls... SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...

  13. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  14. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Science.gov (United States)

    2013-05-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  15. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-21

    ... HUMAN SERVICES Food and Drug Administration (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  16. 75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-09-08

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  17. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-02

    ...; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Otitis... treatment of acute bacterial otitis media (ABOM). This guidance finalizes the revised draft guidance of the...

  18. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective.

    Science.gov (United States)

    Jones, H M; Chen, Y; Gibson, C; Heimbach, T; Parrott, N; Peters, S A; Snoeys, J; Upreti, V V; Zheng, M; Hall, S D

    2015-03-01

    The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. In this study, we provide a cross pharmaceutical industry position on "how PBPK modeling can be applied in industry" focusing on the strategies for application of PBPK at different stages, an associated perspective on the confidence and challenges, as well as guidance on interacting with regulatory agencies and internal best practices.

  19. Co-operation between patient organisations and the drug industry in Finland.

    Science.gov (United States)

    Hemminki, Elina; Toiviainen, Hanna K; Vuorenkoski, Lauri

    2010-04-01

    The aim of the study was to investigate the co-operation between patient organizations and the drug industry in Finland prior to critical discussions on the topic. The data were gathered by a questionnaire survey of 85 patient organisations (response rate 65%, n = 55) and 20 drug firms (response rate 100%) in 2003, and by interviewing 13 organisations and surveying their web-pages and other documents in 2004. In the surveys, half of the patient organisations and 80% of the drug firms considered co-operation important. Most (71%) organisations reported financial support from the drug industry. Most organisations and drug firms had experienced problems. Common problems for organisations were too little or too unpredictable support from industry, and threats to independence and objectivity. Drug firms frequently mentioned unclear rules of co-operation. The patient organisation interviews exhibited similar themes and findings to those found in the surveys, revealing the complexity and importance of co-operation in organisation activities, and the variation between organisations. This case study from Finland showed that co-operation between patient organizations and the drug industry was common, many-sided and not usually transparent. The close connections between patient organizations and commercial companies, particularly drug firms, raise several policy issues and the need for action.

  20. Identification, characterization and HPLC quantification of process-related impurities in Trelagliptin succinate bulk drug: Six identified as new compounds.

    Science.gov (United States)

    Zhang, Hui; Sun, Lili; Zou, Liang; Hui, Wenkai; Liu, Lei; Zou, Qiaogen; Ouyang, Pingkai

    2016-09-05

    A sensitive, selective and stability indicating reversed-phase LC method was developed for the determination of process related impurities of Trelagliptin succinate in bulk drug. Six impurities were identified by LC-MS. Further, their structures were characterized and confirmed utilizing LC-MS/MS, IR and NMR spectral data. The most probable mechanisms for the formation of these impurities were also discussed. To the best of our knowledge, six structures among these impurities are new compounds and have not been reported previously. The superior separation was achieved on an InertSustain C18 (250mm×4.6mm, 5μm) column in a gradient mixture of acetonitrile and 20mmol potassium dihydrogen phosphate with 0.25% triethylamine (pH adjusted to 3.5 with phosphate acid). The method was validated as per regulatory guidelines to demonstrate system suitability, specificity, sensitivity, linearity, robustness, and stability. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations.

    Science.gov (United States)

    Rao, R Nageswara; Guru Prasad, K; Gangu Naidu, Ch; Maurya, Pawan K

    2011-11-01

    A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250 × 4.6 mm, 5 μm), using 20 mM ammonium acetate containing 0.1% (v/v) triethylamine (pH adjusted to 3.0 with trifluoroacetic acid) and acetonitrile as mobile phase at 25°C. The detection was performed at 254 nm. The method was validated and found to be robust, precise, specific and linear between 0.37 and 500 μg/mL. The limits of detection and quantification of telmisartan were 0.11 and 0.37 μg/mL, respectively. The method was successfully applied to quantify related substances and assay of TLM in bulk drugs and commercial tablets. The related substances relate to a novel synthetic route and different from those A-H impurities reported by European Pharmacopeia.

  2. Determination of the main solid-state form of albendazole in bulk drug, employing Raman spectroscopy coupled to multivariate analysis.

    Science.gov (United States)

    Calvo, Natalia L; Arias, Juan M; Altabef, Aída Ben; Maggio, Rubén M; Kaufman, Teodoro S

    2016-09-10

    Albendazole (ALB) is a broad-spectrum anthelmintic, which exhibits two solid-state forms (Forms I and II). The Form I is the metastable crystal at room temperature, while Form II is the stable one. Because the drug has poor aqueous solubility and Form II is less soluble than Form I, it is desirable to have a method to assess the solid-state form of the drug employed for manufacturing purposes. Therefore, a Partial Least Squares (PLS) model was developed for the determination of Form I of ALB in its mixtures with Form II. For model development, both solid-state forms of ALB were prepared and characterized by microscopic (optical and with normal and polarized light), thermal (DSC) and spectroscopic (ATR-FTIR, Raman) techniques. Mixtures of solids in different ratios were prepared by weighing and mechanical mixing of the components. Their Raman spectra were acquired, and subjected to peak smoothing, normalization, standard normal variate correction and de-trending, before performing the PLS calculations. The optimal spectral region (1396-1280cm(-1)) and number of latent variables (LV=3) were obtained employing a moving window of variable size strategy. The method was internally validated by means of the leave one out procedure, providing satisfactory statistics (r(2)=0.9729 and RMSD=5.6%) and figures of merit (LOD=9.4% and MDDC=1.4). Furthermore, the method's performance was also evaluated by analysis of two validation sets. Validation set I was used for assessment of linearity and range and Validation set II, to demonstrate accuracy and precision (Recovery=101.4% and RSD=2.8%). Additionally, a third set of spiked commercial samples was evaluated, exhibiting excellent recoveries (94.2±6.4%). The results suggest that the combination of Raman spectroscopy with multivariate analysis could be applied to the assessment of the main crystal form and its quantitation in samples of ALB bulk drug, in the routine quality control laboratory. Copyright © 2016 Elsevier B.V. All

  3. Toward allocative efficiency in the prescription drug industry.

    Science.gov (United States)

    Guell, R C; Fischbaum, M

    1995-01-01

    Traditionally, monopoly power in the pharmaceutical industry has been measured by profits. An alternative method estimates the deadweight loss of consumer surplus associated with the exercise of monopoly power. Although upper and lower bound estimates for this inefficiency are far apart, they at least suggest a dramatically greater welfare loss than measures of industry profitability would imply. A proposed system would have the U.S. government employing its power of eminent domain to "take" and distribute pharmaceutical patents, providing as "just compensation" the present value of the patent's expected future monopoly profits. Given the allocative inefficiency of raising taxes to pay for the program, the impact of the proposal on allocative efficiency would be at least as good at our lower bound estimate of monopoly costs while substantially improving efficiency at or near our upper bound estimate.

  4. Drug-drug interactions related to altered absorption and plasma protein binding: theoretical and regulatory considerations, and an industry perspective.

    Science.gov (United States)

    Hochman, Jerome; Tang, Cuyue; Prueksaritanont, Thomayant

    2015-03-01

    Drug-drug interactions (DDIs) related to altered drug absorption and plasma protein binding have received much less attention from regulatory agencies relative to DDIs mediated via drug metabolizing enzymes and transporters. In this review, a number of theoretical bases and regulatory framework are presented for these DDI aspects. Also presented is an industry perspective on how to approach these issues in support of drug development. Overall, with the exception of highly permeable and highly soluble (BCS 1) drugs, DDIs related to drug-induced changes in gastrointestinal (GI) physiology can be substantial, thus warranting more attentions. For a better understanding of absorption-associated DDI potential in a clinical setting, mechanistic studies should be conducted based on holistic integration of the pharmaceutical profiles (e.g., pH-dependent solubility) and pharmacological properties (e.g., GI physiology and therapeutic margin) of drug candidates. Although majority of DDI events related to altered plasma protein binding are not expected to be of clinical significance, exceptions exist for a subset of compounds with certain pharmacokinetic and pharmacological properties. Knowledge of the identity of binding proteins and the binding extent in various clinical setting (including disease states) can be valuable in aiding clinical DDI data interpretations, and ensuring safe and effective use of new drugs.

  5. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire...

  6. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is... Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903...

  7. A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations

    Directory of Open Access Journals (Sweden)

    Saurabh Pandey

    2013-03-01

    Full Text Available A stability-indicating high-performance liquid chromatographic (HPLC method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999, recovery (97.9-103%, LOD (0.043-0.047 µgmL-1, LOQ (0.13-0.14 µgmL-1 and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic, oxidative and under photolytic stress conditions. The drug was stable to alkaline and dry heat conditions. This method has been successively applied to pharmaceutical formulation and no interference from the excipients was found.Desenvolveu-se método indicador de estabilidade por Cromatografia a Líquido de Alta Eficiência (CLAE com pequeno tempo de corrida e validado para o ensaio de impurezas relacionadas ao processo de produção de pantoprazol em batelada. A determinação do fármaco, de suas impurezas potenciais e dos produtos de degradação foi realizada com coluna de ODS Hypersil, utilizando gradiente com tampão de fosfato 0,01 M pH 7 e acetonitrila como eluente, no comprimento de onda de detecção de 290 nm. A velocidade de fluxo foi fixada em 1 mLmin-1. O procedimento se mostrou específico, linear (r=0,999, com recuperação (97,9-103%, LOD (0,043-0,047 µgmL-1, LOQ (0,13-0,14 µg mL-1 e robusto. Robustez aceitável indica que o método de ensaio não é afetado por variações pequenas, exceto as planejadas. O pantoprazole degradou em condições ácidas, oxidativas e sob condições de estresse fotolítico. O fármaco foi estável em condições alcalinas e de calor seco. Este m

  8. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Science.gov (United States)

    2013-04-17

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A... announcing the availability of a guidance for industry entitled ``Non-Penicillin Beta- Lactam Drugs: A CGMP... (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the relative...

  9. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Science.gov (United States)

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration... a revised draft guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for...

  10. The road for nanomaterials industry: a review of carbon nanotube production, post-treatment, and bulk applications for composites and energy storage.

    Science.gov (United States)

    Zhang, Qiang; Huang, Jia-Qi; Qian, Wei-Zhong; Zhang, Ying-Ying; Wei, Fei

    2013-04-22

    The innovation on the low dimensional nanomaterials brings the rapid growth of nano community. Developing the controllable production and commercial applications of nanomaterials for sustainable society is highly concerned. Herein, carbon nanotubes (CNTs) with sp(2) carbon bonding, excellent mechanical, electrical, thermal, as well as transport properties are selected as model nanomaterials to demonstrate the road of nanomaterials towards industry. The engineering principles of the mass production and recent progress in the area of CNT purification and dispersion are described, as well as its bulk application for nanocomposites and energy storage. The environmental, health, and safety considerations of CNTs, and recent progress in CNT commercialization are also included. With the effort from the CNT industry during the past 10 years, the price of multi-walled CNTs have decreased from 45 000 to 100 $ kg(-1) and the productivity increased to several hundred tons per year for commercial applications in Li ion battery and nanocomposites. When the prices of CNTs decrease to 10 $ kg(-1) , their applications as composites and conductive fillers at a million ton scale can be anticipated, replacing conventional carbon black fillers. Compared with traditional bulk chemicals, the controllable synthesis and applications of CNTs on a million ton scale are still far from being achieved due to the challenges in production, purification, dispersion, and commercial application. The basic knowledge of growth mechanisms, efficient and controllable routes for CNT production, the environmental and safety issues, and the commercialization models are still inadequate. The gap between the basic scientific research and industrial development should be bridged by multidisciplinary research for the rapid growth of CNT nano-industry.

  11. Petroleum Refining, Industrial Chemical, Drug, and Paper and Allied Products Industries. Reprinted from the Occupational Outlook Handbook, 1978-79 Edition.

    Science.gov (United States)

    Bureau of Labor Statistics (DOL), Washington, DC.

    Focusing on occupations in refining and industrial chemical, drug, and paper manufacturing industries, this document is one in a series of forty-one reprints from the Occupational Outlook Handbook providing current information and employment projections for individual occupations and industries through 1985. The specific occupations covered in…

  12. Regulating drug information in Europe: a pyrrhic victory for pharmaceutical industry critics?

    Science.gov (United States)

    Mulinari, Shai

    2013-06-01

    Informed by recent sociological debates on pharmaceuticalisation, this article examines the evolution of the current EU legal proposal on prescription drug information to patients, as well as the surrounding controversies. In 2008 the European Commission proposed the relaxation of the existing rules governing drug information provision to patients by the pharmaceutical industry. Critics of the industry's influence over health policy and markets, including consumer organisations, industry-independent patient organisations and health professionals, rejected the Commission's proposal, claiming that the industry cannot be considered a reliable source of patient information due to inherent financial conflicts of interest. Since these critics were at least partially successful in rallying opinion against the Commission proposal, they functioned as countervailing forces to promotion-driven pharmaceuticalisation. Even so, as a watered-down version of the proposal moved through the European Parliament it was further modified to ultimately resemble the Swedish system that was held up as a high-quality example of industry-based information provision. Yet this article contends that the Swedish system displays evidence of corporate bias. Significantly, basing EU policy on a drug information system not resistant to corporate bias risks creating practices that violate the legally mandated mission of EU drug regulation, which is to 'promote and protect public health'.

  13. [PHARMACEUTICAL INDUSTRY AND PERSONALIZED MEDICINE: A PARADIGM SHIFT IN THE DEVELOPMENT OF NEW DRUGS].

    Science.gov (United States)

    Scheen, A J

    2015-01-01

    The cost of pharmacotherapy is increasing in the health care budget. The pharmaceutical industry is facing the exhaustion of medications that are largely prescribed and have a high profitability (blockbusters). Because of patient heterogeneity, there is a great interindividual variability of the responses to drug therapy. Thus, it is essential to better detect potential to avoid waste of resources resulting from the prescription of expensive drugs to poor responders. The development of personalized medicine, or precision medicine, certainly offers opportunities to the pharmaceutical industry, but also exposes it to new big challenges.

  14. Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

    Energy Technology Data Exchange (ETDEWEB)

    Radford, L.R.; Rankin, W.L.; Barnes, V.; McGuire, M.V.; Hope, A.M.

    1983-07-01

    This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclear utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.

  15. Barriers to Alzheimer disease drug discovery and development in the biotechnology industry.

    Science.gov (United States)

    Altstiel, L D

    2002-01-01

    The major barrier to Alzheimer disease (AD) drug discovery and development in the biotechnology industry is scale. Most biotechnology companies do not have the personnel or expertise to carry a drug from the bench to the market. Much effort in the industry has been directed toward the elucidation of molecular mechanisms of AD and the identification of new targets. Advances in biotechnology have generated new insights into disease mechanisms, increased the number of lead compounds, and accelerated biologic screening. The majority of costs associated with drug development are in clinical testing and development activities, many of which are driven by regulatory issues. For most biotechnology companies, the costs of such trials and the infrastructure necessary to support them are prohibitive. Another significant barrier is the definition of therapeutic benefit for AD drugs; Food and Drug Administration (FDA) precedent has established that a drug must show superiority to placebo on a performance-based test of cognition and a measure of global clinical function. This restrictive definition is biased toward drugs that enhance performance on memory-based tests. Newer AD drugs are targeted toward slowing disease progression; however, there is currently no accepted definition of what constitutes efficacy in disease progression. Despite these obstacles, the biotechnology industry has much to offer AD drug discovery and development. Biotechnology firms have already developed essential technology for AD drug development and will continue to do so. Biotechnology companies can move more quickly; of course, the trick is to move quickly in the right direction. Speed may offset some of the problems associated with lack of scale. Additionally, biotechnology companies can afford to address markets that may be too restricted for larger pharmaceutical companies. This advantage will have increasing importance, as therapies are developed to address subtypes of AD.

  16. The Politics of Access to Expensive Drugs: INESSS and the Innovative Pharmaceutical Industry

    OpenAIRE

    Hughes, David

    2012-01-01

    The innovative pharmaceutical industry employs thousands of people in Quebec and so has the ability to exert strong political pressure; the public statements of Sanofi-Aventis concerning the provincial reimbursement of certain expensive drugs are an example. “Maintaining a dynamic biopharmaceutical industry” is one of four main axes of the drug policy of Quebec's ministry of health. However, this role of government should not take precedence over the efficient and equitable management of heal...

  17. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Science.gov (United States)

    2011-04-13

    ... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  18. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  19. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  20. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  1. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Science.gov (United States)

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  2. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Science.gov (United States)

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  3. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Science.gov (United States)

    2010-09-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  4. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Science.gov (United States)

    2013-03-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... efficiency of the review process. This draft guidance is not final nor is it in effect at this time....

  5. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  6. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  7. Trends in the organization of drug research : Interfacing industry and universities

    NARCIS (Netherlands)

    Meijer, D.K F; Wilting, J

    1997-01-01

    This article shortly describes some of the current social, political and scientific developments that are considered to be of relevance for the future organization of drug research in Europe. Attention is paid to the social-political changes that affect the academic and industrial research teams. Th

  8. Trends in the organization of drug research : Interfacing industry and universities

    NARCIS (Netherlands)

    Meijer, D.K F; Wilting, J

    This article shortly describes some of the current social, political and scientific developments that are considered to be of relevance for the future organization of drug research in Europe. Attention is paid to the social-political changes that affect the academic and industrial research teams.

  9. Protein crystallography and drug discovery: recollections of knowledge exchange between academia and industry

    Directory of Open Access Journals (Sweden)

    Tom L. Blundell

    2017-07-01

    Full Text Available The development of structure-guided drug discovery is a story of knowledge exchange where new ideas originate from all parts of the research ecosystem. Dorothy Crowfoot Hodgkin obtained insulin from Boots Pure Drug Company in the 1930s and insulin crystallization was optimized in the company Novo in the 1950s, allowing the structure to be determined at Oxford University. The structure of renin was developed in academia, on this occasion in London, in response to a need to develop antihypertensives in pharma. The idea of a dimeric aspartic protease came from an international academic team and was discovered in HIV; it eventually led to new HIV antivirals being developed in industry. Structure-guided fragment-based discovery was developed in large pharma and biotechs, but has been exploited in academia for the development of new inhibitors targeting protein–protein interactions and also antimicrobials to combat mycobacterial infections such as tuberculosis. These observations provide a strong argument against the so-called `linear model', where ideas flow only in one direction from academic institutions to industry. Structure-guided drug discovery is a story of applications of protein crystallography and knowledge exhange between academia and industry that has led to new drug approvals for cancer and other common medical conditions by the Food and Drug Administration in the USA, as well as hope for the treatment of rare genetic diseases and infectious diseases that are a particular challenge in the developing world.

  10. Innovator Organizations in New Drug Development: Assessing the Sustainability of the Biopharmaceutical Industry.

    Science.gov (United States)

    Kinch, Michael S; Moore, Ryan

    2016-06-23

    The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise.

  11. Applying green analytical chemistry for rapid analysis of drugs: Adding health to pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Nazrul Haq

    2017-02-01

    Full Text Available Green RP-HPLC method for a rapid analysis of olmesartan medoxomil (OLM in bulk drugs, self-microemulsifying drug delivery system (SMEDDS and marketed tablets was developed and validated in the present investigation. The chromatographic identification was achieved on Lichrosphere 250 × 4.0 mm RP C8 column having a 5 μm packing as a stationary phase using a combination of green solvents ethyl acetate:ethanol (50:50% v/v as a mobile phase, at a flow rate of 1.0 mL/min with UV detection at 250 nm. The proposed method was validated for linearity, selectivity, accuracy, precision, reproducibility, robustness, sensitivity and specificity. The utility of the proposed method was verified by an assay of OLM in SMEDDS and commercial tablets. The proposed method was found to be selective, precise, reproducible, accurate, robust, sensitive and specific. The amount of OLM in SMEDDS and commercial tablets was found to be 101.25% and 98.67% respectively. The proposed method successfully resolved OLM peak in the presence of its degradation products which indicated stability-indicating property of the proposed method. These results indicated that the proposed method can be successfully employed for a routine analysis of OLM in bulk drugs and commercial formulations.

  12. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2011-08-17

    ... document. Submit electronic comments on the guidance to http://www.regulations.gov . Submit written... impact the products' quality, efficacy, and safety (including abuse potential). Consequently, it is... document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm...

  13. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Science.gov (United States)

    2013-02-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Alzheimer's Disease... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that occur...

  14. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Science.gov (United States)

    2013-11-14

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and...

  15. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    OpenAIRE

    Garth Boehm; Lixin Yao; Liang Han; Qiang Zheng

    2013-01-01

    The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the ...

  16. Oversight of marketing relationships between physicians and the drug and device industry: a comparative study.

    Science.gov (United States)

    Jost, Timothy Stoltzfus

    2010-01-01

    Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This article focuses on one particular aspect of these relationships-payments made by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond to these relationships. Finally, it proposes an approach that would comprehensively address the problems caused by drug and device company marketing to physicians.

  17. 海布胶囊原料药稳定性实验研究%Stability Investigation of Bulk Drug in Haibu Capsule

    Institute of Scientific and Technical Information of China (English)

    王喜斌; 左红香; 王曼力; 黄耀林; 刘庆波; 孙亚楠

    2015-01-01

    目的:考察海布胶囊原料药的稳定性.方法按药物稳定性实验指导原则进行影响因素实验、加速实验和长期实验.结果海布胶囊原料药在实验前后的外观、鉴别、吸湿性、微生物限度检查等均符合规定,实验前后比较差异无统计学意义(P<0.05).结论海布胶囊于室温条件下保存质量稳定,有效期可达2 a.%Objective The stability of bulk drug in Haibu capsule was investigated. Method Stress test, accelerated test and long-term test were carried out according to the principles referring to the drug stability. Results The quality of the principal agent in Haibu capsule, including appearance, identification, moisture absorption and microorganism limitation, accorded with regulation after the stability tests, and no statistical difference was detected ( P<0 . 05 ) . Conclusion The bulk drug can maintain its stability and feasibility for 2 years at room temperature.

  18. In silico screening of drug-membrane thermodynamics reveals linear relations between bulk partitioning and the potential of mean force

    Science.gov (United States)

    Menichetti, Roberto; Kanekal, Kiran H.; Kremer, Kurt; Bereau, Tristan

    2017-09-01

    The partitioning of small molecules in cell membranes—a key parameter for pharmaceutical applications—typically relies on experimentally available bulk partitioning coefficients. Computer simulations provide a structural resolution of the insertion thermodynamics via the potential of mean force but require significant sampling at the atomistic level. Here, we introduce high-throughput coarse-grained molecular dynamics simulations to screen thermodynamic properties. This application of physics-based models in a large-scale study of small molecules establishes linear relationships between partitioning coefficients and key features of the potential of mean force. This allows us to predict the structure of the insertion from bulk experimental measurements for more than 400 000 compounds. The potential of mean force hereby becomes an easily accessible quantity—already recognized for its high predictability of certain properties, e.g., passive permeation. Further, we demonstrate how coarse graining helps reduce the size of chemical space, enabling a hierarchical approach to screening small molecules.

  19. Nanotechnology-based drug delivery systems for Alzheimer's disease management: Technical, industrial, and clinical challenges.

    Science.gov (United States)

    Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management.

  20. Liquid chromatographic method for the simultaneous determination of captopril, piroxicam, and amlodipine in bulk drug, pharmaceutical formulation, and human serum by programming the detector.

    Science.gov (United States)

    Sultana, Najma; Arayne, M Saeed; Ali, Saeeda Nadir

    2013-10-01

    A highly sensitive LC method with UV detection has been developed for the simultaneous determination of coadministered drugs captopril, piroxicam, and amlodipine in bulk drug, pharmaceutical formulations, and human serum at the isosbestic point (235 nm) and at individual λmax (220, 255, and 238 nm, respectively) by programming the detector with time to match the individual analyte's chromophore, which enhanced the sensitivity with linear range. The assay involved an isocratic elution of analytes on a Bondapak C18 (10 μm, 25 × 0.46 cm) column at ambient temperature using a mobile phase of methanol/water 80:20 at pH 2.9 and a flow rate of 1.0 mL/min. Linearity was found to be 0.25-25, 0.10-6.0, and 0.20-13.0 μg/mL with correlation coefficient >0.998 and detection limits of 7.39, 3.90, and 9.38 ng/mL, respectively, whereas calibration curves for wavelength-programmed analysis were 0.10-6.0, 0.04-2.56, and 0.10-10.0 μg/mL with correlation coefficient >0.998 and detection limits of 5.79, 2.68, and 3.87 ng/mL, respectively. All the validated parameters were in the acceptable range. The recovery of drugs was 99.32-100.39 and 98.65-101.96% in pharmaceutical formulation and human serum, respectively, at the isosbestic point and at individual λmax . This method is applicable for the analysis of drugs in bulk drug, tablets, serum, and in clinical samples without interference of excipients or endogenous serum components.

  1. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

    Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

  2. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... current thinking on adaptive design clinical trials for drugs and biologics. It does not create or confer... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides...

  3. 75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

    Science.gov (United States)

    2010-03-29

    ... Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability AGENCY... to the Division of Docket Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm... availability of a guidance for industry entitled ``Standards for Securing the Drug Supply...

  4. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Science.gov (United States)

    2011-06-22

    ... and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design;...

  5. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Science.gov (United States)

    2012-02-13

    ... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the... crude heparin contaminants and to recommend strategies to ensure that the heparin supply chain is not... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Heparin for Drug and...

  6. 76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

    Science.gov (United States)

    2011-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Dosage Delivery Devices for Orally... entitled ``Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products.'' This document is... over-the-counter (OTC) liquid drug products packaged with dosage delivery devices (e.g.,...

  7. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-05-18

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  8. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-08-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  9. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS....

  10. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use;...

  11. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  12. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  13. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-17

    ... wound therapy into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for...

  14. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and...

  15. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use;...

  16. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  17. Development and validation of a reversed-phase HPLC method for separation and simultaneous determination of process-related substances of mirtazapine in bulk drugs and formulations.

    Science.gov (United States)

    Rao, R Nageswara; Raju, A Narasa

    2009-03-01

    A simple and rapid reversed-phase high-performance liquid chromatographic method has been developed for the separation and simultaneous determination of related substances of mirtazapine in bulk drugs and pharmaceutical formulations. Six impurities, including one degradation product of mirtazapine, have been separated on a BDS Hypersil (4.6 x 250 mm; particle size 5 microm) column with a mobile phase consisting of 0.3% triethylamine (pH 3.0)-acetonitrile (78:22 v/v) eluted in an isocratic mode and monitored with a photo diode array detector at 215 nm. The chromatographic behavior of all the analytes was studied under variable compositions of different solvent systems, temperatures, buffer concentrations, and pH values. The method was validated in terms of accuracy, precision, and linearity. The inter- and intra-day assay precision was found to be method was successfully applied to the analysis of commercial formulations and the recoveries of mirtazapine were in the range of 99.38-100.73% with method is useful not only for rapid evaluation of the purity of mirtazapine, but also for the simultaneous determination of related substances in bulk drugs and pharmaceutical formulations.

  18. Analytical tools for determination of new oral antidiabetic drugs, glitazones, gliptins, gliflozins and glinides, in bulk materials, pharmaceuticals and biological samples

    Directory of Open Access Journals (Sweden)

    Gumieniczek Anna

    2016-01-01

    Full Text Available The review presents analytical methods for determination of new oral drugs for the treatment of type 2 diabetes mellitus (T2DM, focusing on peroxisome proliferator-activated receptor gamma agonists (glitazones, dipeptidyl peptidase 4 inhibitors (gliptins and sodium/glucose co-transporter 2 inhibitors (gliflozins. Drugs derived from prandial glucose regulators, such as glinides, are considered because they are present in some new therapeutic options. The review presents analytical procedures suitable for determination of the drugs in bulk substances, such as pharmaceuticals and biological samples, including HPLC-UV, HPLC/LC-MS, TLC/HPTLC, CE/CE-MS, spectrophotometric (UV/VIS, spectrofluorimetric and electrochemical methods, taken from the literature over the past ten years (2006-2016. Some new procedures for extraction, separation and detection of the drugs, including solid phase extraction with molecularly imprinted polymers (SPE-MIP, liquid phase microextraction using porous hollow fibers (HP-LPME, HILIC chromatography, micellar mobile phases, ion mobility spectrometry (IMS and isotopically labeled internal standards, are discussed.

  19. A validated stability-indicating normal phase LC method for clopidogrel bisulfate and its impurities in bulk drug and pharmaceutical dosage form.

    Science.gov (United States)

    Durga Rao, Dantu; Kalyanaraman, L; Sait, Shakil S; Venkata Rao, P

    2010-05-01

    A novel stability-indicating normal phase liquid chromatographic (NP-LC) method was developed for the determination of purity of clopidogrel drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of clopidogrel along with the chiral impurities. This method can be also be used for the estimation of assay of clopidogrel in drug substance as well as in drug product. The method was developed using Chiralcel OJ-H (250mmx4.6mm, 5microm) column. n-Hexane, ethanol and diethyl amine in 95:5:0.05 (v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 240nm. Clopidogrel bisulfate was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.

  20. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review

    DEFF Research Database (Denmark)

    Jørgensen, Anders W; Hilden, Jørgen; Gøtzsche, Peter C

    2006-01-01

    OBJECTIVE: To compare the methodological quality and conclusions in Cochrane reviews with those in industry supported meta-analyses and other meta-analyses of the same drugs. DESIGN: Systematic review comparing pairs of meta-analyses that studied the same two drugs in the same disease and were...... reviews had a meta-analysis that compared two drugs. Twenty four meta-analyses that matched the Cochrane reviews were found: eight were industry supported, nine had undeclared support, and seven had no support or were supported by non-industry sources. On a 0-7 scale, the median quality score was 7...... patients or studies. The seven industry supported reviews that had conclusions recommended the experimental drug without reservations, compared with none of the Cochrane reviews (P = 0.02), although the estimated treatment effect was similar on average (z = 0.46, P = 0.64). Reviews with undeclared support...

  1. BULK AND SURFACE PROPERTIES OF TIN BASED HERBAL DRUG DURING ITS PREPARATION: FINGERPRINTING OF THE ACTIVE PHARMACEUTICAL CONSTITUENT

    Directory of Open Access Journals (Sweden)

    Asit Baran Mandal et al.

    2012-04-01

    Full Text Available The Tin based herbal drug (Vangaparpam - a Siddha system of Medicine has been widely used for the treatment of urinogenital infection and Arthritis. It was prepared by ten sequential stages of calcinations of the medicinally purified tin along with Aloe vera extract. In this study we analysed samples from various stages of preparation using analytical techniques viz., Fourier Transformed Infrared spectroscopy, Powder X ray Diffraction, X ray Photoelectron Spectroscopy, Energy Dispersive X- ray spectroscopy , Scanning Electron Microscopy, to create fingerprints required for the optimisation of the process parameters, detection of toxic impurities and crystal morphology of the Active Pharmaceutical ingredient during the formulation of drug for which reports are not available. Upon analysis of the samples of various stages of calcinations, we found that there was a programmed heating the medicinally purified tin metal was converted to crystalline tin oxide in the tetragonal phase at the first stage of calcinations itself along with a small percentage of therapeutically important elements of Calcium, Iron, and Potassium. Further calcinations steps brought interplay of nano and sub-micro sized particles for optimum bioavailability of the drug.

  2. 氟康唑原料药有关物质的研究%Determination of Related Substances in Fluconazole Bulk Drug

    Institute of Scientific and Technical Information of China (English)

    严小红; 李春盈; 陈安丽; 江英桥; 霍秀敏; 邵颖

    2012-01-01

    目的 建立高效液相色谱梯度法测定氟康唑原料药的有关物质.方法 采用十八烷基硅烷键合硅胶为填充剂,流动相A为0.01 mol · L-1甲酸铵,流动相B为乙腈,梯度洗脱,流速为0.5 mL·min-1,检测波长为261 nm,进样量为20 μL.结果 降解产物和杂质在该色谱条件分离良好,氟康唑与杂质B~D在2.632~21.06、2.688 ~ 53.76、0.853 6 ~ 21.34、2.595 ~20.76μg·mL-1之间线性关系良好,检测限分别为0.20、0.005 2、0.0073、0.13 μg·mL-1,对来自9个厂家17批氟康唑原料药(含国外5批)进行了测定,各杂质能有效检出.结论 该方法简便、快速、灵敏、准确,可用于测定氟康唑原料药的有关物质.%OBJECTIVE To establish an HPLC gradient elution method for the determination of related substances in fluconazole bulk drug. METHODS The separation was achieved by using an ODS column with gradient elution of mobile phase composed of 0. 01 mol·L-1 ammonium formate and acetonitrile. The flow rate was 0.5 mL·min-1. The UV detection wavelength was 261 nm,injection volume is 20 μL. RESULTS Fluconazole and its related substances can be separated effectively by this method, linear relation of fluconazole and impurity B - D were good, the detection limit were 0. 20, 0. 005 2, 0. 007 3, 0. 13 μg·mL-1, seventeen batches sample from nine manufacturers were determined. The related substances in fluconazole bulk drug were effectively determined. CONCLUSION The HPLC method is rapid and accurate which may be used for the inspection of related substances in fluconazole bulk drug.

  3. Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.

    Science.gov (United States)

    Cosgrove, Lisa; Vannoy, Steven; Mintzes, Barbara; Shaughnessy, Allen F

    2016-01-01

    The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.

  4. A validated sensitive liquid chromatographic method for the estimation of Sumatriptan succinate in bulk drug and tablet dosage form

    Directory of Open Access Journals (Sweden)

    Lokesh Singh

    2011-01-01

    Full Text Available Aim: The present study was undertaken to develop a validated, sensitive, rapid, simple and economic an isocratic HPLC method for estimating Sumatriptan succinate in tablet dosage form. Materials and Methods: Normal phase chromatographic analysis was performed on an Ascentis® Si HPLC Column (25cmΧ2.1mm, 5μm with ammonium phosphate − acetonitrile (80:20, v/v, pH 3.5 adjusted with ortho-phosphoric acid at a flow rate of 1 ml/min and detection wavelength of 230 nm. System suitability tests essential for the assurance of quality performance of the method were performed. The method was validated for accuracy, precision, reproducibility, specificity, and robustness, limit of detection (LOD, and limit of quantification (LOQ, as per International Conference on Harmonization (ICH guidelines. Results: A single sharp peak was obtained for Sumatriptan succinate at retention time of 6.8±0.01 min. The polynomial regression data for the calibration plots exhibited good linear relationship (r=0.9999 over a concentration range of 50-1050 ng/ml and the linear regression equation was y=120.9x+33.56. Accuracy ranged from 99.96% to 101.49%. The LOD and LOQ values were 11 and 35 ng/ml, respectively. Conclusion: The proposed method gave good resolution of Sumatriptan succinate. System suitability tests and statistical analysis performed prove that the method is precise, accurate and reproducible, and hence can be employed for routine analysis of Sumatriptan succinate in bulk and commercial formulations.

  5. Development of a validated RP-LC/ESI-MS-MS method for separation, identification and determination of related substances of tamsulosin in bulk drugs and formulations.

    Science.gov (United States)

    Nageswara Rao, R; Kumar Talluri, M V N; Narasa Raju, A; Shinde, Dhananjay D; Ramanjaneyulu, G S

    2008-01-01

    A reversed-phase high performance liquid chromatographic (RP-HPLC) method for evaluation of purity of tamsulosin in bulk drugs and pharmaceuticals was developed. The separation was accomplished on an Inertsil C(18) column using 10 mM ammonium acetate: acetonitrile as a mobile phase in a gradient elution mode. A photodiode array detector set at 280 nm was used for detection. The impurities were identified by ESI-MS-MS. The detection limits were 0.06-0.11 microg/ml. The method was validated with respect to accuracy, precision, linearity, ruggedness and limits of detection and quantification. It finds application not only for monitoring the reactions during the process development but also on quality assurance of tamsulosin.

  6. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Third Parties and Food and Drug...--Requirements for regulatory purposes,'' (ISO 13485:2003) audit report provides FDA a degree of assurance of... GHTF founding members auditing systems include: The Canadian Medical Devices Conformity...

  7. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Science.gov (United States)

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and... clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref...

  8. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Science.gov (United States)

    2013-04-03

    ... Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement... availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting...

  9. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis; Availability...

  10. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2011-10-17

    .... 76, No. 200 / Monday, October 17, 2011 / Notices#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and...

  11. A developed HPLC method for the determination of Alogliptin Benzoate and its potential impurities in bulk drug and tablets

    Directory of Open Access Journals (Sweden)

    Kun Zhang

    2015-04-01

    Full Text Available Alogliptin (AGLT, active ingredient of Alogliptin Benzoate (AGLT-BZ, is a new dipeptidyl peptidase-4 (DPP-4 inhibitor for the treatment of type 2 diabetes. This study aimed to build a suitable method to determine the potential related substances in AGLT-BZ bulk drug and tablets. Seven related substances in Alogliptin Benzoate substances were synthetized and identified by 1H-NMR and ESI-MS. In addition, the impurities were detected by a gradient reverse-phase high performance liquid chromatography (RP-HPLC with UV detection. The chromatographic system consisted of an Angilent Zobax SB-CN column (250 × 4.6 mm; 5 μm. The mobile phase consisted of water/acetonitrile/trifluoroacetic acid 1900:100:1 v/v/v (solution A and acetonitrile/water/trifluoroacetic acid 1900:100:1 v/v/v (solution B using a gradient program at a flow rate of 1.0 ml/min with 278 nm detection and an injection volume of 20 μl. Additionally, selectivity, the limit of quantitation (LOQ and limit of detection (LOD, linearity, accuracy, precision and robustness were determined. Linearity was good over the concentration range 50–1000 ng/ml and the coefficient of determination (R2 were 0.9991–0.9998. RSD% of the determination of precision were <2% (n = 6. The method of RP-HPLC for the determination of impurities in AGLT-BZ was proved to be precise, accurate, robust and reliable. Three batches of self-made bulk drug and three dosages of commercial tablets were detected with this method.

  12. VARIOUS PHARMACEUTICALS INCLUDING DRUGS AND INDUSTRIAL CHEMICALS AS ENVIRONMENTAL HEALTH HAZARDS

    Directory of Open Access Journals (Sweden)

    Anita Kirrolia and Vikas Nehra*

    2012-11-01

    Full Text Available This review describes the potential and, in particular, some relevant hazards associated with the use of veterinary drugs, various pharmaceuticals and industrial chemicals that have produced serious environmental risks and affected the life of people along with other animals by posing great health risks. Risk analysis regarding these problems has also been discussed with the measures to handle the problem at global level. The most contentious residues which occur in meat, milk and eggs along with the environment are antibacterial drugs, hormonal growth promoters, heavy metals and industrial chemicals that are producing potential toxic health effects that include systemic toxicity, mutations, cancer, birth defects and reproductive disorders. Systemic toxicity involves changes in the structure and function of organs and organ systems: weight change, structural alterations and changes in organ system or whole animal function. Functional effects may include changes in the lungs, liver, kidneys, cardiovascular function, brain, nervous system activity, behavior and in production of resistance to disease. Furthermore, continued monitoring and periodic reassessment of risks posed by these contaminants is needed to detect or anticipate new problems so that appropriate action can be taken in the interests of public safety.

  13. Spectrophotometric and spectrofluorimetric determination of some drugs containing secondary amino group in bulk drug and dosage forms via derivatization with 7-Chloro-4-Nitrobenzofurazon

    Directory of Open Access Journals (Sweden)

    Armaan Önal

    2011-01-01

    Full Text Available Sensitive and selective spectrophotometric and spectrofluorimetric methods have been developed for determination of some drugs such as Pramipexole, Nebivolol, Carvedilol, and Eletriptan, which commonly contain secondary amino group. The subject methods were developed via derivatization of the secondary amino groups with 7-Chloro-4-Nitrobenzofurazon in borate buffer where a yellow colored reaction product was obtained and measured spectrophotometrically or spectrofluorimetrically. Concentration ranges were found as 2.0 to 250 μg mL-1 and 0.1 to 3.0 μg mL-1, for spectrophotometric and spectrofluorimetric study, respectively. The described methods can be easily applied by the quality control laboratories in routine analyses of these drugs in pharmaceutical preparations.

  14. Stability-indicating liquid chromatographic method for quantification of new anti-epileptic drug lacosamide in bulk and pharmaceutical formulation

    Directory of Open Access Journals (Sweden)

    Chhalotiya Usmangani K.

    2012-01-01

    Full Text Available An isocratic stability indicating reversed-phase liquid chromatographic determination was developed for the quantitative determination of lacosamide in the pharmaceutical dosage form. A Hypersil C-18, 4.5μm column with mobile phase containing acetonitrile-water (20:80, v/v was used. The flow rate was 1.0 mL min-1 and effluents were monitored at 258 nm. The retention time of lacosamide was 8.9 min. The method was found to be linear in the concentration range of 5-100 μg/ml and the recovery was found to be in the range of 99.15 - 100.09 %. The limit of detection and limit of quantification were found to be 2 μg/ml and 5 μg/ml, respectively. Lacosamide stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The drug was found to be stable to the dry heat and acidic condition attempted. The proposed method was validated and successfully applied to the estimation of lacosamide in tablet dosage forms.

  15. DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE AND LOSARTAN IN BULK DRUG AND TABLET DOSAGE FORMULATION

    Directory of Open Access Journals (Sweden)

    Ramya Gavini

    2012-11-01

    Full Text Available A simple, precise and stability indicating reversed phase liquid chromatographic method was developed and validated for simultaneous estimation of Amlodipine and Losartan potassium in bulk and tablet formulation. The separation was achieved on Enable C18 G (250mm x 4.6mm, 5µm analytical column with mobile phase comprising of 0.005M Potassium dihydrogen phosphate: Acetonitrile (pH 3.0 (50:50v/v at isocratic flow of 1.0ml/min with UV detection at 230 nm. The retention times of amlodipine and losartan potassium was found to be 4.3 and 6.7 minutes respectively. The method was successfully validated in accordance with ICH guidelines for different validation parameters using PDA detector. The linear regression analysis data for calibration plots showed good linear relationship in the concentration range 0.125-0.75 μg/mL for amlodipine and 1.25-7.5 μg/mL for losartan potassium. The drugs were exposed to acidic, basic, oxidation, thermal and photolytic stress degradation conditions and the resultant stressed samples were analyzed by the proposed method and was established to provide high resolution among the degradation products and the analytes. The method could effectively separate the drug from its degradation product; hence it can be employed as a stability- indicating one.

  16. Productive university, industry, and government relationships in preclinical drug discovery and development: considerations toward a synergistic lingua franca.

    Science.gov (United States)

    Janero, David R

    2012-06-01

    Efficiency and productivity shortfalls conspire with subpar economic return to stigmatize the pharmaceutical industry and jeopardize its viability. This complex and costly innovation-to-commercialization failure, the formidable associated costs, and the relevance of various core competencies endemic to universities, the pharmaceutical industry, and government have been major drivers for establishing preclinical drug-discovery alliances involving these constituencies. Such cross-sector alliances have the potential to help restore at least some of the industry's former health by militating risk, enhancing productivity, and improving the quantity/quality of development candidates. This Editorial will highlight certain characteristics of pharma-industry and non-industrial settings that can jeopardize the effectiveness of these sectors for unified preclinical discovery campaigns capable of generating well-characterized drug candidates that merit human testing. Based on decades of research and development (R&D) and business experience spanning international big-pharma, biotechnology, and academic spheres, the author opines that a synergistic lingua franca is required among involved constituencies in order for such cross-sector discovery alliances to emerge as robust drug-discovery engines fueled by joint intellectual effort. Technology-transfer professionals, postdoctoral trainees, and consultants are discussed as resources for helping establish the university-industry-government triumvirate as a normative innovation network for preclinical drug discovery and development in the 21st century.

  17. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... applications for new animal drug products containing medically important antimicrobial new animal drugs for use... recommends that the use of medically important antimicrobial drugs be limited to uses in animals that are... Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI......

  18. Electroreduction of the muscle relaxant drug dantrolene sodium at the mercury electrode and its determination in bulk form and pharmaceutical formulation.

    Science.gov (United States)

    Ghoneim, Enass Mohamed

    2007-10-01

    The electroreduction of the muscle relaxant drug dantrolene sodium at the mercury electrode has been studied in the Britton-Robinson universal buffer of pH 2.5-11.5 containing 20% (v/v) methanol by means of dc-polarography, cyclic voltammetry and controlled-potential coulometry. Its reduction took place via three irreversible cathodic steps in solutions of pH or =10 through the consumption of 10, 8 or 4 electrons, respectively. This behavior was attributed to the reduction of NO(2) group (1st and 2nd steps at pH or =10) and the -CH=N- double bond (3rd step at pH <10). Two polarographic procedures (direct current and differential-pulse modes) and three adsorptive cathodic stripping voltammetric procedures (linear-sweep, differential-pulse and square-wave modes) were described and successfully applied for quantification of dantrolene sodium in its bulk form and in pharmaceutical formulation (Dantrolex tablets).

  19. A validated chiral LC method for enantiomeric separation of nebivolol stereoisomers in bulk drugs and dosage forms on amylose-based stationary phase.

    Science.gov (United States)

    Visweswara Rao, Karri; Padmaja Reddy, Kesareddy; Haldar, Pranab

    2014-10-01

    A novel and reproducible isocratic normal phase liquid chromatographic method was developed for the quantitative determination of 10 stereoisomers of Nebivolol in pharmaceutical bulk drugs and dosage forms. The method was developed using an amylose-based chiral stationary phase, Chiralpak AD-3 (250 × 4.6 mm, 3 μm) column with mobile phase containing n-hexane-ethanol-isopropanol-diethanolamine in the ratio 42:45:13:0.1 (v/v/v/v). The eluted compounds were monitored at 280 nm. Ten stereoisomers of Nebivolol were well separated with resolution >2.0 for all pair of components. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, linearity (R(2) value >0.999), limit of detection, limit of quantification, accuracy (recovery range 95.8-103.2%), precision (relative standard deviation, RSD, <2.5%) and robustness. Nebivolol sample solutions were found to be stable when characterized over a period of 48 h. Forced degradation studies were also performed to demonstrate the stability-indicating power of the developed HPLC method. The method was found to be rugged and robust.

  20. Forced degradation study to develop and validate stability-indicating RP-LC method for the determination of ciclesonide in bulk drug and metered dose inhalers.

    Science.gov (United States)

    Elkady, Ehab F; Fouad, Marwa A

    2011-12-15

    A simple, selective and precise stability-indicating reversed-phase liquid chromatographic method was developed and validated for the determination of ciclesonide. Ciclesonide was subjected to acid and alkali hydrolysis, oxidation, thermal and photo-degradation. The degradation products were well separated from the pure drug. The method was based on isocratic elution of ciclesonide and its degradation products on reversed phase C18 column (250 mm × 4.6 mm, 10 μm) - Phenomenex using a mobile phase consisting of ethanol-water (70:30, v/v) at a flow rate of 1 mL min(-1). Quantitation was achieved with UV detection at 242 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 5-200 μg mL(-1). Desisobutyryl-ciclesonide was prepared by selective alkaline hydrolysis of the ester and proved to be the main degradation product. The proposed method was successfully applied to the determination of ciclesonide in bulk and in its pharmaceutical preparation.

  1. Development and validation of a liquid chromatographic method for the simultaneous determination of aniracetam and its related substances in the bulk drug and a tablet formulation.

    Science.gov (United States)

    Papandreou, Georgios; Zorpas, Kostas; Archontaki, Helen

    2011-11-01

    Simultaneous determination of aniracetam and its related impurities (2-pyrrolidinone, p-anisic acid, 4-p-anisamidobutyric acid and (p-anisoyl)-4-methyl-2-pyrrolidinone) was accomplished in the bulk drug and in a tablet formulation using a high performance liquid chromatographic method with UV detection. Separation was achieved on a Hypersil BDS-CN column (150 mm × 4.0 mm, 5 μm) using a gradient elution program with solvent A composed of phosphate buffer (pH 4.0; 0.010 M) and solvent B of acetonitrile-phosphate buffer (pH 4.0; 0.010 M) (90:10, v/v). The flow rate of the mobile phase was 1.0 mL min(-1) and the total elution time, including the column re-equilibration, was approximately 20 min. The UV detection wavelength was varied appropriately among 210, 250 and 280 nm. Injection volume was 20 μL and experiments were conducted at ambient temperature. The developed method was validated in terms of system suitability, selectivity, linearity, range, precision, accuracy, limits of detection and quantification for the impurities, short term and long term stability of the analytes in the prepared solutions and robustness, following the ICH guidelines. Therefore, the proposed method was suitable for the simultaneous determination of aniracetam and its studied related impurities.

  2. DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GLIPIZIDE AND METFORMIN IN BULK DRUGS AND TABLET DOSAGE FORM

    Directory of Open Access Journals (Sweden)

    D.Triveni

    2012-09-01

    Full Text Available The present work describes development and validation of simple, precise and accurate reversed-phase liquid chromatographic method for simultaneous estimation of glipizide and metformin hydrochloride in both bulk drugs and pharmaceutical dosage forms. The chromatographic separation was achieved on (Enable, symmetry C18, 250mm x 4.6mm, 5μ analytical column. A mobile phase consisting mixture of potassium dihydrogen phosphate (0.2M, pH 5.8 adjusted with dilute sodium hydroxide and acetonitrile in ratio (60:40 v/v at flow rate of 1.0ml/min and UV detector wavelength 258 nm. The retention time of glipizide and metformin Hcl was found to be 7.9 and 2.5 minutes respectively.The method was successfully validated in accordance to ICH guidelines for accuracy, precision, specificity, linearity, ruggedness and robustness. The linear regression analysis data for calibration plots showed good linear relationship in the concentration range 60-140 μg/mL for both glipizide and metformin hydrochloride.

  3. Determination of 5,7-dichloroquinolin-8-ol and 5-chloroquinolin-8-ol in bulk drug powder and pharmaceutical preparation by TLC

    Directory of Open Access Journals (Sweden)

    B H Pavithra

    2011-01-01

    Full Text Available Aim: The study aims to develop a simple, rapid and economical normal phase thin layer chromatography (TLC method for identification and quantification of 5,7-dichloroquinolin-8-ol and 5-chloroquinolin-8-ol, two active ingredients of halquinol, an antimicrobial agent. Materials and Methods: The analysis was performed on silica gel 60 TLC plates pre-washed with disodium ethylenedinitrilotetraacetic acid disodium salt (Na 2 EDTA solution with methanol-ethyl acetate-iso-propyl alcohol-ammonia solution [8:20:1:0.6 (v/v] as the mobile phase. Detection and quantification was performed densitometrically at 247 nm. Results: Responses of both 5,7-dichloroquinolin-8-ol and 5-chloroquinolin-8-ol were linear functions of concentration in the range of 300-800 ng. The intraday precision and intermediate precision of the method for 5,7-dichloroquinolin-8-ol and 5-chloroquinolin-8-ol was determined and it was found to be precise. Conclusion: The TLC method developed for simultaneous quantitative determination of 5,7-dichloroquinolin-8-ol and 5-chloroquinolin-8-ol was found to be simple and economical. Therefore, it can be used in routine quality control analysis of halquinol in bulk drug powder and halquinol bolus.

  4. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Science.gov (United States)

    2013-12-12

    ... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines... antimicrobial drugs intended for use in food-producing animals, as well as data on antimicrobial resistance... Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With...

  5. Industry

    Energy Technology Data Exchange (ETDEWEB)

    Bernstein, Lenny; Roy, Joyashree; Delhotal, K. Casey; Harnisch, Jochen; Matsuhashi, Ryuji; Price, Lynn; Tanaka, Kanako; Worrell, Ernst; Yamba, Francis; Fengqi, Zhou; de la Rue du Can, Stephane; Gielen, Dolf; Joosen, Suzanne; Konar, Manaswita; Matysek, Anna; Miner, Reid; Okazaki, Teruo; Sanders, Johan; Sheinbaum Parado, Claudia

    2007-12-01

    This chapter addresses past, ongoing, and short (to 2010) and medium-term (to 2030) future actions that can be taken to mitigate GHG emissions from the manufacturing and process industries. Globally, and in most countries, CO{sub 2} accounts for more than 90% of CO{sub 2}-eq GHG emissions from the industrial sector (Price et al., 2006; US EPA, 2006b). These CO{sub 2} emissions arise from three sources: (1) the use of fossil fuels for energy, either directly by industry for heat and power generation or indirectly in the generation of purchased electricity and steam; (2) non-energy uses of fossil fuels in chemical processing and metal smelting; and (3) non-fossil fuel sources, for example cement and lime manufacture. Industrial processes also emit other GHGs, e.g.: (1) Nitrous oxide (N{sub 2}O) is emitted as a byproduct of adipic acid, nitric acid and caprolactam production; (2) HFC-23 is emitted as a byproduct of HCFC-22 production, a refrigerant, and also used in fluoroplastics manufacture; (3) Perfluorocarbons (PFCs) are emitted as byproducts of aluminium smelting and in semiconductor manufacture; (4) Sulphur hexafluoride (SF{sub 6}) is emitted in the manufacture, use and, decommissioning of gas insulated electrical switchgear, during the production of flat screen panels and semiconductors, from magnesium die casting and other industrial applications; (5) Methane (CH{sub 4}) is emitted as a byproduct of some chemical processes; and (6) CH{sub 4} and N{sub 2}O can be emitted by food industry waste streams. Many GHG emission mitigation options have been developed for the industrial sector. They fall into three categories: operating procedures, sector-wide technologies and process-specific technologies. A sampling of these options is discussed in Sections 7.2-7.4. The short- and medium-term potential for and cost of all classes of options are discussed in Section 7.5, barriers to the application of these options are addressed in Section 7.6 and the implication of

  6. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Science.gov (United States)

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  7. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    Science.gov (United States)

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  8. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Science.gov (United States)

    2010-04-29

    ... Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration... the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for...

  9. Industrialization

    African Journals Online (AJOL)

    Lucy

    Second World era international system (1945-1990) may not have done any good to ... wedge between the capitalist and socialist blocs, not only blurred Third World .... Politics and the Stages of Economic Growth, Cambridge: Cambridge ... complex industries producing mainly for export, but also producing for local.

  10. Providers' payment and delivery system reforms hold both threats and opportunities for the drug and device industries.

    Science.gov (United States)

    Robinson, James C

    2012-09-01

    For decades, medical device and specialty drug makers have produced a steady stream of breakthroughs and incremental improvements, from cancer therapies to orthopedic joint replacements, drug-eluting stents, and cardiac pacemakers. The advances were financed by a fragmented health care system that paid for whichever clinical technologies were favored by physicians without strong concern for cost. But now hospitals, health systems, insurers, and policy makers are embracing payment reforms that seek to control costs and foster uniformity in the adoption of new drugs and devices. This article explores payment reforms that will have an impact on the medical technology industry and describes opportunities for the industry to flourish in this new, more financially constrained landscape.

  11. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2010-08-03

    ... product lifecycle management--to ensure that the amount of residual drug substance at the end of the... development--as well as during manufacturing and product lifecycle management--to ensure that the amount of... systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an...

  12. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    Science.gov (United States)

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

  13. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Science.gov (United States)

    2010-08-06

    ... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug...) information for drug substances that should be submitted to support original new animal drug applications... of information in section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) have...

  14. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

    ... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act... ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug... intended to assist human drug compounders that choose to register as outsourcing facilities...

  15. [Drug advertising as communication between the pharmaceutical industry and the physician: advertisements for psychotropic drugs in the Dutch medical journal, Nederlands Tijdschrift voor Geneeskunde, 1900-1940].

    Science.gov (United States)

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

    In this article we explore the historical development of drug advertisements for psychotropic drugs in the leading Dutch medical journal from 1900 to 1940. The advertisements for hypnotics and sedatives, in The Nederlands Tijdschrift voor Geneeskunde (Dutch medical journal) reflected the changes in the vocabulary and image promoted by the pharmaceutical companies. In the first two decades, the advertisements were sober and to the point, and included the trademark, company name, molecular formula and therapeutic properties of the medication. The emphasis was on creating a scientific image of reliable symptom control for the therapeutic drug. In doing so, the ethical drug companies tried (successfully) to distinguish themselves from the producers of patent medicines. Once scientific credibility was established, the form and content of the advertisements changed significantly. In the late 1920s and 1930s drug companies embraced modern advertising techniques, developing a figurative language to address the changing beliefs and practices of Dutch physicians. Instead of promoting therapeutic drugs as safe and scientific, the emphasis was on their effectiveness in comparison to similar drugs. In the process, scientific information was reduced to an indispensable standardized minimum, whereby therapeutic drugs were advertised according to the latest pharmacological taxonomy rather than molecular formulas. The image-making of 'ethical marketing' began during the interwar years when marketers applied modern advertising techniques and infotainment strategies. The scanty black and white informational bulletins transitioned into colourful advertisements. The pharmaceutical companies employed the same medical language as used by physicians, so that one word or image in an advertisement would suffice for the physician to recognize a drug and its therapeutic properties. These developments show the changing relationship between the modern ethical pharmaceutical industry and Dutch

  16. Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?

    Science.gov (United States)

    Abraham, John; Reed, Tim

    2003-07-01

    The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.

  17. 78 FR 42965 - Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use...

    Science.gov (United States)

    2013-07-18

    ... Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium... new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat...

  18. How the pill became a lifestyle drug: the pharmaceutical industry and birth control in the United States since 1960.

    Science.gov (United States)

    Watkins, Elizabeth Siegel

    2012-08-01

    Marketing decisions, rather than scientific innovations, have guided the development and positioning of contraceptive products in recent years. I review the stalled progress in contraceptive development in the decades following the advent of the Pill in 1960 and then examine the fine-tuning of the market for oral contraceptives in the 1990s and 2000s. Although birth control has been pitched in the United States as an individual solution, rather than a public health strategy, the purpose of oral contraceptives was understood by manufacturers, physicians, and consumers to be the prevention of pregnancy, a basic health care need for women. Since 1990, the content of that message has changed, reflecting a shift in the drug industry's view of the contraception business. Two factors contributed to bring about this change: first, the industry's move away from research and development in birth control and second, the growth of the class of medications known as lifestyle drugs.

  19. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

    ... Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B... register as outsourcing facilities (outsourcing facilities). DATES: Although you can comment on...

  20. Improving the translation in Europe of nanomedicines (a.k.a. drug delivery) from academia to industry.

    Science.gov (United States)

    Eaton, Michael A W

    2012-12-28

    Over the last decade the involvement of European academic scientists in the translation of Nanomedicines and Drug Delivery into useful therapeutics has been modest. Funders have become increasingly concerned and some attempts have been made in Europe to improve impact. While the consequences are minimal at present for stakeholders, the eventual impact at national and political levels could be serious and is likely to lead to reverse innovation - the import of healthcare products from developing economies - if not addressed. Some knowledge of industrial drug development is critical for innovation in this regulated sector - this information being not easily obtained outside Pharma. While peer review has failings, more important is project inception, since once started research takes on a life of its own. This paper aims to encourage healthcare researchers to take a more translational approach to selecting (applied) drug delivery projects.

  1. Handling of bulk solids theory and practice

    CERN Document Server

    Shamlou, P A

    1990-01-01

    Handling of Bulk Solids provides a comprehensive discussion of the field of solids flow and handling in the process industries. Presentation of the subject follows classical lines of separate discussions for each topic, so each chapter is self-contained and can be read on its own. Topics discussed include bulk solids flow and handling properties; pressure profiles in bulk solids storage vessels; the design of storage silos for reliable discharge of bulk materials; gravity flow of particulate materials from storage vessels; pneumatic transportation of bulk solids; and the hazards of solid-mater

  2. Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs

    NARCIS (Netherlands)

    Broekhof, Martijn

    2002-01-01

    The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing

  3. The gold industry standard for risk and cost of drug and vaccine development revisited

    NARCIS (Netherlands)

    Pronkers, E.S.; Weenen, T.C.; Commandeur, H.R.; Osterhaus, H.R.; Claassen, H.J.H.M.

    2011-01-01

    Gold dimensions of pharmaceutical drug development indicate that it takes on average 11.9 years, with an investment around US$ 0.8 Billion, to launch one product on the market. Furthermore, approximately 22% of the drug candidates successfully complete clinical testing. These universally acknowledge

  4. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Science.gov (United States)

    2011-03-15

    ... are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs... preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a... Outcome Claims.'' The intent of the guidance is to provide common labeling for antihypertensive drugs...

  5. Urinalysis and hair analysis for illicit drugs of driver applicants and drivers in the trucking industry.

    Science.gov (United States)

    Mieczkowski, Tom

    2010-07-01

    The purpose of this article is to compare the differential rate of detection of illicit drugs when using two distinct sample types, hair and urine specimens. The specimens were collected from persons who applied for employment as a truck driver, or were collected from randomly selected currently employed truck drivers. The data is examined for job applicants and employees to determine if any differences in outcomes are associated with employment status or specimen type. The data is also assessed for specific patterns associated with particular drugs and their assay outcomes. Overall, it was determined that drug positive cases are relatively rare. Job applicants are more likely to test positive for an illicit drug than a currently employed driver. Applicants are more frequently positive for a drug by a factor of 3 for both urinalysis and hair analysis when compared to currently employed drivers. Approximately 2% of applicants were urine positive and 9% hair positive for an illegal drug. Considering employed truck drivers 0.6% were drug positive by urinalysis and 3% when using hair analysis. It is concluded that hair assays detect more drug use than urinalysis. It is also concluded that when urine and hair assay outcomes are non-concordant the typical case is a positive hair analysis with a negative urinalysis.

  6. Transparency in the pharmaceutical industry - A cost accounting approach to the prices of drugs

    NARCIS (Netherlands)

    Broekhof, Martijn

    2002-01-01

    The WTO TRIPS agreement grants pharmaceutical companies patent rights on new innovative drugs. Patents give these companies the opportunity to charge higher prices for their drugs in order to recover their R&D expenses. For developing countries this is one of the reasons why people in developing cou

  7. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-06-15

    ... studies for establishing the performance characteristics of in vitro diagnostic devices for the detection... industry and Agency staff with recommendations for studies for establishing the performance... Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection...

  8. To Speed up the Development and Industrialization of Natural Drugs in China

    Institute of Scientific and Technical Information of China (English)

    Hao Xiaojiang

    2001-01-01

    @@ 1.The Current Situation Facing China's accession to the WTO,our pharmaceutical industries must prepare to meet extremely strong competition,because 97% of the synthetic medicines and antibiotics marketed in the country are copies of foreign products.

  9. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ... immunodeficiency virus/acquired immunodeficiency syndrome; and (3) new drugs that are active in the treatment of... Treatment.'' It does not create or confer any rights for or on any person and does not operate to bind FDA...

  10. Exploiting new approaches for natural product drug discovery in the biotechnology industry.

    Science.gov (United States)

    Gullo, Vincent P; Hughes, Dallas E

    2005-01-01

    In recent years, large pharmaceutical companies have significantly reduced or eliminated the search for new therapeutic agents from natural sources. In spite of the many successes from natural product drug discovery, these companies have chosen to focus on compound libraries as the source of new lead compounds. Smaller biotechnology companies are continuing the search for novel natural products by developing and employing new and innovative approaches. This paper will describe some of these recent approaches to natural product drug discovery.:

  11. Formulation and development of industry feasible proniosomal transdermal drug delivery system of granisetron hydrochloride

    Directory of Open Access Journals (Sweden)

    Bhushan Arun Patil

    2015-01-01

    Full Text Available Proniosomes gel is semisolid liquid crystal products of nonionic surfactants, which converted into niosomes upon hydration. A proniosome based transdermal drug delivery system of granisetron hydrochloride (GRA HCL developed by coacervation phase separation method. Formulation optimized by use of 3 2 full factorial design. Span 60 and cholesterol selected as independent variables, while entrapment efficiency (EE and flux selected as dependent variables. Proniosomes evaluated for EE, in vitro permeation study, stability study, microscopial examination by photomicroscopy, scanning electron microscopy, particle size analysis. F5 batch containing 90 mg span 60, and 10 mg cholesterol show maximum entrapment (66.57 ± 0.20% and flux (7.94 ± 0390 μg/cm 2 /h. Comparative in vitro drug release study of plain drug solution and drug in proniosomal gel form was carried out for 48 h on guinea pig skin. It was found that cumulative release and flux of proniosomal gel was nearly two times more than drug solution containing same drug concentration. The study demonstrated the effectiveness of proniosomal transdermal patch containing GRA HCL for effective management of chemotherapy induced nausea and vomiting.

  12. The effect of carrier surface and bulk properties on drug particle detachment from crystalline lactose carrier particles during inhalation, as function of carrier payload and mixing time

    NARCIS (Netherlands)

    Dickhoff, B.H.J.; de Boer, Anne; Lambregts, D.; Frijlink, H.W.

    2003-01-01

    The effect of carrier payload and mixing time on the redispersion of drug particles from adhesive mixtures during inhalation for two different drugs (budesonide and disodium cromoglycate) has been investigated. A special test inhaler which retains carrier crystals during inhalation was used at 30 an

  13. The place of Turkish Armed Forces in the history of Turkish drug industry: the historical development of military drug factory

    Directory of Open Access Journals (Sweden)

    Bilge Sozen sahne

    2015-04-01

    Full Text Available Military services have many contributions to the development of societies all over the world. In war and peace and also in emergencies, they continue to serve to their workers and civilian people. It is known that, Turkish Military Forces as one of the largest military forces in the world have the ability to provide health-care services. Firstly, in the Crimean War between 1853 and 1856, Gulhane Military Hospital in Istanbul began to produce medicine and bandages which are needs of the Turkish Army. Afterwards, in the First World War, the production of such needs continued in a storage Beylerbeyi Palace and in Konya. In 1928, these institutions were combined in Ankara the capital city of the Turkish Republic. The production continues in the pharmaceutical factory under the Ministry of National Defense. The historical evaluation of the military drug factory and its contribution to health services were examined in this study. [TAF Prev Med Bull 2015; 14(2.000: 171-176

  14. Overview of the animal health drug development and registration process: an industry perspective.

    Science.gov (United States)

    Hunter, Robert P; Shryock, Thomas R; Cox, Brian R; Butler, Roger M; Hammelman, Jason E

    2011-05-01

    Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.

  15. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Science.gov (United States)

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  16. Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials.

    Science.gov (United States)

    Havel, Henry A

    2016-11-01

    While nanotechnology advancements have been applied to pharmaceutical products, the number of approved nanodrugs by global health authorities has not kept pace with research and development investments in the field. This article reviews the history of nanodrug development and provides an industrial context for realistic expectations in the future.

  17. The transporter-mediated cellular uptake of pharmaceutical drugs is based on their metabolite-likeness and not on their bulk biophysical properties: Towards a systems pharmacology

    Directory of Open Access Journals (Sweden)

    Douglas B. Kell

    2015-12-01

    Full Text Available Several recent developments are brought together: (i the new availability of a consensus, curated human metabolic network reconstruction (Recon2, approximately a third of whose steps are represented by transporters, (ii the recognition that most successful (marketed drugs, as well as natural products, bear significant similarities to the metabolites in Recon2, (iii the recognition that to get into and out of cells such drugs hitchhike on the transporters that are part of normal intermediary metabolism, and the consequent recognition that for intact biomembrane Phospholipid Bilayer diffusion Is Negligible (PBIN, and (iv the consequent recognition that we need to exploit this and to use more phenotypic assays to understand how drugs affect cells and organisms. I show in particular that lipophilicity is a very poor predictor of drug permeability, and that we need to (and can bring together our knowledge of both pharmacology and systems biology modelling into a new systems pharmacology.

  18. 氟尿嘧啶原料药的质量控制及稳定性研究%Study on quality control and stability of fluorouracil bulk drug

    Institute of Scientific and Technical Information of China (English)

    严宾; 张伟男

    2015-01-01

    目的:建立抗肿瘤药氟尿嘧啶原料药的质量控制方法,并考察其稳定性。方法采用高效液相色谱法测定氟尿嘧啶原料药含量和有关物质,并对其进行稳定性考察。结果建立了氟尿嘧啶原料药的质量控制方法,包括性状、鉴别、干燥失重(≤0.3%)、炽灼残渣(≤0.1%)、重金属(≤0.002%)、有关物质(≤0.5%)和含量测定(98.0%~102.0%),样品检测结果在规定的限度内,对氟尿嘧啶样品进行了影响因素试验考察,在高温、高湿条件下无明显降解,在光照5、10 d条件下含量均无明显变化,并分别在加速试验[(40±2)℃,相对湿度75%±5%]条件下进行了6个月和长期试验[(30±2)℃,相对湿度60%±5%]条件下进行了9个月的稳定性试验,稳定性考察期内各项指标未见明显变化。结论所建立的氟尿嘧啶原料药质量控制方法重复性好、专属性强,结果准确、可靠,耐用性检测结果在规定的限度内,氟尿嘧啶原料药稳定性良好。%Objective To establish the quality control method of antitumor drug fluorouracil bulk drug and to investigate its stability. Methods The content and related substances in fluorouracil bulk drug were determined by high performance liquid chromatography(HPLC) and its stability was investigated. Results The quality control method of fuorouracil bulk drug was estab-lished,including character,identification,drying loss (≤0.3%),residue on ignition (≤0.1%),heavy metals (≤0.002%),related substances(≤0.5%) and content determination(98.0%-102.0%). The sample test results were all within the limits specified. Mean-while,the fuorouracil sample was performed the influencing factor test,the results showed that there was no obvious fluorouracil degradation under the condition of high temperature and high humidity,there were no obvious changes under the condition of 5,10 d illumination,the 6-month and 9-month stability

  19. Binding Free Energy Calculations for Lead Optimization: Assessment of Their Accuracy in an Industrial Drug Design Context.

    Science.gov (United States)

    Homeyer, Nadine; Stoll, Friederike; Hillisch, Alexander; Gohlke, Holger

    2014-08-12

    Correctly ranking compounds according to their computed relative binding affinities will be of great value for decision making in the lead optimization phase of industrial drug discovery. However, the performance of existing computationally demanding binding free energy calculation methods in this context is largely unknown. We analyzed the performance of the molecular mechanics continuum solvent, the linear interaction energy (LIE), and the thermodynamic integration (TI) approach for three sets of compounds from industrial lead optimization projects. The data sets pose challenges typical for this early stage of drug discovery. None of the methods was sufficiently predictive when applied out of the box without considering these challenges. Detailed investigations of failures revealed critical points that are essential for good binding free energy predictions. When data set-specific features were considered accordingly, predictions valuable for lead optimization could be obtained for all approaches but LIE. Our findings lead to clear recommendations for when to use which of the above approaches. Our findings also stress the important role of expert knowledge in this process, not least for estimating the accuracy of prediction results by TI, using indicators such as the size and chemical structure of exchanged groups and the statistical error in the predictions. Such knowledge will be invaluable when it comes to the question which of the TI results can be trusted for decision making.

  20. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Science.gov (United States)

    2012-11-23

    ... system that adjusts insulin infusion based upon the continuous glucose monitor via a control algorithm... recommendations for developing premarket submissions for artificial pancreas device systems (APDS) and is the... Pancreas Device Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  1. Results of a survey of biological drug and device industries inspected by FDA under the Team Biologics Program.

    Science.gov (United States)

    Buchholz, Steve; Gangi, Victor J; Johnson, Anne; Little, Jacqueline; Mendivil, Steven; Trott, Carolyn; Webber, Keith; Weinstein, Mark

    2007-01-01

    The Product Quality Research Institute, in conjunction with the Food and Drug Administration, conducted an anonymous, electronic survey of the biological products manufacturing industry inspected by Team Biologics, with emphasis in obtaining industry input on inspection and compliance aspects of program operations. Representatives from all of the product-specific manufacturing industries inspected under the Team Biologics Program responded to this survey (vaccines; fractionated plasma proteins and recombinant analogs; allergenics; therapeutics and in-vivo diagnostics; and in-vitro diagnostics, including blood grouping reagents). Data and written feedback was obtained regarding each firm's interactions and experiences of Team Biologics inspections at its facilities over the past three years. The three areas most impacted by Team Biologic inspections were "Production and Process Controls", "Failure Investigations" and "Facility / Equipment Controls". Overall assessment of the program was generally positive with 68% identifying a positive impact on the sites operations and 88% assessed the inspections as being conducted fairly. The findings and conclusions of this report will be utilized by the FDA to evaluate and further assess the impact of the Team Biologics Program and to implement any necessary changes. This report provides useful information to companies currently manufacturing licensed biologic products subject to Team Biologics inspections and also to those companies anticipating these inspections for future product manufacturing.

  2. Public perceptions of the pharmaceutical industry and drug safety: implications for the pharmacovigilance professional and the culture of safety.

    Science.gov (United States)

    Olsen, Axel K; Whalen, Matthew D

    2009-01-01

    A survey of the US public titled 'Consumer Perceptions on Drug Safety' was conducted in October 2006. The survey was undertaken at that time because of the heightened public awareness of drug safety concerns over rofecoxib (Vioxx(R)) and pediatric antidepressant use. The survey was designed with questions related to public perception of the pharmaceutical industry, the US FDA, Congress and whether the US public perceived there to be a safety crisis. The survey consisted of 1726 US men and women aged 18 years and over. The survey results showed that the FDA, Congress and US pharmaceutical companies are perceived as having a notable amount of responsibility to ensure safety (by 75%, 41% and 70% of respondents, respectively). Additionally, 96% of the survey respondents indicated that they had some level of concern about adverse reactions to prescription drugs that are taken as directed. Seventy-six percent of the respondents were 'fairly' to 'extremely' concerned about adverse reactions, while approximately 42% of the survey respondents' opinions ranged from 'somewhat distrusting' to 'strongly distrusting' of the pharmaceutical companies that develop drugs. These findings are comparable to those in surveys conducted by the Kaiser Family Foundation in 2005 and PriceWaterhouseCoopers in 2007. These surveys suggest that about half the respondents believe there is both the need and desire for reform in drug safety by the pharmaceutical industry and the FDA. In reports from 2006 and 2007, the Institute of Medicine challenges the healthcare system and the FDA to adopt the principles of the culture of safety. While there have been steps taken to address the recommendations of the reports, as exemplified by the FDA Amendment Act of 2007 and the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium, true reform across the life sciences sector will only come through broad adoption of these principles. Thus, it is particularly important for

  3. Formulation and development of industry feasible proniosomal transdermal drug delivery system of granisetron hydrochloride

    OpenAIRE

    Bhushan Arun Patil; Prashant Keshav Puranik; Shankar Dadasaheb Pol; Prajakta Kalidas Khobragade; Pritee Shamrao Ramteke; Rajashree Gopal Palasakar; Nitiraj Ransing-Patil

    2015-01-01

    Proniosomes gel is semisolid liquid crystal products of nonionic surfactants, which converted into niosomes upon hydration. A proniosome based transdermal drug delivery system of granisetron hydrochloride (GRA HCL) developed by coacervation phase separation method. Formulation optimized by use of 3 2 full factorial design. Span 60 and cholesterol selected as independent variables, while entrapment efficiency (EE) and flux selected as dependent variables. Proniosomes evaluated for EE, in vitro...

  4. Delays in new drug applications in Japan and industrial R&D strategies.

    Science.gov (United States)

    Hirai, Y; Kinoshita, H; Kusama, M; Yasuda, K; Sugiyama, Y; Ono, S

    2010-02-01

    The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

  5. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating a particular dose of a drug. Such an abrupt alteration in metabolism or transport can change the known safety...

  6. Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective.

    Science.gov (United States)

    Brown, Alan P; Drew, Philip; Knight, Brian; Marc, Philippe; Troth, Sean; Wuersch, Kuno; Zandee, Joyce

    2016-12-01

    Histopathology data comprise a critical component of pharmaceutical toxicology studies and are typically presented as finding incidence counts and severity scores per organ, and tabulated on multiple pages which can be challenging for review and aggregation of results. However, the SEND (Standard for Exchange of Nonclinical Data) standard provides a means for collecting and managing histopathology data in a uniform fashion which can allow informatics systems to archive, display and analyze data in novel ways. Various software applications have become available to convert histopathology data into graphical displays for analyses. A subgroup of the FDA-PhUSE Nonclinical Working Group conducted intra-industry surveys regarding the use of graphical displays of histopathology data. Visual cues, use-cases, the value of cross-domain and cross-study visualizations, and limitations were topics for discussion in the context of the surveys. The subgroup came to the following conclusions. Graphical displays appear advantageous as a communication tool to both pathologists and non-pathologists, and provide an efficient means for communicating pathology findings to project teams. Graphics can support hypothesis-generation which could include cross-domain interactive visualizations and/-or aggregating large datasets from multiple studies to observe and/or display patterns and trends. Incorporation of the SEND standard will provide a platform by which visualization tools will be able to aggregate, select and display information from complex and disparate datasets.

  7. Development and Validation of a Stability-Indicating HPTLC Method for Analysis of Rasagiline Mesylate in the Bulk Drug and Tablet Dosage Form

    Directory of Open Access Journals (Sweden)

    Singaram Kathirvel

    2012-01-01

    Full Text Available A simple and sensitive thin-layer chromatographic method has been established for analysis of rasagiline mesylate in pharmaceutical dosage form. Chromatography on silica gel 60 F254 plates with 6 : 1 : 2(v/v/v butanol-methanol water as mobile phase furnished compact spots at Rf  0.76±0.01. Densitometric analysis was performed at 254 nm. To show the specificity of the method, rasagiline mesylate was subjected to acid, base, neutral hydrolysis, oxidation, photolysis, and thermal decomposition, and the peaks of degradation products were well resolved from that of the pure drug. Linear regression analysis revealed a good linear relationship between peak area and amount of rasagiline mesylate in the range of 100–350 ng/band. The minimum amount of rasagiline mesylate that could be authentically detected and quantified was 11.12 and 37.21 ng/band, respectively. The method was validated, in accordance with ICH guidelines for precision, accuracy, and robustness. Since the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.

  8. Biocatalysis: synthesis of chiral intermediates for drugs.

    Science.gov (United States)

    Patel, Ramesh N

    2006-11-01

    Chirality is a key factor in the safety and efficacy of many drug products and thus the production of single enantiomers of drug intermediates has become increasingly important in the pharmaceutical industry. Chiral intermediates and fine chemicals are in high demand for the bulk preparation of drug substances and agricultural products. There has been an increasing awareness of the enormous potential of the use of microorganisms and microorganism-derived enzymes for the transformation of synthetic chemicals with high chemo-, regio- and enantioselectivities. In this article, biocatalytic processes are described for the synthesis of chiral intermediates for drugs.

  9. Advanced and new developments in bulk metal forming

    DEFF Research Database (Denmark)

    Bay, Niels; Wanheim, Tarras; Ravn, Bjarne Gottlieb;

    2000-01-01

    Increasing demands to manufacturing industry of faster, better and cheaper production has intensified the research and development of bulk metal forming. The present paper gives examples on European industrial research on secondary bulk metal forming processes. The R&D follows three lines of appr...

  10. Analysis of the importance of drug packaging quality for end users and pharmaceutical industry as a part of the quality management system

    Directory of Open Access Journals (Sweden)

    Lončar Irma M.

    2013-01-01

    Full Text Available In this study, we collected and analyzed information on the importance of drug packaging quality to end users and pharmaceutical industry, as an indicator of the process of traceability and originality of drugs. Two surveys were conducted: one among the end users of drugs (252 patients and the other among professionals working in seven pharmaceutical companies in Serbia. For most end users (82.5% quality on the packaging of drugs was important, but only 41.8% of them thought that the appearance of the packaging could be an indicator of genuinity of drugs. The existence of the control marks (KM on drug packaging was not of great importance, since most of them (86.9% know, its function, but majority (60.2% would nevertheless decide to buy the drug without KM. Regarding the experts from the pharmaceutical industry, more then two-thirds of them (68.4% believed that the existence of KM did not contribute to efficient operations. Although a great number of pharmaceutical industry professionals (84.2% answered that the introduction of GS1 DataMatrix system would allow for complete traceability of the drug from the manufacturer to the end user, only 22.2% of them introduced this system to their products. This study also showed that domestic producers did not have a great interest for additional protection (special inks, holograms, special graphics, smart multicolor design, watermark, chemically labeled paper and cardboard etc.. on their products, given that only 15.8 % of them had some kind of additional protection against counterfeiting. Monitoring drug traceability from a manufacturer to end user is achieved by many complex activities regulated by law. A high percentage of responders said they were satisfied with the functionality of traceability systems used in their companies. As a way to increase the quality of drug packaging and business performance most responders saw in the continuous improvement of the system of traceability within the company

  11. Influence of kidney disease on drug disposition: An assessment of industry studies submitted to the FDA for new chemical entities 1999-2010.

    Science.gov (United States)

    Matzke, Gary R; Dowling, Thomas C; Marks, Samantha A; Murphy, John E

    2016-04-01

    In 1998, the United States Food and Drug Administration (FDA) released the first guidance for industry regarding pharmacokinetic (PK) studies in renally impaired patients. This study aimed to determine if the FDA renal PK guidance influenced the frequency and rigor of renal studies conducted for new chemical entities (NCEs). FDA-approved package inserts (APIs) and clinical pharmacology review documents were analyzed for 194 NCEs approved from 1999 to 2010. Renal studies were conducted in 71.6% of NCEs approved from 1999 to 2010, a significant increase over the 56.3% conducted from 1996 to 1997 (P = .0242). Renal studies were more likely to be completed in highly renally excreted drugs (fe ≥ 30%) compared with drugs with low renal excretion, fe FDA guidance has resulted in improved availability of PK and drug-dosing recommendations, particularly for high fe drugs.

  12. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Science.gov (United States)

    2012-04-13

    ... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals... Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug...

  13. Bulk Nanostructured Materials

    Science.gov (United States)

    Koch, C. C.; Langdon, T. G.; Lavernia, E. J.

    2017-09-01

    This paper will address three topics of importance to bulk nanostructured materials. Bulk nanostructured materials are defined as bulk solids with nanoscale or partly nanoscale microstructures. This category of nanostructured materials has historical roots going back many decades but has relatively recent focus due to new discoveries of unique properties of some nanoscale materials. Bulk nanostructured materials are prepared by a variety of severe plastic deformation methods, and these will be reviewed. Powder processing to prepare bulk nanostructured materials requires that the powders be consolidated by typical combinations of pressure and temperature, the latter leading to coarsening of the microstructure. The thermal stability of nanostructured materials will also be discussed. An example of bringing nanostructured materials to applications as structural materials will be described in terms of the cryomilling of powders and their consolidation.

  14. Bulk Superconductors in Mobile Application

    Science.gov (United States)

    Werfel, F. N.; Delor, U. Floegel-; Rothfeld, R.; Riedel, T.; Wippich, D.; Goebel, B.; Schirrmeister, P.

    We investigate and review concepts of multi - seeded REBCO bulk superconductors in mobile application. ATZ's compact HTS bulk magnets can trap routinely 1 T@77 K. Except of magnetization, flux creep and hysteresis, industrial - like properties as compactness, power density, and robustness are of major device interest if mobility and light-weight construction is in focus. For mobile application in levitated trains or demonstrator magnets we examine the performance of on-board cryogenics either by LN2 or cryo-cooler application. The mechanical, electric and thermodynamical requirements of compact vacuum cryostats for Maglev train operation were studied systematically. More than 30 units are manufactured and tested. The attractive load to weight ratio is more than 10 and favours group module device constructions up to 5 t load on permanent magnet (PM) track. A transportable and compact YBCO bulk magnet cooled with in-situ 4 Watt Stirling cryo-cooler for 50 - 80 K operation is investigated. Low cooling power and effective HTS cold mass drives the system construction to a minimum - thermal loss and light-weight design.

  15. Influence of foreign drug patent policy on pharmaceutical industry%国外药品专利政策对制药业的影响分析

    Institute of Scientific and Technical Information of China (English)

    倪娜; 刁天喜; 王磊; 赵晓宇

    2011-01-01

    通过研究美国、日本和印度三个具有代表性的国家的药品专利政策,分析了药品专利政策对制药业的影响,分别阐述了近期美国的专利法改革及其他药品相关法案中药品专利政策对制药业的影响,对运用专利战略非常成功的日本专利制度改革进行了分析,比较了印度旧专利法和新专利法中药品相关专利政策对印度生物制药业的影响.最后分析了典型国家专利政策对我国的启示.%The contents of this paper included drug patent policy of the developed countries such as USA and Japan and developing countries like India, and analysis of the foreign experiences. The first part introduced the influence of the reform of USA patent law on pharmaceutical industries. The cases of most important drug patents were analyzed. The second part analyzed the drug patent policy reform of Japan, in which the patent strategy is very successful. According to the four stages of development in pharmaceutical industry, this part examined the Japanese drug patent policy reform and the influences on industry. The third part introduced the Indian drug patent policy and the influences of patent laws, and also presented the strategies of some Indian medicine companies. Finally the last part gave recommendations on strategies of drug patent policy to improve the protection of patent.

  16. FDA Revisits Rules on Drug and Device Communication: Will the Agency Relax Existing Industry-Opposed Restrictions?

    Science.gov (United States)

    Barlas, Stephen

    2017-03-01

    The Food and Drug Administration issued draft guidances in January that tackled health care economic information and product labeling. Do these publications indicate a potential shift in on- and off-label policies for drugs and devices?

  17. Large area bulk superconductors

    Science.gov (United States)

    Miller, Dean J.; Field, Michael B.

    2002-01-01

    A bulk superconductor having a thickness of not less than about 100 microns is carried by a polycrystalline textured substrate having misorientation angles at the surface thereof not greater than about 15.degree.; the bulk superconductor may have a thickness of not less than about 100 microns and a surface area of not less than about 50 cm.sup.2. The textured substrate may have a thickness not less than about 10 microns and misorientation angles at the surface thereof not greater than about 15.degree.. Also disclosed is a process of manufacturing the bulk superconductor and the polycrystalline biaxially textured substrate material.

  18. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Science.gov (United States)

    2011-06-17

    ... Enforcement Policy for Over-the- Counter Sunscreen Drug Products Marketed Without an Approved Application... ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' The draft guidance... enforcement policy for certain OTC sunscreen products marketed without an approved new drug application....

  19. Characteristics of trapped magnetic fields in HTS bulk annuli with various axial spaces for compact NMR magnets

    Energy Technology Data Exchange (ETDEWEB)

    Kim, S.B., E-mail: kim@elec.okayama-u.ac.j [Electrical and Electronic Engineering, Okayama University, 3-1-1, Tsushima Naka, Kita-ku, Okayama 700-8530 (Japan); Francis Bitter Magnet Laboratory, Massachusetts Institute of Technology, 170 Albany Street, Cambridge, MA 02139 (United States); Imai, M.; Takano, R.; Kashima, K.; Hahn, S. [Electrical and Electronic Engineering, Okayama University, 3-1-1, Tsushima Naka, Kita-ku, Okayama 700-8530 (Japan); Francis Bitter Magnet Laboratory, Massachusetts Institute of Technology, 170 Albany Street, Cambridge, MA 02139 (United States)

    2010-11-01

    Recently, the performance of high-temperature superconducting (HTS) bulks such as a critical current density, size, and mechanical strength has been improved. In consequence, various applications with HTS bulks such as motors, bearings, and flywheels are being investigated by many research groups; Compact nuclear magnetic resonance (NMR) magnet is one of the new applications after a technique to enhance maximum trapped field of an HTS bulk more than 11.7 T, 500 MHz {sup 1}H NMR frequency, has been developed. This new compact NMR magnet out of HTS bulks is far less expensive than those conventional NMR magnets and expected to be widely used in food and drug industry. In design and manufacture of those compact NMR magnets, the issues of spatial homogeneity and temporal stability of trapped magnetic fields in HTS bulk annuli are very important. In this paper, the characteristics of the trapped magnetic fields in a stack of assembled HTS bulk annuli were investigated with various axial spaces between HTS bulks, experimentally and analytically.

  20. State-of-the-art and dissemination of computational tools for drug-design purposes: a survey among Italian academics and industrial institutions.

    Science.gov (United States)

    Artese, Anna; Alcaro, Stefano; Moraca, Federica; Reina, Rocco; Ventura, Marzia; Costantino, Gabriele; Beccari, Andrea R; Ortuso, Francesco

    2013-05-01

    During the first edition of the Computationally Driven Drug Discovery meeting, held in November 2011 at Dompé Pharma (L'Aquila, Italy), a questionnaire regarding the diffusion and the use of computational tools for drug-design purposes in both academia and industry was distributed among all participants. This is a follow-up of a previously reported investigation carried out among a few companies in 2007. The new questionnaire implemented five sections dedicated to: research group identification and classification; 18 different computational techniques; software information; hardware data; and economical business considerations. In this article, together with a detailed history of the different computational methods, a statistical analysis of the survey results that enabled the identification of the prevalent computational techniques adopted in drug-design projects is reported and a profile of the computational medicinal chemist currently working in academia and pharmaceutical companies in Italy is highlighted.

  1. 77 FR 72869 - Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug...

    Science.gov (United States)

    2012-12-06

    ... flexibility, but they also may be used for different functions in other dosage forms. Phthalates also are... Excipients in CDER-Regulated Products.'' This guidance provides the pharmaceutical industry with the Center... guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates...

  2. Technical Modification Within the Healthcare Industry: Improving Both the Efficacy of the National Drug Code Carrier and the Accessibility of Electronic Health Records to Reduce Adverse Drug Events

    Science.gov (United States)

    2013-06-01

    an ADE. A few scenarios from the perspective of a clinician at the doctor’s office, an EMT, and a pharmacist all tasked to administer drugs to a...has also been made. The final assumption is that the EMT, pharmacist , and clinician , all have the proper credentials and permissions to 93...Figure 39. Clinician drug interaction cross-check with an indirect-encoded/hybrid QR code In the case of an EMT or pharmacist , the procedures

  3. 阿加曲班原料药中催化剂钯残留监测方法建立%Establishment of a Method for Monitoring the Catalyst Palladium Residual Content in Argatroban Bulk Drug

    Institute of Scientific and Technical Information of China (English)

    郭旭光; 郑子栋; 郭毅

    2014-01-01

    目的:建立凝血酶抑制剂阿加曲班原料药中催化剂钯的残留量测定方法。方法采用石墨炉原子吸收分光光度法测定阿加曲班中钯的残留量。试验条件:光源为钯空心阴极灯,波长247.6 nm,狭缝0.5 nm,灯电流10 mA,燃烧器高度2 mm,石墨管以横向加热方式,氩气压力0.4 MPa,进样体积20μL,背景校正D2,石墨炉程序升温。结果钯在0.015~0.2μg·mL-1范围内与吸光度呈良好的线性关系(r=0.9996);检出限为0.00057μg·mL-1;特征浓度为0.00107μg·mL-1;平均回收率为99.8%;RSD 为4.08%(n=9)。结论该方法经方法学验证可用于阿加曲班原料药中痕量钯含量的测定,可为该原料药质量标准的完善提供参考。%Objective To establish a method for the content determination of palladium catalyst residue in thrombin inhibitor argatroban bulk drug.Methods Graphite furnace atomic absorption spectrometry (AAS)method was used to determine palladium residue content in argatroban.Test conditions were as follows.The palladium hollow cathode lamp was used for light source.The detection wavelength was 247.6 nm,and the slit was 0.5 nm.The lamp current was 10 mA,and the burner height was 2 mm with transverse heating graphite tube.The argon pressure was 0.4 MPa.The injection volume was 20μL with background correction D2.The temperature program was used for graphite furnace.Results It showed a good linear relationship within the concentration range of 0.0 1 5-0.2 μg · mL-1 (r=0.9 9 9 6 ). The detection limit and the characteristic concentration were 0.00057 μg · mL-1 and 0.00107 μg · mL-1 , respectively.The average recovery was 99.8%,with RSD of 4.08% (n=9).Conclusion This method could be used for the determination of the trace palladium content in argatroban bulk drug after methodology verification,and could provide reference for improving quality standard of the raw material medicine.

  4. Electrochemical treatment of industrial wastewater

    Energy Technology Data Exchange (ETDEWEB)

    Rajkumar, D. [Centre for Environmental Studies, Anna University, Chennai 600 025 (India); Palanivelu, K. [Centre for Environmental Studies, Anna University, Chennai 600 025 (India)]. E-mail: kpvelu@hotmail.com

    2004-09-10

    This paper presents the results of the treatment of phenolic compounds containing wastewater generated from phenol-formaldehyde resin manufacturing, oil refinery and bulk drug manufacturing industries by electrochemical method. Experiments were conducted at a fixed current density of 5.4 A/dm{sup 2} using Ti/TiO{sub 2}-RuO{sub 2}-IrO{sub 2} electrode and an undivided reactor. During the various stages of electrolysis, parameters such as COD and TOC concentrations were determined in order to know the feasibility of electrochemical treatment. Adsorbable organic halogens (AOX) were detected at high concentrations during the electrolytic treatment of the effluents. However, it was observed that increasing the electrolysis time bring down the AOX concentration to lower levels. Energy consumption and current efficiency during the electrolysis were calculated and presented. The present study proves the effectiveness of electrochemical treatment for highly concentrated bio-refractory organic pollutants present in the industrial wastewater.

  5. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Science.gov (United States)

    2012-03-13

    ... Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre... entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review... advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term...

  6. Technical issues of a high-Tc superconducting bulk magnet

    Science.gov (United States)

    Fujimoto, Hiroyuki

    2000-06-01

    Superconducting magnets made of high-Tc superconductors are promising for industrial applications. It is well known that REBa2Cu3O7-x superconductors prepared by melt processes have a high critical current density, Jc, at 77 K and high magnetic fields. The materials are very promising for high magnetic field applications as a superconducting permanent/bulk magnet with liquid-nitrogen refrigeration. Light rare-earth (LRE) BaCuO bulks, compared with REBaCuO bulks, exhibit a larger Jc in high magnetic fields and a much improved irreversibility field, Hirr, at 77 K. In this study, we discuss technical issues of a high-Tc superconducting bulk magnet, namely the aspects of the melt processing for bulk superconductors, their characteristic superconducting properties and mechanical properties, and trapped field properties of a superconducting bulk magnet. One of the possible applications is a superconducting bulk magnet for the magnetically levitated (Maglev) train in the future.

  7. The combination of glycerol metabolic engineering and drug resistance marker-aided genome shuffling to improve very-high-gravity fermentation performances of industrial Saccharomyces cerevisiae.

    Science.gov (United States)

    Wang, Pin-Mei; Zheng, Dao-Qiong; Liu, Tian-Zhe; Tao, Xiang-Lin; Feng, Ming-Guang; Min, Hang; Jiang, Xin-Hang; Wu, Xue-Chang

    2012-03-01

    A challenge associated with the ethanol productivity under very-high-gravity (VHG) conditions, optimizing multi-traits (i.e. byproduct formation and stress tolerance) of industrial yeast strains, is overcome by a combination of metabolic engineering and genome shuffling. First, industrial strain Y12 was deleted with a glycerol exporter Fps1p and hetero-expressed with glyceraldehydes-3-phosphate dehydrogenase, resulting in the modified strain YFG12 with lower glycerol yield. Second, YFG12 was subjected to three rounds of drug resistance marker-aided genome shuffling to increase its ethanol tolerance, and the best shuffled strain TS5 was obtained. Compared with wild strain Y12, shuffled strain TS5 not only decreased glycerol formation by 14.8%, but also increased fermentation rate and ethanol yield by 3.7% and 7.6%, respectively. Moreover, the system of genetic modification and Cre/loxP in aid of three different drug-resistance markers presented in the study significantly improved breeding efficiency and will facilitate the application of breeding technologies in prototrophic industrial microorganisms.

  8. Bulk chemicals from biomass

    NARCIS (Netherlands)

    Haveren, van J.; Scott, E.L.; Sanders, J.P.M.

    2008-01-01

    Given the current robust forces driving sustainable production, and available biomass conversion technologies, biomass-based routes are expected to make a significant impact on the production of bulk chemicals within 10 years, and a huge impact within 20-30 years. In the Port of Rotterdam there is a

  9. Auctioning Bulk Mobile Messages

    NARCIS (Netherlands)

    S. Meij (Simon); L-F. Pau (Louis-François); H.W.G.M. van Heck (Eric)

    2003-01-01

    textabstractThe search for enablers of continued growth of SMS traffic, as well as the take-off of the more diversified MMS message contents, open up for enterprises the potential of bulk use of mobile messaging , instead of essentially one-by-one use. In parallel, such enterprises or value added

  10. Bulk chemicals from biomass

    NARCIS (Netherlands)

    Haveren, van J.; Scott, E.L.; Sanders, J.P.M.

    2008-01-01

    Given the current robust forces driving sustainable production, and available biomass conversion technologies, biomass-based routes are expected to make a significant impact on the production of bulk chemicals within 10 years, and a huge impact within 20-30 years. In the Port of Rotterdam there is a

  11. Industrial lab-on-a-chip: design, applications and scale-up for drug discovery and delivery.

    Science.gov (United States)

    Vladisavljević, Goran T; Khalid, Nauman; Neves, Marcos A; Kuroiwa, Takashi; Nakajima, Mitsutoshi; Uemura, Kunihiko; Ichikawa, Sosaku; Kobayashi, Isao

    2013-11-01

    Microfluidics is an emerging and promising interdisciplinary technology which offers powerful platforms for precise production of novel functional materials (e.g., emulsion droplets, microcapsules, and nanoparticles as drug delivery vehicles- and drug molecules) as well as high-throughput analyses (e.g., bioassays, detection, and diagnostics). In particular, multiphase microfluidics is a rapidly growing technology and has beneficial applications in various fields including biomedicals, chemicals, and foods. In this review, we first describe the fundamentals and latest developments in multiphase microfluidics for producing biocompatible materials that are precisely controlled in size, shape, internal morphology and composition. We next describe some microfluidic applications that synthesize drug molecules, handle biological substances and biological units, and imitate biological organs. We also highlight and discuss design, applications and scale up of droplet- and flow-based microfluidic devices used for drug discovery and delivery. © 2013.

  12. Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies.

    Science.gov (United States)

    Kesisoglou, Filippos; Chung, John; van Asperen, Judith; Heimbach, Tycho

    2016-09-01

    In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of these models in the biopharmaceutics field and their use to inform formulation development. In this report, we present 5 case studies of use of such models in this biopharmaceutics/formulation space across different pharmaceutical companies. The case studies cover different aspects of biopharmaceutics or formulation questions including (1) prediction of absorption prior to FIH studies; (2) optimization of formulation and dissolution method post-FIH data; (3) early exploration of a modified-release formulation; (4) addressing bridging questions for late-stage formulation changes; and (5) prediction of pharmacokinetics in the fed state for a Biopharmaceutics Classification System class I drug with fasted state data. The discussion of the case studies focuses on how such models can facilitate decisions and biopharmaceutic understanding of drug candidates and the opportunities for increased use and acceptance of such models in drug development and regulatory interactions.

  13. GPCR structure, function, drug discovery and crystallography: report from Academia-Industry International Conference (UK Royal Society) Chicheley Hall, 1-2 September 2014.

    Science.gov (United States)

    Heifetz, Alexander; Schertler, Gebhard F X; Seifert, Roland; Tate, Christopher G; Sexton, Patrick M; Gurevich, Vsevolod V; Fourmy, Daniel; Cherezov, Vadim; Marshall, Fiona H; Storer, R Ian; Moraes, Isabel; Tikhonova, Irina G; Tautermann, Christofer S; Hunt, Peter; Ceska, Tom; Hodgson, Simon; Bodkin, Mike J; Singh, Shweta; Law, Richard J; Biggin, Philip C

    2015-08-01

    G-protein coupled receptors (GPCRs) are the targets of over half of all prescribed drugs today. The UniProt database has records for about 800 proteins classified as GPCRs, but drugs have only been developed against 50 of these. Thus, there is huge potential in terms of the number of targets for new therapies to be designed. Several breakthroughs in GPCRs biased pharmacology, structural biology, modelling and scoring have resulted in a resurgence of interest in GPCRs as drug targets. Therefore, an international conference, sponsored by the Royal Society, with world-renowned researchers from industry and academia was recently held to discuss recent progress and highlight key areas of future research needed to accelerate GPCR drug discovery. Several key points emerged. Firstly, structures for all three major classes of GPCRs have now been solved and there is increasing coverage across the GPCR phylogenetic tree. This is likely to be substantially enhanced with data from x-ray free electron sources as they move beyond proof of concept. Secondly, the concept of biased signalling or functional selectivity is likely to be prevalent in many GPCRs, and this presents exciting new opportunities for selectivity and the control of side effects, especially when combined with increasing data regarding allosteric modulation. Thirdly, there will almost certainly be some GPCRs that will remain difficult targets because they exhibit complex ligand dependencies and have many metastable states rendering them difficult to resolve by crystallographic methods. Subtle effects within the packing of the transmembrane helices are likely to mask and contribute to this aspect, which may play a role in species dependent behaviour. This is particularly important because it has ramifications for how we interpret pre-clinical data. In summary, collaborative efforts between industry and academia have delivered significant progress in terms of structure and understanding of GPCRs and will be

  14. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-07

    ... children's toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to... No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry... guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to...

  15. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Science.gov (United States)

    2013-02-08

    ... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money... responses to questions FDA has received regarding the issuance of civil money penalties for violations of...

  16. Radiative Bulk Viscosity

    CERN Document Server

    Chen, X

    2001-01-01

    Viscous resistance to changes in the volume of a gas arises when different degrees of freedom have different relaxation times. Collisions tend to oppose the resulting departures from equilibrium and, in so doing, generate entropy. Even for a classical gas of hard spheres, when the mean free paths or mean flight times of constituent particles are long, we find a nonvanishing bulk viscosity. Here we apply a method recently used to uncover this result for a classical rarefied gas to radiative transfer theory and derive an expression for the radiative stress tensor for a gray medium with absorption and Thomson scattering. We determine the transport coefficients through the calculation of the comoving entropy generation. When scattering dominates absorption, the bulk viscosity becomes much larger than either the shear viscosity or the thermal conductivity.

  17. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  18. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

    Science.gov (United States)

    Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-02-07

     To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the

  19. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Science.gov (United States)

    2013-06-25

    ... risks of crude heparin contaminants and to recommend strategies to ensure that the heparin supply chain... Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER... ruminant materials. The control of the quality of crude heparin is important to ensure the safety of...

  20. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Science.gov (United States)

    2010-11-12

    ... biological products emerges throughout a product's lifecycle. For marketed products, there may be occasions... health care providers to important new information about a marketed drug or biological product. This... them more effective communication tools for new information about marketed products. DATES: Although...

  1. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-14

    ... of RF energy, and the RF wireless emissions from one product or device could potentially affect the... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2006D-0504) Radio Frequency Wireless...) is announcing the availability of the guidance entitled ``Radio Frequency Wireless Technology in...

  2. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration... devices-- Quality management systems--Requirements for regulatory purposes,'' may voluntarily submit the... Japanese Medical Device Ministry of Health, Labour and Welfare system. This notice of availability...

  3. Characteristics of the magnetic field distribution on compact NMR magnets using cryocooled HTS bulks

    Energy Technology Data Exchange (ETDEWEB)

    Kim, S.B., E-mail: kim@elec.okayama-u.ac.j [Department of Electrical and Electronic Engineering, Okayama University, 3-1-1, Tsushima Naka, Okayama 700-8530 (Japan); Takano, R.; Nakano, T.; Imai, M. [Department of Electrical and Electronic Engineering, Okayama University, 3-1-1, Tsushima Naka, Okayama 700-8530 (Japan); Hahn, S.Y. [Francis Bitter Magnet Laboratory, MIT, NW14-3117, 170 Albany Street, Cambridge, MA 02139 (United States)

    2009-10-15

    Recently, the performance of high temperature superconducting (HTS) bulks such as critical current density, size, and mechanical strength has been improved rapidly. So, various applications using HTS bulks such as motors, bearings and flywheels have been investigated by many research groups. A compact nuclear magnetic resonance (NMR) magnet is one of the new applications after a technique to enhance maximum trapped field of the HTS bulk more than 11.7 T (500 MHz {sup 1}H NMR frequency) has been developed. This new compact NMR magnet out of HTS bulks is cost-effective compared with conventional NMR magnets and then expected to be widely used in food and drug industry. In design and manufacture of the compact NMR magnets, spatial field homogeneity of the large trapped magnetic field in HTS bulk annuli is a crucial issue because the behavior of a trapped field is highly non-linear and, as a result, a technique to improve the field homogeneity such as active/passive shimming now becomes more challenging compared with that of the conventional counterparts. This paper presents the magnetic field distributions in single and three assembled HTS bulk annuli measured by a 3-axis and multi-arrayed Hall sensor under two different cryogenic environments: (1) in a bath of liquid nitrogen (LN{sub 2}) and (2) dry cooling by a cryocooler. The spatial homogeneity changes with various operating temperatures were investigated and the effect of critical current density enhancement by lowering the operating temperature on the field homogeneity improvement was discussed in detail.

  4. Performance comparison of two herbal and industrial medicines using nanoparticles with a starch/cellulose shell and alginate core for drug delivery: In vitro studies.

    Science.gov (United States)

    Esmaeili, Akbar; Behzadi, Sahar

    2017-07-18

    In this study, the performance of two kinds of industrial and herbal drugs encapsulated in nanoparticles with a shell of starch and cellulose and an alginate core were examined as a new technique for nanoparticle drug delivery. The test method involved creating a suspension of starch and alginate, which was then dried, mixed with cellulose, and heated to form core-shell nanoparticles. The industrial drug calcitonin and an extract of the herb Amaranthus retroflexcus L. were added separately and in combination to the nanoparticles, and the performance of each configuration was evaluated. Variables like shape, size of nanoparticle, and pH were examined for their effect in vitro. Response surface methodology (RSM) was employed for optimization of parameters. The properties of the nanoparticles were studied by scanning electron microscopy (SEM) and Ultraviolet-visible spectroscopy (UV-vis). The most optimal conditions for formation of the smallest nanoparticles were found to be pH 4 with a concentration of 0.15g starch, 0.04g alginate, and 0.01g cellulose, which resulted in a spherical nanoparticle size of 25.6-68.7nm. This novel method for helping bone regeneration offers a potentially major advance in the medical treatment of osteoporosis. The results of optimization indicated that the most optimal conditions of the tests were performed at pH 4, CA=0.04, CS=0.21, and CC=0.01. In acidic pH the size of nanoparticles was less than 100nm. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Current Approaches for Absorption, Distribution, Metabolism, and Excretion Characterization of Antibody-Drug Conjugates: An Industry White Paper.

    Science.gov (United States)

    Kraynov, Eugenia; Kamath, Amrita V; Walles, Markus; Tarcsa, Edit; Deslandes, Antoine; Iyer, Ramaswamy A; Datta-Mannan, Amita; Sriraman, Priya; Bairlein, Michaela; Yang, Johnny J; Barfield, Matthew; Xiao, Guangqing; Escandon, Enrique; Wang, Weirong; Rock, Dan A; Chemuturi, Nagendra V; Moore, David J

    2016-05-01

    An antibody-drug conjugate (ADC) is a unique therapeutic modality composed of a highly potent drug molecule conjugated to a monoclonal antibody. As the number of ADCs in various stages of nonclinical and clinical development has been increasing, pharmaceutical companies have been exploring diverse approaches to understanding the disposition of ADCs. To identify the key absorption, distribution, metabolism, and excretion (ADME) issues worth examining when developing an ADC and to find optimal scientifically based approaches to evaluate ADC ADME, the International Consortium for Innovation and Quality in Pharmaceutical Development launched an ADC ADME working group in early 2014. This white paper contains observations from the working group and provides an initial framework on issues and approaches to consider when evaluating the ADME of ADCs.

  6. How to create innovation by building the translation bridge from basic research into medicinal drugs: an industrial perspective.

    Science.gov (United States)

    Germann, Paul G; Schuhmacher, Alexander; Harrison, Juan; Law, Ronald; Haug, Kevin; Wong, Gordon

    2013-03-05

    The global healthcare industry is undergoing substantial changes and adaptations to the constant decline of approved new medical entities. This decrease in internal research productivity is resulting in a major decline of patent-protected sales (patent cliff) of most of the pharmaceutical companies. Three major global adaptive trends as driving forces to cope with these challenges are evident: cut backs of internal research and development jobs in the western hemisphere (Europe and USA), following the market growth potential of Asia by building up internal or external research and development capabilities there and finally, 'early innovation hunting' with an increased focus on identifying and investing in very early innovation sources within academia and small start-up companies. Early innovation hunting can be done by different approaches: increased corporate funding, establishment of translational institutions to bridge innovation, increasing sponsored collaborations and formation of technology hunting groups for capturing very early scientific ideas and concepts. This emerging trend towards early innovation hunting demands special adaptations from both the pharmaceutical industry and basic researchers in academia to bridge the translation into new medicines which deliver innovative medicines that matters to the patient. This opinion article describes the different modalities of cross-fertilisation between basic university or publicly funded institutional research and the applied research and development activities within the pharmaceutical industry. Two key factors in this important translational bridge can be identified: preparation of both partnering organisations to open up for new and sometime disruptive ideas and creation of truly trust-based relationships between the different groups allowing long-term scientific collaborations while acknowledging that value-creating differences are an essential factor for successful collaboration building.

  7. Bulk-Fill Resin Composites

    DEFF Research Database (Denmark)

    Benetti, Ana Raquel; Havndrup-Pedersen, Cæcilie; Honoré, Daniel;

    2015-01-01

    the restorative procedure. The aim of this study, therefore, was to compare the depth of cure, polymerization contraction, and gap formation in bulk-fill resin composites with those of a conventional resin composite. To achieve this, the depth of cure was assessed in accordance with the International Organization...... for Standardization 4049 standard, and the polymerization contraction was determined using the bonded-disc method. The gap formation was measured at the dentin margin of Class II cavities. Five bulk-fill resin composites were investigated: two high-viscosity (Tetric EvoCeram Bulk Fill, SonicFill) and three low......-viscosity (x-tra base, Venus Bulk Fill, SDR) materials. Compared with the conventional resin composite, the high-viscosity bulk-fill materials exhibited only a small increase (but significant for Tetric EvoCeram Bulk Fill) in depth of cure and polymerization contraction, whereas the low-viscosity bulk...

  8. Explosive bulk charge

    Energy Technology Data Exchange (ETDEWEB)

    Miller, Jacob Lee

    2015-04-21

    An explosive bulk charge, including: a first contact surface configured to be selectively disposed substantially adjacent to a structure or material; a second end surface configured to selectively receive a detonator; and a curvilinear side surface joining the first contact surface and the second end surface. The first contact surface, the second end surface, and the curvilinear side surface form a bi-truncated hemispherical structure. The first contact surface, the second end surface, and the curvilinear side surface are formed from an explosive material. Optionally, the first contact surface and the second end surface each have a substantially circular shape. Optionally, the first contact surface and the second end surface consist of planar structures that are aligned substantially parallel or slightly tilted with respect to one another. The curvilinear side surface has one of a smooth curved geometry, an elliptical geometry, and a parabolic geometry.

  9. The Incredible Bulk

    CERN Document Server

    Fukushima, Keita; Kumar, Jason; Sandick, Pearl; Yamamoto, Takahiro

    2014-01-01

    Recent experimental results from the LHC have placed strong constraints on the masses of colored superpartners. The MSSM parameter space is also constrained by the measurement of the Higgs boson mass, and the requirement that the relic density of lightest neutralinos be consistent with observations. Although large regions of the MSSM parameter space can be excluded by these combined bounds, leptophilic versions of the MSSM can survive these constraints. In this paper we consider a scenario in which the requirements of minimal flavor violation, vanishing $CP$-violation, and mass universality are relaxed, specifically focusing on scenarios with light sleptons. We find a large region of parameter space, analogous to the original bulk region, for which the lightest neutralino is a thermal relic with an abundance consistent with that of dark matter. We find that these leptophilic models are constrained by measurements of the magnetic and electric dipole moments of the electron and muon, and that these models have ...

  10. Creating bulk nanocrystalline metal.

    Energy Technology Data Exchange (ETDEWEB)

    Fredenburg, D. Anthony (Georgia Institute of Technology, Atlanta, GA); Saldana, Christopher J. (Purdue University, West Lafayette, IN); Gill, David D.; Hall, Aaron Christopher; Roemer, Timothy John (Ktech Corporation, Albuquerque, NM); Vogler, Tracy John; Yang, Pin

    2008-10-01

    Nanocrystalline and nanostructured materials offer unique microstructure-dependent properties that are superior to coarse-grained materials. These materials have been shown to have very high hardness, strength, and wear resistance. However, most current methods of producing nanostructured materials in weapons-relevant materials create powdered metal that must be consolidated into bulk form to be useful. Conventional consolidation methods are not appropriate due to the need to maintain the nanocrystalline structure. This research investigated new ways of creating nanocrystalline material, new methods of consolidating nanocrystalline material, and an analysis of these different methods of creation and consolidation to evaluate their applicability to mesoscale weapons applications where part features are often under 100 {micro}m wide and the material's microstructure must be very small to give homogeneous properties across the feature.

  11. Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

    Science.gov (United States)

    Zetterqvist, Anna V.; Merlo, Juan; Mulinari, Shai

    2015-01-01

    companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct. Conclusions The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias. PMID:25689460

  12. Complaints, complainants, and rulings regarding drug promotion in the United Kingdom and Sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation.

    Directory of Open Access Journals (Sweden)

    Anna V Zetterqvist

    2015-02-01

    serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations and urologics (UK, n = 6; Sweden, n = 13; 9% revealed various types of violations: misleading claims (n = 23; 58%; failure to comply with undertakings (n = 9; 23%; pre-licensing (n = 7; 18% or off-label promotion (n = 2; 5%; and promotion of prescription drugs to the public (n = 6; 15%. Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct.The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias.

  13. Developing bulk exchange spring magnets

    Energy Technology Data Exchange (ETDEWEB)

    Mccall, Scott K.; Kuntz, Joshua D.

    2017-06-27

    A method of making a bulk exchange spring magnet by providing a magnetically soft material, providing a hard magnetic material, and producing a composite of said magnetically soft material and said hard magnetic material to make the bulk exchange spring magnet. The step of producing a composite of magnetically soft material and hard magnetic material is accomplished by electrophoretic deposition of the magnetically soft material and the hard magnetic material to make the bulk exchange spring magnet.

  14. The US generic drug industry: lessons from the first 25 years%美国仿制药行业发展头25年的经验教训

    Institute of Scientific and Technical Information of China (English)

    Garth Boehm; 姚立新; 韩亮; 郑强

    2012-01-01

    The lessons in the development of the US generic drug industry since the enacting of Drug Price Competition and Patent Term Restoration Act ( DPC & PTR Act) that resulted in the creation of the US generic drug industry were summarized. The evolution and key events in the development of the US generic drug industry in the first 25 years, including generic drug scandal, the evolution of approval for generic drugs, bioequivalence and switchability, bioequivalence for complicated dosage forms, patent evergreening, authorized generics, generic drug safety, the issues in generic drug review, the generic drug substitution system, $4 generics, were systemically reviewed and analyzed. The history of the first 25 years of the US Generic Drug Industry has presented several lessons which are of benefit to others wishing to establish or reestablish a domestic generic drug industry.%本文回顾了自《1984年药品价格竞争与专利期补偿法案》实施、创立美国仿制药行业以来,美国仿制药行业的发展经验和教训.对仿制药丑闻、仿制药审批制度发展、生物等效性与可替代性、复杂剂型的生物等效性方法、专利常青、授权仿制药、仿制药安全性、仿制药审评、仿制药替代、4美元仿制药等美国仿制药行业发展中的关键性事件和过程进行了系统回顾与分析.美国仿制药行业在头25年发展历程中的经验教训,对其他希望建立或重新建立国内仿制药行业的国家有借鉴作用.

  15. Advanced and new developments in bulk metal forming

    DEFF Research Database (Denmark)

    Bay, Niels; Wanheim, Tarras; Ravn, Bjarne Gottlieb

    2000-01-01

    Increasing demands to manufacturing industry of faster, better and cheaper production has intensified the research and development of bulk metal forming. The present paper gives examples on European industrial research on secondary bulk metal forming processes. The R&D follows three lines...... of approach, 1. the classical process development, 2. development of physical as well as numerical modelling techniques and 3. the thematic approach, where integrated analysis of the interactions between workpiece, tool and press are now possible with objectives like prediction of workpiece defects...

  16. Brane Couplings from Bulk Loops

    OpenAIRE

    Georgi, Howard; Grant, Aaron K.; Hailu, Girma

    2000-01-01

    We compute loop corrections to the effective action of a field theory on a five-dimensional $S_1/Z_2$ orbifold. We find that the quantum loop effects of interactions in the bulk produce infinite contributions that require renormalization by four-dimensional couplings on the orbifold fixed planes. Thus bulk couplings give rise to renormalization group running of brane couplings.

  17. Can bulk viscosity drive inflation

    Energy Technology Data Exchange (ETDEWEB)

    Pacher, T.; Stein-Schabes, J.A.; Turner, M.S.

    1987-09-15

    Contrary to other claims, we argue that bulk viscosity associated with the interactions of non- relativistic particles with relativistic particles around the time of the grand unified theory (GUT) phase transition cannot lead to inflation. Simply put, the key ingredient for inflation, negative pressure, cannot arise due to the bulk-viscosity effects of a weakly interacting mixture of relativistic and nonrelativistic particles.

  18. A Batch Feeder for Inhomogeneous Bulk Materials

    Science.gov (United States)

    Vislov, I. S.; Kladiev, S. N.; Slobodyan, S. M.; Bogdan, A. M.

    2016-04-01

    The work includes the mechanical analysis of mechanical feeders and batchers that find application in various technological processes and industrial fields. Feeders are usually classified according to their design features into two groups: conveyor-type feeders and non-conveyor feeders. Batchers are used to batch solid bulk materials. Less frequently, they are used for liquids. In terms of a batching method, they are divided into volumetric and weighting batchers. Weighting batchers do not provide for sufficient batching accuracy. Automatic weighting batchers include a mass controlling sensor and systems for automatic material feed and automatic mass discharge control. In terms of operating principle, batchers are divided into gravitational batchers and batchers with forced feed of material using conveyors and pumps. Improved consumption of raw materials, decreased loss of materials, ease of use in automatic control systems of industrial facilities allows increasing the quality of technological processes and improve labor conditions. The batch feeder suggested by the authors is a volumetric batcher that has no comparable counterparts among conveyor-type feeders and allows solving the problem of targeted feeding of bulk material batches increasing reliability and hermeticity of the device.

  19. 我国化学原料药企业产业升级的内容与途径%Contents and approaches of industrial upgrading of chemical raw drug enterprises in China

    Institute of Scientific and Technical Information of China (English)

    戴开金; 胡炜

    2011-01-01

    The chemical raw drug industry is the superior sub-industry of the pharmaceutical industry in China, but the chemical raw drug industry of China as a whole is on the bottom of the pharmaceutical industry value chain. As a result, industry development is in urgent needs of industrial upgrading. This paper has analyzed the contents and approaches of industrial upgrading from the perspective of global value chain. The proposed contents and approaches of industrial upgrad -ing include integrating the supply chain, optimizing the varieties, applying for international certification, strengthening tech -nical transformation and innovation, extending the industry chain, striving for international research and development out -sourcing, implementing industrial re-transfer, etc. It also proposes to take integrating the supply chain, improving products quality, optimizing the product structure and strengthening technology transformation and technological innovation as the core of industrial upgrading, strengthening rush imitation of raw drugs with expired patent or expiring patent, developing the formulation industry at the right time and extending the industry chain under mature conditions. It can develop into the generic drug supplier gradually by relying on technological innovation, and realize the industrial upgrading through innova -tive new drugs development, production and marketing, as the reference for persons concerned.%化学原料药是我国医药行业的优势子行业,但我国化学原料药行业整体上处于国际医药行业价值链的底端,产业升级是行业发展的迫切需求.本文从全球价值链的角度分析产业升级的内容和途径,提出产业升级的内容与途径有:整合供应链、优化品种、争取国际认证、加强技术改造和技术创新、延伸产业链、争取国际研发外包以及实行产业再转移等.本文同时提出把整合供应链、提高产品质量、优化产品结构、加大技术改造和

  20. Integrated analysis software for bulk power system stability

    Energy Technology Data Exchange (ETDEWEB)

    Tanaka, T.; Nagao, T.; Takahashi, K. [Central Research Inst. of Electric Power Industry, Tokyo (Japan)

    1994-12-31

    This paper presents Central Research Inst.of Electric Power Industry - CRIEPI`s - own developed three softwares for bulk power network analysis and the user support system which arranges tremendous data necessary for these softwares with easy and high reliability. (author) 3 refs., 7 figs., 2 tabs.

  1. 我国医药产业创新药物研发面临的问题及对策探讨%Discussion on Problems of Innovative Drug R&D Faced by Pharmaceutical Industry and Countermeasures in China

    Institute of Scientific and Technical Information of China (English)

    刘昌孝

    2012-01-01

    目的:为推动我国医药产业创新药物研发提供参考.方法:在研究我国创新药物研发现状的基础上,分析创新药物研发所面临的问题.结果与结论:我国创新药物研发面临研发资金投入不足、研发主题错位、知识产权保护不力、机制落后等问题.建议加大研发资金投入、促使企业成为研发主体、完善知识产权保护、优化相关机制.相信随着我国医药产业结构的调整,行业规范日趋合理,市场运行机制日趋完善,一定能够实现从原料药和仿制药大国到创新药大国的跨越.%OBJECTIVE: To provide reference for the promotion of innovative drug R&D in pharmaceutical industry in China. METHODS: Based on the status quo of innovative drug R&D in China, the problems of innovative drug R&D were analyzed. RE-SULTS&CONCLUSION: The problems of innovative drug R&D are inadequate fund, R&D subject misplacement, insufficient intellectual property protection, behindhand mechanism, etc. It is suggested to expand input, promote enterprise to be R&D subject, perfect intellectual property protection, optimize related mechanism. The crossover from raw material drug and global generic-drugs great power to innovative drug great power could be realized by adjusting pharmaceutical industrial structure, standardizing industry norms, perfecting operation mechanism.

  2. Bulk solitary waves in elastic solids

    Science.gov (United States)

    Samsonov, A. M.; Dreiden, G. V.; Semenova, I. V.; Shvartz, A. G.

    2015-10-01

    duct-like polymer shell and proved, that there is no tensile area behind the wave, the bulk soliton propagates on a distance many times longer than its wave length, while both its shape and amplitude remain unchanged. We demonstrated recently how the strain solitons can be used for non-destructive testing (NDT) of laminated composites, used nowadays for various applications, e.g., in microelectronics, aerospace and automotive industries, and bulk strain solitons are among prospective instruments for NDT. Being aimed to propose the bulk strain solitons as an instrument for NDT in solids, we studied numerically the evolution of them in various wave guides with local defects, and shown that the strain soliton undergoes changes in amplitude, phase shift and the shape, that are distinctive and can be estimated. To sum up, now we are able to propose a new NDT technique, based on bulk strain soliton propagation in structural elements.

  3. Can bulk viscosity drive inflation

    Energy Technology Data Exchange (ETDEWEB)

    Pacher, T.; Stein-Schabes, J.A.; Turner, M.S.

    1987-04-01

    Contrary to other claims, we argue that, bulk viscosity associated with the interactions of nonrelativistic particles with relativistic particles around the time of the grand unified theory (GUT) phase transition cannot lead to inflation. Simply put, the key ingredient for inflation, negative pressure, cannot arise due to the bulk viscosity effects of a weakly-interacting mixture of relativistic and nonrelativistic particles. 13 refs., 1 fig.

  4. Food and Drug Administration

    Science.gov (United States)

    ... trials, Critical Path Initiative and more Icon for Business & Industry section. For Industry Guidance, registration and listing, ... Map Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 ...

  5. 新形势下食品药品的人才培养与产业发展%Train of Talented Person and Industry Development of Food and Drug Under the New Situation

    Institute of Scientific and Technical Information of China (English)

    姚晓敏; 王国康; 林爱斌

    2014-01-01

    In an increasingly competitive moment, train of talented person and industry development of food and drug, which are complementary and inseparable, are all endowed the new requirements of the times. Namely, industry development of food and drug leads the direction to train of talented person, and provides the needs of train of talented person, while train of talented person boosts industry development again. Only the coordination of train of talented person and industry development in the development process, and common development of science, high-quality talented persons can been obtained, industry development of safe and high efficiency can been promoted.%在竞争日趋激烈的当下,食品药品的人才培养与产业发展均赋予了新时代要求,且二者相辅相成,密不可分。即产业发展引领人才培养方向、提供人才培养的必需;而人才培养又助推产业发展。只有两者在发展过程中相互协调,共同科学的发展,才能得到高素质食品药品专业的人才资源,同时又促进安全高效的食品药品产业发展。

  6. Análise comparativa da concentração industrial e de turnover da indústria farmacêutica no Brasil para os segmentos de medicamentos de marca e genéricos Comparative analysis of the Industrial Concentration and Turnover of the pharmaceutical industry in Brazil for the segments of mark and generic drugs

    Directory of Open Access Journals (Sweden)

    Gerson Rosenberg

    2010-04-01

    Full Text Available Este artigo analisa a evolução da estrutura do segmento de medicamentos de marca e genéricos no Brasil a partir de 1997. Após a entrada dos medicamentos genéricos, constatou-se que não houve diminuição significativa da concentração na indústria farmacêutica brasileira, porém, o mesmo não ocorreu em nível mundial, verificando-se um aumento da concentração a partir de 2001, impulsionado pelo expressivo processo de fusões e aquisições nos últimos anos da década de 1990. Em relação ao turnover, notou-se que este foi muito baixo para o grupo das maiores empresas em ambos os segmentos de medicamentos. Entretanto, observa-se um elevado turnover com a entrada dos genéricos, mostrando o fortalecimento da indústria nacional. Verifica-se que o processo de fusões e aquisições entre empresas nacionais é pouco significativo, o que pode ser uma alternativa para as pequenas empresas farmacêuticas aumentarem a sua participação no mercado brasileiro.This paper analyzes the evolution of brand-name and generic drugs structure in Brazil since 1997. After the introduction of generic drugs it was not verified a significant decrease in the concentration of Brazilian pharmaceutical industry. The process of mergers and acquisitions in the 90's enhanced the process of concentration in the international market. However, a non-expressive turnover can be demonstrated in both pharmaceutical and generic markets. At the same time, the entrance of the generic industry in Brazil explains the invigoration of the national industry. The mergers and acquisitions process in the pharmaceutical industry is quite intense in Europe and in the USA, although in Brazil it is still not significant.

  7. Industrial Hygiene Air Sampling and Bulk Sampling Instructions

    Science.gov (United States)

    1990-12-01

    PCBs) 13 - SKC 225-16 37 Gelman Type A/E PTFE (Zefluor) 37 2 Gelman P5PJ037 (For PAH) 37 2 Membrana - PVC 37 5 Gelman 66467 37 5 Nuclepore 361850 filter...665-0651 800-752-8472 800-521-1520 10. Supelco 4. Membrana Inc. Supelco Park 7070 Commerce Circle Bellefonte, PA 16823-0048 Pleasanton, CA 94566-3294

  8. Microalgae bulk growth model with application to industrial scale systems

    NARCIS (Netherlands)

    Quinn, J.; Winter, de L.; Bradley, T.

    2011-01-01

    The scalability of microalgae growth systems is a primary research topic in anticipation of the commercialization of microalgae-based biofuels. To date, there is little published data on the productivity of microalgae in growth systems that are scalable to commercially viable footprints. To inform

  9. Microalgae bulk growth model with application to industrial scale systems

    NARCIS (Netherlands)

    Quinn, J.; Winter, de L.; Bradley, T.

    2011-01-01

    The scalability of microalgae growth systems is a primary research topic in anticipation of the commercialization of microalgae-based biofuels. To date, there is little published data on the productivity of microalgae in growth systems that are scalable to commercially viable footprints. To inform t

  10. Microalgae bulk growth model with application to industrial scale systems

    NARCIS (Netherlands)

    Quinn, J.; Winter, de L.; Bradley, T.

    2011-01-01

    The scalability of microalgae growth systems is a primary research topic in anticipation of the commercialization of microalgae-based biofuels. To date, there is little published data on the productivity of microalgae in growth systems that are scalable to commercially viable footprints. To inform t

  11. The potential for bulk undercooling as an industrial process

    Science.gov (United States)

    Laxmanan, V.

    1984-01-01

    The main focus is on solidification occurring in highly supercooled melts. Solidification rates in such melts are extremely high, an attractive feature from a commercial standpoint. Thus, the reported growth velocities for pure Ni and Co dendrites at a supercooling of 175 K are in excess of 180 km/hr. Rapidly quenched crystalline alloys produced by various atomization processes (e.g., centrifugal atomization or inert gas atomization) or melt spinning are examples of solidification processes, currently being intensively explored commercially, wherein extremely high solidification rates are achieved. Estimated dendrite tip growth rates are about 2 km/hr in a binary Al-4.5 wt % alloy, with a heat transfer coefficient of 6.4x10 sub 5 w/sq cm K or 15 cal/cu cm sK. In the limit, when the solidification rate exceeds a critical value, a glassy microstructure is obtained even in highly alloyed melts, which under normal conditions would solidity to form one or more crystalline phases. Glassy metals, also called metallic glasses, are candidate materials for distribution transformers because of their very low energy losses and are also being used in brazing and soldering applications.

  12. Analysis and Suggestions on the Current Status of Chinese Veterinary Drug Industry Production Development%我国兽药产业发展现状分析与建议

    Institute of Scientific and Technical Information of China (English)

    李逸波; 周瑾; 张亮

    2015-01-01

    The paper analyzed and discussed the situation and problems of veterinary drug industry from the two aspects of industrial organization and production results. The research results shows that Chinese veterinary drug industry has characteristics such as total scale of enterprises is huge, obvious structural and regional differences, big differences of output value and production capacity utilization level among different categories of enterprises, high and stable product sampling qualified rate, etc. While, from the aspect of the whole industry, Chinese veterinary drug industry has also some problems such as low industry concentration level, diseconomy of scale, low-level redundant construction, low profit, irrational industrial structure, and irregularities of industrial organization internal management, etc. Therefore, it is urgent for the government to reasonably layout plan, accelerate structural adjustment, allocate resources combined with enterprises, ensure industrial operation efficiency; besides, the enterprises should be people-oriented, pay great attention to the talents and management, and increase their own strength.%我国兽药产业呈现企业总量规模较庞大,结构差异性与区域性明显,不同类别企业产值、产能利用水平差异大,出厂产品的抽检合格率水平较高且较为稳定等特点。但就产业整体来看,我国兽药产业生产环节存在产业集中水平低,规模不经济;低水平重复建设,利润低;产业结构不合理;产业组织内部管理不规范等问题。因此,亟待政府合理规划布局,加速结构调整;政府与企业联合配置资源,保障产业运行效率;企业内部也需以人为本,重视人才与管理,提升企业自身实力。

  13. Looking for a bulk point

    CERN Document Server

    Maldacena, Juan; Zhiboedov, Alexander

    2015-01-01

    We consider Lorentzian correlators of local operators. In perturbation theory, singularities occur when we can draw a position-space Landau diagram with null lines. In theories with gravity duals, we can also draw Landau diagrams in the bulk. We argue that certain singularities can arise only from bulk diagrams, not from boundary diagrams. As has been previously observed, these singularities are a clear diagnostic of bulk locality. We analyze some properties of these perturbative singularities and discuss their relation to the OPE and the dimensions of double-trace operators. In the exact nonperturbative theory, we expect no singularity at these locations. We prove this statement in 1+1 dimensions by CFT methods.

  14. Investigations of waste heat recovery from bulk milk cooler

    OpenAIRE

    S.N. Sapali; S.M. Pise; A.T. Pise; D.V. Ghewade

    2014-01-01

    Bulk milk coolers are used to chill the milk from its harvest temperature of 35–4 °C to arrest the bacterial growth and maintain the quality of harvested milk. Milk chilling practices are energy intensive with low coefficient of performance (COP) of about 3.0. Increased energy cost concern encouraged an investigation of heat recovery from bulk milk cooler as one conservation alternative for reducing water heating cost in dairy industry. Heat dissipated to atmosphere through condenser is recov...

  15. Dry bulk freight rates and chartering: players, strategy and the market

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-12-31

    The report focuses on three vital areas of the dry bulk charter market: strategic chartering choices; roles of key players; and market cycles. It gives an overview of the bulk shipping and charter market and discusses the mechanics of bulk chartering methods and options. It goes on to consider the strategic choices available for bulk chartering decisions. The next section identifies market players amongst cargo owners, charterers and bulk shipping operations. This includes the coal, iron ore, foods, petroleum coke, steel, and cement industries. Past trends in the dry bulk market and freight rates are analyzed and the driving forces and potential for change in the bulk charter market are discussed. Appendices include data on seaborne trade, fleet development, chartering activity, freight rates, and time charter fixtures.

  16. Bulk nano-crystalline alloys

    OpenAIRE

    T.-S. Chin; Lin, C. Y.; Lee, M.C.; R.T. Huang; S. M. Huang

    2009-01-01

    Bulk metallic glasses (BMGs) Fe–B–Y–Nb–Cu, 2 mm in diameter, were successfully annealed to become bulk nano-crystalline alloys (BNCAs) with α-Fe crystallite 11–13 nm in size. A ‘crystallization-and-stop’ model was proposed to explain this behavior. Following this model, alloy-design criteria were elucidated and confirmed successful on another Fe-based BMG Fe–B–Si–Nb–Cu, 1 mm in diameter, with crystallite sizes 10–40 nm. It was concluded that BNCAs can be designed in general by the proposed cr...

  17. Pharmacist-industry relationships.

    Science.gov (United States)

    Saavedra, Keene; O'Connor, Bonnie; Fugh-Berman, Adriane

    2017-01-18

    The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry. An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis. All pharmacists reported interactions with pharmaceutical company representatives. Most had received free resources or services from industry, including educational courses. Respondents uniformly believed that industry promotional efforts are primarily directed towards physicians. Although respondents felt strongly that drug prices were excessive and that 'me-too' drugs were of limited use, they generally had a neutral-to-positive view of industry-funded adherence/compliance programmes, coupons, vouchers, and copay payment programmes. Interviewees viewed direct-to-consumer advertising negatively, but had a generally positive view of industry-funded drug information. Pharmacists may represent a hitherto under-identified cohort of health professionals who are targeted for industry influence; expanding roles for pharmacists may make them even more attractive targets for future industry attention. Pharmacy schools should ensure that students learn to rely on unbiased information sources and should teach students about conflicts of interest and the risks of interacting with industry. Further research should be conducted on the extent to which pharmacists' attitudes towards their duties and towards drug assessment and recommendation are influenced by the pharmaceutical industry. © 2017 Royal Pharmaceutical Society.

  18. Longitudinal bulk acoustic mass sensor

    DEFF Research Database (Denmark)

    Hales, Jan Harry; Teva, Jordi; Boisen, Anja

    2009-01-01

    A polycrystalline silicon longitudinal bulk acoustic cantilever is fabricated and operated in air at 51 MHz. A mass sensitivity of 100 Hz/fg (1 fg=10(-15) g) is obtained from the preliminary experiments where a minute mass is deposited on the device by means of focused ion beam. The total noise...

  19. Bulk viscosity and deflationary universes

    CERN Document Server

    Lima, J A S; Waga, I

    2007-01-01

    We analyze the conditions that make possible the description of entropy generation in the new inflationary model by means of a nearequilibrium process. We show that there are situations in which the bulk viscosity cannot describe particle production during the coherent field oscillations phase.

  20. The Universe With Bulk Viscosity

    Institute of Scientific and Technical Information of China (English)

    2003-01-01

    Exact solutions for a model with variable G, A and bulk viscosity areobtained. Inflationary solutions with constant (de Sitter-type) and variable energydensity are found. An expanding anisotropic universe is found to isotropize duringits expansion but a static universe cannot isotropize. The gravitational constant isfound to increase with time and the cosmological constant decreases with time asAo∝t-2.

  1. Determination of te spontaneous ignition temperature of bulk materials. Simple to handle possibility for the practice; Bestimmung der Selbstentzuendungstemperatur von Schuettguetern. Einfach handhabbarer Weg fuer die Praxis

    Energy Technology Data Exchange (ETDEWEB)

    Kimpel, Sebastian; Horn, Joerg; Franke, Juergen [consilab Gesellschaft fuer Anlagensicherheit mbH, Frankfurt am Main (Germany)

    2012-06-15

    Bulk materials are widely used in industry. Bulk materials come up not only in mining (coal), in agriculture (flour) and food industry (coffee), but also in the pharmaceutical industry for example in the production of specialty chemicals and pigments. Mass-produced goods in tonnages are produced, processed, transported and stored. Due to the poor heat transfer in the bulks the relatively large storage volumes are especially critical in view of a possible self-ignition.

  2. Towards the first generation micro bulk forming system

    DEFF Research Database (Denmark)

    Arentoft, Mogens; Eriksen, Rasmus Solmer; Hansen, Hans Nørgaard

    2011-01-01

    The industrial demand for micro mechanical components has surged in the later years with the constant introduction of more integrated products. The micro bulk forming process holds a promising pledge of delivering high quality micro mechanical components at low cost and high production rates. Thi...... press. The system is demonstrated on an advanced micro forming case where a dental component is formed in medical grade Titanium....

  3. Introduction to bulk metallic glass composite and its recent applications

    OpenAIRE

    2011-01-01

    Bulk metallic glass (BMG) materials are hot topics in recent years, not to mention BMG matrix composites, which further improve the magnetic and mechanical properties of BMG materials. BMG and BMG matrix materials are fast developing and promising materials in modern industry due to their extraordinary properties such as high strength, low density, excellent resistibility to high temperature and corrosion. In this paper, I reviewed processing and application of several recently developed BMG ...

  4. Cosmic bulk viscosity through backreaction

    CERN Document Server

    Barbosa, Rodrigo M; Zimdahl, Winfried; Piattella, Oliver F

    2015-01-01

    We consider an effective viscous pressure as the result of a backreaction of inhomogeneities within Buchert's formalism. The use of an effective metric with a time-dependent curvature radius allows us to calculate the luminosity distance of the backreaction model. This quantity is different from its counterpart for a "conventional" spatially flat bulk viscous fluid universe. Both expressions are tested against the SNIa data of the Union2.1 sample with only marginally different results.

  5. Industrial diamond

    Science.gov (United States)

    Olson, D.W.

    2001-01-01

    An overview of the industrial diamond industry is provided. More than 90 percent of the industrial diamond consumed in the U.S. and the rest of the world is manufactured diamond. Ireland, Japan, Russia, and the U.S. produce 75 percent of the global industrial diamond output. In 2000, the U.S. was the largest market for industrial diamond. Industrial diamond applications, prices for industrial diamonds, imports and exports of industrial diamonds, the National Defense Stockpile of industrial diamonds, and the outlook for the industrial diamond market are discussed.

  6. 企业付费法案与仿制药产业发展%Generic User Fee Program and its impacts on the development of the generic drug industry

    Institute of Scientific and Technical Information of China (English)

    Garth Boehm; 姚立新; 郑强

    2013-01-01

    目的:研究美国FDA如何借助企业付费的方法来应对药品生产、供应全球化和不断增长的工作量的挑战,以便提高药品可及性和缓解药品短缺.方法:根据美国FDA、国会和政府问责办公室的资料及业界报告等,分析企业付费对保证药品安全性、可及性和监管机构透明度方面的作用.结果:采取公开、整体性的企业付费方式,有助于加速仿制药审评、实现海内外生产设施检查频率一致、保障药品的可及性和安全性及增加监管透明度.结论:仿制药企业付费法案对推动政企合作,合理利用企业资源,解决监管机构、产业界和利益攸关方共同面对的棘手问题,推动全球化时代药品监管方式的转变,提供了一条可行的途径.%Objective: To explore the user fee approach taken by the FDA to deal with the challenges from pharmaceutical manufacturing, supply globalization, and the review backlog that has kept escalating continuously to expedite the access of the drug products and mitigate the drug shortage. Methods: the impacts of the user fee on the safety, accessibility of the generic drugs and transparency of the regulatory agency were analyzed based on the reports of the FDA, U. S. Congress, GAO, and the industry. Results:The open and holistic program of the user fee can facilitate the streamlining of the generic drug review, ensuring the safety and access of the drug products, and improving the transparency of the regulatory agency. Conclusion: The generic drug user fee provides with a feasible approach to promote public-private partnership by using the enterprise resources to deal with the issues faced by the regulatory agency, industry and the stakeholders in the globalization of the pharmaceutical industry, and promote the paradigm shift of pharmaceutical regulation in the age of globalization.

  7. Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation

    OpenAIRE

    Anna V Zetterqvist; Juan Merlo; Shai Mulinari

    2015-01-01

    Editors' Summary Background Making and selling medicines is big business. In 2013, the global revenue of pharmaceutical companies was nearly US$1 trillion. And every year, a large proportion of this revenue—maybe as much as one-third—is spent on drug promotion. The pharmaceutical companies claim that drug promotion (for example, advertisements in journals and visits from pharmaceutical sales representatives) helps to inform and educate health care professionals about the risks and benefits of...

  8. Bulk Moisture and Salinity Sensor

    Science.gov (United States)

    Nurge, Mark; Monje, Oscar; Prenger, Jessica; Catechis, John

    2013-01-01

    Measurement and feedback control of nutrient solutions in plant root zones is critical to the development of healthy plants in both terrestrial and reduced-gravity environments. In addition to the water content, the amount of fertilizer in the nutrient solution is important to plant health. This typically requires a separate set of sensors to accomplish. A combination bulk moisture and salinity sensor has been designed, built, and tested with different nutrient solutions in several substrates. The substrates include glass beads, a clay-like substrate, and a nutrient-enriched substrate with the presence of plant roots. By measuring two key parameters, the sensor is able to monitor both the volumetric water content and salinity of the nutrient solution in bulk media. Many commercially available moisture sensors are point sensors, making localized measurements over a small volume at the point of insertion. Consequently, they are more prone to suffer from interferences with air bubbles, contact area of media, and root growth. This makes it difficult to get an accurate representation of true moisture content and distribution in the bulk media. Additionally, a network of point sensors is required, increasing the cabling, data acquisition, and calibration requirements. measure the dielectric properties of a material in the annular space of the vessel. Because the pore water in the media often has high salinity, a method to measure the media moisture content and salinity simultaneously was devised. Characterization of the frequency response for capacitance and conductance across the electrodes was completed for 2-mm glass bead media, 1- to 2-mm Turface (a clay like media), and 1- to 2-mm fertilized Turface with the presence of root mass. These measurements were then used to find empirical relationships among capacitance (C), the dissipation factor (D), the volumetric water content, and the pore water salinity.

  9. Toughness of Bulk Metallic Glasses

    Directory of Open Access Journals (Sweden)

    Shantanu V. Madge

    2015-07-01

    Full Text Available Bulk metallic glasses (BMGs have desirable properties like high strength and low modulus, but their toughness can show much variation, depending on the kind of test as well as alloy chemistry. This article reviews the type of toughness tests commonly performed and the factors influencing the data obtained. It appears that even the less-tough metallic glasses are tougher than oxide glasses. The current theories describing the links between toughness and material parameters, including elastic constants and alloy chemistry (ordering in the glass, are discussed. Based on the current literature, a few important issues for further work are identified.

  10. 医药产业及药品研发的现状与思考%Current situation and thinking of the pharmaceutical industry and drug R&D

    Institute of Scientific and Technical Information of China (English)

    王华; 杨悦

    2011-01-01

    文中采用文献研究、比较研究方法,介绍了全球医药市场及药品研发现状,分析了我国的有利和不利因素,针对不足之处进行思考,并提出了建议.目前,我国医药产业机遇和挑战并存,建议有关各方加大药品研发投入、提高企业药品研发能力、加强药品知识产权保护等.%Based on literature and comparative methods, we introduced the current situation of the global pharmaceutical market and drug R&D, analyzed the advantages and disadvantages, and considered the solutions. The pharmaceutical industry and drug R&D in our country are now facing both opportunities and challenges, so we need to increase R&D investment, improve drug research capabilities, consummate drug intellectual property protection, and so on.

  11. Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional Generic drugs in Brazil: impacts of public policies upon the national industry

    Directory of Open Access Journals (Sweden)

    Cristiane Quental

    2008-04-01

    Full Text Available O presente artigo faz eco a trabalhos recentes da Abrasco¹, Gadelha² e Guimarães³, que enfatizam a necessidade de uma maior integração entre as políticas voltadas para o desenvolvimento do sistema de saúde e aquelas voltadas para a promoção do desenvolvimento industrial e da inovação, como forma de garantir para o país os benefícios econômicos gerados pelos gastos em saúde, assegurando a continuidade da política social, num círculo virtuoso. Embora apresente o caso dos medicamentos genéricos como uma experiência de sucesso na integração das políticas sociais voltadas para um maior acesso da população a medicamentos com qualidade garantida, com as políticas econômicas voltadas para o desenvolvimento industrial, discute os impactos e as limitações da política dialogando com a análise da competitividade da indústria de medicamentos genéricos brasileira realizada por Abreu4.This paper echoes recent works of Abrasco¹, Gadelha² and Guimarães³ emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

  12. Organization of bulk power markets: A concept paper

    Energy Technology Data Exchange (ETDEWEB)

    Kahn, E.; Stoft, S. [Lawrence Berkeley Lab., CA (United States). Energy and Environment Div.

    1995-12-01

    The electricity industry in the US today is at a crossroads. The restructuring debate going on in most regions has made it clear that the traditional model of vertically integrated firms serving defined franchise areas and regulated by state commissions may not be the pattern for the future. The demands of large customers seeking direct access to power markets, the entry of new participants, and proposed reforms of the regulatory process all signify a momentum for fundamental change in the organization of the industry. This paper addresses electricity restructuring from the perspective of bulk power markets. The authors focus attention on the organization of electricity trade and the various ways it has been and might be conducted. Their approach concentrates on conceptual models and empirical case studies, not on specific proposals made by particular utilities or commissions. They review literature in economics and power system engineering that is relevant to the major questions. The objective is to provide conceptual background to industry participants, e.g. utility staff, regulatory staff, new entrants, who are working on specific proposals. While they formulate many questions, they do not provide definitive answers on most issues. They attempt to put the industry restructuring dialogue in a neutral setting, translating the language of economists for engineers and vice versa. Towards this end they begin with a review of the basic economic institutions in the US bulk power markets and a summary of the engineering practices that dominate trade today.

  13. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study

    Science.gov (United States)

    Hughes, Shannon; Cohen, David; Jaggi, Rachel

    2014-01-01

    Objective To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies. Design Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles. Setting Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health. Main outcome measure 3 coders extracted data on the numbers and types of SAEs. Results 244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles’ (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; pjournal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov. Conclusions Substantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to complete and accurate data from clinical trials of drugs currently in use remains a

  14. New fermions in the bulk

    CERN Document Server

    de Brito, K P S

    2016-01-01

    Spinor fields on 5-dimensional Lorentzian manifolds are classified, according to the geometric Fierz identities that involve their bilinear covariants. Based upon this classification that generalises the celebrated 4-dimensional Lounesto classification of spinor fields, new non-trivial classes of 5-dimensional spinor fields are, hence, found, with important potential applications regarding bulk fermions and their subsequent localisation on brane-worlds. In addition, quaternionic bilinear covariants are used to derive the quaternionic spin density, through the truncated exterior bundle. In order to accomplish a realisation of these new spinors, a Killing vector field is constructed on the horizon of 5-dimensional Kerr black holes. This Killing vector field is shown to reach the time-like Killing vector field at the spatial infinity, through a current 1-form density, constructed with the derived new spinor fields. The current density is, moreover, expressed as the f\\"unfbein components, assuming a condensed for...

  15. New fermions in the bulk

    Science.gov (United States)

    de Brito, K. P. S.; da Rocha, Roldão

    2016-10-01

    The spinor fields on 5-dimensional Lorentzian manifolds are classified according to the geometric Fierz identities, which involve their bilinear covariants. Based upon this classification, which generalises the celebrated 4-dimensional Lounesto classification of spinor fields, new non-trivial classes of 5-dimensional spinor fields are hence found, with important potential applications regarding bulk fermions and their subsequent localisation on brane-worlds. In addition, quaternionic bilinear covariants are used to derive the quaternionic spin density through the truncated exterior bundle. In order to accomplish the realisation of these new spinors, a Killing vector field is constructed on the horizon of a 5-dimensional Kerr black hole. This Killing vector field is shown to reach the time-like Killing vector field at spatial infinity through a current 1-form density, constructed with the new derived spinor fields. The current density is, moreover, expressed as the fünfbein component, assuming a condensed form.

  16. Nanofluidics, from bulk to interfaces.

    Science.gov (United States)

    Bocquet, Lydéric; Charlaix, Elisabeth

    2010-03-01

    Nanofluidics has emerged recently in the footsteps of microfluidics, following the quest for scale reduction inherent to nanotechnologies. By definition, nanofluidics explores transport phenomena of fluids at nanometer scales. Why is the nanometer scale specific? What fluid properties are probed at nanometric scales? In other words, why does 'nanofluidics' deserve its own brand name? In this critical review, we will explore the vast manifold of length scales emerging for fluid behavior at the nanoscale, as well as the associated mechanisms and corresponding applications. We will in particular explore the interplay between bulk and interface phenomena. The limit of validity of the continuum approaches will be discussed, as well as the numerous surface induced effects occurring at these scales, from hydrodynamic slippage to the various electro-kinetic phenomena originating from the couplings between hydrodynamics and electrostatics. An enlightening analogy between ion transport in nanochannels and transport in doped semi-conductors will be discussed (156 references).

  17. Permanent magnet with MgB{sub 2} bulk superconductor

    Energy Technology Data Exchange (ETDEWEB)

    Yamamoto, Akiyasu, E-mail: yamamoto@appchem.t.u-tokyo.ac.jp [The University of Tokyo, 7-3-1 Hongo, Bunkyo, Tokyo 113-8656 (Japan); JST-PRESTO, 4-1-8 Honcho, Kawaguchi, Saitama 332-0012 (Japan); Ishihara, Atsushi; Tomita, Masaru [Railway Technical Research Institute, 2-8-38 Hikari, Kokubunji, Tokyo 185-8540 (Japan); Kishio, Kohji [The University of Tokyo, 7-3-1 Hongo, Bunkyo, Tokyo 113-8656 (Japan)

    2014-07-21

    Superconductors with persistent zero-resistance currents serve as permanent magnets for high-field applications requiring a strong and stable magnetic field, such as magnetic resonance imaging. The recent global helium shortage has quickened research into high-temperature superconductors (HTSs)—materials that can be used without conventional liquid-helium cooling to 4.2 K. Herein, we demonstrate that 40-K-class metallic HTS magnesium diboride (MgB{sub 2}) makes an excellent permanent bulk magnet, maintaining 3 T at 20 K for 1 week with an extremely high stability (<0.1 ppm/h). The magnetic field trapped in this magnet is uniformly distributed, as for single-crystalline neodymium-iron-boron. Magnetic hysteresis loop of the MgB{sub 2} permanent bulk magnet was determined. Because MgB{sub 2} is a simple-binary-line compound that does not contain rare-earth metals, polycrystalline bulk material can be industrially fabricated at low cost and with high yield to serve as strong magnets that are compatible with conventional compact cryocoolers, making MgB{sub 2} bulks promising for the next generation of Tesla-class permanent-magnet applications.

  18. Epitaxial and bulk growth of cubic silicon carbide on off-oriented 4H-silicon carbide substrates

    OpenAIRE

    Norén, Olof

    2015-01-01

    The growth of bulk cubic silicon carbide has for a long time seemed to be something for the future. However, in this thesis the initial steps towards bulk cubic silicon carbide have been taken. The achievement of producing bulk cubic silicon carbide will have a great impact in various fields of science and industry such as for example the fields of semiconductor technology within electronic- and optoelectronic devices and bio-medical applications. The process that has been used to grow the bu...

  19. Industry Employment

    Science.gov (United States)

    Occupational Outlook Quarterly, 2012

    2012-01-01

    This article illustrates projected employment change by industry and industry sector over 2010-20 decade. Workers are grouped into an industry according to the type of good produced or service provided by the establishment for which they work. Industry employment projections are shown in terms of numeric change (growth or decline in the total…

  20. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study

    OpenAIRE

    Hughes, S; Cohen, D.; Jaggi, R

    2014-01-01

    Objective: To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies. Design: Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles. Setting: Clinicalstudyresults.org, sponsored by Pharmaceutical Research and M...

  1. Industry sponsorship and research outcome

    DEFF Research Database (Denmark)

    Lundh, Andreas; Sismondo, Sergio; Lexchin, Joel

    2012-01-01

    Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor's product compared with studies...

  2. Industrial Chain: Industrial Vertical Definition

    Institute of Scientific and Technical Information of China (English)

    YifeiDu; GuojunJiang; ShimingLi

    2004-01-01

    Like value chain and supply chain, “industrial chain” becomes the focus of attention. The implication of “industrial chain” has gained a large range of extension. It not only expresses the industrial “chain” structure and relationship of “back and forward”in order or “up and down” in direction, but also it represents a cluster of large scale of firms in an area or colony. It is a network, or a community. Consequently, we conclude that “industrial chain” is a synthesis of industrial chain, industrial cluster, or industrial network.In this article, firstly we will distinguish industry chain from industry. An industry is the collection of firms that have the same attribute, so an industry can be defined by firm collection of certain attribute. We indicate that industrial chain is a kind of vertical and orderly industrial link. It is defined according to a series of specific product or service created. Secondly we analyze the vertical orderly defiinition process from the aspects of social division of labor and requirement division, self-organization system, and value analysis.Non-symmetry and depending on system or community of large scale of industrial units lead to entire industry to “orderly” structure. On the other hand, the draught of diversity and complexity of requirement simultaneously lead to entire industry to be more “orderly”. Along with processes of self-organization, industrial will appi'oach the state of more orderly and steady, and constantly make industrial chain upgrade. Each firm or unit, who will gain the value, has to establish channels of value, which we called “industrial value chain”. Lastly,we discuss the consequence of vertical and orderly definition, which is exhibited by a certain relationship body. The typical forms of industrial chain include industrial cluster, strategy alliance and vertical integration etc.

  3. Carrier Bulk-Lifetime Measurements

    Directory of Open Access Journals (Sweden)

    M. Solcansky

    2012-01-01

    Full Text Available For the measurement of the minority carrier bulk-lifetime the characterization method MW-PCD is used, where the result of measurement is the effective carrier lifetime, which is very dependent on the surface recombination velocity and therefore on the quality of a silicon surface passivation. This work deals with an examination of a different solution types for the chemical passivation of a silicon surface. Various solutions are tested on silicon wafers for their consequent comparison. The main purpose is to find optimal solution, which suits the requirements of a time stability and start-up velocity of passivation, reproducibility of the measurements and a possibility of a perfect cleaning of a passivating solution remains from a silicon surface, so that the parameters of a measured silicon wafer will not worsen and there will not be any contamination of the other wafers series in the production after a repetitive return of the measured wafer into the production process. The cleaning process itself is also a subject of a development.

  4. Coupling brane fields to bulk supergravity

    Energy Technology Data Exchange (ETDEWEB)

    Parameswaran, Susha L. [Uppsala Univ. (Sweden). Theoretical Physics; Schmidt, Jonas [Deutsches Elektronen-Synchrotron (DESY), Hamburg (Germany)

    2010-12-15

    In this note we present a simple, general prescription for coupling brane localized fields to bulk supergravity. We illustrate the procedure by considering 6D N=2 bulk supergravity on a 2D orbifold, with brane fields localized at the fixed points. The resulting action enjoys the full 6D N=2 symmetries in the bulk, and those of 4D N=1 supergravity at the brane positions. (orig.)

  5. Relative entropy equals bulk relative entropy

    CERN Document Server

    Jafferis, Daniel L; Maldacena, Juan; Suh, S Josephine

    2015-01-01

    We consider the gravity dual of the modular Hamiltonian associated to a general subregion of a boundary theory. We use it to argue that the relative entropy of nearby states is given by the relative entropy in the bulk, to leading order in the bulk gravitational coupling. We also argue that the boundary modular flow is dual to the bulk modular flow in the entanglement wedge, with implications for entanglement wedge reconstruction.

  6. 33 CFR 127.313 - Bulk storage.

    Science.gov (United States)

    2010-07-01

    ...) WATERFRONT FACILITIES WATERFRONT FACILITIES HANDLING LIQUEFIED NATURAL GAS AND LIQUEFIED HAZARDOUS GAS Waterfront Facilities Handling Liquefied Natural Gas Operations § 127.313 Bulk storage. (a) The...

  7. Applications of bulk high-temperature superconductors

    Science.gov (United States)

    Hull, J. R.

    The development of high-temperature superconductors (HTS's) can be broadly generalized into thin-film electronics, wire applications, and bulk applications. We consider bulk HTS's to include sintered or crystallized forms that do not take the geometry of filaments or tapes, and we discuss major applications for these materials. For the most part applications may be realized with the HTS's cooled to 77 K, and the properties of the bulk HTS's are often already sufficient for commercial use. A non-exhaustive list of applications for bulk HTS's includes trapped field magnets, hysteresis motors, magnetic shielding, current leads, and magnetic bearings. These applications are briefly discussed in this paper.

  8. Hyperon bulk viscosity in strong magnetic fields

    CERN Document Server

    Sinha, Monika

    2008-01-01

    We study bulk viscosity in neutron star matter including $\\Lambda$ hyperons in the presence of quantizing magnetic fields. Relaxation time and bulk viscosity due to both the non-leptonic weak process involving $\\Lambda$ hyperons and the direct Urca (dUrca) process are calculated here. In the presence of a strong magnetic field, bulk viscosity coefficients are enhanced when protons, electrons and muons are populated in their respective zeroth Landau levels compared with the field free cases. The enhancement of bulk viscosity coefficient is larger for the dUrca case.

  9. Understanding Bulk Power Reliability: The Importance of Good Data and A Critical Review of Existing Sources

    Energy Technology Data Exchange (ETDEWEB)

    Fisher, Emily; Eto, Joseph H.; LaCommare, Kristina Hamachi

    2011-10-19

    Bulk power system reliability is of critical importance to the electricity sector. Complete and accurate information on events affecting the bulk power system is essential for assessing trends and efforts to maintain or improve reliability. Yet, current sources of this information were not designed with these uses in mind. They were designed, instead, to support real-time emergency notification to industry and government first-responders. This paper reviews information currently collected by both industry and government sources for this purpose and assesses factors that might affect their usefulness in supporting the academic literature that has relied upon them to draw conclusions about the reliability of the US electric power system.

  10. Characterisation of ferroelectric bulk materials and thin films

    CERN Document Server

    Cain, Markys G

    2014-01-01

    This book presents a comprehensive review of the most important methods used in the characterisation of piezoelectric, ferroelectric and pyroelectric materials. It covers techniques for the analysis of bulk materials and thick and thin film materials and devices. There is a growing demand by industry to adapt and integrate piezoelectric materials into ever smaller devices and structures. Such applications development requires the joint development of reliable, robust, accurate and - most importantly - relevant and applicable measurement and characterisation methods and models. In the past f

  11. Industrial Engineering

    DEFF Research Database (Denmark)

    Karlsson, Christer

    2015-01-01

    Industrial engineering is a discipline that is concerned with increasing the effectiveness of (primarily) manufacturing and (occasionally).......Industrial engineering is a discipline that is concerned with increasing the effectiveness of (primarily) manufacturing and (occasionally)....

  12. Bulk flow and diffusion revisited, and clinical applications.

    Science.gov (United States)

    Reulen, Hans-J

    2010-01-01

    The first Klatzo-Lecture pays homage to an exceptional academician, scientist and teacher. The author spent nearly 1 year in Klatzo's laboratory at the NHI in Bethesda, and the first part of results presented here originate directly from this collaboration. It was shown that following cortical injury, movement of edema fluid into the tissue occurs by bulk flow, and that the driving force is a small tissue pressure gradient. Resolution of edema fluid is achieved by clearance into the ventricular and subarachnoid CSF, is enhanced in the presence of pressure gradients and is supported by re-absorption into capillaries. Using appropriate techniques, the formation rate as well as clearance of edema into CSF and tissue resorption could be determined in human brain metastases and malignant gliomas. Three examples of clinical applications based on the discussed mechanisms are presented: a. Fluorescence-guided surgery of gliomas is based on the accumulation of 5-ALA in tumour cells; there being enzymatically converted to PP-IX, a compound with deep red fluorescence. This fluorescence is used for the more accurate surgical removal of gliomas. b. Radioimmunotherapy of gliomas uses an anti-tenascin antibody, coupled with a nuclide, administered postoperatively into the tumour cavity, from where it diffuses into tissue, couples to the receptor at the glioma cells. Then the isotope destroys the tumour cells. c. Convection-enhanced delivery is based on the interstitial infusion of an appropriate cytotoxic drug into the white matter at low pressure. Thus, the method employs bulk flow, distributes a drug in a larger tissue volume and eventually achieves drug concentrations greater than systemic levels. Experimental studies and clinical results are presented for all three clinical applications.I am very grateful to Z. Czernicki and the organizing group for being offered the great honour of presenting the first Igor Klatzo Lecture. In this report first previous results of bulk flow

  13. Packaged bulk micromachined triglyceride biosensor

    Science.gov (United States)

    Mohanasundaram, S. V.; Mercy, S.; Harikrishna, P. V.; Rani, Kailash; Bhattacharya, Enakshi; Chadha, Anju

    2010-02-01

    Estimation of triglyceride concentration is important for the health and food industries. Use of solid state biosensors like Electrolyte Insulator Semiconductor Capacitors (EISCAP) ensures ease in operation with good accuracy and sensitivity when compared to conventional sensors. In this paper we report on packaging of miniaturized EISCAP sensors on silicon. The packaging involves glass to silicon bonding using adhesive. Since this kind of packaging is done at room temperature, it cannot damage the thin dielectric layers on the silicon wafer unlike the high temperature anodic bonding technique and can be used for sensors with immobilized enzyme without denaturing the enzyme. The packaging also involves a teflon capping arrangement which helps in easy handling of the bio-analyte solutions. The capping solves two problems. Firstly, it helps in the immobilization process where it ensures the enzyme immobilization happens only on one pit and secondly it helps with easy transport of the bio-analyte into the sensor pit for measurements.

  14. Desenvolvimento e validação de método por cromatografia líquida de alta eficiência para determinação simultânea das impurezas timina e timidina na matéria-prima estavudina Development and validation of a high performance liquid chromatographic method for simultaneous determination of the impurities thymine and thymidine in stavudine bulk drug

    Directory of Open Access Journals (Sweden)

    Gisele Rodrigues da Silva

    2008-01-01

    Full Text Available A HPLC method was developed to quantify thymine and thymidine impurities in stavudine bulk drug. The separation was carried out in isocratic mode using methanol/water (20:80 as mobile phase, a C18 column and UV detection at 266 nm. The method provided selectivity based on peak purities and resolution among peaks. It was linear over the range of 0.5-5.0 µg/mL. The quantitation limits were 0.021 µg/mL for thymine and 0.134 µg/mL for thymidine. The average accuracies of three concentrations ranged from 97.06 to 102.61% and precision was close to 1%. The method showed robustness, remaining unaffected by deliberate variations in relevant parameters.

  15. Advanced Wear Simulation for Bulk Metal Forming Processes

    Directory of Open Access Journals (Sweden)

    Behrens Bernd-Arno

    2016-01-01

    Full Text Available In the recent decades the finite element method has become an essential tool for the cost-efficient virtual process design in the metal forming sector in order to counter the constantly increasing quality standards, particularly from the automotive industry as well as intensified international competition in the forging industry. An optimized process design taking precise tool wear prediction into account is a way to increase the cost-efficiency of the bulk metal forming processes. The main objective of the work presented in this paper is a modelling algorithm, which allows predicting die wear with respect to a geometry update during the forming simulation. Changes in the contact area caused by geometry update lead to the different die wear distribution. It primarily concerns the die areas, which undergo high thermal and mechanical loads.

  16. 27 CFR 20.191 - Bulk articles.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Bulk articles. 20.191... Users of Specially Denatured Spirits Operations by Users § 20.191 Bulk articles. Users who convey articles in containers exceeding one gallon may provide the recipient with a photocopy of subpart G of...

  17. Bulk deposition of atmospheric inorganic nitrogen in mountainous heathland ecosystems in North-Western Spain

    Science.gov (United States)

    Calvo-Fernández, Javier; Marcos, Elena; Calvo, Leonor

    2017-01-01

    Nitrogen (N) deposition has been identified as one of the main traits of terrestrial ecosystems, affecting their structure and functioning. However, few studies have been developed under natural field conditions to evaluate the amount of N deposition in low nutrient status heathland ecosystems. Therefore, a field experiment was carried out to investigate the bulk inorganic N inputs in mountainous heathlands of North-Western Spain. Two study sites (La Majúa and San Isidro) were selected on the south side of the Cantabrian Mountains, as a representative monitoring of N-sensitive ecosystems. Three replicated bulk collectors and one rain gauge were installed at each study site to collect monthly bulk deposition samples over three-year period (2011-2014). Bulk inorganic N deposition was different between the study sites (2.81 kg N ha- 1 yr- 1 in La Majúa and 4.56 kg N ha- 1 yr- 1 in San Isidro), but showed the same seasonal dynamic, with higher N deposition rate in the wet period (October to April) compared to the dry period (May to September). Annual bulk NO3- deposition was comparable to annual bulk NH4+ deposition in La Majúa (1.42 vs. 1.39 kg N ha- 1 yr- 1), and higher in San Isidro (2.89 vs. 1.67 kg N ha- 1 yr- 1). San Isidro displayed a characteristic bulk NH4+/NO3- deposition ratio below 1 of industrialized areas (0.58), while La Majúa displayed a bulk NH4+/NO3- deposition ratio close to 1 (0.98), distinctive of an intermediate situation between industrialized and agricultural areas. Total bulk inorganic N depositions observed in the present field study are consistent with the modelled estimation of N depositions for North-Western Spain, but only San Isidro was consistent with the estimated dominance of oxidized N over reduced N.

  18. Industrial Waste

    DEFF Research Database (Denmark)

    Christensen, Thomas Højlund

    2011-01-01

    Industrial waste is waste from industrial production and manufacturing. Industry covers many industrial sectors and within each sector large variations are found in terms of which raw materials are used, which production technology is used and which products are produced. Available data on unit...... generation rates and material composition as well as determining factors are discussed in this chapter. Characterizing industrial waste is faced with the problem that often only a part of the waste is handled in the municipal waste system, where information is easily accessible. In addition part...... of the industrial waste may in periods, depending on market opportunities and prices, be traded as secondary rawmaterials. Production-specificwaste from primary production, for example steel slag, is not included in the current presentation. In some countries industries must be approved or licensed and as part...

  19. Industrial Waste

    DEFF Research Database (Denmark)

    Christensen, Thomas Højlund

    2011-01-01

    of the system industry has to inform at the planning stage and afterwards in yearly reports on their waste arising and how the waste is managed. If available such information is very helpful in obtaining information about that specific industry. However, in many countries there is very little information......Industrial waste is waste from industrial production and manufacturing. Industry covers many industrial sectors and within each sector large variations are found in terms of which raw materials are used, which production technology is used and which products are produced. Available data on unit...... generation rates and material composition as well as determining factors are discussed in this chapter. Characterizing industrial waste is faced with the problem that often only a part of the waste is handled in the municipal waste system, where information is easily accessible. In addition part...

  20. Bulk equations of motion from CFT correlators

    CERN Document Server

    Kabat, Daniel

    2015-01-01

    To O(1/N) we derive, purely from CFT data, the bulk equations of motion for interacting scalar fields and for scalars coupled to gauge fields and gravity. We first uplift CFT operators to mimic local AdS fields by imposing bulk microcausality. This requires adding an infinite tower of smeared higher-dimension double-trace operators to the CFT definition of a bulk field, with coefficients that we explicitly compute. By summing the contribution of the higher-dimension operators we derive the equations of motion satisfied by these uplifted CFT operators and show that we precisely recover the expected bulk equations of motion. We exhibit the freedom in the CFT construction which corresponds to bulk field redefinitions.

  1. Bulk equations of motion from CFT correlators

    Energy Technology Data Exchange (ETDEWEB)

    Kabat, Daniel [Department of Physics and Astronomy,Lehman College, City University of New York, Bronx NY 10468 (United States); Lifschytz, Gilad [Department of Physics and Astronomy,Lehman College, City University of New York, Bronx NY 10468 (United States); Physics Department,City College, City University of New York, New York NY 10031 (United States); Department of Mathematics and Physics,University of Haifa at Oranim, Kiryat Tivon 36006 (Israel)

    2015-09-10

    To O(1/N) we derive, purely from CFT data, the bulk equations of motion for interacting scalar fields and for scalars coupled to gauge fields and gravity. We first uplift CFT operators to mimic local AdS fields by imposing bulk microcausality. This requires adding an infinite tower of smeared higher-dimension double-trace operators to the CFT definition of a bulk field, with coefficients that we explicitly compute. By summing the contribution of the higher-dimension operators we derive the equations of motion satisfied by these uplifted CFT operators and show that we precisely recover the expected bulk equations of motion. We exhibit the freedom in the CFT construction which corresponds to bulk field redefinitions.

  2. Development and Validation of HLPC Method for the Estimation of Lamotrigine in Bulk and Pharmaceutical Formulations

    Directory of Open Access Journals (Sweden)

    T. Vijaya Bhaskara Reddy

    2013-01-01

    Full Text Available A simple, precise, accurate, and rapid HPLC method was developed to estimate the amount of lamotrigine in bulk and its pharmaceutical formulations. Waters Alliance HPLC system equipped with autosampler, ultraviolet detector, and Symmetry C8 (4.6 mm ID × 150 mm, 3.5 μm, Make: XTerra column were used for the quantification of the drug. Separation was carried out at a flow rate of 0.7 mL/min. of mobile phase (acetonitrile and potassium dihydrogen phosphate buffer of pH=7.0 in the ratio 60 : 40 v/v, and the detection was carried out at a wavelength of 215 nm. The retention time of lamotrigine was found to be 2.797 min. The linearity was obeyed in the range of concentration 5–25 μg/mL. The developed method was found to be repeatable and reproducible; hence, it can be used as an alternative method in assay of the lamotrigine in any pharmaceutical industries.

  3. Oxygen Behavior in Bulk Amorphous Zr-base Alloy

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    Bulk Zr55Al10Ni5Cu30 metallic glass plates with a dimension of 85 mm×35mm×4 mm and a complicated plate werefabricated by injecting casting method using spongy zirconium and industrial purity aluminum, nickel and copper asraw materials. It was shown that the holding time of liquid metals at elevated temperatures had a great influence onthe oxygen content of the plates due to the contamination resulting from the atmosphere. Increasing holding timeresulted in the increase of oxygen content in the injected alloy. The glass transition temperatures of the bulk metallicglass plates are higher than that reported in the literature and crystallization temperature is lower for the one withhigher oxygen content at the same heating rate. The extension of the undercooled liquid region △Tx reaching about87 K is 3 K higher than that previously reported and 26 K higher than that with oxygen content of 0.076 wt pct forthe one with oxygen content as high as 0.065 wt pct. Therefore the oxygen content of the alloy has a significantinfluence on the glass forming ability and thermal stability of bulk metal glass. It is suggested that direct correlationbetween high glass forming ability and large △Tx is only valid for a well-defined Iow oxygen concentration or has tobe reconsidered by incorporating oxygen as an additional alloying element.

  4. Business Pattern Innovation in Bulk Production Material Circulation Enterprises under the Trend of Disintermediation in China——The Business Practice of Zhejiang Material Industry Group%流通脱媒趋势下生产资料流通企业商业模式创新——来自浙江物产集团的商业实践

    Institute of Scientific and Technical Information of China (English)

    刘庆岩

    2016-01-01

    In recent years,with the rise of ICT and the increasing pressure brought by higher upstream cost and inefficient downstream demand,to shorten circulation channel,reduce circulation links,reduce circulation cost,or extent to the field of service to pursue"the third profit source",manufacturing enterprises increasingly strengthen their power of control on channels, and directly establish the strategic alliance with the absence of intermediaries. To some extent,these measures will shrink the living space of traditional circulation enterprises and lead to the phenomenon of disintermediation. And the enterprises will transform from being comprehensive to being specialized,from independently owning the resources to sharing that,and from being rival to each other to cooperating with each other. To better cope with the trend of disintermediation,ZJMI Group integrates the role of wholesaler,logistic service provider,transaction interface,market explorer,and modular integration service provider and embeds the link of supply chain to successfully expand its business scope,form the customer-demand-oriented supply chain integrated service pattern,and establish its own competitiveness. The experience of ZJMI cannot only be learn by other bulk production material enterprises,but also provide other traditional circulation enterprises with important implications. To cope with impact brought by new technology,at the stage of transferring from old balance to new balance,circulation enterprises should reconsider their functional positioning,take the value of upstream and downstream customers as the target,fully give play to the role of information,logistic,and management technological fruits,make innovation in business pattern,rebuild the competitiveness,effectively reduce agent cost,promote the return of intermediaries,and promote the rapid development of service outsourcing industry.%近年来,随着网络通信技术的兴起,受上游成本高企与下游需求不足双重压力

  5. 5 MJ flywheel based on bulk HTS magnetic suspension

    Science.gov (United States)

    Poltavets, V.; Kovalev, K.; Ilyasov, R.; Glazunov, A.; Maevsky, V.; Verzbitsky, L.; Akhmadyshev, V.; Shikov, A.

    2014-05-01

    Nowadays the flywheel energy storage systems (FES) are developed intensively as uninterruptible power supply (UPS) devices for on-land and transport (especially airborne) applications worldwide. This work is devoted to the FES with magnetic suspension on the base of bulk HTS YBCO elements and permanent magnets. The developed FES is intended to be used as UPS in Russian atomic industry in case of an emergency. For the successful design of the FES the following questions should be solved: design of the motor/generator, design of the rotor (flywheel), design of the bearing system, design of the control system and system of power load matching, design of the cooling system. The developed small-scale FES with the stored energy 0.5 MJ was used to solve these basic questions. The elaborated FES consists of the synchronous electric machine with permanent magnets, the solid flywheel with axial magnetic suspension on the base of YBCO bulks and permanent magnets, the system of control and power load matching, and the system of liquid nitrogen cooling. The results of theoretical modeling of different schematics of magnetic suspension and experimental investigations of the constructed FES are presented. The design of the future full-scale FES with the stored energy ~5 MJ and output power up to 100 kW is described. The test results of the flywheel rotor and HTS magnetic suspension of 5 MJ FES are presented. This work is done under support of Rosatom within the frames of Russian Project "Superconducting Industry"

  6. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use Hurts Kids Drug Use Hurts Unborn Children Drug Use Hurts Your Health Drug Use Hurts ... Find Treatment/Rehab Resources Prevent Drug Use Help Children and Teens Stay Drug-Free Talking to Kids ...

  7. Drug Facts

    Medline Plus

    Full Text Available ... Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use and Other People Drug Use and Families Drug Use and Kids Drug Use and Unborn ...

  8. Longshoring Industry

    Science.gov (United States)

    2001-01-01

    a)(1). (5) ANSI Z-89.1-1986, Personnel Protection-Protective Headwear for Industrial Workers-Requirements; IBR approved for 1917.93(b). (6) ANSI Z-41... Headwear for Industrial Workers-Requirements.” (c) Protective hats previously worn shall be cleaned and disinfected before issuance by the employer to... Headwear for Industrial Workers-Requirements; IBR approved for §1918.103(b). (6) ANSI Z-41-1991, American National Standard for Personal Protection

  9. Biotechnology Industry

    Science.gov (United States)

    2007-01-01

    Countries Growing GMO , 2007). Herbicide and insect resistance traits will continue to be pursued since 25% of food crops are lost each year to insect...daily lives from the clothing we wear, the fuel we use, the food we eat, and the medicines we take. From the earliest days, humans have used the...industry is very broad and includes health care, food , agriculture, industrial, and environmental industries. It is one of the fastest growing sciences

  10. The relationship between rational drug design and drug side effects.

    Science.gov (United States)

    Wang, Juan; Li, Zhi-xin; Qiu, Cheng-xiang; Wang, Dong; Cui, Qing-hua

    2012-05-01

    Previous analysis of systems pharmacology has revealed a tendency of rational drug design in the pharmaceutical industry. The targets of new drugs tend to be close with the corresponding disease genes in the biological networks. However, it remains unclear whether the rational drug design introduces disadvantages, i.e. side effects. Therefore, it is important to dissect the relationship between rational drug design and drug side effects. Based on a recently released drug side effect database, SIDER, here we analyzed the relationship between drug side effects and the rational drug design. We revealed that the incidence drug side effect is significantly associated with the network distance of drug targets and diseases genes. Drugs with the distances of three or four have the smallest incidence of side effects, whereas drugs with the distances of more than four or smaller than three show significantly greater incidence of side effects. Furthermore, protein drugs and small molecule drugs show significant differences. Drugs hitting membrane targets and drugs hitting cytoplasm targets also show differences. Failure drugs because of severe side effects show smaller network distances than approved drugs. These results suggest that researchers should be prudent on rationalizing the drug design. Too small distances between drug targets and diseases genes may not always be advantageous for rational design for drug discovery.

  11. Holographic representation of local bulk operators

    CERN Document Server

    Hamilton, A; Lifschytz, G; Lowe, D A; Hamilton, Alex; Kabat, Daniel; Lifschytz, Gilad; Lowe, David A.

    2006-01-01

    The Lorentzian AdS/CFT correspondence implies a map between local operators in supergravity and non-local operators in the CFT. By explicit computation we construct CFT operators which are dual to local bulk fields in the semiclassical limit. The computation is done for general dimension in global, Poincare and Rindler coordinates. We find that the CFT operators can be taken to have compact support in a region of the complexified boundary whose size is set by the bulk radial position. We show that at finite N the number of independent commuting operators localized within a bulk volume saturates the holographic bound.

  12. Trapped field measurements of Gd-Ba-Cu-O bulk superconductor in controlled pulse field magnetizing

    Energy Technology Data Exchange (ETDEWEB)

    Ida, T [Department of Electronic Control Engineering, Hiroshima National College of Maritime Technology, 4272-1, Higashino, Ohsakikamijima-cho, Toyota-gun, Hiroshima 725-0231 (Japan); Kimura, Y; Sano, T; Yamaguchi, K; Izumi, M [Department of Marine Electronics and Mechanical Engineering, Tokyo University of Marine Science and Technology, 2-1-6, Etchu-jima, Koto-ku, Tokyo 135-8533 (Japan); Miki, M [Kitano Seiki Co. Ltd., 7-13-7, Chuo, Ohta-ku, Tokyo 143-0024 (Japan)], E-mail: ida@hiroshima-cmt.ac.jp

    2008-02-01

    For large-scale electric power application of the melt-processed high temperature superconductor (HTS) bulks, especially at rotating machine, development of trapping much higher magnetic fields by using pulsed magnetization technique is essential. It is difficult to use static field cooling (FCM) technique that is most effective magnetizing method for the general industrial HTS applications, because the FCM requires large-scale superconducting magnets. Because the rise in temperature due to the magnetic flux motion decreases the pinning force, we controlled the magnetic flux penetrating to the bulk for the effective magnetization. A couple of vortex-type copper coils applied a magnetic field to a Gd-Ba-Cu-O bulk, which dimension was 45mm in diameter and 19 mm in thickness. HTS bulk was magnetized by the controlled pulse field without passive LCR pulse. We controlled waveform by using the discharge current that IGBT chopper in pulse magnetizer intermitted. We applied the pulse magnetic field with the various risetime to the HTS bulk in liquid nitrogen. The various conditions of the controlled waveform pulse to trap well-dressed profile magnetized the Gd-Ba-Cu-O bulk, strongly at 77K. In the present study, we show several properties which was measured in the PFM of the HTS bulk.

  13. Technical issues of a high-T{sub c} superconducting bulk magnet

    Energy Technology Data Exchange (ETDEWEB)

    Fujimoto, Hiroyuki [Railway Technical Research Institute, 2-8-38 Hikari-cho, Kokubunji-shi, Tokyo 185-8540 (Japan). E-mail: fujimoto at rtri.or.jp

    2000-06-01

    Superconducting magnets made of high-T{sub c} superconductors are promising for industrial applications. It is well known that REBa{sub 2}Cu{sub 3}O{sub 7-}x superconductors prepared by melt processes have a high critical current density, J{sub c}, at 77 K and hig{sub h} magnetic fields. The materials are very promising for high magnetic field applications as a superconducting permanent/bulk magnet with liquid-nitrogen refrigeration. Light rare-earth (LRE) BaCuO bulks, compared with REBaCuO bulks, exhibit a larger J{sub c} in high magnetic fields and a much improved irreversibility field, H{sub irr}, at 77 K. In this study, we discuss technical issues of a high-T{sub c} superconducting bulk magnet, namely the aspects of the melt processing for bulk superconductors, their characteristic superconducting properties and mechanical properties, and trapped field properties of a superconducting bulk magnet. One of the possible applications is a superconducting bulk magnet for the magnetically levitated (Maglev) train in the future. (author)

  14. Superconducting bulk magnets for magnetic levitation systems

    Science.gov (United States)

    Fujimoto, H.; Kamijo, H.

    2000-06-01

    The major applications of high-temperature superconductors have mostly been confined to products in the form of wires and thin films. However, recent developments show that rare-earth REBa 2Cu 3O 7- x and light rare-earth LREBa 2Cu 3O 7- x superconductors prepared by melt processes have a high critical-current density at 77 K and high magnetic fields. These superconductors will promote the application of bulk high-temperature superconductors in high magnetic fields; the superconducting bulk magnet for the Maglev train is one possible application. We investigated the possibility of using bulk magnets in the Maglev system, and examined flux-trapping characteristics of multi-superconducting bulks arranged in array.

  15. 78 FR 69133 - Drug Enforcement Administration

    Science.gov (United States)

    2013-11-18

    ... Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Lin Zhi... renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the... Administration. BILLING CODE 4410-09-P...

  16. Industrial Communications.

    Science.gov (United States)

    Lindsay, Dan

    Intended for seniors planning a career in industry as skilled laborers, this specialized course in Industrial Communications offers the student basic communications skills which he will need in his work and in his daily life. Since class activities center around short, factual oral reports, class size will be limited to 20, providing a maximum of…

  17. Measuring Bulk Flows in Large Scale Surveys

    CERN Document Server

    Feldman, H A; Feldman, Hume A.; Watkins, Richard

    1993-01-01

    We follow a formalism presented by Kaiser to calculate the variance of bulk flows in large scale surveys. We apply the formalism to a mock survey of Abell clusters \\'a la Lauer \\& Postman and find the variance in the expected bulk velocities in a universe with CDM, MDM and IRAS--QDOT power spectra. We calculate the velocity variance as a function of the 1--D velocity dispersion of the clusters and the size of the survey.

  18. The Bulk Multicore Architecture for Improved Programmability

    Science.gov (United States)

    2009-12-01

    algorithm, forcing the same order of chunk commits as in the recording step. This design, which we call PicoLog , typically incurs a performance cost... PicoLog . Data-race detection at production- run speed. The Bulk Multicore can support an efficient data-race detec- tor based on the “happens-before...Bulk Multicore (a), with a possible OrderOnly execution log (b) and PicoLog execution log (c). contributed articles DECEMBER 2009 | VOL. 52

  19. Upholding Morals and Integrity:the Key to Ensure Drug Quality in Traditional Chinese Medicine Industry%坚守道德诚信是中药产业确保药品质量的关键

    Institute of Scientific and Technical Information of China (English)

    屈聪玲; 蒋传中

    2015-01-01

    Objective:To reveal the phenomena of moral loss in the production of Chinese traditional medicine, analyze its causes and put forward suggestions to improve the construction of moral integrity in the production of traditional Chinese medicine. Methods:With regard to the particularity of Chinese medicine products, causes and hazards were analyzed for current industrial chaos such as dyeing of Chinese herbal medicine and Chinese decoction pieces, weight increment, "blending into medicine", reduction of feeding, adulteration, tampering production process, out-of-workshop production, and the countermeasures were put forward. Results and Conclusion: Chinese medicine enterprises should conscientiously undertake social responsibilities, organize production with integrity, improve the integrity mechanism, and increase the intensity of punishment. Relevant authorities should perfect the quality standard as quickly as possible, improve the price management system, guide the Chinese medicine industry to emphasize quality and conscience in drug production, so as to ensure safety and efifcacy of public drug use.%目的:通过揭示中药生产道德失范的种种现象,分析其根源,提出在中药生产中完善道德诚信建设的建议。方法:针对中药产品的特殊性,分析目前中药材及中药饮片染色、增重、“勾兑成药”、减量投料、掺杂使假、擅改工艺、车间外生产等行业乱象产生的原因及其危害,提出应对建议。结果与结论:中药企业应切实担当社会责任,实施诚信生产;健全诚信机制,加大处罚力度;尽快完善质量标准,健全价格管理机制,引导中药产业重质量、讲诚信、做良心药,才能确保民众用药安全、有效。

  20. Industry honoured

    CERN Multimedia

    2008-01-01

    CERN has organised a day to thank industry for its exceptional contributions to the LHC project. Lucio Rossi addresses CERN’s industrial partners in the Main Auditorium.The LHC inauguration provided an opportunity for CERN to thank all those who have contributed to transforming this technological dream into reality. Industry has been a major player in this adventure. Over the last decade it has lent its support to CERN’s teams and participating institutes in developing, building and assembling the machine, its experiments and the computing infrastructure. CERN involved its industrial partners in the LHC inauguration by organising a special industry prize-giving day on 20 October. Over 70 firms accepted the invitation. The firms not only made fundamental contributions to the project, but some have also supported LHC events in 2008 and the inauguration ceremony through generous donations, which have been coordinated by Carmen Dell’Erba, who is responsible for secu...

  1. Prospects for Detecting a Cosmic Bulk Flow

    Science.gov (United States)

    Rose, Benjamin; Garnavich, Peter M.; Mathews, Grant James

    2015-01-01

    The ΛCDM model is based upon a homogeneous, isotropic space-time leading to uniform expansion with random peculiar velocities caused by local gravitation perturbations. The Cosmic Microwave Background (CMB) radiation evidences a significant dipole moment in the frame of the Local Group. This motion is usually explained with the Local Group's motion relative to the background Hubble expansion. An alternative explanation, however, is that the dipole moment is the result of horizon-scale curvature remaining from the birth of space-time, possibly a result of quantum entanglement with another universe. This would appear as a single velocity (a bulk flow) added to all points in space. These two explanations differ observationally on cosmic distance scales (z > 0.1). There have been many differing attempts to detect a bulk flow, many with no detectable bulk flow but some with a bulk flow velocity as large as 1000 km/s. Here we report on a technique based upon minimizing the scatter around the expected cosine distribution of the Hubble redshift residuals with respect to angular distance on the sky. That is, the algorithm searches for a directional dependence of Hubble residuals. We find results consistent with most other bulk flow detections at z Type Ia Supernovae to be ~0.01, whereas the current error (~0.2.) is more than an order of magnitude too large for the detection of bulk flow beyond z~0.05.

  2. 1st meeting on topical drug delivery to the nail.

    Science.gov (United States)

    Murdan, Sudaxshina

    2007-07-01

    The first ever symposium dedicated solely to drug delivery to the nail following topical application was held on the 2nd April 2007, in London, UK, organised by Dr Clive Roper (Charles River Laboratories, Scotland) and Dr Sudaxshina Murdan (School of Pharmacy, University of London, UK), under the auspices of Skin Forum. The 1-day meeting was attended by approximately 35 delegates from industry, academia and hospitals, and provided a much-needed forum for the presentation and discussion of research and problems in this emerging field. Topical drug delivery is especially suitable for onychomycosis (fungal infections of the nail plate and/or nail bed) and nail psoriasis, which affect 2 - 13 and 1 - 3% of the general population, respectively, and make up the bulk of nail disorders. Topical therapy would avoid the adverse events and drug interactions of systemic antifungal agents and the pain of injection when antipsoriatic agents are injected into affected nail folds. However, successful topical therapy is extremely challenging due to the very low permeability of the nail plate. Five speakers spoke about various aspects of topical drug delivery to the nail, including review of the nail plate structure, function, diseases, their existing therapies (systemic and topical), limitations and global sales. The need for effective topical drug delivery to the nail to overcome the problems associated with present treatment, and the fact that there are few topical formulations available for the treatment of nail fungal infections and psoriasis, and the even fewer effective formulations, was highlighted.

  3. Drug Facts

    Medline Plus

    Full Text Available ... Addiction? Addiction Risk Factors Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use Hurts Other People Drug Use Hurts Families Drug Use Hurts Kids Drug Use Hurts Unborn ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... Use Hurts Unborn Children Drug Use Hurts Your Health Drug Use Hurts Bodies Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

  5. Drug Allergy

    Science.gov (United States)

    ... Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days or ... you take the drug. Drugs commonly linked to allergies Although any drug can cause an allergic reaction, ...

  6. Drug Facts

    Medline Plus

    Full Text Available ... Addiction? Addiction Risk Factors Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use Hurts Other People Drug Use Hurts Families Drug Use Hurts Kids Drug Use Hurts Unborn ...

  7. Drug Facts

    Medline Plus

    Full Text Available ... The Link Between Drug Use and HIV/AIDS Recovery & Treatment Drug Treatment Facts Does Drug Treatment Work? ... and Family Can Help Find Treatment/Rehab Resources Prevent Drug Use Help Children and Teens Stay Drug- ...

  8. Discussion on Investigation on Illegal Cases of Fake and InferiorVeterinary Drugs Transportation in Logistics and Express Industry%查处物流快递涉假劣兽药违法案件的讨论

    Institute of Scientific and Technical Information of China (English)

    刘雪萍; 李昌主

    2015-01-01

    In recent years,with strong convert,low cost,high efficiency of logistics and express industry,the illegal cases of transport fake and inferior veterinary drugs with logistics and express,which are hard to investigate and penalize,have been increasing year by year. This paper analyzed the problems in such illegal cases and made suggestions of routine law enforcement,investigation and inspection,case clue collection,collaboration of various department,participation of public,etc.,as to strengthen supervision,and make good orders of the regional veterinary medicine market.%不法分子利用物流快递隐蔽性强、成本低、效率高等特点,进行非法托运、贩运假劣兽药的案件数量逐年上升。该类案件的查处和定罪难度较大。本文分析了假劣兽药监管在物流快递业中存在的问题,提出在日常执法、调查取证、线索收集、部门联合、公众参与等方面加强监管,净化区域兽药经营的市场秩序的建议。

  9. Chemistry in the Pharmaceutical Industry

    Science.gov (United States)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  10. 75 FR 64585 - Bulk Solid Hazardous Materials: Harmonization With the International Maritime Solid Bulk Cargoes...

    Science.gov (United States)

    2010-10-19

    ... nonsubstantive changes, however, to correct grammar, internal paragraph references, and a temperature conversion... means the English version of the ``International Maritime Solid Bulk Cargoes Code'' published by...

  11. Industrial pioneers

    NARCIS (Netherlands)

    Wassink, J.

    2014-01-01

    With their knowledge of metallurgy, mechanics and thermodynamics, mechanical engineers had to give shape to the industrial revolution in the Netherlands 150 years ago. This revolution only slowly gathered momentum, however, especially in comparison with England.

  12. Industrial Chemistry.

    Science.gov (United States)

    Gumprecht, Donald L.; Thrasher, Joseph S.

    1990-01-01

    Described is a course designed to better prepare students for employment in chemical industries. A course schedule for this interim course and a list of sources of speakers and speaker credentials is provided. (CW)

  13. Evaluation of physicochemical parameters influencing bulking episodes in a municipal WWTP; Evaluacion de la influencia de los parametros fisicoquimicos en los episodios de bulking en una EDAR muncipal

    Energy Technology Data Exchange (ETDEWEB)

    Bayo, J.; Angosto, J. M.; Serrano-Aniorte, J.; Lopez-Castellanos, J.; Puerta, J.

    2009-07-01

    A study of physicochemical parameters in a municipal wastewater treatment plant (WWTP) was undertaken over 12-month period, to consider the presence of bulking phenomena by means of statistical and logistic regression analyses. the WWTP is situated in Cartagena, Southeast of Spain, with domestic and industrial wastewater contributions, and a mean flow rate of 27,000 m{sup 3}/day. (Author) 28 refs.

  14. Electronics Industry

    Science.gov (United States)

    2006-01-01

    companies to begin listing stock options as expenses on financial reports (Chappell, 2005). The industry had used stock options extensively to help... stock options (Chappell, 2005). Industry representatives interviewed by the group argued against the requirement since they predict U.S. companies...may be less inclined now to offer stock options , and subsequently talent may be lost to aggressive foreign competition (Anonymous interviews, 2006

  15. Development of superconductor bulk for superconductor bearing

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Chan Joong; Jun, Byung Hyuk; Park, Soon Dong (and others)

    2008-08-15

    Current carrying capacity is one of the most important issues in the consideration of superconductor bulk materials for engineering applications. There are numerous applications of Y-Ba-Cu-O (YBCO) bulk superconductors e.g. magnetic levitation train, flywheel energy storage system, levitation transportation, lunar telescope, centrifugal device, magnetic shielding materials, bulk magnets etc. Accordingly, to obtain YBCO materials in the form of large, single crystals without weak-link problem is necessary. A top seeded melt growth (TSMG) process was used to fabricate single crystal YBCO bulk superconductors. The seeded and infiltration growth (IG) technique was also very promising method for the synthesis of large, single-grain YBCO bulk superconductors with good superconducting properties. 5 wt.% Ag doped Y211 green compacts were sintered at 900 .deg. C {approx} 1200 .deg.C and then a single crystal YBCO was fabricated by an infiltration method. A refinement and uniform distribution of the Y211 particles in the Y123 matrix were achieved by sintering the Ag-doped samples. This enhancement of the critical current density was ascribable to a fine dispersion of the Y211 particles, a low porosity and the presence of Ag particles. In addition, we have designed and manufactured large YBCO single domain with levitation force of 10-13 kg/cm{sup 2} using TSMG processing technique.

  16. Into the Bulk: A Covariant Approach

    CERN Document Server

    Engelhardt, Netta

    2016-01-01

    I propose a general, covariant way of defining when one region is "deeper in the bulk" than another. This definition is formulated outside of an event horizon (or in the absence thereof) in generic geometries; it may be applied to both points and surfaces, and may be used to compare the depth of bulk points or surfaces relative to a particular boundary subregion or relative to the entire boundary. Using the recently proposed "lightcone cut" formalism, the comparative depth between two bulk points can be determined from the singularity structure of Lorentzian correlators in the dual field theory. I prove that, by this definition, causal wedges of progressively larger regions probe monotonically deeper in the bulk. The definition furthermore matches expectations in pure AdS and in static AdS black holes with isotropic spatial slices, where a well-defined holographic coordinate exists. In terms of holographic RG flow, this new definition of bulk depth makes contact with coarse-graining over both large distances ...

  17. Analytical, Characterization and Stability Studies of Chemicals, Bulk Drugs and Drug Formulations

    Science.gov (United States)

    1997-10-01

    information, Oct 97). Other requests for this document shall be referred to U.S. Army Medical Research and Materiel Command, 504 Scott Street, Fort...Research and Materiel Command, 504 Scott Street, Fort Detrick, Maryland 21702-5012. 13.BASTRACT NAk2d=nmd# The overall purpose of this contract was to...Lim Principal Investigator Phone: (650) 859-3029 Fax: (650) 859-4291 E-Mail: lim@pearl.sri.com Lor r Orson Assistant Principal Investigator Phone

  18. Preparation of Chemicals and Bulk Drug Substances for the U.S. Army Drug Development Program

    Science.gov (United States)

    1997-12-01

    which was purified by sublimation followed by chromatography. The purified acid was alkylated with 2- chloroethanol in the presence of base and the...3CH3 Cl Resolution of the corresponding dibutylaminophenanthrenemethanol (halofantrine) by fractional crystallization of the d- camphoric acid salt

  19. Preparation of Chemicals and Bulk Drug Substances for the U.S. Army Drug Development Program.

    Science.gov (United States)

    1997-12-01

    methanol (550 mL) was added to the ester 2 (42.0 g, 0.092 mol). The reaction was stirred at room temperature for 7 days. The progress of the reaction ...THF, b= Et 20, c= DMF, d= DME , e= CH3CN 3. Results classified as: a= no reaction , b= no isolated products, c= no desired product, d= desired product...8217 Dichlorobenzaldehyde 4 was reacted c- HO N cl H-CHCOCH 3 C 3 4 1 d Cl C02CH 5 0 5 6 with acetone in the presence of base to give 5 in 67% yield. Reaction of

  20. A diphoton resonance from bulk RS

    Science.gov (United States)

    Csáki, Csaba; Randall, Lisa

    2016-07-01

    Recent LHC data hinted at a 750 GeV mass resonance that decays into two photons. A significant feature of this resonance is that its decays to any other Standard Model particles would be too low to be detected so far. Such a state has a compelling explanation in terms of a scalar or a pseudoscalar that is strongly coupled to vector states charged under the Standard Model gauge groups. Such a scenario is readily accommodated in bulk RS with a scalar localized in the bulk away from but close to the Higgs. Turning this around, we argue that a good way to find the elusive bulk RS model might be the search for a resonance with prominent couplings to gauge bosons.

  1. A stereoscopic look into the bulk

    Science.gov (United States)

    Czech, Bartlomiej; Lamprou, Lampros; McCandlish, Samuel; Mosk, Benjamin; Sully, James

    2016-07-01

    We present the foundation for a holographic dictionary with depth perception. The dictionary consists of natural CFT operators whose duals are simple, diffeomorphisminvariant bulk operators. The CFT operators of interest are the "OPE blocks," contributions to the OPE from a single conformal family. In holographic theories, we show that the OPE blocks are dual at leading order in 1 /N to integrals of effective bulk fields along geodesics or homogeneous minimal surfaces in anti-de Sitter space. One widely studied example of an OPE block is the modular Hamiltonian, which is dual to the fluctuation in the area of a minimal surface. Thus, our operators pave the way for generalizing the Ryu-Takayanagi relation to other bulk fields.

  2. Bulk amorphous Mg-based alloys

    DEFF Research Database (Denmark)

    Pryds, Nini

    2004-01-01

    The present paper describes the preparation and properties of bulk amorphous quarternary Mg-based alloys and the influence of additional elements on the ability of the alloy to form bulk amorphous. The main goal is to find a Mg-based alloy system which shows both high strength to weight ratio...... and a low glass transition temperature. The alloys were prepared by using a relatively simple technique, i.e. rapid cooling of the melt in a copper wedge mould. The essential structural changes that are achieved by going from the amorphous to the crystalline state through the supercooled liquid state...... are discussed in this paper. On the basis of these measurements phase diagrams of the different systems were constructed. Finally, it is demonstrated that when pressing the bulk amorphous alloy onto a metallic dies at temperatures within the supercooled liquid region, the alloy faithfully replicates the surface...

  3. Orchestrating Bulk Data Movement in Grid Environments

    Energy Technology Data Exchange (ETDEWEB)

    Vazhkudai, SS

    2005-01-25

    Data Grids provide a convenient environment for researchers to manage and access massively distributed bulk data by addressing several system and transfer challenges inherent to these environments. This work addresses issues involved in the efficient selection and access of replicated data in Grid environments in the context of the Globus Toolkit{trademark}, building middleware that (1) selects datasets in highly replicated environments, enabling efficient scheduling of data transfer requests; (2) predicts transfer times of bulk wide-area data transfers using extensive statistical analysis; and (3) co-allocates bulk data transfer requests, enabling parallel downloads from mirrored sites. These efforts have demonstrated a decentralized data scheduling architecture, a set of forecasting tools that predict bandwidth availability within 15% error and co-allocation architecture, and heuristics that expedites data downloads by up to 2 times.

  4. Bulk fields from the boundary OPE

    CERN Document Server

    Guica, Monica

    2016-01-01

    Previous work has established an equality between the geodesic integral of a free bulk field in AdS and the contribution of the conformal descendants of its dual CFT primary operator to the OPE of two other operators inserted at the endpoints of the geodesic. Working in the context of AdS$_3$/CFT$_2$, we extend this relation to include all $1/N$ corrections to the bulk field obtained by dressing it with i) a $U(1)$ current and ii) the CFT stress tensor, and argue it equals the contribution of the Ka\\v{c}-Moody/the Virasoro block to the respective boundary OPE. This equality holds for a particular framing of the bulk field to the boundary that involves a split Wilson line.

  5. Multiphase composites with extremal bulk modulus

    DEFF Research Database (Denmark)

    Gibiansky, L. V.; Sigmund, Ole

    2000-01-01

    This paper is devoted to the analytical and numerical study of isotropic elastic composites made of three or more isotropic phases. The ranges of their effective bulk and shear moduli are restricted by the Hashin-Shtrikman-Walpole (HSW) bounds. For two-phase composites, these bounds are attainable......, that is, there exist composites with extreme bulk and shear moduli. For multiphase composites, they may or may not be attainable depending on phase moduli and volume fractions. Sufficient conditions of attainability of the bounds and various previously known and new types of optimal composites...... are described. Most of our new results are related to the two-dimensional problem. A numerical topology optimization procedure that solves the inverse homogenization problem is adopted and used to look for two-dimensional three-phase composites with a maximal effective bulk modulus. For the combination...

  6. Bulk Comptonization by Turbulence in Accretion Disks

    CERN Document Server

    Kaufman, J

    2016-01-01

    Radiation pressure dominated accretion discs around compact objects may have turbulent velocities that greatly exceed the electron thermal velocities within the disc. Bulk Comptonization by the turbulence may therefore dominate over thermal Comptonization in determining the emergent spectrum. Bulk Comptonization by divergenceless turbulence is due to radiation viscous dissipation only. It can be treated as thermal Comptonization by solving the Kompaneets equation with an equivalent "wave" temperature, which is a weighted sum over the power present at each scale in the turbulent cascade. Bulk Comptonization by turbulence with non-zero divergence is due to both pressure work and radiation viscous dissipation. Pressure work has negligible effect on photon spectra in the limit of optically thin turbulence, and in this limit radiation viscous dissipation alone can be treated as thermal Comptonization with a temperature equivalent to the full turbulent power. In the limit of extremely optically thick turbulence, ra...

  7. A Diphoton Resonance from Bulk RS

    CERN Document Server

    Csaki, Csaba

    2016-01-01

    Recent LHC data hints at a 750 GeV mass resonance that decays into two photons. A significant feature of this resonance is that its decays to Higges and to any other Standard Model particles are so far too low to be detected. Such a state has a compelling explanation in terms of a scalar or a pseudoscalar that is strongly coupled to vector states charged under the Standard Model gauge groups. We argue that if the state is a scalar, some form of sequestering is likely to be necessary to naturally explain the suppressed scalar-Higgs interactions. Such a scenario is readily accommodated in bulk RS with a scalar localized in the bulk away from the Higgs. Turning this around, we argue that a good way to find the elusive bulk RS model might be the search for a resonance with prominent couplings to gauge bosons.

  8. Spherically symmetric brane spacetime with bulk gravity

    Science.gov (United States)

    Chakraborty, Sumanta; SenGupta, Soumitra

    2015-01-01

    Introducing term in the five-dimensional bulk action we derive effective Einstein's equation on the brane using Gauss-Codazzi equation. This effective equation is then solved for different conditions on dark radiation and dark pressure to obtain various spherically symmetric solutions. Some of these static spherically symmetric solutions correspond to black hole solutions, with parameters induced from the bulk. Specially, the dark pressure and dark radiation terms (electric part of Weyl curvature) affect the brane spherically symmetric solutions significantly. We have solved for one parameter group of conformal motions where the dark radiation and dark pressure terms are exactly obtained exploiting the corresponding Lie symmetry. Various thermodynamic features of these spherically symmetric space-times are studied, showing existence of second order phase transition. This phenomenon has its origin in the higher curvature term with gravity in the bulk.

  9. Benchmark tests on symmetry and continuity characteristics between BSIM4 and ULTRA-BULK

    Institute of Scientific and Technical Information of China (English)

    Niu Xudong; Li Bo; Song Yan; Zhang Lining; He Jin

    2009-01-01

    This paper presents the benchmark test results on the symmetry and continuity characteristics between BSIM4 from Berkeley and ULTRA-BULK from Peking University. It is shown that the industry standard model BSIM4 has a series of the shortcomings of the continuity and symmetry, such as the charge, high-order current derivatives, and the trans-capacitances while the latest advanced surface-potential based MOSFET compact model, ULTRA-BULK, demonstrates all necessary continuity and symmetry characteristics, which are very important for analog and RF circuit design.

  10. Development of a Bulk-Format System to Harvest, Handle, Store, and Deliver High-Tonnage Low-Moisture Switchgrass Feedstock

    Energy Technology Data Exchange (ETDEWEB)

    Womac, Alvin [Genera Energy LLC, Vonore, TN (United States); Groothuis, Mitch [Genera Energy LLC, Vonore, TN (United States); Westover, Tyler [Genera Energy LLC, Vonore, TN (United States); Phanphanich, Manunya [Genera Energy LLC, Vonore, TN (United States); Webb, Erin [Genera Energy LLC, Vonore, TN (United States); Sokhansanj, Shahab [Genera Energy LLC, Vonore, TN (United States); Turhollow, Anthony [Genera Energy LLC, Vonore, TN (United States)

    2013-09-24

    This project evaluates and compares comprehensive feedstock logistics systems (FLS), where a FLS is defined to comprehensively span from biomass material standing in a field to conveyance of a uniform, industrial-milled product into the throat of a biomass conversion facility (BCF). Elements of the bulk-format FLS evaluated in this project include: field-standing switchgrass dry chopped into bulk format on the farm, hauled (either loose or bulk compacted) to storage, stored with confining overburden in a protective facility, reclaimed and conveyed to bulk-format discharge, bulk compacted into an ejector trailer, and conveyed as bulk flow into the BCF. In this FLS evaluation, bulk storage bins served as a controlled and sensored proxy for large commercial stacks protected from moisture with a membrane cover.

  11. Core bulk of wool fibres as a function of their curvature and diameter

    Energy Technology Data Exchange (ETDEWEB)

    Kozyreff, G.; Wake, G.; Ockendon, H.; Sumner, R.M.W

    2003-08-11

    The compressibility of a fibre mass affects processing and end-product performance. The compressibility of wool can be measured by compressing a sample of clean fibre in a cylinder with a standard weight. The specific volume of the sample after compression is termed its bulk, or core bulk if a short core bored sample is used. Prediction of core bulk from the standard simultaneous measures of fibre diameter and fibre curvature would reduce testing costs. This applies to all types of fibre assemblies, but the potential for highest industrial influence is with natural fibres (wool, hairs, etc.) as the key characteristic of bulk is controlled by relatively few genes, and the ability is available to increase the bulkiness of a fibre from animals by carefully selective breeding procedures. A first approach to the problem is to model the wool sample as a collection of flexible rings. The Euler strut equation is then used to describe the rings and compute their linear deformation in response to the applied load. The resulting formula reveals that the core bulk depends on the fibre diameter and the fibre curvature only through their product. This agrees with an expression for the core bulk derived from van Wyk's formula (van Wyk, 1946) in one limit.

  12. Investigations of waste heat recovery from bulk milk cooler

    Directory of Open Access Journals (Sweden)

    S.N. Sapali

    2014-11-01

    Full Text Available Bulk milk coolers are used to chill the milk from its harvest temperature of 35–4 °C to arrest the bacterial growth and maintain the quality of harvested milk. Milk chilling practices are energy intensive with low coefficient of performance (COP of about 3.0. Increased energy cost concern encouraged an investigation of heat recovery from bulk milk cooler as one conservation alternative for reducing water heating cost in dairy industry. Heat dissipated to atmosphere through condenser is recovered to improve the energy efficiency of plant. The waste heat is utilized to heat the water which is used to clean the milk processing equipments thus saving thermal or electrical energy used to heat the water separately. Shell and coil type heat exchanger is designed and used to recover the waste heat during condensation process. Heat rejected in condensation process consists of superheat and latent heat of the refrigerant. In this work, attempt has been made to recover complete superheat along with part of latent heat which is a present research issue. The results show that complete superheat and 35% of latent heat is recovered. Heat recovery rate is measured for various mass flow rates. Water is flowing on shell side and refrigerant through tubes. The effectiveness of the heat exchanger is determined and the results achieved are presented in this paper. Significant improvements have been achieved and COP of the system is increased from 3 to 4.8.

  13. Making bulk-conductive glass microchannel plates

    Science.gov (United States)

    Yi, Jay J. L.; Niu, Lihong

    2008-02-01

    The fabrication of microchannel plate (MCP) with bulk-conductive characteristics has been studied. Semiconducting clad glass and leachable core glass were used for drawing fibers and making MCP. Co-axial single fiber was drawn from a platinum double-crucible in an automatic fiberizing system, and the fibers were stacked and redrawn into multifiber by a special gripping mechanism. The multifibers were stacked again and the boule was made and sliced into discs. New MCPs were made after chemically leaching process without the traditional hydrogen firing. It was shown that bulk-conductive glass MCP can operate at higher voltage with lower noise.

  14. "Work-Hardenable" ductile bulk metallic glass.

    Science.gov (United States)

    Das, Jayanta; Tang, Mei Bo; Kim, Ki Buem; Theissmann, Ralf; Baier, Falko; Wang, Wei Hua; Eckert, Jürgen

    2005-05-27

    Usually, monolithic bulk metallic glasses undergo inhomogeneous plastic deformation and exhibit poor ductility (< 1%) at room temperature. We present a new class of bulk metallic glass, which exhibits high strength of up to 2265 MPa together with extensive "work hardening" and large ductility of 18%. Significant increase in the flow stress was observed during deformation. The "work-hardening" capability and ductility of this class of metallic glass is attributed to a unique structure correlated with atomic-scale inhomogeneity, leading to an inherent capability of extensive shear band formation, interactions, and multiplication of shear bands.

  15. Synthesis of Bulk Superconducting Magnesium Diboride

    Directory of Open Access Journals (Sweden)

    Margie Olbinado

    2002-06-01

    Full Text Available Bulk polycrystalline superconducting magnesium diboride, MgB2, samples were successfully prepared via a one-step sintering program at 750°C, in pre Argon with a pressure of 1atm. Both electrical resistivity and magnetic susceptibility measurements confirmed the superconductivity of the material at 39K, with a transition width of 5K. The polycrystalline nature, granular morphology, and composition of the sintered bulk material were confirmed using X-ray diffractometry (XRD, scanning electron microscopy (SEM, and energy dispersive X-ray analysis (EDX.

  16. Towards a Reconstruction of General Bulk Metrics

    CERN Document Server

    Engelhardt, Netta

    2016-01-01

    We prove that the metric of a general holographic spacetime can be reconstructed (up to an overall conformal factor) from distinguished spatial slices - "light-cone cuts" - of the conformal boundary. Our prescription is covariant and applies to bulk points in causal contact with the boundary. Furthermore, we describe a procedure for determining the light-cone cuts corresponding to bulk points in the causal wedge of the boundary in terms of the divergences of correlators in the dual field theory. Possible extensions for determining the conformal factor and including the cuts of points outside of the causal wedge are discussed. We also comment on implications for subregion/subregion duality.

  17. 78 FR 5816 - Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical...

    Science.gov (United States)

    2013-01-28

    ... assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating... interested persons engaged in new drug development in evaluating how variations in the human...

  18. Improving drug manufacturing with process analytical technology.

    Science.gov (United States)

    Rodrigues, Licinia O; Alves, Teresa P; Cardoso, Joaquim P; Menezes, José C

    2006-01-01

    Within the process analytical technology (PAT) framework, as presented in the US Food and Drug Administration guidelines, the aim is to design, develop and operate processes consistently to ensure a pre-defined level of quality at the end of the manufacturing process. Three PAT implementation scenarios can be envisaged. Firstly, PAT could be used in its most modest version (in an almost non-PAT manner) to simply replace an existing quality control protocol (eg, using near-infrared spectroscopy for an in-process quality control, such as moisture content). Secondly, the use of in-process monitoring and process analysis could be integrated to enhance process understanding and operation for an existing industrial process. Thirdly, PAT could be used extensively and exclusively throughout development, scale-up and full-scale production of a new product and process. Although the first type of implementations are well known, reports of the second and third types remain scarce. Herein, results obtained from PAT implementations of the second and third types are described for two industrial processes for preparing bulk active pharmaceutical ingredients, demonstrating the benefits in terms of increased process understanding and process control.

  19. Drugs and Drug Abuse.

    Science.gov (United States)

    Anastas, Robert, Comp.; And Others.

    GRADES OR AGES: Secondary grades. SUBJECT MATTER: Drugs and drug abuse. ORGANIZATION AND PHYSICAL APPEARANCE: The guide is divided into several sections, each of which is in outline or list form. It is xeroxed and spiral-bound with a paper cover. OBJECTIVES AND ACTIVITIES: No objectives are mentioned. The major portion of the guide contains a…

  20. Drug allergies

    Science.gov (United States)

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The ...

  1. 印度仿制药产业现状及发展策略浅析%Current Situation and Development Strategy of India’s Generic Drug and Biosimilars Industry

    Institute of Scientific and Technical Information of China (English)

    任晓明

    2013-01-01

      印度制药业充分利用本国专利法和国家药品政策,以及国际上相关的药品法规的不完善,抓住发展机遇,实现了从单纯仿制到仿研结合、自主研发的转变.从 20 世纪 80 年代末,印度制药企业大量制造仿制药,至 2000 年前后,印度药品 50% 以上(大部分为仿制药)供出口,成为全球药品出口大国.印度生物制药企业能够生产生物仿制药 40 余种,2012 年,其生物仿制药市场达到 5.8 亿美元.印度仿制药产业的成功带给我们诸多启示,如:应注重国际知识产权游戏规则的研究;应有效利用外包,以提升自主研发的能力,等等.%Benefiting from the domestic patent law and preferential medicine policies, India’s pharmaceutical industry enjoys significant development by taking advantage of the defectiveness in relevant international pharmaceutical legislation. It opens up a new road to development, from simple copy via combination of copy&research and finally to independent R&D. From the end of 1980s, India pharmaceutical companies started the mass-manufacture of generic drugs and India became a dominant medicine exporter with its 50%of total outputs ( majority being generics) for international market in 2000. Indian pharmaceutical enterprises can produce more than 40 kinds of bio-similars. In 2012, the market value of Indian bio-similars reached 580 million USD. The success achieved by Indian pharmaceutical industry can give us some inspirations, such as, pay attention to the research on game rules of international intellectual property;take full advantage of outsourcing to enhance the ability of independent research and development, and so on.

  2. Industrial diamond

    Science.gov (United States)

    Olson, D.W.

    2013-01-01

    Estimated 2012 world production of natural and synthetic industrial diamond was about 4.45 billion carats. During 2012, natural industrial diamonds were produced in at least 20 countries, and synthetic industrial diamond was produced in at least 12 countries. About 99 percent of the combined natural and synthetic global output was produced in Belarus, China, Ireland, Japan, Russia, South Africa and the United States. During 2012, China was the world’s leading producer of synthetic industrial diamond followed by the United States and Russia. In 2012, the two U.S. synthetic producers, one in Pennsylvania and the other in Ohio, had an estimated output of 103 million carats, valued at about $70.6 million. This was an estimated 43.7 million carats of synthetic diamond bort, grit, and dust and powder with a value of $14.5 million combined with an estimated 59.7 million carats of synthetic diamond stone with a value of $56.1 million. Also in 2012, nine U.S. firms manufactured polycrystalline diamond (PCD) from synthetic diamond grit and powder. The United States government does not collect or maintain data for either domestic PCD producers or domestic chemical vapor deposition (CVD) diamond producers for quantity or value of annual production. Current trade and consumption quantity data are not available for PCD or for CVD diamond. For these reasons, PCD and CVD diamond are not included in the industrial diamond quantitative data reported here.

  3. Trojan Microparticles for Drug Delivery

    OpenAIRE

    Vandamme, Thierry F.; Nicolas Anton; Anshuman Jakhmola

    2012-01-01

    During the last decade, the US Food and Drug Administration (FDA) have regulated a wide range of products, (foods, cosmetics, drugs, devices, veterinary, and tobacco) which may utilize micro and nanotechnology or contain nanomaterials. Nanotechnology allows scientists to create, explore, and manipulate materials in nano-regime. Such materials have chemical, physical, and biological properties that are quite different from their bulk counterparts. For pharmaceutical applications and in order t...

  4. Hospitality Industry

    Directory of Open Access Journals (Sweden)

    Marian Ionel

    2017-03-01

    Full Text Available Development of accommodation, as basic services offered to tourists, led to the creation of a genuine hospitality industry. Currently, the hospitality industry is no longer just the accommodation service itself but also requires an atmosphere that ensures leisure tourists in the hotel. Thus, hospitable unit manager offers its service in addition to accommodation and catering services, leisure services, treatment services, business services required.. The existence of factors such as revenue growth, increasing leisure time, the development of transport services, the emergence of new tourist attractions have caused increasing international flows of tourists, with consequent development of units hospitable, and therefore a strong hospitality industry. In Romania, after 1990, the tourism sector experienced a true expansion, both through the development of the hotel sector, but also by developing rural hospitality units.

  5. Stability-indicating HPLC method for posaconazole bulk assay.

    Science.gov (United States)

    Garcia, Cássia V; Costa, Gislaine R; Mendez, Andreas S L

    2012-01-01

    A stability-indicating liquid chromatographic (LC) method was developed for the determination of posaconazole in bulk. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system, with a mobile phase composed of methanol-water (75:25, v/v), at 1.0 mL min(-1) flow. Samples were exposed to degradation under thermal, oxidative and acid/basic conditions, and no interference in the analysis was observed. System suitability was evaluated and results were satisfactory (N = 4,900.00 tailing factor 1.04; RSD between injections = 0.65). The retention time of posaconazole was about 8.5 min and the method was validated within the concentration range 5-60 μg mL(-1) (r = 0.9996). Adequate results were obtained for repeatability (RSD % = 0.86-1.22), inter-day precision (RSD % = 1.21) and accuracy (98.13% mean recovery). Robustness was also determined to be satisfactory after evaluation. The proposed method was successfully applied to posaconazole bulk quantification, showing the method is useful for determination of the drug in routine analysis.

  6. Fiabilidad industrial

    OpenAIRE

    Griful Ponsati, Eulàlia

    2001-01-01

    El presente libro ha sido escrito y editado para los estudios de segundo ciclo de Ingeniería de Organización Industrial que se imparten en la ETSEIT de la UPC. La materia de fiabilidad que se imparte en este texto es una introducción a las técnicas estadísticas para resolver cuestiones de fiabilidad industrial. Se estudian distintos modelos probabilísticos del tiempo de vida y se presentan distintas formas de recabar información y de estimar, en cada caso, la fiabilidad de los componentes y s...

  7. Industrial Networks

    DEFF Research Database (Denmark)

    Karlsson, Christer

    2015-01-01

    the focus of operations management from managing the own organization to continuously developing and managing a network of external and internal resources forming a production system. This perspective may be called managing an “extraprise” rather than an “enterprise.” It should be noted that “an industrial...... network” should not be seen as an organizational form but as a perspective that can be used to enrich one's understanding of organizations. The industrial network perspective has three basic building blocks: actors, resources, and activities. The three building blocks and their relations constitute...

  8. Polymer-fullerene bulk heterojunction solar cells

    NARCIS (Netherlands)

    Janssen, RAJ; Hummelen, JC; Saricifti, NS

    2005-01-01

    Nanostructured phase-separated blends, or bulk heterojunctions, of conjugated Polymers and fullerene derivatives form a very attractive approach to large-area, solid-state organic solar cells.The key feature of these cells is that they combine easy, processing from solution on a variety of substrate

  9. Failure by fracture in bulk metal forming

    DEFF Research Database (Denmark)

    Silva, C.M.A.; Alves, Luis M.; Nielsen, Chris Valentin

    2015-01-01

    This paper revisits formability in bulk metal forming in the light of fundamental concepts of plasticity,ductile damage and crack opening modes. It proposes a new test to appraise the accuracy, reliability and validity of fracture loci associated with crack opening by tension and out-of-plane she...

  10. THE OPTIMIZATION OF PLUSH YARNS BULKING PROCESS

    Directory of Open Access Journals (Sweden)

    VINEREANU Adam

    2014-05-01

    Full Text Available This paper presents the experiments that were conducted on the installation of continuous bulking and thermofixing “SUPERBA” type TVP-2S for optimization of the plush yarns bulking process. There were considered plush yarns Nm 6.5/2, made of the fibrous blend of 50% indigenous wool sort 41 and 50% PES. In the first stage, it performs a thermal treatment with a turboprevaporizer at a temperature lower than thermofixing temperature, at atmospheric pressure, such that the plush yarns - deposed in a freely state on a belt conveyor - are uniformly bulking and contracting. It was followed the mathematical modeling procedure, working with a factorial program, rotatable central composite type, and two independent variables. After analyzing the parameters that have a direct influence on the bulking degree, there were selected the pre-vaporization temperature (coded x1,oC and the velocity of belt inside pre-vaporizer (coded x 2, m/min. As for the dependent variable, it was chosen the plush yarn diameter (coded y, mm. There were found the coordinates of the optimal point, and then this pair of values was verified in practice. These coordinates are: x1optim= 90oC and x 2optim= 6.5 m/min. The conclusion is that the goal was accomplished: it was obtained a good cover degree f or double-plush carpets by reducing the number of tufts per unit surface.

  11. Forming of bulk metallic glass microcomponents

    DEFF Research Database (Denmark)

    Wert, John A.; Thomsen, Christian; Jensen, Rune Debel

    2009-01-01

    The present article considers forward extrusion, closed-die forging and backward extrusion processes for fabrication of individual microcomponents from two bulk metallic glass (BMG) compositions: Mg60Cu30Y10 and Zr44Cu40Ag8Al8. Two types of tooling were used in the present work: relatively massive...

  12. Bulk viscosity effects on ultrasonic thermoacoustic instability

    Science.gov (United States)

    Lin, Jeffrey; Scalo, Carlo; Hesselink, Lambertus

    2016-11-01

    We have carried out unstructured fully-compressible Navier-Stokes simulations of a minimal-unit traveling-wave ultrasonic thermoacoustic device in looped configuration. The model comprises a thermoacoustic stack with 85% porosity and a tapered area change to suppress the fundamental standing-wave mode. A bulk viscosity model, which accounts for vibrational and rotational molecular relaxation effects, is derived and implemented via direct modification of the viscous stress tensor, τij ≡ 2 μSij +λ/2 μ ∂uk/∂xk δij , where the bulk viscosity is defined by μb ≡ λ +2/3 μ . The effective bulk viscosity coefficient accurately captures acoustic absorption from low to high ultrasonic frequencies and matches experimental wave attenuation rates across five decades. Using pressure-based similitude, the model was downscaled from total length L = 2 . 58 m to 0 . 0258 m, corresponding to the frequency range f = 242 - 24200 Hz, revealing the effects of bulk viscosity and direct modification of the thermodynamic pressure. Simulations are carried out to limit cycle and exhibit growth rates consistent with linear stability analyses, based on Rott's theory.

  13. Longitudinal bulk a coustic mass sensor

    DEFF Research Database (Denmark)

    Hales, Jan Harry; Teva, Jordi; Boisen, Anja;

    2009-01-01

    Design, fabrication and characterization, in terms of mass sensitivity, is presented for a polycrystalline silicon longitudinal bulk acoustic cantilever. The device is operated in air at 51 MHz, resulting in a mass sensitivity of 100 HZ/fg (1 fg = 10{su−15 g). The initial characterization...

  14. Winterization strategies for bulk storage of pickles

    Science.gov (United States)

    Cucumbers are commercially fermented and stored in bulk in outdoor open top fiberglass tanks. During winter, snow and ice accumulates around and on top of tanks influencing heat transfer in an unpredictable manner, often compromising the fruit quality. This study evaluates the performance of inexpen...

  15. A Stereoscopic Look into the Bulk

    CERN Document Server

    Czech, Bartlomiej; McCandlish, Samuel; Mosk, Benjamin; Sully, James

    2016-01-01

    We present the foundation for a holographic dictionary with depth perception. The dictionary consists of natural CFT operators whose duals are simple, diffeomorphism-invariant bulk operators. The CFT operators of interest are the "OPE blocks," contributions to the OPE from a single conformal family. In holographic theories, we show that the OPE blocks are dual at leading order in 1/N to integrals of effective bulk fields along geodesics or homogeneous minimal surfaces in anti-de Sitter space. One widely studied example of an OPE block is the modular Hamiltonian, which is dual to the fluctuation in the area of a minimal surface. Thus, our operators pave the way for generalizing the Ryu-Takayanagi relation to other bulk fields. Although the OPE blocks are non-local operators in the CFT, they admit a simple geometric description as fields in kinematic space--the space of pairs of CFT points. We develop the tools for constructing local bulk operators in terms of these non-local objects. The OPE blocks also allow ...

  16. Fluctuating brane in a dilatonic bulk

    CERN Document Server

    Brax, P; Rodríguez-Martinez, M; Brax, Philippe; Langlois, David; Rodriguez-Martinez, Maria

    2003-01-01

    We consider a cosmological brane moving in a static five-dimensional bulk spacetime endowed with a scalar field whose potential is exponential. After studying various cosmological behaviours for the homogeneous background, we investigate the fluctuations of the brane that leave spacetime unaffected. A single mode embodies these fluctuations and obeys a wave equation which we study for bouncing and ever-expanding branes.

  17. Drug: D03306 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D03306 Drug Polycarbophil calcium (JAN); Calcium polycarbophil (USP); Mitrolan (TN)...phil calcium (JAN); Calcium polycarbophil (USP) Anatomical Therapeutic Chemical (... CONSTIPATION A06AC Bulk-forming laxatives A06AC08 Polycarbophil calcium D03306 Polycarbophil calcium (JAN); Calcium polycarbophil (USP) PubChem: 17397457 ...

  18. VALIDATED SPECTROPHOTMETRIC METHOD FOR THE DETERMINATION OF SALBUTAMOL SULPHATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

    Directory of Open Access Journals (Sweden)

    Eswarudu.M.M

    2012-04-01

    Full Text Available A new, simple, accurate and sensitive spectrophotometric method has been developed for the estimation of Salbutamol sulphate in bulk and in pharmaceutical formulations. Salbutamol sulphate shows ʎ max at 292 nm. The drug follows the beer’s lambert’s law in the concentration range of 20-100µ ml. the method was validated by following the analytical performance parameters as suggested by the international conference on harmonization which included accuracy, precision, linearity. All validation parameters were with in the acceptable range. The developed method was successfully applied to estimate the amount of Salbutamol sulphate in bulk and pharmaceutical dosage forms.

  19. Spectrophotometric determination of nateglinide in bulk and tablet dosage forms

    Directory of Open Access Journals (Sweden)

    Jain Suresh

    2009-01-01

    Full Text Available Nateglinide (NTG is available as tablet dosage form in 60 mg and 120 mg strength. In the present study, two simple, reproducible and efficient UV spectrophotometric methods for the estimation of this drug in bulk and pharmaceutical dosage forms have been developed. In method I, methanol-AR was used as solvent, while in method II, Methanol-AR + 10% V/V 3N NaOH was used as reference solvent. In method I, nateglinide shows λmax at 216 nm, which is then shifted to 225.4 nm on increasing the basicity of the reference solvent in method II. The linearity for nateglinide was observed to be statistically in the range of 10-100 μg/ml in method I and 100-1000 μg/ml in method II. Both the methods were validated using ANOVA. The recovery studies confirmed the accuracy of the proposed methods.

  20. Analytical Applications of Transport Through Bulk Liquid Membranes.

    Science.gov (United States)

    Diaconu, Ioana; Ruse, Elena; Aboul-Enein, Hassan Y; Bunaciu, Andrei A

    2016-07-03

    This review discusses the results of research in the use of bulk liquid membranes in separation processes and preconcentration for analytical purposes. It includes some theoretical aspects, definitions, types of liquid membranes, and transport mechanism, as well as advantages of using liquid membranes in laboratory studies. These concepts are necessary to understand fundamental principles of liquid membrane transport. Due to the multiple advantages of liquid membranes several studies present analytical applications of the transport through liquid membranes in separation or preconcentration processes of metallic cations and some organic compounds, such as phenol and phenolic derivatives, organic acids, amino acids, carbohydrates, and drugs. This review presents coupled techniques such as separation through the liquid membrane coupled with flow injection analysis.

  1. Meteoroid Bulk Density and Ceplecha Types

    Science.gov (United States)

    Blaauw, R. C.; Moser, D. E.; Moorhead, A. V.

    2017-01-01

    The determination of asteroid bulk density is an important aspect of Near Earth Object (NEO) characterization. A fraction of meteoroids originate from asteroids (including some NEOs), thus in lieu of mutual perturbations, satellites, or expensive spacecraft missions, a study of meteoroid bulk densities can potentially provide useful insights into the densities of NEOs and PHOs (Potentially Hazardous Objects). Meteoroid bulk density is still inherently difficult to measure, and is most often determined by modeling the ablation of the meteoroid. One approach towards determining a meteoroid density distribution entails using a more easily measured proxy for the densities, then calibrating the proxy with known densities from meteorite falls, ablation modelling, and other sources. An obvious proxy choice is the Ceplecha type, KB (Ceplecha, 1958), which is thought to indicate the strength of a meteoroid and often correlated to different bulk densities in literature. KB is calculated using the air density at the beginning height of the meteor, the initial velocity, and the zenith angle of the radiant; quantities more readily determined than meteoroid bulk density itself. Numerical values of K(sub B) are sorted into groups (A, B, C, etc.), which have been matched to meteorite falls or meteor showers with known composition such as the porous Draconids. An extensive survey was conducted to establish the strength of the relationship between bulk density and K(sub B), specifically looking at those that additionally determined K(sub B) for the meteors. In examining the modeling of high-resolution meteor data from Kikwaya et al. (2011), the correlation between K(sub B) and bulk density was not as strong as hoped. However, a distinct split by dynamical type was seen with Jovian Tisserand parameter (T(sub J)), with meteoroids from Halley Type comets (T(sub J) densities than those originating from Jupiter Family comets and asteroids (T(sub J) > 2). Therefore, this work indicates

  2. Drug Facts

    Medline Plus

    Full Text Available ... Use and Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

  3. Club Drugs

    Science.gov (United States)

    ... uses. Other uses of these drugs are abuse. Club drugs are also sometimes used as "date rape" drugs, to make someone unable to say no to or fight back against sexual assault. Abusing these drugs can ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... Nicotine Facts Other Drugs of Abuse What is Addiction? Do You or a Loved One Have a Drug Use Problem? Signs of Drug Use and Addiction How Does Drug Use Become Addiction? Addiction Risk ...

  5. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & ...

  6. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg... specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug...

  7. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Science.gov (United States)

    2013-09-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Fluticasone... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone...

  8. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendation... Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence... of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for...

  9. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Science.gov (United States)

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... the availability of a revised draft guidance for industry entitled ``Bioequivalence Recommendations... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone...

  10. Integration of bulk piezoelectric materials into microsystems

    Science.gov (United States)

    Aktakka, Ethem Erkan

    Bulk piezoelectric ceramics, compared to deposited piezoelectric thin-films, provide greater electromechanical coupling and charge capacity, which are highly desirable in many MEMS applications. In this thesis, a technology platform is developed for wafer-level integration of bulk piezoelectric substrates on silicon, with a final film thickness of 5-100microm. The characterized processes include reliable low-temperature (200°C) AuIn diffusion bonding and parylene bonding of bulk-PZT on silicon, wafer-level lapping of bulk-PZT with high-uniformity (+/-0.5microm), and low-damage micro-machining of PZT films via dicing-saw patterning, laser ablation, and wet-etching. Preservation of ferroelectric and piezoelectric properties is confirmed with hysteresis and piezo-response measurements. The introduced technology offers higher material quality and unique advantages in fabrication flexibility over existing piezoelectric film deposition methods. In order to confirm the preserved bulk properties in the final film, diaphragm and cantilever beam actuators operating in the transverse-mode are designed, fabricated and tested. The diaphragm structure and electrode shapes/sizes are optimized for maximum deflection through finite-element simulations. During tests of fabricated devices, greater than 12microm PP displacement is obtained by actuation of a 1mm2 diaphragm at 111kHz with management IC, which incorporates a supply-independent bias circuitry, an active diode for low-dropout rectification, a bias-flip system for higher efficiency, and a trickle battery charger. The overall system does not require a pre-charged battery, and has power consumption of sleep-mode (simulated). Under lg vibration at 155Hz, a 70mF ultra-capacitor is charged from OV to 1.85V in 50 minutes.

  11. 46 CFR 148.04-23 - Unslaked lime in bulk.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 5 2010-10-01 2010-10-01 false Unslaked lime in bulk. 148.04-23 Section 148.04-23... HAZARDOUS MATERIALS IN BULK Special Additional Requirements for Certain Material § 148.04-23 Unslaked lime in bulk. (a) Unslaked lime in bulk must be transported in unmanned, all steel, double-hulled...

  12. Fermentation Industry.

    Science.gov (United States)

    Grady, C. P. L., Jr.; Grady, J. K.

    1978-01-01

    Presents a literature review of wastes from the fermentation industry, covering publications of 1976-77. This review focuses on: (1) alcoholic beverage production; (2) pharmaceuticals and biochemicals production; and (3) biomass production. A list of 62 references is also presented. (HM)

  13. Fermentation Industry.

    Science.gov (United States)

    Grady, C. P. L., Jr.; Grady, J. K.

    1978-01-01

    Presents a literature review of wastes from the fermentation industry, covering publications of 1976-77. This review focuses on: (1) alcoholic beverage production; (2) pharmaceuticals and biochemicals production; and (3) biomass production. A list of 62 references is also presented. (HM)

  14. Shifting Industries

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    Coastal city Beihai aspires to revive its economy by developing its electronic information industry Against a clear sky,the blue sea hums along a shining beach,with villas in the distance.This beautiful scene is in Beihai,in south China’s Guangxi Zhuang Autonomous Region.

  15. Microbial biotransformation as a tool for drug development based on natural products from mevalonic acid pathway: A review

    Directory of Open Access Journals (Sweden)

    Mohamed-Elamir F. Hegazy

    2015-01-01

    Full Text Available Natural products are structurally and biologically interesting metabolites, but they have been isolated in minute amounts. The syntheses of such natural products help in obtaining them in bulk amounts. The recognition of microbial biotransformation as important manufacturing tool has increased in chemical and pharmaceutical industries. In recent years, microbial transformation is increasing significantly from limited interest into highly active area in green chemistry including preparation of pharmaceutical products. This is the first review published on the usage of microbial biocatalysts for some natural product classes and natural product drugs.

  16. Sheet-bulk metal forming – forming of functional components from sheet metals

    Directory of Open Access Journals (Sweden)

    Merklein Marion

    2015-01-01

    Full Text Available The paper gives an overview on the application of sheet-bulk metal forming operations in both scientific and industrial environment. Beginning with the need for an innovative forming technology, the definition of this new process class is introduced. The rising challenges of the application of bulk metal forming operations on sheet metals are presented and the demand on a holistic investigation of this topic is motivated. With the help of examples from established production processes, the latest state of technology and the lack on fundamental knowledge is shown. Furthermore, perspectives regarding new research topics within sheet-bulk metal forming are presented. These focus on processing strategies to improve the quality of functional components by the application of process-adapted semi-finished products as well as the local adaption of the tribological system.

  17. 2013 mask industry survey

    Science.gov (United States)

    Malloy, Matt

    2013-09-01

    A comprehensive survey was sent to merchant and captive mask shops to gather information about the mask industry as an objective assessment of its overall condition. 2013 marks the 12th consecutive year for this process. Historical topics including general mask profile, mask processing, data and write time, yield and yield loss, delivery times, maintenance, and returns were included and new topics were added. Within each category are multiple questions that result in a detailed profile of both the business and technical status of the mask industry. While each year's survey includes minor updates based on feedback from past years and the need to collect additional data on key topics, the bulk of the survey and reporting structure have remained relatively constant. A series of improvements is being phased in beginning in 2013 to add value to a wider audience, while at the same time retaining the historical content required for trend analyses of the traditional metrics. Additions in 2013 include topics such as top challenges, future concerns, and additional details in key aspects of mask masking, such as the number of masks per mask set per ground rule, minimum mask resolution shipped, and yield by ground rule. These expansions beyond the historical topics are aimed at identifying common issues, gaps, and needs. They will also provide a better understanding of real-life mask requirements and capabilities for comparison to the International Technology Roadmap for Semiconductors (ITRS).

  18. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2013-04-04

    ... Manufacturing Organizations. Contract Agreements. Drug Safety. Emerging Active Pharmaceutical Ingredients (API... industry as well as explore strategies and approaches for ensuring conformance with regulations to... the development of global regulatory strategies, while industry professionals from some of...

  19. Anaerobic Fermentation for Production of Carboxylic Acids as Bulk Chemicals from Renewable Biomass.

    Science.gov (United States)

    Wang, Jufang; Lin, Meng; Xu, Mengmeng; Yang, Shang-Tian

    Biomass represents an abundant carbon-neutral renewable resource which can be converted to bulk chemicals to replace petrochemicals. Carboxylic acids have wide applications in the chemical, food, and pharmaceutical industries. This chapter provides an overview of recent advances and challenges in the industrial production of various types of carboxylic acids, including short-chain fatty acids (acetic, propionic, butyric), hydroxy acids (lactic, 3-hydroxypropionic), dicarboxylic acids (succinic, malic, fumaric, itaconic, adipic, muconic, glucaric), and others (acrylic, citric, gluconic, pyruvic) by anaerobic fermentation. For economic production of these carboxylic acids as bulk chemicals, the fermentation process must have a sufficiently high product titer, productivity and yield, and low impurity acid byproducts to compete with their petrochemical counterparts. System metabolic engineering offers the tools needed to develop novel strains that can meet these process requirements for converting biomass feedstock to the desirable product.

  20. Bulk locality and boundary creating operators

    Science.gov (United States)

    Nakayama, Yu; Ooguri, Hirosi

    2015-10-01

    We formulate a minimum requirement for CFT operators to be localized in the dual AdS. In any spacetime dimensions, we show that a general solution to the requirement is a linear superposition of operators creating spherical boundaries in CFT, with the dilatation by the imaginary unit from their centers. This generalizes the recent proposal by Miyaji et al. for bulk local operators in the three dimensional AdS. We show that Ishibashi states for the global conformal symmetry in any dimensions and with the imaginary di-latation obey free field equations in AdS and that incorporating bulk interactions require their superpositions. We also comment on the recent proposals by Kabat et al., and by H. Verlinde.

  1. Bulk Locality and Boundary Creating Operators

    CERN Document Server

    Nakayama, Yu

    2015-01-01

    We formulate a minimum requirement for CFT operators to be localized in the dual AdS. In any spacetime dimensions, we show that a general solution to the requirement is a linear superposition of operators creating spherical boundaries in CFT, with the dilatation by the imaginary unit from their centers. This generalizes the recent proposal by Miyaji et al. for bulk local operators in the three dimensional AdS. We show that Ishibashi states for the global conformal symmetry in any dimensions and with the imaginary dilatation obey free field equations in AdS and that incorporating bulk interactions require their superpositions. We also comment on the recent proposals by Kabat et al., and by H. Verlinde.

  2. Bulk locality and boundary creating operators

    Energy Technology Data Exchange (ETDEWEB)

    Nakayama, Yu [Walter Burke Institute for Theoretical Physics, California Institute of Technology, Pasadena, California 91125 (United States); Ooguri, Hirosi [Walter Burke Institute for Theoretical Physics, California Institute of Technology, Pasadena, California 91125 (United States); Kavli Institute for the Physics and Mathematics of the Universe, University of Tokyo, 5-1-5 Kashiwanoha, Kashiwa, Chiba 277-8583 (Japan)

    2015-10-19

    We formulate a minimum requirement for CFT operators to be localized in the dual AdS. In any spacetime dimensions, we show that a general solution to the requirement is a linear superposition of operators creating spherical boundaries in CFT, with the dilatation by the imaginary unit from their centers. This generalizes the recent proposal by Miyaji et al. for bulk local operators in the three dimensional AdS. We show that Ishibashi states for the global conformal symmetry in any dimensions and with the imaginary dilatation obey free field equations in AdS and that incorporating bulk interactions require their superpositions. We also comment on the recent proposals by Kabat et al., and by H. Verlinde.

  3. Bulk and shear viscosity in Hagedorn fluid

    Energy Technology Data Exchange (ETDEWEB)

    Tawfik, A.; Wahba, M. [Egyptian Center for Theoretical Physics (ECTP), MTI University, Faculty of Engineering, Cairo (Egypt)

    2010-11-15

    Assuming that the Hagedorn fluid composed of known particles and resonances with masses m <2 GeV obeys the first-order theory (Eckart) of relativistic fluid, we discuss the transport properties of QCD confined phase. Based on the relativistic kinetic theory formulated under the relaxation time approximation, expressions for bulk and shear viscosity in thermal medium of hadron resonances are derived. The relaxation time in the Hagedorn dynamical fluid exclusively takes into account the decay and eventually van der Waals processes. We comment on the in-medium thermal effects on bulk and shear viscosity and averaged relaxation time with and without the excluded-volume approach. As an application of these results, we suggest the dynamics of heavy-ion collisions, non-equilibrium thermodynamics and the cosmological models, which require thermo- and hydro-dynamics equations of state. (Abstract Copyright [2010], Wiley Periodicals, Inc.)

  4. Bulk and Shear Viscosity in Hagedorn Fluid

    CERN Document Server

    Tawfik, A

    2010-01-01

    Assuming that the Hagedorn fluid composed of known particles and resonances with masses $m<2\\,$GeV obeys the {\\it first-order} theory (Eckart) of relativistic fluid, we discuss the transport properties of QCD confined phase. Based on the relativistic kinetic theory formulated under the relaxation time approximation, expressions for bulk and shear viscosity in thermal medium are derived. The relaxation time in the Hagedorn dynamical fluid exclusively takes into account the decay and eventually van der Waals processes. We comment on the {\\it in-medium} thermal effects on bulk and shear viscosities and averaged relaxation time with and without the excluded-volume approach. As an application of these results, we suggest the dynamics of heavy-ion collisions, non-equlibrium thermodynamics and the cosmological models, which require thermo and hydrodynamics equations of state.

  5. Portable design rules for bulk CMOS

    Science.gov (United States)

    Griswold, T. W.

    1982-01-01

    It is pointed out that for the past several years, one school of IC designers has used a simplified set of nMOS geometric design rules (GDR) which is 'portable', in that it can be used by many different nMOS manufacturers. The present investigation is concerned with a preliminary set of design rules for bulk CMOS which has been verified for simple test structures. The GDR are defined in terms of Caltech Intermediate Form (CIF), which is a geometry-description language that defines simple geometrical objects in layers. The layers are abstractions of physical mask layers. The design rules do not presume the existence of any particular design methodology. Attention is given to p-well and n-well CMOS processes, bulk CMOS and CMOS-SOS, CMOS geometric rules, and a description of the advantages of CMOS technology.

  6. Fully antisymmetrised dynamics for bulk fermion systems

    CERN Document Server

    Vantournhout, Klaas

    2011-01-01

    The neutron star's crust and mantel are typical examples of non-uniform bulk systems with spacial localisations. When modelling such systems at low temperatures, as is the case in the crust, one has to work with antisymmetrised many-body states to get the correct fermion behaviour. Fermionic molecular dynamics, which works with an antisymmetrised product of localised wave packets, should be an appropriate choice. Implementing periodic boundary conditions into the fermionic molecular dynamics formalism would allow the study of the neutron star's crust as a bulk quantum system. Unfortunately, the antisymmetrisation is a non-local entanglement which reaches far out of the periodically repeated unit cell. In this proceeding, we give a brief overview how periodic boundary conditions and fermionic molecular dynamics can be combined without truncating the long-range many-body correlation induced by the antisymmetry of the many-body state.

  7. Large bulk Micromegas detectors for TPC applications

    CERN Document Server

    Anvar, S; Boyer, M; Beucher, J; Calvet, D; Colas, P; De La Broise, X; Delagnes, E; Delbart, A; Druillole, F; Emery, S; Giganti, C; Giomataris, I; Mazzucato, E; Monmarthe, E; Nizery, F; Pierre, F; Ritou, J L; Sarrat, A; Zito, M; Catanesi, M G; Radicioni, E; De Oliveira, R; Blondel, A; Di Marco, M; Ferrere, D; Perrin, E; Ravonel, M; Jover, G; Lux, T; Rodriguez, A Y; Sanchez, F; Cervera, A; Hansen, C; Monfregola, L

    2009-01-01

    A large volume TPC will be used in the near future in a variety of experiments including T2K. The bulk Micromegas detector for this TPC is built using a novel production technique particularly suited for compact, thin and robust low mass detectors. The capability to pave a large surface with a simple mounting solution and small dead space is of particular interest for these applications. We have built several large bulk Micromegas detectors () and we have tested one in the former HARP field cage with a magnetic field. Prototypes cards of the T2K front end electronics, based on the AFTER ASIC chip, have been used in this TPC test for the first time. Cosmic ray data have been acquired in a variety of experimental conditions. Good detector performances, space point resolution and energy loss measurement have been achieved.

  8. Bulk micromegas detectors for large TPC applications

    CERN Document Server

    Bouchez, J; Cavata, Ch; Colas, P; De La Broise, X; Delbart, A; Giganon, Arnaud; Giomataris, Ioanis; Graffin, P; Mols, J Ph; Pierre, F; Ritou, J L; Sarrat, A; Virique, E; Zito, M; Radicioni, E; De Oliveira, R; Dumarchez, J; Abgrall, N; Bene, P; Blondel, A; Cervera-Villanueva, Anselmo; Ferrère, D; Maschiocchi, F; Perrin, E; Richeux, J P; Schroeter, R; Jover, G; Lux,; Rodriguez, A Y; Sánchez, F

    2007-01-01

    A large volume TPC will be used in the near future in a variety of experiments including T2K. The bulk Micromegas detector for this TPC is built using a novel production technique particularly suited for compact and robust low mass detectors. The capability to pave a large surface with a simple mounting solution and small dead space between modules is of particular interest for these applications. We have built several large bulk Micromegas detectors and we have tested them in the former HARP field cage setup with a magnetic field. Cosmic ray data have been acquired in a variety of experimental conditions. Good detector performances and space point resolution have been achieved.

  9. Effective pure states for bulk quantum computation

    Energy Technology Data Exchange (ETDEWEB)

    Knill, E.; Chuang, I.; Laflamme, R.

    1997-11-01

    In bulk quantum computation one can manipulate a large number of indistinguishable quantum computers by parallel unitary operations and measure expectation values of certain observables with limited sensitivity. The initial state of each computer in the ensemble is known but not pure. Methods for obtaining effective pure input states by a series of manipulations have been described by Gershenfeld and Chuang (logical labeling) and Corey et al. (spatial averaging) for the case of quantum computation with nuclear magnetic resonance. We give a different technique called temporal averaging. This method is based on classical randomization, requires no ancilla qubits and can be implemented in nuclear magnetic resonance without using gradient fields. We introduce several temporal averaging algorithms suitable for both high temperature and low temperature bulk quantum computing and analyze the signal to noise behavior of each.

  10. Modeling direct interband tunneling. I. Bulk semiconductors

    Energy Technology Data Exchange (ETDEWEB)

    Pan, Andrew, E-mail: pandrew@ucla.edu [Department of Electrical Engineering, University of California, Los Angeles, Los Angeles, California 90095 (United States); Chui, Chi On [Department of Electrical Engineering, University of California, Los Angeles, Los Angeles, California 90095 (United States); California NanoSystems Institute, University of California, Los Angeles, Los Angeles, California 90095 (United States)

    2014-08-07

    Interband tunneling is frequently studied using the semiclassical Kane model, despite uncertainty about its validity. Revisiting the physical basis of this formula, we find that it neglects coupling to other bands and underestimates transverse tunneling. As a result, significant errors can arise at low and high fields for small and large gap materials, respectively. We derive a simple multiband tunneling model to correct these defects analytically without arbitrary parameters. Through extensive comparison with band structure and quantum transport calculations for bulk InGaAs, InAs, and InSb, we probe the accuracy of the Kane and multiband formulas and establish the superiority of the latter. We also show that the nonlocal average electric field should be used when applying either of these models to nonuniform potentials. Our findings are important for efficient analysis and simulation of bulk semiconductor devices involving tunneling.

  11. Towards a reconstruction of general bulk metrics

    Science.gov (United States)

    Engelhardt, Netta; Horowitz, Gary T.

    2017-01-01

    We prove that the metric of a general holographic spacetime can be reconstructed (up to an overall conformal factor) from distinguished spatial slices—‘light-cone cuts’—of the conformal boundary. Our prescription is covariant and applies to bulk points in causal contact with the boundary. Furthermore, we describe a procedure for determining the light-cone cuts corresponding to bulk points in the causal wedge of the boundary in terms of the divergences of correlators in the dual field theory. Possible extensions for determining the conformal factor and including the cuts of points outside of the causal wedge are discussed. We also comment on implications for subregion/subregion duality.

  12. Metal reduction at bulk chemical filtration

    Science.gov (United States)

    Umeda, Toru; Daikoku, Shusaku; Tsuzuki, Shuichi; Murakami, Tetsuya

    2017-03-01

    OK73 thinner and cyclohexanone, both of which were spiked with metals were passed through Nylon 6,6 filter, varying flow rate, which include the conditions of both point-of-use and bulk filtrations. The influent and effluent metal concentrations were measured using ICP-MS for metal removal efficiency of the filtration. As a result, removal efficiency for some metals descended depending on the flow rate, while others maintained. Slower flow rate is recommended to maintain low metal concentration in bulk filtration based on the result. Metals in cyclohexanone were reduced at higher efficiency than in OK73 thinner, agrees with a metal removal model of hydrophilic adsorbent in organic solvent, evidenced in our previous paper. Further, metal reduction on 300 mm φ Si wafer after coating organic solvents with Nylon 6,6 filtration was evidenced with TREX analysis.

  13. Multilayer Integrated Film Bulk Acoustic Resonators

    CERN Document Server

    Zhang, Yafei

    2013-01-01

    Multilayer Integrated Film Bulk Acoustic Resonators mainly introduces the theory, design, fabrication technology and application of a recently developed new type of device, multilayer integrated film bulk acoustic resonators, at the micro and nano scale involving microelectronic devices, integrated circuits, optical devices, sensors and actuators, acoustic resonators, micro-nano manufacturing, multilayer integration, device theory and design principles, etc. These devices can work at very high frequencies by using the newly developed theory, design, and fabrication technology of nano and micro devices. Readers in fields of IC, electronic devices, sensors, materials, and films etc. will benefit from this book by learning the detailed fundamentals and potential applications of these advanced devices. Prof. Yafei Zhang is the director of the Ministry of Education’s Key Laboratory for Thin Films and Microfabrication Technology, PRC; Dr. Da Chen was a PhD student in Prof. Yafei Zhang’s research group.

  14. Microfabricated bulk wave acoustic bandgap device

    Science.gov (United States)

    Olsson, Roy H.; El-Kady, Ihab F.; McCormick, Frederick; Fleming, James G.; Fleming, Carol

    2010-06-08

    A microfabricated bulk wave acoustic bandgap device comprises a periodic two-dimensional array of scatterers embedded within the matrix material membrane, wherein the scatterer material has a density and/or elastic constant that is different than the matrix material and wherein the periodicity of the array causes destructive interference of the acoustic wave within an acoustic bandgap. The membrane can be suspended above a substrate by an air or vacuum gap to provide acoustic isolation from the substrate. The device can be fabricated using microelectromechanical systems (MEMS) technologies. Such microfabricated bulk wave phononic bandgap devices are useful for acoustic isolation in the ultrasonic, VHF, or UHF regime (i.e., frequencies of order 1 MHz to 10 GHz and higher, and lattice constants of order 100 .mu.m or less).

  15. Dissolution of bulk specimens of silicon nitride

    Science.gov (United States)

    Davis, W. F.; Merkle, E. J.

    1981-01-01

    An accurate chemical characterization of silicon nitride has become important in connection with current efforts to incorporate components of this material into advanced heat engines. However, there are problems concerning a chemical analysis of bulk silicon nitride. Current analytical methods require the pulverization of bulk specimens. A pulverization procedure making use of grinding media, on the other hand, will introduce contaminants. A description is given of a dissolution procedure which overcomes these difficulties. It has been found that up to at least 0.6 g solid pieces of various samples of hot pressed and reaction bonded silicon nitride can be decomposed in a mixture of 3 mL hydrofluoric acid and 1 mL nitric acid overnight at 150 C in a Parr bomb. High-purity silicon nitride is completely soluble in nitric acid after treatment in the bomb. Following decomposition, silicon and hydrofluoric acid are volatilized and insoluble fluorides are converted to a soluble form.

  16. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... No. FDA-2013-D-0589] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral...

  17. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  18. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in... for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol...

  19. Raman characterization of bulk ferromagnetic nanostructured graphite

    Energy Technology Data Exchange (ETDEWEB)

    Pardo, Helena, E-mail: hpardo@fq.edu.uy [Centro NanoMat, Polo Tecnologico de Pando, Facultad de Quimica, Universidad de la Republica, Cno. Aparicio Saravia s/n, 91000, Pando, Canelones (Uruguay); Crystallography, Solid State and Materials Laboratory (Cryssmat-Lab), DETEMA, Facultad de Quimica, Universidad de la Republica, Gral. Flores 2124, P.O. Box 1157, Montevideo (Uruguay); Divine Khan, Ngwashi [Mantfort University, Leicester (United Kingdom); Faccio, Ricardo [Centro NanoMat, Polo Tecnologico de Pando, Facultad de Quimica, Universidad de la Republica, Cno. Aparicio Saravia s/n, 91000, Pando, Canelones (Uruguay); Crystallography, Solid State and Materials Laboratory (Cryssmat-Lab), DETEMA, Facultad de Quimica, Universidad de la Republica, Gral. Flores 2124, P.O. Box 1157, Montevideo (Uruguay); Araujo-Moreira, F.M. [Grupo de Materiais e Dispositivos-CMDMC, Departamento de Fisica e Engenharia Fisica, UFSCar, Caixa Postal 676, 13565-905, Sao Carlos SP (Brazil); Fernandez-Werner, Luciana [Centro NanoMat, Polo Tecnologico de Pando, Facultad de Quimica, Universidad de la Republica, Cno. Aparicio Saravia s/n, 91000, Pando, Canelones (Uruguay); Crystallography, Solid State and Materials Laboratory (Cryssmat-Lab), DETEMA, Facultad de Quimica, Universidad de la Republica, Gral. Flores 2124, P.O. Box 1157, Montevideo (Uruguay)

    2012-08-15

    Raman spectroscopy was used to characterize bulk ferromagnetic graphite samples prepared by controlled oxidation of commercial pristine graphite powder. The G:D band intensity ratio, the shape and position of the 2D band and the presence of a band around 2950 cm{sup -1} showed a high degree of disorder in the modified graphite sample, with a significant presence of exposed edges of graphitic planes as well as a high degree of attached hydrogen atoms.

  20. On bulk viscosity and moduli decay

    OpenAIRE

    M. Laine

    2010-01-01

    This pedagogically intended lecture, one of four under the header "Basics of thermal QCD", reviews an interesting relationship, originally pointed out by Bodeker, that exists between the bulk viscosity of Yang-Mills theory (of possible relevance to the hydrodynamics of heavy ion collision experiments) and the decay rate of scalar fields coupled very weakly to a heat bath (appearing in some particle physics inspired cosmological scenarios). This topic serves, furthermore, as a platform on whic...