WorldWideScience

Sample records for drug product information

  1. Animal Product Safety Information

    Science.gov (United States)

    ... Home Animal & Veterinary Safety & Health Product Safety Information Product Safety Information Share Tweet Linkedin Pin it More ... to report adverse experiences with veterinary drugs. Additional Product Information Questions and Answers: Evanger’s Dog and Cat ...

  2. Television advertisement format and the provision of risk information about prescription drug products.

    Science.gov (United States)

    Glinert, Lewis H; Schommer, Jon C

    2005-06-01

    Considerable attention has been afforded to analyzing the content of and assessing consumers' reaction to print direct-to-consumer drug ads, but not so for televised ads. To determine whether advertisements with different risk severity and risk presentation would significantly affect viewers' (1) recall of information contained in the advertisement, (2) evaluation of the advertisement, and (3) perceptions of the advertised product's risks. Data were collected from a sample of 135 first-year pharmacy students at a Midwestern college of pharmacy. After viewing 1 of the 6 advertisements designed for this study, participants were asked to complete a self-administered survey. Chi-square and analysis of variance were used to analyze the data. A 2x3 between subjects design was used to test the effects of 2 levels of risk severity (high- vs low-risk severity) and 3 levels of risk presentation (original ad containing integrated risk message, deintegrated risk message/dual modality using male voice-over, deintegrated risk message/dual modality using female voice-over). Results of analysis of variance procedures revealed that deintegrating risk information by placing it at the end of the advertisement and the use of captions in addition to oral messages (dual modality) (1) improved the recall of general and specific side effect information, (2) led to a perception that the advertisement had greater informational content, (3) resulted in lower Advertisement Distraction, and (4) lessened cognitive and affective aspects of information overload for the advertisement containing the high-risk severity medication. However, this pattern of findings was not found for the low-risk severity medication. Alternative methods for presenting risk information in direct-to-consumer ads affected some aspects of information recall and advertisement evaluation, but were not shown to affect risk perceptions regarding the advertised products.

  3. Information for Consumers (Drugs)

    Science.gov (United States)

    ... approved drugs Drugs@FDA Information on FDA-approved brand name and generic drugs including labeling and regulatory history Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) REMS is a risk management plan required by FDA for certain prescription drugs, ...

  4. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

  5. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

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

  6. Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents.

    Science.gov (United States)

    Cornelius, Victoria R; Liu, Kun; Peacock, Janet; Sauzet, Odile

    2016-03-20

    To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in the USA and Europe. For each drug, data were extracted from the US Product Inserts and the European Summary of Product Characteristics documents between 09/2013 and 01/2015. Individuals contributing ADR information to product information documents. All ADRs reported in product information sections 5 and 6 (USA), and 4·4 and 4·8 (Europe). Twelve brand drugs--24 paired documents--were included. On average, there were 77 more ADRs reported in the USA compared with in the European product information document, with a median number of 201 ADRs (range: 65-425) and 114 (range: 56-265), respectively. More product information documents in the USA reported information on the source of evidence (10 vs 5) and risk (9 vs 5) for greater than 80% of ADRs included in the document. There was negligible information included regarding duration, severity, reversibility or recurrence of ADRs. On average, only 29% of ADR terms were reported in both paired documents. Product information documents contained a large number of ADRs, but lacked contextual data and information important to patients and prescribers, such as duration, severity and reversibility. The ADR profile was found to be inconsistently reported between the USA and Europe, for the same drug. Identifying, selecting, summarising and presenting multidimensional harm data should be underpinned by practical evidence-based guidelines. In order for prescribers to provide considered risk-benefit advice across competing drug therapies to patients, they need access to comprehensible and reliable ADR information. Published by the BMJ Publishing Group Limited

  7. Drug Information in Space Medicine

    Science.gov (United States)

    Bayuse, Tina M.

    2009-01-01

    Published drug information is widely available for terrestrial conditions. However, information on dosing, administration, drug interactions, stability, and side effects is scant as it relates to use in Space Medicine. Multinational crews on board the International Space Station present additional challenges for drug information because medication nomenclature, information available for the drug as well as the intended use for the drug is not standard across countries. This presentation will look at unique needs for drug information and how the information is managed in Space Medicine. A review was conducted of the drug information requests submitted to the Johnson Space Center Pharmacy by Space Medicine practitioners, astronaut crewmembers and researchers. The information requested was defined and cataloged. A list of references used was maintained. The wide range of information was identified. Due to the information needs for the medications in the on-board medical kits, the Drug Monograph Project was created. A standard method for answering specific drug information questions was generated and maintained by the Johnson Space Center Pharmacy. The Drug Monograph Project will be presented. Topic-centered requests, including multinational drug information, drug-induced adverse reactions, and medication events due to the environment will be highlighted. Information management of the drug information will be explained. Future considerations for drug information needs will be outlined.

  8. Drug product selection: legal issues.

    Science.gov (United States)

    Christensen, T P; Kirking, D M; Ascione, F J; Welage, L S; Gaither, C A

    2001-01-01

    To review the potential legal liability of the pharmacist in the drug product selection process. Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions. Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation. Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.

  9. Photostability and Photostabilization of Drugs and Drug Products

    Directory of Open Access Journals (Sweden)

    Iqbal Ahmad

    2016-01-01

    Full Text Available Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups important for the photoreactivity of drugs, explains photophysical processes, and deals with the kinetics of photochemical reactions. The various modes of photodegradation of drugs with examples of selected compounds are presented. The biological consequences of the effect of light on the drug degradation are described. The photostability testing of drugs and drug products and the requirements under ICH guideline are discussed. Some information on the packaging requirements for the formulated products is provided. The various methods used for the photostabilization of solid and liquid dosage forms are also discussed.

  10. Index to Drug-Specific Information

    Science.gov (United States)

    ... Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Share Tweet Linkedin Pin ... options Linkedin Pin it Email Print Note: This Index does not include all FDA approved drugs. It ...

  11. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Science.gov (United States)

    2010-11-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... Products.'' This guidance updates recommendations regarding degradation products and updates the draft... information on listing of degradation products, setting acceptance criteria, and qualifying degradation...

  12. Optimizing clinical drug product performance

    DEFF Research Database (Denmark)

    Dickinson, Paul A.; Kesisoglou, Filippos; Flanagan, Talia

    2016-01-01

    The aim of Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid is to facilitate optimization of clinical performance of drug products. BioRAM strategy relies on therapy-driven drug delivery and follows an integrated systems approach for formulating and addressing critical...... questions and decision-making (J Pharm Sci. 2014,103(11): 3777-97). In BioRAM, risk is defined as not achieving the intended in vivo drug product performance, and success is assessed by time to decision-making and action. Emphasis on time to decision-making and time to action highlights the value of well....... Application of the BioRAM Scoring Grid is illustrated using published literature. Organizational considerations for implementing BioRAM strategy, including the interactions, function, and skillsets of the BioRAM group members, are also reviewed. As a creative and innovative systems approach, we believe...

  13. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    DEFF Research Database (Denmark)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl

    2014-01-01

    as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n...

  14. INFORMATION ABOUT DRUGS IN FAMILY MAGAZINES

    NARCIS (Netherlands)

    VANTRIGT, AM; VANDENBERG, LTWD; PASMAN, M; HAAIJER-RUSKAMP, FM; WILLEMS, J; TROMP, TFJ

    1995-01-01

    Family magazines can play an important role in the diffusion of medical information and information regarding drugs to a 'lay audience'. We describe what kind of drugs are discussed in the family magazines and which information regarding these drugs is given. Furthermore, we look into the

  15. Electronic Animal Drug Product Listing Directory

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Electronic Animal Drug Product Listing Directory is a directory of all animal drug products that have been listed electronically since June 1, 2009, to comply...

  16. MedlinePlus: Drug Information

    Science.gov (United States)

    ... supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions. All herbs and ... Alternative Therapies Cancer Chemotherapy Cold and Cough Medicines Complementary ...

  17. Pesticide Product Information System (PPIS)

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Pesticide Product Information System contains information concerning all pesticide products registered in the United States. It includes registrant name and...

  18. Photostability and Photostabilization of Drugs and Drug Products

    OpenAIRE

    Ahmad, Iqbal; Ahmed, Sofia; Anwar, Zubair; Sheraz, Muhammad Ali; Sikorski, Marek

    2016-01-01

    Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups ...

  19. Role of Information Anxiety and Information Load on Processing of Prescription Drug Information Leaflets.

    Science.gov (United States)

    Bapat, Shweta S; Patel, Harshali K; Sansgiry, Sujit S

    2017-10-16

    In this study, we evaluate the role of information anxiety and information load on the intention to read information from prescription drug information leaflets (PILs). These PILs were developed based on the principals of information load and consumer information processing. This was an experimental prospective repeated measures study conducted in the United States where 360 (62% response rate) university students (>18 years old) participated. Participants were presented with a scenario followed by exposure to the three drug product information sources used to operationalize information load. The three sources were: (i) current practice; (ii) pre-existing one-page text only; and (iii) interventional one-page prototype PILs designed for the study. Information anxiety was measured as anxiety experienced by the individual when encountering information. The outcome variable of intention to read PILs was defined as the likelihood that the patient will read the information provided in the leaflets. A survey questionnaire was used to capture the data and the objectives were analyzed by performing a repeated measures MANOVA using SAS version 9.3. When compared to current practice and one-page text only leaflets, one-page PILs had significantly lower scores on information anxiety ( p information load ( p Information anxiety and information load significantly impacted intention to read ( p < 0.001). Newly developed PILs increased patient's intention to read and can help in improving the counseling services provided by pharmacists.

  20. Indian aspects of drug information resources and impact of drug information centre on community.

    Science.gov (United States)

    Chauhan, Nitesh; Moin, Sabeeya; Pandey, Anushree; Mittal, Ashu; Bajaj, Umakant

    2013-04-01

    Drug information centre refer to facility specially set aside for, and specializing in the provision of drug information and related issues. The purpose of drug information center is to provide authentic individualized, accurate, relevant and unbiased drug information to the consumers and healthcare professionals regarding medication related inquiries to the nation for health care and drug safety aspects by answering their call regarding the all critical problems on drug information, their uses and their side effects. Apart from that the center also provides in-depth, impartial source of crucial drug information to meet the needs of the practicing physicians, pharmacists and other health care professionals to safeguard the health, financial and legal interests of the patient and to broaden the pharmacist role visible in the society and community. The service should include collecting, reviewing, evaluating, indexing and distributing information on drugs to health workers. Drug and poisons information centers are best established within major teaching hospitals. This allows access to clinical experience, libraries, research facilities and educational activities. Information present in the current paper will not only enlighten the role of drug information center but also focused on the rational use of drug.

  1. Indian aspects of drug information resources and impact of drug information centre on community

    Directory of Open Access Journals (Sweden)

    Nitesh Chauhan

    2013-01-01

    Full Text Available Drug information centre refer to facility specially set aside for, and specializing in the provision of drug information and related issues. The purpose of drug information center is to provide authentic individualized, accurate, relevant and unbiased drug information to the consumers and healthcare professionals regarding medication related inquiries to the nation for health care and drug safety aspects by answering their call regarding the all critical problems on drug information, their uses and their side effects. Apart from that the center also provides in-depth, impartial source of crucial drug information to meet the needs of the practicing physicians, pharmacists and other health care professionals to safeguard the health, financial and legal interests of the patient and to broaden the pharmacist role visible in the society and community. The service should include collecting, reviewing, evaluating, indexing and distributing information on drugs to health workers. Drug and poisons information centers are best established within major teaching hospitals. This allows access to clinical experience, libraries, research facilities and educational activities. Information present in the current paper will not only enlighten the role of drug information center but also focused on the rational use of drug.

  2. Clinical information in drug package inserts in India

    Directory of Open Access Journals (Sweden)

    Shivkar Y

    2009-01-01

    Full Text Available Background: It is widely recognized that accurate and reliable product information is essential for the safe and effective use of medications. Pharmaceutical companies are the primary source of most drug information, including package inserts. Package inserts are printed leaflets accompanying marketed drug products and contain information approved by the regulatory agencies. Studies on package inserts in India, in 1996, had shown that crucial information was often missing and they lacked uniformity. Aim: To assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Materials and Methods: Package inserts accompanying allopathic drug products marketed by pharmaceutical companies in India were collected. These package inserts were analyzed for the content of clinically important information in various sections. Statistical Analysis: The results were expressed as absolute numbers and percentages. Results: Preliminary analyses revealed that most package inserts did contain information under headings, such as, therapeutic indications, contraindications, undesirable effects, etc., listed in the Drugs and Cosmetics Rules 1945. The findings indicated considerable improvement in package inserts since 1996. However, on critical evaluation it was revealed that clinically important information was not well presented and was often incomplete. Information with regard to pediatric and geriatric use was present in only 44% and 13% of the package inserts, respectively. Only five of the inserts had information on the most frequent adverse drug reactions associated with the drug. Also, information on interactions and overdosage was often missing. Conclusion: Although the package inserts appear to have improved over the past decade there is still a definite need to further refine the clinical information contained, to minimize the risks to patients. This could be brought about by self

  3. 75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

    Science.gov (United States)

    2010-06-11

    ...] Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for... Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product...

  4. Quality of drug label information on QT interval prolongation

    DEFF Research Database (Denmark)

    Warnier, Miriam J; Holtkamp, Frank A; Rutten, Frans H

    2014-01-01

    BACKGROUND: Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies. OBJECTIVE: To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product......-prolongation'/'QT-prolongation') and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association. RESULTS: Of the 175 screened products, 44 contained information on QT in the SPC ('no QT-prolongation': 23%, 'unclear drug-QT association': 43%, 'possibly QT-prolongation': 16%, 'QT......-prolongation': 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC ('no prolongation': 10% and for the category 'QT...

  5. Production (information sheets)

    NARCIS (Netherlands)

    2007-01-01

    Documentation sheets: Geo energy 2 Integrated System Approach Petroleum Production (ISAPP) The value of smartness 4 Reservoir permeability estimation from production data 6 Coupled modeling for reservoir application 8 Toward an integrated near-wellbore model 10 TNO conceptual framework for "E&P

  6. Information, Technology, and Information Worker Productivity

    OpenAIRE

    Aral, Sinan; Brynjolfsson, Erik; Van Alstyne, Marshall

    2009-01-01

    We econometrically evaluate information worker productivity at a midsize executive recruiting firm and assess whether the knowledge that workers accessed through their electronic communication networks enabled them to multitask more productively. We estimate dynamic panel data models of multitasking, knowledge networks, and productivity using several types of micro-level data: (a) direct observation of more than 125,000 email messages over a period of 10 months; (b) detailed accounting data o...

  7. Accuracy and completeness of drug information in Wikipedia medication monographs.

    Science.gov (United States)

    Reilly, Timothy; Jackson, William; Berger, Victoria; Candelario, Danielle

    The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U.S. product inserts were used as the standard comparator. Wikipedia demonstrated significantly lower completeness and accuracy scores compared with Micromedex (mean composite scores 18.55 vs. 38.4, respectively; P <0.01). No difference was found between the mean composite scores for brand versus generic drugs in either reference (17.8 vs. 19.3, respectively [P = 0.62], for Wikipedia; 39.2 vs. 37.6, [P = 0.06] for Micromedex). Limitations to these results include the speed with which information is edited on Wikipedia, that there was no evaluation of off-label information, and the limited number of drugs that were evaluated. Wikipedia lacks the accuracy and completeness of standard clinical references and should not be a routine part of clinical decision making. More research should be conducted to evaluate the rationale for health care providers' use of Wikipedia. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  8. Information Based Productivity.

    Science.gov (United States)

    Bennett, Scott

    A digital project undertaken last year at Yale (Connecticut) offers an opportunity to explore productivity matters. The project aimed at improving the quality of library support and of student learning in one of the most heavily enrolled undergraduate courses at Yale, "Introduction to the History of Art, from Prehistory to the…

  9. 21 CFR 720.4 - Information requested about cosmetic products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Information requested about cosmetic products. 720... (CONTINUED) COSMETICS VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS § 720.4 Information requested about cosmetic products. (a) Form FDA-2512 requests information on: (1) The name and...

  10. Development Considerations for Nanocrystal Drug Products.

    Science.gov (United States)

    Chen, Mei-Ling; John, Mathew; Lee, Sau L; Tyner, Katherine M

    2017-05-01

    Nanocrystal technology has emerged as a valuable tool for facilitating the delivery of poorly water-soluble active pharmaceutical ingredients (APIs) and enhancing API bioavailability. To date, the US Food and Drug Administration (FDA) has received over 80 applications for drug products containing nanocrystals. These products can be delivered by different routes of administration and are used in a variety of therapeutic areas. To aid in identifying key developmental considerations for these products, a retrospective analysis was performed on the submissions received by the FDA to date. Over 60% of the submissions were for the oral route of administration. Based on the Biopharmaceutics Classification System (BCS), most nanocrystal drugs submitted to the FDA are class II compounds that possess low aqueous solubility and high intestinal permeability. Impact of food on drug bioavailability was reduced for most nanocrystal formulations as compared with their micronized counterparts. For all routes of administration, dose proportionality was observed for some, but not all, nanocrystal products. Particular emphasis in the development of nanocrystal products was placed on the in-process tests and controls at critical manufacturing steps (such as milling process), mitigation and control of process-related impurities, and the stability of APIs or polymorphic form (s) during manufacturing and upon storage. This emphasis resulted in identifying challenges to the development of these products including accurate determination of particle size (distribution) of drug substance and/or nanocrystal colloidal dispersion, identification of polymorphic form (s), and establishment of drug substance/product specifications.

  11. Inactive ingredient Search for Approved Drug Products

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final...

  12. 21 CFR 333.350 - Labeling of acne drug products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of acne drug products. 333.350 Section... Acne Drug Products § 333.350 Labeling of acne drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “acne...

  13. Productive Information Foraging

    Science.gov (United States)

    Furlong, P. Michael; Dille, Michael

    2016-01-01

    This paper presents a new algorithm for autonomous on-line exploration in unknown environments. The objective of the algorithm is to free robot scientists from extensive preliminary site investigation while still being able to collect meaningful data. We simulate a common form of exploration task for an autonomous robot involving sampling the environment at various locations and compare performance with a simpler existing algorithm that is also denied global information. The result of the experiment shows that the new algorithm has a statistically significant improvement in performance with a significant effect size for a range of costs for taking sampling actions.

  14. Examining the production costs of antiretroviral drugs.

    Science.gov (United States)

    Pinheiro, Eloan; Vasan, Ashwin; Kim, Jim Yong; Lee, Evan; Guimier, Jean Marc; Perriens, Joseph

    2006-08-22

    To present direct manufacturing costs and price calculations of individual antiretroviral drugs, enabling those responsible for their procurement to have a better understanding of the cost structure of their production, and to indicate the prices at which these antiretroviral drugs could be offered in developing country markets. Direct manufacturing costs and factory prices for selected first and second-line antiretroviral drugs were calculated based on cost structure data from a state-owned company in Brazil. Prices for the active pharmaceutical ingredients (API) were taken from a recent survey by the World Health Organization (WHO). The calculated prices for antiretroviral drugs are compared with quoted prices offered by privately-owned, for-profit manufacturers. The API represents the largest component of direct manufacturing costs (55-99%), while other inputs, such as salaries, equipment costs, and scale of production, have a minimal impact. The calculated prices for most of the antiretroviral drugs studied fall within the lower quartile of the range of quoted prices in developing country markets. The exceptions are those drugs, primarily for second-line therapy, for which the API is either under patent, in short supply, or in limited use in developing countries (e.g. abacavir, lopinavir/ritonavir, nelfinavir, saquinavir). The availability of data on the cost of antiretroviral drug production and calculation of factory prices under a sustainable business model provide benchmarks that bulk purchasers of antiretroviral drugs could use to negotiate lower prices. While truly significant price decreases for antiretroviral drugs will depend largely on the future evolution of API prices, the present study demonstrates that for several antiretroviral drugs price reduction is currently possible. Whether or not these reductions materialize will depend on the magnitude of indirect cost and profit added by each supplier over the direct production costs. The ability to

  15. 21 CFR 211.94 - Drug product containers and closures.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... and use that can cause deterioration or contamination of the drug product. (c) Drug product containers...

  16. Regulatory considerations concerning IND radiopharmaceutical drug products

    International Nuclear Information System (INIS)

    Nissel, M.

    1985-01-01

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

  17. Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study.

    Science.gov (United States)

    Hochheiser, Harry; Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

    2016-04-11

    Because vital details of potential pharmacokinetic drug-drug interactions are often described in free-text structured product labels, manual curation is a necessary but expensive step in the development of electronic drug-drug interaction information resources. The use of nonexperts to annotate potential drug-drug interaction (PDDI) mentions in drug product label annotation may be a means of lessening the burden of manual curation. Our goal was to explore the practicality of using nonexpert participants to annotate drug-drug interaction descriptions from structured product labels. By presenting annotation tasks to both pharmacy experts and relatively naïve participants, we hoped to demonstrate the feasibility of using nonexpert annotators for drug-drug information annotation. We were also interested in exploring whether and to what extent natural language processing (NLP) preannotation helped improve task completion time, accuracy, and subjective satisfaction. Two experts and 4 nonexperts were asked to annotate 208 structured product label sections under 4 conditions completed sequentially: (1) no NLP assistance, (2) preannotation of drug mentions, (3) preannotation of drug mentions and PDDIs, and (4) a repeat of the no-annotation condition. Results were evaluated within the 2 groups and relative to an existing gold standard. Participants were asked to provide reports on the time required to complete tasks and their perceptions of task difficulty. One of the experts and 3 of the nonexperts completed all tasks. Annotation results from the nonexpert group were relatively strong in every scenario and better than the performance of the NLP pipeline. The expert and 2 of the nonexperts were able to complete most tasks in less than 3 hours. Usability perceptions were generally positive (3.67 for expert, mean of 3.33 for nonexperts). The results suggest that nonexpert annotation might be a feasible option for comprehensive labeling of annotated PDDIs across a broader

  18. 21 CFR 340.50 - Labeling of stimulant drug products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of stimulant drug products. 340.50 Section 340.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 340.50...

  19. Drug Products in the Medicaid Drug Rebate Program

    Data.gov (United States)

    U.S. Department of Health & Human Services — Active drugs that have been reported by participating drug manufacturers under the Medicaid Drug Rebate Program. All drugs are identified by National Drug Code...

  20. A Development of Hybrid Drug Information System Using Image Recognition

    Directory of Open Access Journals (Sweden)

    HwaMin Lee

    2015-04-01

    Full Text Available In order to prevent drug abuse or misuse cases and avoid over-prescriptions, it is necessary for medicine taker to be provided with detailed information about the medicine. In this paper, we propose a drug information system and develop an application to provide information through drug image recognition using a smartphone. We designed a contents-based drug image search algorithm using the color, shape and imprint of drug. Our convenient application can provide users with detailed information about drugs and prevent drug misuse.

  1. Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

    Science.gov (United States)

    ... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

  2. Defining Patient Centric Pharmaceutical Drug Product Design.

    Science.gov (United States)

    Stegemann, Sven; Ternik, Robert L; Onder, Graziano; Khan, Mansoor A; van Riet-Nales, Diana A

    2016-09-01

    The term "patient centered," "patient centric," or "patient centricity" is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.e., assuring adequate patient adherence and the anticipate drug safety and effectiveness. Relevant pharmaceutical design aspects may e.g., involve the selection of the route of administration, the tablet size and shape, the ease of opening the package, the ability to read the user instruction, or the ability to follow the recommended (in-use) storage conditions. Currently, a harmonized definition on patient centric drug development/design has not yet been established. To stimulate scientific research and discussions and the consistent interpretation of test results, it is essential that such a definition is established. We have developed a first draft definition through various rounds of discussions within an interdisciplinary AAPS focus group of experts. This publication summarizes the outcomes and is intended to stimulate further discussions with all stakeholders towards a common definition of patient centric pharmaceutical drug product design that is useable across all disciplines involved.

  3. 21 CFR 601.50 - Confidentiality of data and information in an investigational new drug notice for a biological...

    Science.gov (United States)

    2010-04-01

    ... investigational new drug notice for a biological product. 601.50 Section 601.50 Food and Drugs FOOD AND DRUG... biological product. (a) The existence of an IND notice for a biological product will not be disclosed by the... availability for public disclosure of all data and information in an IND file for a biological product shall be...

  4. Informational and symbolic content of over-the-counter drug advertising on television.

    Science.gov (United States)

    Tsao, J C

    1997-01-01

    The informational and symbolic content of 150 over-the-counter drug commercials on television are empirically analyzed in this study. Results on the informational content suggest that over-the-counter drug ads tend to focus on the concern of what the drug will do for the consumer, rather than on the reasons why the drug should be ingested. Accordingly, advertising strategy is centered on consumer awareness of the product as the primary goal. Educational commitment, however, did not seem to be blended into the promotional efforts for over-the-counter drugs. Findings on the symbolic content of over-the-counter drug ads reveal that drug images have been distorted. Performance of most drugs has been portrayed to be simple resolutions to relieve the symptom. Moreover, a casual attitude toward drug usage is encouraged in the commercials, while time lapse of drug effects is overlooked.

  5. Recreational drug discovery: natural products as lead structures for the synthesis of smart drugs.

    Science.gov (United States)

    Appendino, Giovanni; Minassi, Alberto; Taglialatela-Scafati, Orazio

    2014-07-01

    Covering: up to December 2013. Over the past decade, there has been a growing transition in recreational drugs from natural materials (marijuana, hashish, opium), natural products (morphine, cocaine), or their simple derivatives (heroin), to synthetic agents more potent than their natural prototypes, which are sometimes less harmful in the short term, or that combine properties from different classes of recreational prototypes. These agents have been named smart drugs, and have become popular both for personal consumption and for collective intoxication at rave parties. The reasons for this transition are varied, but are mainly regulatory and commercial. New analogues of known illegal intoxicants are invisible to most forensic detection techniques, while the alleged natural status and the lack of avert acute toxicity make them appealing to a wide range of users. On the other hand, the advent of the internet has made possible the quick dispersal of information among users and the on-line purchase of these agents and/or the precursors for their synthesis. Unlike their natural products chemotypes (ephedrine, mescaline, cathinone, psilocybin, THC), most new drugs of abuse are largely unfamiliar to the organic chemistry community as well as to health care providers. To raise awareness of the growing plague of smart drugs we have surveyed, in a medicinal chemistry fashion, their development from natural products leads, their current methods of production, and the role that clandestine home laboratories and underground chemists have played in the surge of popularity of these drugs.

  6. [Parenting Information: Drugs. Informacion Para los Padres: Sobre las Drojas.

    Science.gov (United States)

    Moreno, Steve

    These two booklets provide basic information about drugs and drug abuse and are part of a series of 22 booklets, designed specifically to help parents understand their children and help them to learn. "Let's Talk about Drug Abuse," (booklet #18), reviews foreign substances or drugs young people are often exposed to (i.e., tobacco,…

  7. Prescription Drug Abuse and Youth. Information Brief.

    Science.gov (United States)

    Department of Justice, Washington, DC. National Drug Intelligence Center.

    Prescription drugs, a category of psychotherapeutics that comprises prescription-type pain relievers, tranquilizers, stimulants, and sedatives, are among the substances most commonly abused by young people in the United States. Prescription drugs are readily available and can easily be obtained by teenagers who abuse these drugs to experience a…

  8. Advice on drug safety in pregnancy: are there differences between commonly used sources of information?

    Science.gov (United States)

    Frost Widnes, Sofia K; Schjøtt, Jan

    2008-01-01

    Safety regarding use in pregnancy is not established for many drugs. Inconsistencies between sources providing drug information can give rise to confusion with possible therapeutic consequences. Therefore, it is important to measure clinically important differences between drug information sources. The objective of this study was to compare two easily accessible Norwegian sources providing advice on drug safety in pregnancy - the product monographs in the Felleskatalog (FK), published by the pharmaceutical companies, and the five regional Drug Information Centres (DICs) in Norway - in addition to assessing the frequency of questions regarding drug safety in pregnancy made to the DICs according to the Anatomical Therapeutic Chemical (ATC) classification system. Advice on drug use in pregnancy provided by the DICs in 2003 and 2005 were compared with advice in the product monographs for the respective drugs in the FK. Comparison of advice was based on categorization to one of four categories: can be used, benefit-risk assessment, should not be used, or no available information. A total of 443 drug advice were categorized. Seven out of ten of drugs frequently enquired about, according to the ATC system, were drugs acting on the nervous system (group N). For 208 (47%) of the drugs, advice differed between the DICs and FK. Advice from the FK was significantly (p drugs that were newly introduced and those that had been on the market for a longer time, advice regarding use of drugs in the first trimester and advice regarding use of drugs in the second or third trimester, or between advice provided during 2003 and during 2005. The results of this study show considerable differences between two Norwegian sources providing advice on the use of drugs in pregnancy. Based on the knowledge that healthcare providers choose sources of information in a random manner, our results may be of clinical importance. We believe that the problem with heterogeneous drug information on this

  9. Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on...

  10. Evaluation of Information Contained in Drug Advertisement and ...

    African Journals Online (AJOL)

    Evaluation of Information Contained in Drug Advertisement and Promotion Materials in Nigeria. ... Conclusion: This study reveals that advertising materials used in promoting drugs in Nigeria have incomplete ... AJOL African Journals Online.

  11. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Science.gov (United States)

    2013-05-31

    ... products. This guidance revises the guidance for industry entitled ``Clinical Development Programs for... Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville...

  12. The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets.

    Science.gov (United States)

    Sukkari, Sana R; Al Humaidan, Abdullah S; Sasich, Larry D

    2012-07-01

    Inadequate access to useful scientifically accurate patient information is a major cause of the inappropriate use of drugs resulting in serious personal injury and related costs to the health care system. The definition of useful scientifically accurate patient information for prescription drugs was accepted by the US Secretary of the Department of Health and Human Services in 1996 as that derived from or consistent with the US FDA approved professional product label for a drug. Previous quality content studies found that English language patient drug information leaflets distributed by US pharmacies failed to meet minimum criteria defining useful and scientifically accurate information. Evaluation forms containing the explicit elements that define useful scientifically accurate information for three drugs with known serious adverse drug reactions were created based on the current US FDA approved professional product labels. The Arabic language patient drug information leaflets for celecoxib, paroxetine, and lamotrigine were obtained locally and evaluated using a methodology similar to that used in previous quality content patient drug information studies in the US. The Arabic leaflets failed to meet the definition of useful scientifically accurate information. The celecoxib leaflet contained 30% of the required information and the paroxetine and lamotrigine leaflets contained 24% and 20%, respectively. There are several limitations to this study. The Arabic leaflets from only one commercial North American vendor were evaluated and the evaluation included a limited number of drugs. A larger study is necessary to be able to generalize these results. The study results are consistent with those of previous quality content studies of commercially available English patient drug information leaflets. The results have important implications for patients as access to a reliable source of drug information may prevent harm or limit the suffering from serious adverse drug

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

    International Nuclear Information System (INIS)

    Abel, N.M.

    1986-01-01

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

  14. United States National Library of Medicine Drug Information Portal.

    Science.gov (United States)

    Hochstein, Colette; Goshorn, Jeanne; Chang, Florence

    2009-01-01

    The Drug Information Portal is a free Web resource from the National Library of Medicine (NLM) that provides a user-friendly gateway to current information for more than 15,000 drugs. The site guides users to related resources of NLM, the National Institutes of Health (NIH), and other government agencies. Current drug-related information regarding consumer health, clinical trials, AIDS, MeSH pharmacological actions, MEDLINE/PubMed biomedical literature, and physical properties and structure is easily retrieved by searching on a drug name. A varied selection of focused topics in medicine and drugs is also available from displayed subject headings. This column provides background information about the Drug Information Portal, as well as search basics.

  15. Medicare Prescription Drug Coverage - General Information

    Data.gov (United States)

    U.S. Department of Health & Human Services — The MMA legislation provides seniors and people with disabilities with the first comprehensive prescription drug benefit ever offered under the Medicare program, the...

  16. Sources of drug information and their influence on the prescribing ...

    African Journals Online (AJOL)

    Sources of drug information and their influence on the prescribing behaviour of doctors in a teaching hospital in Ibadan, Nigeria. ... Drug information was sourced from colleagues (161, 98.8%), reference books (158, 96.9%), pharmaceutical sales representatives-PSRs (152, 93.2%), promotion materials (151, 92.6%), ...

  17. Annual Report of Recorded Phone Calls to Iran's Drug and Poison Information Centers (2014-2015

    Directory of Open Access Journals (Sweden)

    Talat Ghane

    2015-09-01

    Conclusion: Iranian people seems to have numerous unmet drug information needs. This may especially be the case for antibiotics, nutrients and anti-depressants. Pharmaceutical products are the main subjects of poisoning-related calls to DPICs in Iran. Public education on usage, safety and storage of drugs as well as strict terms of sale should be implemented.

  18. Plant natural products research in tuberculosis drug discovery and ...

    African Journals Online (AJOL)

    Plant natural products research in tuberculosis drug discovery and development: A situation report ... African Journal of Biotechnology ... tuberculosis (XDR-TB), call for the development of new anti-tuberculosis drugs to combat this disease.

  19. A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.

    Science.gov (United States)

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components

  20. Pesticide Product Information System (PPIS)

    Science.gov (United States)

    PPIS includes registrant name and address, chemical ingredients, toxicity category, product names, distributor brand names, site/pest uses, pesticidal type, formulation code, and registration status for all products registered in the U.S.

  1. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a) The...

  2. Changing effects of direct-to-consumer broadcast drug advertising information sources on prescription drug requests.

    Science.gov (United States)

    Lee, Annisa Lai

    2009-06-01

    This study tracks the changes of the effects of 4 information sources for direct-to-consumer drug advertising on patients' requests for prescription drugs from physicians since the inception of the "Guidance for Industry about Consumer-directed Broadcast Advertisements." The Guidance advises pharmaceuticals to use four information sources for consumers to seek further information to supplement broadcast drug advertisements: small-print information, the Internet, a toll-free number, and health-care providers (nurses, doctors, and pharmacists). Logistic models were created by using survey data collected by the Food and Drug Administration in 1999 and 2002. Results show that throughout the years, health-care providers remain the most used and strongest means associated with patients' direct requests for nonspecific and specific prescription drugs from doctors. The small-print information source gains power and changes from an indirect means associated with patients' discussing drugs with health-care providers to a direct means associated with patients' asking about nonspecific and specific drugs from their doctors. The Internet is not directly related to drug requests, but the effect of its association with patients seeking information from health-care providers grew 11-fold over the course of the study. The toll-free number lost its power altogether for both direct request for a prescription drug and further discussion with health-care providers. Patient demographics will be considered for specific policy implications.

  3. The production and sales of anti-tuberculosis drugs in China.

    Science.gov (United States)

    Huang, Yang-Mu; Zhao, Qi-Peng; Ren, Qiao-Meng; Peng, Dan-Lu; Guo, Yan

    2016-10-04

    Tuberculosis (TB) is a major infectious disease globally. Adequate and proper use of anti-TB drugs is essential for TB control. This study aims to study China's production capacity and sales situation of anti-TB drugs, and to further discuss the potential for China to contribute to global TB control. The production data of anti-TB drugs in China from 2011 to 2013 and the sales data from 2010 to 2014 were extracted from Ministry of Industry and Information Technology database of China and IMS Health database, respectively. The number of drugs was standardized to the molecular level of the key components before calculating. All data were described and analyzed by Microsoft Excel. First-line drugs were the majority in both sales (89.5 %) and production (92.3 %) of anti-TB drugs in China. The production of rifampicin held the majority share in active pharmaceutical ingredients (APIs) and finished products, whilst ethambutol and pyrazinamide were the top two sales in finished products. Fixed-dose combinations only held small percentages in total production and sales weight, though a slight increase was observed. The production and sales of streptomycin showed a tendency of decrease after 2012. The trends and proportion of different anti-TB drugs were similar in production and sales, however, the production weight was much larger than that of sales, especially for rifampicin and isoniazid. First-line drugs were the predominant medicine produced and used in China. While the low production and sales of the second-line TB drugs and FDCs rose concerns for the treatment of multiple drug resistant TB. The redundant production amount, as well as the prompt influence of national policy on drug production and sales, indicated the potential for China to better contribute to global TB control.

  4. Where to find information about drugs.

    Science.gov (United States)

    Day, Richard O; Snowden, Leone

    2016-06-01

    Good medicines information is critical to medical practice. Choose high-quality, pre-appraised sources first and make sure they are current. Select the information that is most relevant to the needs of your particular patient. Take the time to become familiar with the features of the resources you use. Australian Medicines Handbook, Therapeutic Guidelines, Australian Prescriber and NPS MedicineWise cover most routine clinical practice needs.

  5. Student-peer mentoring on a drug information response.

    Science.gov (United States)

    Rodis, Jennifer Lin; Backo, Jennifer; Schmidt, Brittany M; Pruchnicki, Maria C

    2014-03-12

    To implement a student peer-mentoring program with a drug information response assignment in an introductory pharmacy practice course. Second-year student pharmacists (P2 mentors) enrolled in an independent study course were randomly assigned first-year student pharmacists (P1 mentees) to mentor on a drug information assignment. The P2 mentors provided feedback to P1 mentees' assignment drafts. The P1 mentees had the opportunity to revise the draft prior to turning in the completed assignment to course faculty members for grading. Both P1 mentees and P2 mentors agreed the mentorship improved their ability to prepare a drug information response (76% and 100%, respectively). A majority of the student pharmacists would choose to be involved in the program again. The student peer-mentoring program was successful in improving student pharmacists' perceptions of ability to compose a drug information response.

  6. 77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

    Science.gov (United States)

    2012-11-20

    ... must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION...

  7. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Science.gov (United States)

    2013-12-04

    ... reporting of product information by registered outsourcing facilities under section 503B of the FD&C Act... collection techniques, when appropriate, and other forms of information technology. Under the draft guidance... report should include the following information for all drugs compounded by the outsourcing facility...

  8. 21 CFR 336.50 - Labeling of antiemetic drug products.

    Science.gov (United States)

    2010-04-01

    ... years of age. “Do not take this product, unless directed by a doctor, if you have a breathing problem... Section 336.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... under 12 years of age. “Do not give this product to children who have a breathing problem such as...

  9. Drug Production in Tertiary Health Institutions – Needs, Constraints ...

    African Journals Online (AJOL)

    The use of questionnaires was employed in the study covering all pharmacists in the pharmaceutical services department, pharmacy technicians and quality control technologist in the drug production unit of the hospital. It was unanimously agreed by the respondents that local drug production was necessary in tertiary ...

  10. High Production Volume Information System (HPVIS)

    Data.gov (United States)

    U.S. Environmental Protection Agency — The High Production Volume Information System (HPVIS) provides access to select health and environmental effect information on chemicals that are manufactured in...

  11. Engineering Information Infrastructure for Product Lifecycle Managment

    Science.gov (United States)

    Kimura, Fumihiko

    For proper management of total product life cycle, it is fundamentally important to systematize design and engineering information about product systems. For example, maintenance operation could be more efficiently performed, if appropriate parts design information is available at the maintenance site. Such information shall be available as an information infrastructure for various kinds of engineering operations, and it should be easily accessible during the whole product life cycle, such as transportation, marketing, usage, repair/upgrade, take-back and recycling/disposal. Different from the traditional engineering database, life cycle support information has several characteristic requirements, such as flexible extensibility, distributed architecture, multiple viewpoints, long-time archiving, and product usage information, etc. Basic approaches for managing engineering information infrastructure are investigated, and various information contents and associated life cycle applications are discussed.

  12. Collaborative production indicators in information architecture

    Directory of Open Access Journals (Sweden)

    Zayr Claudio Gomes da Silva

    2017-04-01

    Full Text Available Information architecture is considered a strategic domain of collaborative production of Information Science. We describe the conditions of collaborative production in information architecture, considering it a sub-area of the study of Information Science. In order to do so, we specifically address indicators of scientific production that include topics of study, typology and authorship, postgraduate programs and areas to which it is linked, among others. This is an exploratory and descriptive research. The scientific production of the National Meeting of Information Science Research (ENANCIB, from 2003 to 2013, is mapped in the "Network Matters" repository. Bibliometry is used to identify paratextual and textual elements that form evidence of collaborative production in information architecture. We verified the plurality in the academic formation of the researchers that approach information architecture, the sharing of languages, some indications of the disciplinary convergences from the collaboration in coauthorship, as well as a plexus of relations through the indirect citations that represent the sharing of elements Theoretical-methodological approaches in interdisciplinary production. In addition, the academic training of the researchers with the highest productivity index is mainly related to Librarianship and Computer Science. The collaborative production in the information architecture is presented as a multidisciplinary production process, constituting a convergent domain that allows the effectiveness of interdisciplinary practices in Information Science.

  13. Marketing Information Products and Services

    International Development Research Centre (IDRC) Digital Library (Canada)

    Librarians ... may have failed to adopt marketing theory and practices for a variety of .... of marketing principles in the context of libraries and information centres. ...... The membership fee is tax deductible as a business expense in some countries. ...... Prepared by Chin Saik Yoon, Publisher, Southbound, Penang, Malaysia, ...

  14. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  15. Pharmaceutical companies and their drugs on social media: a content analysis of drug information on popular social media sites.

    Science.gov (United States)

    Tyrawski, Jennifer; DeAndrea, David C

    2015-06-01

    Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies' social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers who interacted with pharmaceutical

  16. Pharmaceutical Companies and Their Drugs on Social Media: A Content Analysis of Drug Information on Popular Social Media Sites

    Science.gov (United States)

    2015-01-01

    Background Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Objective Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Methods Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. Results From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies’ social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers

  17. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Science.gov (United States)

    2012-12-04

    ... PET Drug Products--Questions and Answers.'' This guidance provides questions and answers that address.... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in... availability of a guidance entitled ``FDA Oversight of PET Drug Products--Questions and Answers.'' In 1997...

  18. Drug-device combination products: regulatory landscape and market growth.

    Science.gov (United States)

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  19. Impurities in Drug Products and Active Pharmaceutical Ingredients.

    Science.gov (United States)

    Kątny, M; Frankowski, M

    2017-05-04

    Analytical methods should be selective and fast. In modern times, scientists strive to meet the criteria of green chemistry, so they choose analytical procedures that are as short as possible and use the least toxic solvents. It is quite obvious that the products intended for human consumption should be characterized as completely as possible. The safety of a drug is dependent mainly on the impurities that it contains. High pressure liquid chromatography and ultra-high pressure liquid chromatography have been proposed as the main techniques for forced degradation and impurity profiling. The aim of this article was to characterize the relevant classification of drug impurities and to review the methods of impurities determination for atorvastatin (ATV) and duloxetine (DLX) (both in active pharmaceutical ingredients and in different dosage forms). These drugs have an impact on two systems of the human body: cardiac and nervous. Simple characteristics of ATV and DLX, their properties and specificity of action on the human body, are also included in this review. The analyzed pharmaceuticals-ATV (brand name Lipiron) and DLX (brand name Cymbalta)-were selected for this study based on annual rankings prepared by Information Medical Statistics.

  20. Science and scepticism: Drug information, young men and counterpublic health.

    Science.gov (United States)

    Farrugia, Adrian; Fraser, Suzanne

    2017-11-01

    It is perhaps no surprise that young people can be sceptical of the drug-related information they receive in school-based health education, health promotion and the media. Significant societal anxiety surrounds young people's drug consumption, so it is tempting to approach this scepticism as a problem to be solved. In this article, we look closely at a group of young Australian men (n = 25), all of whom hold deeply sceptical views about the drug information they received in schools, social marketing campaigns and public speech generally. We do not approach their scepticism as a problem to be solved in itself, however. Instead, we analyse its origins and how it relates to the way knowledge is constructed in drug education, health promotion and media accounts of drug use. To conceptualise this scepticism, we draw on Irwin and Michael's analysis of the changing relationship between science and society, Warner's theorisation of publics and counterpublics, and Race's related notion of 'counterpublic health'. The article organises the data into three key themes: scepticism about the accuracy of the claims made about drug risks and dangers, scepticism about representations of drug users, and scepticism about the motivations behind the health messages and drug policy in general. We then draw these different aspects of scepticism together to argue that the young men can be seen to constitute a health 'counterpublic', and we consider the implications of this approach, arguing for what has been described as a more diplomatic engagement between science and publics.

  1. Production and Productivity Effects of Informal Contract Farming in ...

    African Journals Online (AJOL)

    This paper uses data from a 2001 household survey of small-scale farming households in Kirinyaga District, Kenya to explore production effects of informal credit contracts in French bean farming where formal markets for surplus production are seemingly shallow and imperfect. Specifically, it examines whether informal ...

  2. New drug information resources for pharmacists at the National Library of Medicine.

    Science.gov (United States)

    Knoben, James E; Phillips, Steven J

    2014-01-01

    To provide an overview of selected drug information-related databases of the National Library of Medicine (NLM), with a focus on newer resources that support the professional information needs of pharmacists and other health care providers. NLM, which is the world's largest medical library, provides an array of bibliographic, factual, and evidence-based drug, herbal remedy, and dietary supplement information resources. Five of the more recently introduced online resources include areas of particular importance to pharmacists, including a repository of current product labeling/package inserts, with automated search links to associated information resources; a portal to drug information that allows pharmacists to search multiple databases simultaneously and link to related medication and health care information resources; authoritative information on the effects of medications, herbal remedies, and dietary supplements in nursing infants and their mothers; comprehensive information, including a case registry, on the potential for liver toxicity due to drugs, herbal remedies, and dietary supplements; and a pill identification system with two intuitive search methodologies. NLM provides several clinical-scientific drug information resources that are particularly useful in meeting the professional information needs of pharmacists.

  3. Adherence to drug treatment in association with how the patient perceives care and information on drugs.

    Science.gov (United States)

    Ulfvarson, Johanna; Bardage, Carola; Wredling, Regina A-M; von Bahr, Christer; Adami, Johanna

    2007-01-01

    This study was to explore concordance with drugs prescribed and the patient's self-reported drug consumption, in relation to the older patient's perceived care and information given. Lack of adherence to prescriptions may lead to therapeutic failure with risks for relapse, unnecessary suffering and increased costs. A cross-sectional study with structured interviews of 200 patients who had recently been treated in a medical ward. Patients' medical records were studied to obtain information on their current use of drugs. The data were analyzed by logistic regression, adherence being the dependent response variable. The mean age of the study group was 79 years. The number of drugs reported in the medical chart ranged from one to 17 with a mean of 6.9. The patients reported a drug consumption ranging from 0 to 24 with a mean of 7.3. When comparing the interview results with the information in the medical charts, 30% of the patients showed adherence. An association was found between adherence and self-reported health status. Patients in the non-adherent group reported a higher consumption of drugs. Patients felt that the opportunity to ask questions of either the responsible physicians or of the nurses was influential in decreasing risk. In this study, the patient's total drug consumption was considered. The study showed a large discrepancy between the drugs stated in the medical chart and patient's self-reported drug consumption. The study failed to show that perceived information or educational level had an impact on the results but implicate that the quality of information influences adherence. It is of importance to recognize patients at risk for non-adherence. Decreased health status and many drugs are the main risk factors for patients being non-adherent, and should be recognized as such.

  4. Planning for management information systems in drug treatment organizations.

    Science.gov (United States)

    Zalkind, D; Zelon, H; Moore, M; Kaluzny, A

    1979-02-01

    An attempt to set up a management information system for individual drug abuse programs throughout a state is described. The principles upon which the system is based are discussed along with the problems encountered in its implementation. A series of guidelines for establishing management information systems in operating human services agencies is included.

  5. The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

    Directory of Open Access Journals (Sweden)

    Aggeliki V. Tsaprantzi MD

    2016-03-01

    Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

  6. Information and interaction : influencing drug prescribing in Swedish primary care

    OpenAIRE

    Stålsby Lundborg, Cecilia

    1999-01-01

    Aim The studies concern drug information and continuing education on drug treatment, focusing on doctors' prescribing in primary care in Sweden. The long-term aim has been to develop educational models accepted by the doctors, and to develop and apply means of evaluating the education. Methods Data have been collected from the study populations mainly through questionnaires and dispensed prescriptions, i.e., quantitative data. In addition, qualitative interview data w...

  7. Success rates for product development strategies in new drug development.

    Science.gov (United States)

    Dahlin, E; Nelson, G M; Haynes, M; Sargeant, F

    2016-04-01

    While research has examined the likelihood that drugs progress across phases of clinical trials, no research to date has examined the types of product development strategies that are the most likely to be successful in clinical trials. This research seeks to identify the strategies that are most likely to reach the market-those generated using a novel product development strategy or strategies that combine a company's expertise with both drugs and indications, which we call combined experience strategies. We evaluate the success of product development strategies in the drug development process for a sample of 2562 clinical trials completed by 406 US pharmaceutical companies. To identify product development strategies, we coded each clinical trial according to whether it consisted of an indication or a drug that was new to the firm. Accordingly, a clinical trial that consists of both an indication and a drug that were both new to the firm represents a novel product development strategy; indication experience is a product development strategy that consists of an indication that a firm had tested previously in a clinical trial, but with a drug that was new to the firm; drug experience is a product development strategy that consists of a drug that the firm had prior experience testing in clinical trials, but with an indication that was new to the firm; combined experience consists of both a drug and an indication that the firm had experience testing in clinical trials. Success rates for product development strategies across clinical phases were calculated for the clinical trials in our sample. Combined experience strategies had the highest success rate. More than three and a half percent (0·036) of the trials that combined experience with drugs and indications eventually reached the market. The next most successful strategy is drug experience (0·025) with novel strategies trailing closely (0·024). Indication experience strategies are the least successful (0·008

  8. 21 CFR 341.72 - Labeling of antihistamine drug products.

    Science.gov (United States)

    2010-04-01

    ..., unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or... Section 341.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution...

  9. Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

    Science.gov (United States)

    Hong, Song Hee; Shepherd, Marvin D; Scoones, David; Wan, Thomas T H

    2005-01-01

    This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P new product-line extension introduced for an original brand helps the original price be

  10. Progressive anticonvulsant hypersensitivity syndrome associated with change of drug product

    DEFF Research Database (Denmark)

    Sabroe, T.P.; Sabers, A.

    2008-01-01

    This report describes the laboratory and physical manifestations of lamotrigine-like toxicity in a young man with refractory epilepsy receiving lamotrigine presenting as anticonvulsant hypersensitivity syndrome (AHS) associated with an abrupt change of drug product Udgivelsesdato: 2008/6...

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

    Science.gov (United States)

    Kiyosawa, Naoki; Manabe, Sunao

    2016-01-01

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

  12. Information logistics: A production-line approach to information services

    Science.gov (United States)

    Adams, Dennis; Lee, Chee-Seng

    1991-01-01

    Logistics can be defined as the process of strategically managing the acquisition, movement, and storage of materials, parts, and finished inventory (and the related information flow) through the organization and its marketing channels in a cost effective manner. It is concerned with delivering the right product to the right customer in the right place at the right time. The logistics function is composed of inventory management, facilities management, communications unitization, transportation, materials management, and production scheduling. The relationship between logistics and information systems is clear. Systems such as Electronic Data Interchange (EDI), Point of Sale (POS) systems, and Just in Time (JIT) inventory management systems are important elements in the management of product development and delivery. With improved access to market demand figures, logisticians can decrease inventory sizes and better service customer demand. However, without accurate, timely information, little, if any, of this would be feasible in today's global markets. Information systems specialists can learn from logisticians. In a manner similar to logistics management, information logistics is concerned with the delivery of the right data, to the ring customer, at the right time. As such, information systems are integral components of the information logistics system charged with providing customers with accurate, timely, cost-effective, and useful information. Information logistics is a management style and is composed of elements similar to those associated with the traditional logistics activity: inventory management (data resource management), facilities management (distributed, centralized and decentralized information systems), communications (participative design and joint application development methodologies), unitization (input/output system design, i.e., packaging or formatting of the information), transportations (voice, data, image, and video communication systems

  13. Default Drug Doses in Anesthesia Information Management Systems.

    Science.gov (United States)

    Rodriquez, Luis I; Smaka, Todd J; Mahla, Michael; Epstein, Richard H

    2017-07-01

    In the United States, anesthesia information management systems (AIMS) are well established, especially within academic practices. Many hospitals are replacing their stand-alone AIMS during migration to an enterprise-wide electronic health record. This presents an opportunity to review choices made during the original implementation, based on actual usage. One area amenable to this informatics approach is the configuration in the AIMS of quick buttons for typical drug doses. The use of such short cuts, as opposed to manual typing of doses, simplifies and may improve the accuracy of drug documentation within the AIMS. We analyzed administration data from 3 different institutions, 2 of which had empirically configured default doses, and one in which defaults had not been set up. Our first hypothesis was that most (ie, >50%) of drugs would need at least one change to the existing defaults. Our second hypothesis was that for most (>50%) drugs, the 4 most common doses at the site lacking defaults would be included among the most common doses at the 2 sites with defaults. If true, this would suggest that having default doses did not affect the typical administration behavior of providers. The frequency distribution of doses for all drugs was determined, and the 4 most common doses representing at least 5% of total administrations for each drug were identified. The appropriateness of the current defaults was determined by the number of changes (0-4) required to match actual usage at the 2 hospitals with defaults. At the institution without defaults, the most frequent doses for the 20 most commonly administered drugs were compared with the default doses at the other institutions. At the 2 institutions with defaults, 84.7% and 77.5% of drugs required at least 1 change in the default drug doses (P default drug doses, 100% of the 20 most commonly administered doses (representing ≥5% of use for that drug) were included in the most commonly administered doses at the other 2

  14. "Legal highs" on the net-Evaluation of UK-based Websites, products and product information.

    Science.gov (United States)

    Schmidt, Martin M; Sharma, Akhilesh; Schifano, Fabrizio; Feinmann, Charlotte

    2011-03-20

    A vast array of substances are marketed as "legal highs" in the UK. These products are mainly marketed online and are packaged and produced to mimic illicit drugs. Little is known about the full range of products available at present and no studies have evaluated the product information provided to consumers. AIMS & HYPOTHESIS: To describe the available legal high products marketed by UK-based Internet retailers and evaluate the product information provided to consumers. Websites were identified using the terms "buy legal highs+UK" and two search engines. The first 100 hits and a random sample of 5% of the remaining results were screened. Websites based in the UK were included and all products were entered on a database. Information on product name, list price, claimed effects, side effects, contraindications and interactions was extracted. A descriptive analysis was conducted using SPSS v14. 115 Websites met the inclusion criteria but due to duplicate listings this was reduced to 39 unique Websites. 1308 products were found and evaluated. The average product price was 9.69 British pounds. Products took the form of pills (46.6%), smoking material (29.7%) and single plant material/extract (18.1%). Most products claimed to be stimulants (41.7%), sedatives (32.3%), or hallucinogens (12.9%). 40.1% of products failed to list ingredients, 91.9% failed to list side effects, 81.9% failed to list contraindications and 86.3% failed to list drug interactions. Top 5 products (with active ingredients in brackets) by frequency were Salvia divinorum (Salivinorin A), Kratom (Mitragynine), Hawaiian Baby Woodrose Seeds (Lysergic Acid Amide), Fly Agaric (Ibotenic Acid, Muscimol) and Genie (JWH018, CP47497). Products marketed as "legal highs" are easily available from UK-based Internet retailers and are reasonably affordable. Safety information provided to consumers is poor. Uninformed users risk serious adverse effects. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  15. Toward a generic approach for : Stress testing of drug substances and drug products

    NARCIS (Netherlands)

    Klick, Silke; Muijselaar, Pim G.; Waterval, Joop; Eichinger, Thomas; Korn, Christian; Gerding, Thijs K.; Debets, Alexander J.; Sänger-Van De Griend, Cari; Van Den Beld, Cas; Somsen, Govert W.; De Jong, Gerhardus J.

    The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates

  16. Print advertisements for Alzheimer's disease drugs: informational and transformational features.

    Science.gov (United States)

    Gooblar, Jonathan; Carpenter, Brian D

    2013-06-01

    We examined print advertisements for Alzheimer's disease drugs published in journals and magazines between January 2008 and February 2012, using an informational versus transformational theoretical framework to identify objective and persuasive features. In 29 unique advertisements, we used qualitative methods to code and interpret identifying information, charts, benefit and side effect language, and persuasive appeals embedded in graphics and narratives. Most elements contained a mixture of informational and transformational features. Charts were used infrequently, but when they did appear the accompanying text often exaggerated the data. Benefit statements covered an array of symptoms, drug properties, and caregiver issues. Side effect statements often used positive persuasive appeals. Graphics and narrative features emphasized positive emotions and outcomes. We found subtle and sophisticated attempts both to educate and to persuade readers. It is important for consumers and prescribing physicians to read print advertisements critically so that they can make informed treatment choices.

  17. Online drug information platform for the public in Hong Kong-Review of local drug information use and needs.

    Science.gov (United States)

    Cheng, F W T; So, S W K; Fung, B W T; Hung, W H; Lee, V W Y

    2018-06-01

    In view of the popularity of Internet usage in Hong Kong, an interactive web-based drug information platform entitled "Ask My Pharmacist - Online University Led drug Enquiry Platform" (AMPOULE) was launched in 2009 to better serve the needs of drug information in Hong Kong. This paper aimed to evaluate the utility of AMPOULE in improving drug-related knowledge among the public and to reassess the needs of the general public in Hong Kong. All enquiries sent via AMPOULE were reviewed. Demographic data, nature of questions and types of drug class covered were analyzed. The workload of pharmacists was examined with respect to the preparation time needed for the enquiry, the lag days to reply and also the timing of enquiry recipient. 2122 enquiries were received from 2009 to 2017. Most enquirers were from Hong Kong (56.6%) and female gender (49.2%). 13% of the concerned subjects were aged over 61-year-old. The most frequent types of questions and medications covered were "Drug Ingredients and Indications" (28.0%) and Adverse Drug Reactions (26.8%) and "Cardiovascular Medication" (21.9%) respectively but these varied in different age groups or enquirer groups. The median time for preparation was 40.0 min (IQR: 25-65 min) while the median time lag was found to be 2.5 days (IQR: 1.0-5.0 days). The number of enquiries received was evenly distributed throughout the day except during 1:00 am to 9:00 am and 7:00 pm to 8:00 pm. AMPOULE has demonstrated that an online platform providing patient-oriented drug information service through the Internet is promising and further promotion is warranted. Current data suggested that the need of different age groups and enquirer groups are different and should therefore be individualized. Copyright © 2018 Elsevier B.V. All rights reserved.

  18. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Science.gov (United States)

    2010-04-01

    .... Bromfenac sodium: All drug products containing bromfenac sodium. Butamben: All parenteral drug products...). Dexfenfluramine hydrochloride: All drug products containing dexfenfluramine hydrochloride. Diamthazole... dihydrostreptomycin sulfate. Dipyrone: All drug products containing dipyrone. Encainide hydrochloride: All drug...

  19. Natural Products for Drug Discovery in the 21st Century: Innovations for Novel Drug Discovery

    Directory of Open Access Journals (Sweden)

    Nicholas Ekow Thomford

    2018-05-01

    Full Text Available The therapeutic properties of plants have been recognised since time immemorial. Many pathological conditions have been treated using plant-derived medicines. These medicines are used as concoctions or concentrated plant extracts without isolation of active compounds. Modern medicine however, requires the isolation and purification of one or two active compounds. There are however a lot of global health challenges with diseases such as cancer, degenerative diseases, HIV/AIDS and diabetes, of which modern medicine is struggling to provide cures. Many times the isolation of “active compound” has made the compound ineffective. Drug discovery is a multidimensional problem requiring several parameters of both natural and synthetic compounds such as safety, pharmacokinetics and efficacy to be evaluated during drug candidate selection. The advent of latest technologies that enhance drug design hypotheses such as Artificial Intelligence, the use of ‘organ-on chip’ and microfluidics technologies, means that automation has become part of drug discovery. This has resulted in increased speed in drug discovery and evaluation of the safety, pharmacokinetics and efficacy of candidate compounds whilst allowing novel ways of drug design and synthesis based on natural compounds. Recent advances in analytical and computational techniques have opened new avenues to process complex natural products and to use their structures to derive new and innovative drugs. Indeed, we are in the era of computational molecular design, as applied to natural products. Predictive computational softwares have contributed to the discovery of molecular targets of natural products and their derivatives. In future the use of quantum computing, computational softwares and databases in modelling molecular interactions and predicting features and parameters needed for drug development, such as pharmacokinetic and pharmacodynamics, will result in few false positive leads in drug

  20. Natural Products for Drug Discovery in the 21st Century: Innovations for Novel Drug Discovery.

    Science.gov (United States)

    Thomford, Nicholas Ekow; Senthebane, Dimakatso Alice; Rowe, Arielle; Munro, Daniella; Seele, Palesa; Maroyi, Alfred; Dzobo, Kevin

    2018-05-25

    The therapeutic properties of plants have been recognised since time immemorial. Many pathological conditions have been treated using plant-derived medicines. These medicines are used as concoctions or concentrated plant extracts without isolation of active compounds. Modern medicine however, requires the isolation and purification of one or two active compounds. There are however a lot of global health challenges with diseases such as cancer, degenerative diseases, HIV/AIDS and diabetes, of which modern medicine is struggling to provide cures. Many times the isolation of "active compound" has made the compound ineffective. Drug discovery is a multidimensional problem requiring several parameters of both natural and synthetic compounds such as safety, pharmacokinetics and efficacy to be evaluated during drug candidate selection. The advent of latest technologies that enhance drug design hypotheses such as Artificial Intelligence, the use of 'organ-on chip' and microfluidics technologies, means that automation has become part of drug discovery. This has resulted in increased speed in drug discovery and evaluation of the safety, pharmacokinetics and efficacy of candidate compounds whilst allowing novel ways of drug design and synthesis based on natural compounds. Recent advances in analytical and computational techniques have opened new avenues to process complex natural products and to use their structures to derive new and innovative drugs. Indeed, we are in the era of computational molecular design, as applied to natural products. Predictive computational softwares have contributed to the discovery of molecular targets of natural products and their derivatives. In future the use of quantum computing, computational softwares and databases in modelling molecular interactions and predicting features and parameters needed for drug development, such as pharmacokinetic and pharmacodynamics, will result in few false positive leads in drug development. This review

  1. Using cooperative learning for a drug information assignment.

    Science.gov (United States)

    Earl, Grace L

    2009-11-12

    To implement a cooperative learning activity to engage students in analyzing tertiary drug information resources in a literature evaluation course. The class was divided into 4 sections to form expert groups and each group researched a different set of references using the jigsaw technique. Each member of each expert group was reassigned to a jigsaw group so that each new group was composed of 4 students from 4 different expert groups. The jigsaw groups met to discuss search strategies and rate the usefulness of the references. In addition to group-based learning, teaching methods included students' writing an independent research paper to enhance their abilities to search and analyze drug information resources. The assignment and final course grades improved after implementation of the activity. Students agreed that class discussions were a useful learning experience and 75% (77/102) said they would use the drug information references for other courses. The jigsaw technique was successful in engaging students in cooperative learning to improve critical thinking skills regarding drug information.

  2. Lessons from innovation in drug-device combination products.

    Science.gov (United States)

    Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

    2012-01-01

    Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. Copyright © 2011 Elsevier B.V. All rights reserved.

  3. Nano-sized crystalline drug production by milling technology.

    Science.gov (United States)

    Moribe, Kunikazu; Ueda, Keisuke; Limwikrant, Waree; Higashi, Kenjirou; Yamamoto, Keiji

    2013-01-01

    Nano-formulation of poorly water-soluble drugs has been developed to enhance drug dissolution. In this review, we introduce nano-milling technology described in recently published papers. Factors affecting the size of drug crystals are compared based on the preparation methods and drug and excipient types. A top-down approach using the comminution process is a method conventionally used to prepare crystalline drug nanoparticles. Wet milling using media is well studied and several wet-milled drug formulations are now on the market. Several trials on drug nanosuspension preparation using different apparatuses, materials, and conditions have been reported. Wet milling using a high-pressure homogenizer is another alternative to preparing production-scale drug nanosuspensions. Dry milling is a simple method of preparing a solid-state drug nano-formulation. The effect of size on the dissolution of a drug from nanoparticles is an area of fundamental research, but it is sometimes incorrectly evaluated. Here, we discuss evaluation procedures and the associated problems. Lastly, the importance of quality control, process optimization, and physicochemical characterization are briefly discussed.

  4. Information delivery manuals to integrate building product information into design

    DEFF Research Database (Denmark)

    Berard, Ole Bengt; Karlshøj, Jan

    2011-01-01

    Despite continuing BIM progress, professionals in the AEC industry often lack the information they need to perform their work. Although this problem could be alleviated by information systems similar to those in other industries, companies struggle to model processes and information needs...... them in information systems. BIM implies that objects are bearers of information and logic. The present study has three main aims: (1) to explore IDMs capability to capture all four perspectives, (2) to determine whether an IDM’s collaborative methodology is valid for developing standardized processes......, and (3) to ascertain whether IDM’s business rules can support the development of information and logic-bearing BIM objects. The research is based on a case study of re-engineering the bidding process for a design-build project to integrate building product manufacturers, subcontractors...

  5. Information, Technology and Information Worker Productivity: Task Level Evidence

    OpenAIRE

    Sinan Aral; Erik Brynjolfsson; Marshall Van Alstyne

    2007-01-01

    In an effort to reveal the fine-grained relationships between IT use, patterns of information flows, and individual information-worker productivity, we study task level practices at a midsize executive recruiting firm. We analyze both project-level and individual-level performance using: (1) detailed accounting data on revenues, compensation, project completion rates, and team membership for over 1300 projects spanning 5 years, (2) direct observation of over 125,000 email messages over a peri...

  6. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

  7. "Product on Stopper" in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?

    Science.gov (United States)

    Mehta, Shyam B; Roy, Shouvik; Yang, Han-Chang Cathy

    2018-06-01

    During manufacturing of a lyophilized drug product, operator errors in product handling during loading of product filled vials onto the lyophilizer can lead to a seemingly cosmetic defect which can impact certain critical quality attributes of finished product. In this study, filling of a formulated monoclonal antibody in vials was performed using a peristaltic pump filling unit, and subsequently, the product was lyophilized. After lyophilization, upon visual inspection, around 40% of vials had cosmetic defect with residual product around stopper of the vial and were categorized as "product on stopper" vials, whereas remaining 60% vials with no cosmetic defect were called "acceptable vials." Both groups of vials from 1 single batch were tested for critical quality attributes including protein concentration (ultraviolet absorbance at 280), residual moisture (Karl Fischer), sterility (membrane filtration), and container closure integrity (CCI) (blue dye ingress). Analysis of protein quality attributes such as aggregation, protein concentration, residual moisture showed no significant difference between vials with "product on stopper" and "acceptable vials." However, CCI of the "product on stopper" vials was compromised due to the presence of product around stopper of the vial. The results from this case study demonstrate the following 2 important findings: (1) that a seemingly cosmetic defect may impact product quality, compromising the integrity of the product and (2) that CCI test method can be used as an orthogonal method to sterility testing to evaluate sterility assurance of the product. The corrective action proposed to mitigate this defect is use of a larger sized vial that can potentially minimize this defect that arises because of product handling errors. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  8. Cell culture media impact on drug product solution stability.

    Science.gov (United States)

    Purdie, Jennifer L; Kowle, Ronald L; Langland, Amie L; Patel, Chetan N; Ouyang, Anli; Olson, Donald J

    2016-07-08

    To enable subcutaneous administration of monoclonal antibodies, drug product solutions are often needed at high concentrations. A significant risk associated with high drug product concentrations is an increase in aggregate level over the shelf-life dating period. While much work has been done to understand the impact of drug product formulation on aggregation, there is limited understanding of the link between cell culture process conditions and soluble aggregate growth in drug product. During cell culture process development, soluble aggregates are often measured at harvest using cell-free material purified by Protein A chromatography. In the work reported here, cell culture media components were evaluated with respect to their impact on aggregate levels in high concentration solution drug product during accelerated stability studies. Two components, cysteine and ferric ammonium citrate, were found to impact aggregate growth rates in our current media (version 1) leading to the development of new chemically defined media and concentrated feed formulations. The new version of media and associated concentrated feeds (version 2) were evaluated across four cell lines producing recombinant IgG4 monoclonal antibodies and a bispecific antibody. In all four cell lines, the version 2 media reduced aggregate growth over the course of a 12 week accelerated stability study compared with the version 1 media, although the degree to which aggregate growth decreased was cell line dependent. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:998-1008, 2016. © 2016 American Institute of Chemical Engineers.

  9. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

  10. Using market information in product development

    DEFF Research Database (Denmark)

    Søndergaard, Helle Alsted; Harmsen, Hanne

    2007-01-01

    development are also fulfilled since the development teams recognize the value of the information and actively use it in their product development decision making. However, the means-end approach cannot (in its present form) reveal experienced quality since the approach includes no trying of the product...... of abstraction in consumers' minds. At the same time they are reminded that this information should feed into the process of making decisions in product development....... on the understanding of consumers' vertical and horizontal decision structure) combined with considerations on effective internal use of the information. Design/methodology/approach - The suggested model is applied in case studies in an action research project, and experiences with the application are discussed...

  11. Information needs for making clinical recommendations about potential drug-drug interactions: a synthesis of literature review and interviews.

    Science.gov (United States)

    Romagnoli, Katrina M; Nelson, Scott D; Hines, Lisa; Empey, Philip; Boyce, Richard D; Hochheiser, Harry

    2017-02-22

    Drug information compendia and drug-drug interaction information databases are critical resources for clinicians and pharmacists working to avoid adverse events due to exposure to potential drug-drug interactions (PDDIs). Our goal is to develop information models, annotated data, and search tools that will facilitate the interpretation of PDDI information. To better understand the information needs and work practices of specialists who search and synthesize PDDI evidence for drug information resources, we conducted an inquiry that combined a thematic analysis of published literature with unstructured interviews. Starting from an initial set of relevant articles, we developed search terms and conducted a literature search. Two reviewers conducted a thematic analysis of included articles. Unstructured interviews with drug information experts were conducted and similarly coded. Information needs, work processes, and indicators of potential strengths and weaknesses of information systems were identified. Review of 92 papers and 10 interviews identified 56 categories of information needs related to the interpretation of PDDI information including drug and interaction information; study design; evidence including clinical details, quality and content of reports, and consequences; and potential recommendations. We also identified strengths/weaknesses of PDDI information systems. We identified the kinds of information that might be most effective for summarizing PDDIs. The drug information experts we interviewed had differing goals, suggesting a need for detailed information models and flexible presentations. Several information needs not discussed in previous work were identified, including temporal overlaps in drug administration, biological plausibility of interactions, and assessment of the quality and content of reports. Richly structured depictions of PDDI information may help drug information experts more effectively interpret data and develop recommendations

  12. Drugs from the Oceans: Marine Natural Products as Leads for Drug Discovery.

    Science.gov (United States)

    Altmann, Karl-Heinz

    2017-10-25

    The marine environment harbors a vast number of species that are the source of a wide array of structurally diverse bioactive secondary metabolites. At this point in time, roughly 27'000 marine natural products are known, of which eight are (were) at the origin of seven marketed drugs, mostly for the treatment of cancer. The majority of these drugs and also of drug candidates currently undergoing clinical evaluation (excluding antibody-drug conjugates) are unmodified natural products, but synthetic chemistry has played a central role in the discovery and/or development of all but one of the approved marine-derived drugs. More than 1000 new marine natural products have been isolated per year over the last decade, but the pool of new and unique structures is far from exhausted. To fully leverage the potential offered by the structural diversity of marine-produced secondary metabolites for drug discovery will require their broad assessment for different bioactivities and the productive interplay between new fermentation technologies, synthetic organic chemistry, and medicinal chemistry, in order to secure compound supply and enable lead optimization.

  13. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product states...

  14. Assessing the quality of pharmacist answers to telephone drug information questions.

    Science.gov (United States)

    Woodward, C T; Stevenson, J G; Poremba, A

    1990-04-01

    A quality assurance (QA) program is described in which frontline pharmacists were asked test drug information questions via anonymous telephone calls. The program was instituted at a university hospital that began providing decentralized pharmaceutical services in 1985. Questions were developed on the basis of a pilot study conducted to determine the types and complexity of drug information questions received by frontline pharmacists at the hospital. Data on departmental clinical productivity were used to determine the number of questions that would be posed during each shift in the various service areas. The questions were posed during a 10-day period; the pharmacists were aware of the program, but the callers did not identify their affiliation with it. In response to 105 questions asked, 86 were judged to have been answered correctly, 13 answers were deemed incomplete, and 6 were judged incorrect. Pharmacists were more likely to respond incorrectly to complex questions and questions posed during the night shift. As a result of the audit, staff members with advanced clinical knowledge were asked to help less experienced pharmacists, the position of assistant director for drug information and staff development was created, and educational programs were instituted. The QA audit has been repeated twice. Posing test drug information questions via anonymous telephone calls is effective in assessing the quality of drug information provided by pharmacists in patient-care areas.

  15. Drug-target interaction prediction from PSSM based evolutionary information.

    Science.gov (United States)

    Mousavian, Zaynab; Khakabimamaghani, Sahand; Kavousi, Kaveh; Masoudi-Nejad, Ali

    2016-01-01

    The labor-intensive and expensive experimental process of drug-target interaction prediction has motivated many researchers to focus on in silico prediction, which leads to the helpful information in supporting the experimental interaction data. Therefore, they have proposed several computational approaches for discovering new drug-target interactions. Several learning-based methods have been increasingly developed which can be categorized into two main groups: similarity-based and feature-based. In this paper, we firstly use the bi-gram features extracted from the Position Specific Scoring Matrix (PSSM) of proteins in predicting drug-target interactions. Our results demonstrate the high-confidence prediction ability of the Bigram-PSSM model in terms of several performance indicators specifically for enzymes and ion channels. Moreover, we investigate the impact of negative selection strategy on the performance of the prediction, which is not widely taken into account in the other relevant studies. This is important, as the number of non-interacting drug-target pairs are usually extremely large in comparison with the number of interacting ones in existing drug-target interaction data. An interesting observation is that different levels of performance reduction have been attained for four datasets when we change the sampling method from the random sampling to the balanced sampling. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Responsiveness to physicians' requests for information concerning drug interactions: a comparison of brand and generic companies.

    Science.gov (United States)

    Thomas, M; Lexchin, J

    1990-01-01

    Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This study evaluates pharmaceutical company behavior with regard to these issues. Two drug-drug interactions were identified, along with all of the companies in Canada marketing any of the four drugs involved. Each company received a letter describing symptoms suggestive of an interaction in a patient taking its particular product and the relevant second drug. The companies were asked if they were aware of any evidence of an interaction involving the two drugs. They were also asked to provide references regarding the interaction. Responses were received from all companies contacted except one. There were no significant differences (in the hypothesized direction) between the generic and brand companies with regard to either the accuracy or promptness of the response, or the usefulness of the references cited. On the contrary, generic firms were markedly quicker to respond than were brand manufacturers. The latter were slightly more likely to acknowledge evidence of an adverse drug interaction, and to provide useful references to relevant published research.

  17. Package selection for moisture protection for solid, oral drug products.

    Science.gov (United States)

    Waterman, Kenneth C; MacDonald, Bruce C

    2010-11-01

    This review describes how best to select the appropriate packaging options for solid, oral drug products based on both chemical and physical stability, with respect to moisture protection. This process combines an accounting for the initial moisture content of dosage form components, moisture transfer into (out of) packaging based on a moisture vapor transfer rate (MVTR), and equilibration between drug products and desiccants based on their moisture sorption isotherms to provide an estimate of the instantaneous relative humidity (RH) within the packaging. This time-based RH is calculationally combined with a moisture-sensitive Arrhenius equation (determined using the accelerated stability assessment program, ASAP) to predict the drug product's chemical stability over time as a function of storage conditions and packaging options. While physical stability of dosage forms with respect to moisture has been less well documented, a process is recommended based on the threshold RH at which changes (e.g., dosage form dissolution, tablet hardness, drug form) become problematic. The overall process described allows packaging to be determined for a drug product scientifically, with the effect of any changes to storage conditions or packaging to be explicitly accounted for. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association

  18. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP).

    Science.gov (United States)

    Paskiet, Diane; Jenke, Dennis; Ball, Douglas; Houston, Christopher; Norwood, Daniel L; Markovic, Ingrid

    2013-01-01

    The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development. The collaborative activities of PQRI participants have, in the case of orally inhaled and nasal drug products (OINDPs), resulted in comprehensive and widely-accepted recommendations for leachables assessments to help ensure patient safety with respect to this class of packaged drug products. These recommendations, which include scientifically justified safety thresholds for leachables, represent a significant milestone towards establishing standardized approaches for safety qualification of leachables in OINDP. To build on the success of the OINDP effort, PQRI's Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group was formed to extrapolate the OINDP threshold concepts and best practice recommendations to other dosage forms with high concern for interaction with packaging/delivery systems. This article considers the general aspects of leachables and their safety assessment, introduces the PODP Work Plan and initial study Protocol, discusses the laboratory studies being conducted by the PODP Chemistry Team, outlines the strategy being developed by the PODP Toxicology Team for the safety qualification of PODP leachables, and considers the issues associated with application of the safety thresholds, particularly with respect to large-volume parenterals. Lastly, the unique leachables issues associated with biologics are described. The Product Quality Research Institute (PQRI) is a non-profit consortium involving industry organizations, academia, and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality. The collaborative activities of the PQRI Orally Inhaled and Nasal Drug Products Leachables and Extractables Working Group resulted in a

  19. Development of Prescription Drug Information Leaflets: Impact of Cognitive Effort and Patient Involvement on Prescription Medication Information Processing.

    Science.gov (United States)

    Patel, Harshali K; Bapat, Shweta S; Bhansali, Archita H; Sansgiry, Sujit S

    2018-01-01

    The objective of this study was to develop a one-page (1-page) prescription drug information leaflet (PILs) and assess their impact on the information processing variables, across 2 levels of patient involvement. One-page PILs were developed using cognitive principles to lower mental effort and improve comprehension. An experimental, 3 × 2 repeated measures study was conducted to determine the impact of cognitive effort, manipulated using leaflet type on comprehension across 2 levels (high/low) of patient involvement. Adults (≥18 years) in a university setting in Houston were recruited for the study. Each participant was exposed to 3 different types of prescription drug information leaflet (the current practice, preexisting 1-page text-only, and 1-page PILs) for the 3 drugs (Celebrex, Ventolin HFA, Prezista) for a given involvement scenario. A prevalidated survey instrument was used to measure product knowledge, attitude toward leaflet, and intention to read. Multivariate analysis of variance indicated significant positive effect of cognitive effort, involvement, and their interaction effect across all measured variables. Mean scores for product knowledge, attitude toward leaflet, and intention to read were highest for PILs ( P information processing for consumers by reducing their cognitive effort.

  20. An Experimental Comparison of a Co-Design Visualizing Personal Drug Information and Patient Information Leaflets: Usability Aspects.

    Science.gov (United States)

    Khodambashi, Soudabeh; Haugland, Dagrun; Ellingsberg, Anette; Kottum, Hanne; Sund, Janne Kutschera; Nytrø, Øystein

    2017-01-01

    Providing patients with specific information about their own drugs can reduce unintentional misuse and improve compliance. Searching for information is time-consuming when information is not personalized and is written using medical vocabulary that is difficult for patients to understand. In this study we explored patient information needs regarding visualizing of drug information and interrelationships by conducting a total of four co-design workshops with patients, other users and pharmacists. We developed a prototype and drug ontology to support reasoning about drug interactions. We evaluated individual performance in finding information, understanding the drug interactions, and learning from the provided information in the prototype compared to using patient information leaflets (PILs). We concluded that interactive visualization of drug information helps individuals find information about drugs, their side effects and interactions more quickly and correctly compared to using PILs. Our study is limited to co-morbid patients with transient ischaemic attack with several chronic diseases.

  1. 21 CFR 344.52 - Labeling of ear drying aid drug products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of ear drying aid drug products. 344.52 Section 344.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Labeling of ear drying aid drug products. (a) Statement of identity. The labeling of the product contains...

  2. 21 CFR 212.71 - What actions must I take if a batch of PET drug product does not conform to specifications?

    Science.gov (United States)

    2010-04-01

    ... PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Finished Drug Product Controls and..., operations, records, complaints, and any other relevant sources of information concerning the nonconforming...

  3. Developing and promoting an intranet site for a drug information service.

    Science.gov (United States)

    Costerison, Emily C; Graham, Angie S

    2008-04-01

    The development and promotion of a drug information service (DIS) intranet site are described. Stanford Hospital and Clinics (SHC) is an acute and tertiary care facility with 613 licensed inpatient beds and 48 outpatient clinics. A DIS intranet site was developed to allow better accessibility to pharmacy forms and products (e.g., drug shortage list, reference guides) and to reduce repetitive requests to the DIS. The goal was to continue to provide information to SHC health care providers but allow the drug information specialist to focus on answering clinical questions. The intranet site was completed over a four-month period. The intranet site was divided into seven webpages: DIS overview, pharmacy and therapeutics, frequently asked questions, quick drug reference guide, ask the pharmacist, drug information resources, and referral center. The preparation for and implementation of the promotional phase took approximately two months. Promotional strategies included the creation and dissemination of brochures and stickers. The intranet site went live on January 1, 2007, and the advertising campaign began one month later. The utility of the site was measured for five months by tracking the number of visits to the site, the number of visits to each webpage, and the number of downloaded files. Request volume, caller affiliation, and question types received by the DIS call center were also recorded. Establishing a DIS intranet site required a considerable time investment and a willingness to work with existing infrastructures, such as the marketing and communications department and Web marketing staff.

  4. Adequacy of pharmacological information provided in pharmaceutical drug advertisements in African medical journals.

    Directory of Open Access Journals (Sweden)

    Oshikoya KA

    2009-06-01

    Full Text Available Pharmaceutical advertisement of drugs is a means of advocating drug use and their selling but not a substitute for drug formulary to guide physicians in safe prescribing. Objectives: To evaluate drug advertisements in Nigerian and other African medical journals for their adequacy of pharmacological information. Methods: Twenty four issues from each of West African Journal of Medicine (WAJM, East African Medical Journal (EAMJ, South African Medical Journal (SAMJ, Nigerian Medical Practitioner (NMP, Nigerian Quarterly Journal of Hospital Medicine (NQJHM and Nigerian Postgraduate Medical Journal (NPMJ were reviewed. While EAMJ, SAMJ and NMP are published monthly, the WAJM, NQJHM and NPMJ are published quarterly. The monthly journals were reviewed between January 2005 and December 2006, and the quarterly journals between January 2001 and December 2006. The drug information with regards to brand/non-proprietary name, pharmacological data, clinical information, pharmaceutical information and legal aspects was evaluated as per World Health Organisation (WHO criteria. Counts in all categories were collated for each advertiser.Results: Forty one pharmaceutical companies made 192 advertisements. 112 (58.3% of these advertisements were made in the African medical journals. Pfizer (20.3% and Swipha (12.5% topped the list of the advertising companies. Four (2.1% adverts mentioned generic names only, 157 (81.8% mentioned clinical indications. Adults and children dosage (39.6%, use in special situations such as pregnancy and renal or liver problems (36.5%, adverse effects (30.2%, average duration of treatment (26.0%, and potential for interaction with other drugs (18.7% were less discussed. Pharmaceutical information such as available dosage forms and product and package information {summary of the generic and proprietary names, the formulation strength, active ingredient, route of administration, batch number, manufactured and expiry dates, and the

  5. Marine natural products: a new wave of drugs?

    Science.gov (United States)

    Montaser, Rana; Luesch, Hendrik

    2011-01-01

    The largely unexplored marine world that presumably harbors the most biodiversity may be the vastest resource to discover novel ‘validated’ structures with novel modes of action that cover biologically relevant chemical space. Several challenges, including the supply problem and target identification, need to be met for successful drug development of these often complex molecules; however, approaches are available to overcome the hurdles. Advances in technologies such as sampling strategies, nanoscale NMR for structure determination, total chemical synthesis, fermentation and biotechnology are all crucial to the success of marine natural products as drug leads. We illustrate the high degree of innovation in the field of marine natural products, which in our view will lead to a new wave of drugs that flow into the market and pharmacies in the future. PMID:21882941

  6. 21 CFR 250.250 - Hexachlorophene, as a component of drug and cosmetic products.

    Science.gov (United States)

    2010-04-01

    ... cosmetic products. 250.250 Section 250.250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Requirements for Drugs and Cosmetics § 250.250 Hexachlorophene, as a component of drug and cosmetic products... cosmetic products has expanded widely in recent years. It is used in such products because of its...

  7. Online drug databases: a new method to assess and compare inclusion of clinically relevant information.

    Science.gov (United States)

    Silva, Cristina; Fresco, Paula; Monteiro, Joaquim; Rama, Ana Cristina Ribeiro

    2013-08-01

    Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB. To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use. Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created. A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed

  8. Auditing Information System : Delivery Product Service

    Directory of Open Access Journals (Sweden)

    Purwoko Purwoko

    2011-05-01

    Full Text Available Purpose of the research is to ensure the securities of information system asset and to ensure if informa-tion system support the operational and data collected was valid. Research method that used in this research were library studies and field studies. Field studies such an observation, questioner, and inter-view. the expected result are founding the weakness of security management control, operational man-agement control, input control, and output control of risk happened in the company. Conclusion of this research are the system on the company work good and there’s no potential risk happened and make an impact to the delivery process of information system.Index Terms - Auditing Information system, Delivery product process.

  9. Identification of antimycotic drugs transformation products upon UV exposure

    International Nuclear Information System (INIS)

    Casado, Jorge; Rodríguez, Isaac; Ramil, María; Cela, Rafael

    2015-01-01

    Highlights: • Evaluation of antimycotic drugs UV stabilities in model supports. • Simultaneous detection of precursor drugs and transformation products. • Transformation products identification from their scan, accurate MS/MS spectra. • Directed search of identified transformation products in sand and soil samples. • Preliminary toxicity estimations. - Abstract: The reactivity of three imidazolic, environmental persistent antimycotic drugs (clotrimazole, CTZ; ketoconazole, KTZ; and miconazole, MCZ) upon exposure to ultraviolet (UV) radiation is discussed. First, precursor compounds were immobilized in a silicone support which was further exposed to UV light at two different wavelengths: 254 and 365 nm. After solvent desorption, degradation kinetics of the precursor pharmaceuticals, identification of the arising transformation products (TPs) and evaluation of their time-course were investigated by liquid chromatography (LC) with quadrupole time-of-flight (QTOF) mass spectrometry (MS) detection. The three antimycotics displayed similar stabilities when exposed to 254 nm light; however, CTZ was significantly more stable than MCZ and KTZ when irradiated with the 365 nm lamp. TPs identified in silicone supports resulted from de-chlorination, cleavage, intra-molecular cyclization and hydroxylation reactions. Many of these species were also detected when exposing other solid matrices, such as sand and agricultural soil, previously spiked with target compounds, to UV light. The 50% estimated lethal concentration, calculated using the 48-h Daphnia magna test, for the two main TPs of CTZ and MCZ, at both wavelengths, were lower than those corresponding to the precursor drugs

  10. Identification of antimycotic drugs transformation products upon UV exposure

    Energy Technology Data Exchange (ETDEWEB)

    Casado, Jorge; Rodríguez, Isaac, E-mail: isaac.rodriguez@usc.es; Ramil, María; Cela, Rafael

    2015-05-30

    Highlights: • Evaluation of antimycotic drugs UV stabilities in model supports. • Simultaneous detection of precursor drugs and transformation products. • Transformation products identification from their scan, accurate MS/MS spectra. • Directed search of identified transformation products in sand and soil samples. • Preliminary toxicity estimations. - Abstract: The reactivity of three imidazolic, environmental persistent antimycotic drugs (clotrimazole, CTZ; ketoconazole, KTZ; and miconazole, MCZ) upon exposure to ultraviolet (UV) radiation is discussed. First, precursor compounds were immobilized in a silicone support which was further exposed to UV light at two different wavelengths: 254 and 365 nm. After solvent desorption, degradation kinetics of the precursor pharmaceuticals, identification of the arising transformation products (TPs) and evaluation of their time-course were investigated by liquid chromatography (LC) with quadrupole time-of-flight (QTOF) mass spectrometry (MS) detection. The three antimycotics displayed similar stabilities when exposed to 254 nm light; however, CTZ was significantly more stable than MCZ and KTZ when irradiated with the 365 nm lamp. TPs identified in silicone supports resulted from de-chlorination, cleavage, intra-molecular cyclization and hydroxylation reactions. Many of these species were also detected when exposing other solid matrices, such as sand and agricultural soil, previously spiked with target compounds, to UV light. The 50% estimated lethal concentration, calculated using the 48-h Daphnia magna test, for the two main TPs of CTZ and MCZ, at both wavelengths, were lower than those corresponding to the precursor drugs.

  11. Prudent Use of Veterinary Drugs: Impact on Safe Animal Products ...

    African Journals Online (AJOL)

    Like any other therapeutic compounds, veterinary drugs are used to alleviate diseases in animals as either therapeutic or prophylactic compounds for specific disease entities. They can also be used as production aids in food producing animals to increase market sale of these animals whereby the producers save on the ...

  12. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Science.gov (United States)

    2010-04-01

    ...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that... this chapter for definition of bullet. (ii) The warning required by § 369.21 of this chapter for drugs...

  13. Production of drug nanosuspensions: effect of drug physical properties on nanosizing efficiency.

    Science.gov (United States)

    Liu, Tao; Müller, Rainer H; Möschwitzer, Jan P

    2018-02-01

    Drug nanosuspension is one of the established methods to improve the bioavailability of poorly soluble drugs. Drug physical properties aspect (morphology, solid state, starting size et al) is a critical parameter determining the production efficiency. Some drug modification approaches such as spray-drying were proved to improve the millability of drug powders. However, the mechanism behind those improved performances is unclear. This study is to systematically investigate the influence of those physical properties. Five different APIs (active pharmaceutical ingredients) with different millabilities, i.e. resveratrol, hesperetin, glibenclamide, rutin, and quercetin, were processed by standard high pressure homogenization (HPH), wet bead milling (WBM), and a combinative method of spray-drying and HPH. Smaller starting sizes of certain APIs could accelerate the particle size reduction velocity during both HPH and WBM processes. Spherical particles were observed for almost all spray-dried powders (except spray-dried hesperetin) after spray-drying. The crystallinity of some spray-dried samples such as rutin and glibenclamide became much lower than their corresponding unmodified powders. Almost all spray-dried drug powders after HPH processes could lead to smaller nanocrystal particle size than unmodified APIs. The modified microstructure instead of solid state after spray-drying explained the potential reason for improved nanosizing efficiency. In addition, the contribution of starting size on the production efficiency was also critical according to both HPH and WBM results.

  14. Tuberculosis drug issues: prices, fixed-dose combination products and second-line drugs.

    Science.gov (United States)

    Laing, R O; McGoldrick, K M

    2000-12-01

    Access to tuberculosis drugs depends on multiple factors. Selection of a standard list of TB drugs to procure is the first step. This paper reviews the advantages and disadvantages of procuring and using fixed-dose combination (FDC) products for both the intensive and continuation phases of treatment. The major advantages are to prevent the emergence of resistance, to simplify logistic management and to reduce costs. The major disadvantage is the need for the manufacturers to assure the quality of these FDCs by bioavailability testing. The paper reports on the inclusion of second-line TB drugs in the 1999 WHO Essential Drug List (EDL). The need to ensure that these drugs are used within established DOTS-Plus programs is stressed. The price of TB drugs is determined by many factors, including producer prices, local taxes and duties as well as mark-ups and fees. TB drug prices for both the public and private sectors from industrialized and developing countries are reported. Price trends over time are also reported. The key findings of this study are that TB drug prices have generally declined in developing countries while they have increased in developed countries, both for the public and private sectors. Prices vary between countries, with the US paying as much as 95 times the price paid in a specific developing country. The prices of public sector first-line TB drugs vary little between countries, although differences do exist due to the procurement methods used. The price of tuberculin, a diagnostic agent, has increased dramatically in the US, with substantial inter-country variations in price. The paper suggests that further research is necessary to identify the reasons for the price disparities and changes over time, and suggests methods which can be used by National Tuberculosis Programme managers to ensure availability of quality assured TB drugs at low prices.

  15. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

    2010-01-01

    AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...... included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category...... of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring...

  16. VETSTAT - the Danish system for surveillance of the veterinary use of drugs for production animals

    DEFF Research Database (Denmark)

    Stege, H.; Bager, Flemming; Jacobsen, Erik

    2003-01-01

    The Danish Ministry of Food, Agriculture and Fisheries funds a monitoring system based on drug usage information collected at the herd level: VETSTAT. VETSTAT is constructed as a relational database and data originates from three sources: pharmacies, veterinarians and feed mills. All administration...... of drugs for use in animal production is reported on a monthly basis. Pharmacies provided 95% of the total weight antimicrobial compounds used in Denmark in 2001. More than 80% of the antimicrobial compounds reported by pharmacies were sold on prescription to end-users (owners) and included information...

  17. Marketing information: The technical report as product

    Science.gov (United States)

    Stoher, F. F.; Pinelli, T. E.

    1981-01-01

    Technical reports constitute a product, the primary means for communicating the results of research to the user. The Langley scientific and technical information (STI) review and evaluation project undertook a review of the technical report as an effective product for information communication. Style manuals describing theory and practice in technical report preparation; publication manuals covering such factors as design, layout, and type style; and copies of technical reports were obtained from industrial, academic, governmental, and research organizations. Based on an analysis of this material, criteria will be established for the report components, for the relationship of the components within the report context, and for the overall report organization. The criteria will be used as bench marks and compared with the publication standards currently used to prepare NASA technical reports.

  18. Effect of warning placement on the information processing of college students reading an OTC drug facts panel.

    Science.gov (United States)

    Bhansali, Archita H; Sangani, Darshan S; Mhatre, Shivani K; Sansgiry, Sujit S

    2018-01-01

    To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students. University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010. A current FDA label was compared to two experimental labels developed using the theory of CHREST to test information processing by re-positioning the warning information within the Drug Facts panel. Congruency was defined as placing like information together. Information processing was evaluated using the OTC medication Label Evaluation Process Model (LEPM): label comprehension, ease-of-use, attitude toward the product, product evaluation, and purchase intention. Experimental label with chunked congruent information (uses-directions-other information-warnings) was rated significantly higher than the current FDA label and had the best average scores among the LEPM information processing variables. If replications uphold these findings, the FDA label design might be revised to improve information processing.

  19. Cumulative exposure to phthalates from phthalate-containing drug products

    DEFF Research Database (Denmark)

    Ennis, Zandra Nymand; Broe, Anne; Pottegård, Anton

    2018-01-01

    European regulatory limit of exposure ranging between 380-1710 mg/year throughout the study period. Lithium-products constituted the majority of dibutyl phthalate exposure. Diethyl phthalate exposure, mainly caused by erythromycin, theophylline and diclofenac products, did not exceed the EMA regulatory...... to quantify annual cumulated phthalate exposure from drug products among users of phthalate-containing oral medications in Denmark throughout the period of 2004-2016. METHODS: We conducted a Danish nationwide cohort study using The Danish National Prescription Registry and an internal database held...

  20. 21 CFR 20.2 - Production of records by Food and Drug Administration employees.

    Science.gov (United States)

    2010-04-01

    ... upon an officer or employee of the Food and Drug Administration commanding the production of any record... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

  1. Association of Risk Perception and Information Provided on the Labels of Over-the-Counter Drugs: Role of Race, Education, Age and Income

    Directory of Open Access Journals (Sweden)

    Sunil Mathur

    2014-01-01

    Full Text Available Background: The use of over-the-counter (OTC drugs has increased tremendously, however, information on risk perception regarding the use of OTC drugs and their potential toxicity is scarce. Hence, the purpose of this study was to investigate the perception of OTC drug safety and efficacy based on reading product packaging and the effect of race, education, age and income. Methods: We used the HINTS 2012 data set with total sample size of 2,554. Results: OTC drug users having some high school education had a lower chance of frequently reading information included in the product labeling with the OTC medication. OTC drug users less than 50 years of age were always likely to read drug information on the OTC drug labeling. Also, Non-Hispanic blacks were more likely to read OTC drug labeling than Non-Hispanic whites.  OTC drug users less than 50 years of age consider OTC drugs safer than prescription drugs.  Conversely, OTC drug users with a high school, some college or bachelor’s degree consider OTC drugs less safe than prescription drugs.  Non-Hispanic blacks, non-Hispanic whites, and subjects of lower income were less likely to consider OTC drugs safer than prescription drugs.  OTC drug users with a high school education and some college perceive OTC drugs to be less effective than prescription drugs.Conclusion: To conclude, age, education, race, and income affect risk perception on OTC drugs.  Consumer information programs need to be designed so that meaningful results can be incorporated into public policy. Providing information on the labeling of OTC drugs and likelihood of patients reading this information require further study.

  2. A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

    Science.gov (United States)

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered

  3. 21 CFR 347.50 - Labeling of skin protectant drug products.

    Science.gov (United States)

    2010-04-01

    ... omitted. (f) Products containing only cocoa butter, petrolatum, or white petrolatum identified in § 347.10... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of skin protectant drug products. 347.50... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347...

  4. The internet as a source of drug information: a profile of utilization by ...

    African Journals Online (AJOL)

    Open Access DOWNLOAD FULL TEXT ... Introduction: The internet is a useful tool which could provide quality drug information if well applied. Its utilization as a source of drug information by junior doctors in Nigeria is not well documented.

  5. Information technology-based approaches to reducing repeat drug exposure in patients with known drug allergies.

    Science.gov (United States)

    Cresswell, Kathrin M; Sheikh, Aziz

    2008-05-01

    There is increasing interest internationally in ways of reducing the high disease burden resulting from errors in medicine management. Repeat exposure to drugs to which patients have a known allergy has been a repeatedly identified error, often with disastrous consequences. Drug allergies are immunologically mediated reactions that are characterized by specificity and recurrence on reexposure. These repeat reactions should therefore be preventable. We argue that there is insufficient attention being paid to studying and implementing system-based approaches to reducing the risk of such accidental reexposure. Drawing on recent and ongoing research, we discuss a number of information technology-based interventions that can be used to reduce the risk of recurrent exposure. Proven to be effective in this respect are interventions that provide real-time clinical decision support; also promising are interventions aiming to enhance patient recognition, such as bar coding, radiofrequency identification, and biometric technologies.

  6. 78 FR 65904 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

    Science.gov (United States)

    2013-11-04

    ... Manufacturing of Certain Drug or Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed.... The Fabrazyme shortage resulted from contamination at the manufacturing [[Page 65910

  7. Potential of Continuous Manufacturing for Liposomal Drug Products.

    Science.gov (United States)

    Worsham, Robert D; Thomas, Vaughan; Farid, Suzanne S

    2018-05-21

    Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g. improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application. This article is protected by copyright. All rights reserved.

  8. Liposomal Drug Product Development and Quality: Current US Experience and Perspective.

    Science.gov (United States)

    Kapoor, Mamta; Lee, Sau L; Tyner, Katherine M

    2017-05-01

    Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency has received over 400 liposomal drug product submissions (excluding combination therapies), and there are currently eight approved liposomal drug products on the US market. In order to identify the pain points in development and manufacturing of liposomal drug products, a retrospective analysis was performed from a quality perspective on submissions for new and generic liposomal drug products. General analysis on liposomal drug product submissions was also performed. Results indicated that 96% of the submissions were Investigational New Drug (IND) applications, 3% were New Drug Applications (NDAs), and the remaining 1% was Abbreviated New Drug Applications (ANDAs). Doxorubicin hydrochloride was the most commonly used drug substance incorporated into the liposomes (31%). The majority of the liposomal products were administered via intravenous route (84%) with cancer (various types) being the most common indication (63%). From a quality perspective, major challenges during the development of liposomal drug products included identification and (appropriate) characterization of critical quality attributes of liposomal drug products and suitable control strategies during product development. By focusing on these areas, a faster and more efficient development of liposomal drug products may be achieved. Additionally, in this way, the drug review process for such products can be streamlined.

  9. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

  10. Characterization of SNARE Cleavage Products Generated by Formulated Botulinum Neurotoxin Type-A Drug Products

    Directory of Open Access Journals (Sweden)

    Jack Xie

    2010-08-01

    Full Text Available The study evaluated substrate cleavage product(s generated by three botulinum neurotoxin serotype A (BoNT/A medicinal drug products utilizing a novel and highly specific, light-chain activity, high-performance liquid chromatography (LCA-HPLC method. Samples were reacted with a commercially available BoNT/A fluorescent substrate derived from the SNAP-25 sequence. Reaction products were separated by reversed-phase HPLC. The method detected an atypical cleavage pattern by one of the formulated drug products. IncobotulinumtoxinA produced two cleavage fragments rather than the single fragment typically generated by BoNT/A. Identification confirmed the secondary cleavage at a position corresponding to SNAP-25 Arg198–Ala199 (normal BoNT/A cleavage is Gln197–Arg198. Arg198–Ala199 is also the cleavage site for trypsin and serotype C toxin. Normal cleavage was observed for all other BoNT/A drug product samples, as well as 900-kD and 150-kD bulk toxin BoNT/A. The reason for this unexpected secondary cleavage pattern by one formulated BoNT/A drug product is unknown. Possible explanations include a contaminating protease and/or damage to the 150-kD type-A toxin causing nonspecific substrate recognition and subsequent cleavage uncharacteristic of type-A toxin. The BoNT/A drug products were also analyzed via the LCA-HPLC assay using a commercial BoNT/C fluorescent substrate derived from the syntaxin sequence. Cleavage of the serotype C substrate by incobotulinumtoxinA was also confirmed whilst neither of the other drug products cleaved the syntaxin substrate.

  11. Exploring the e-Supply Chain of Information Products

    OpenAIRE

    Raafat George Saadé

    2012-01-01

    Digital information product producers have not taken advantage of the e-supply chain paradigm of today. However, in this information-based sector, a different set of supply chain management challenges exist. Very little research has been done in the supply chain of information products. This study focuses on the process analysis of the supply chain paradigm for digital information products. A framework for digital information products production in e-learning is proposed followed by an exampl...

  12. Prenatal drug exposure and teratological risk: one-year experience of an Italian Teratology Information Service.

    Science.gov (United States)

    De Santis, Marco; Cesari, Elena; Ligato, Maria Serena; Nobili, Elena; Straface, Gianluca; Cavaliere, Annafranca; Caruso, Alessandro

    2008-02-01

    Concern about exposure to drugs, radiation, or infection during pregnancy occur often because pregnancy is not always planned. A teratology information service offers rapid scientific counseling to all those worried about prenatal exposure. The aim of this study is to present data on the most common pharmaceutical products responsible for teratogenic risk in the one-year experience of a teratology information service in Italy. The survey was conducted among 8664 callers who contacted our Teratology Information Service in Rome between January and December 2006. Data on maternal age, gravidity, parity, maternal health status, and details of exposure (dose and timing) were collected and stored in a specific data base. Scientific counseling on prenatal exposure was given to the caller by a specialized service operator, specifying the type of risk and suggesting appropriate tests for prenatal diagnosis. Most of the people called regarding drug exposure; increased risk was present in only 5% of the pregnant women calling during pregnancy. Selective serotonin reuptake inhibitors (SSRIs) are the first category that are actually considered of increased risk to the fetus. The second category is represented by antiepileptic drugs. This experience confirms previous data that there is a high teratological risk perception among both women and physicians. The drugs estimated to present increased risk are medications used for chronic neurological diseases, mainly mood disorders and epilepsy. Preconceptional counseling for these women could be an effective strategy to prevent such exposure and to improve maternal and fetal outcome.

  13. Structure-based synthesis from natural products to drug prototypes

    International Nuclear Information System (INIS)

    Hanessian, S.

    2009-01-01

    X-Ray crystallographic data available from complexes of natural and synthetic molecules with the enzyme thrombin has aided to the design and synthesis of truncated and hybrid molecules exhibiting excellent inhibition in vitro. The vital importance of natural products for the well-being of man has been known lor millennia. Their therapeutic benefits to alleviate pain or cure diseases continue to rank natural products among the primary sources of potential drugs. Great advances have been made in the methods of isolation, identification, and structure elucidation of some of the most complex natural products in recent years. The advent of molecular biology and genetic mapping has also aided in our understanding of the intriguing biosynthetic pathways leading to various classes of therapeutically relevant antibiotic, anticancer, and related natural products. Elegant and practical methodology has been developed leading to the total synthesis of virtually every class of medicinally important natural product. In some cases, natural products or their chemically modified congeners have been manufactured by total synthesis on an industrial level which is a testament to the ingenuity of process chemists. In spite of their potent activities HI enzymatic ox receptor-mediated assays, not all natural products are amenable to being developed as marketable drags. In many instances unfavorable pharmacological effects cannot be overcome without drastic structural and functional modifications, which may also result in altered efficacy. Structure modification through truncation, functional group variations, isosteric replacements, and skeletal rigidifications aided by molecular modeling, X ray crystallography of protein targets, or NMR data are valid objectives in the context of small molecule drug discovery starting with bioactive natural products. A large proportion of these pertain to chemotherapeutic agents against cancer

  14. [Drug information management through the intranet of a hospital center].

    Science.gov (United States)

    Juárez Giménez, J C; Mendarte Barrenechea, L; Gil Luján, G; Sala Piñol, F; Lalueza Broto, P; Girona Brumós, L; Monterde Junyent, J

    2006-01-01

    This paper describes the methodology used for the implementation and validation of a network resource incorporated to the intranet of the Hospital, in order to retain and disseminate information from the Drug Information Center (DIC) of a pharmacy service in a hospital center. A working group designed the structure, contents, memory needs, priority of access for users and a quality assessment questionnaire. The resource developed by the working group had a capacity of 70 Gb and its structure was based on HTML documents, including files with different format and 12 theme areas. Two levels of priority of access were established depending on the user and two persons were in charge of the resource. The questionnaire was delivered after three months of use. Sixty nine per cent of the users regarded the resource as very useful and 31%, as useful. The final structure, according to the results of the survey, had 11 theme areas. The use of the hospital Intranet in order to include and organize DIC information can be very simple and economic. Furthermore, the involvement of all the users in its design and structure can facilitate the practical use of this tool and improve its quality.

  15. A dataset of 200 structured product labels annotated for adverse drug reactions.

    Science.gov (United States)

    Demner-Fushman, Dina; Shooshan, Sonya E; Rodriguez, Laritza; Aronson, Alan R; Lang, Francois; Rogers, Willie; Roberts, Kirk; Tonning, Joseph

    2018-01-30

    Adverse drug reactions (ADRs), unintended and sometimes dangerous effects that a drug may have, are one of the leading causes of morbidity and mortality during medical care. To date, there is no structured machine-readable authoritative source of known ADRs. The United States Food and Drug Administration (FDA) partnered with the National Library of Medicine to create a pilot dataset containing standardised information about known adverse reactions for 200 FDA-approved drugs. The Structured Product Labels (SPLs), the documents FDA uses to exchange information about drugs and other products, were manually annotated for adverse reactions at the mention level to facilitate development and evaluation of text mining tools for extraction of ADRs from all SPLs. The ADRs were then normalised to the Unified Medical Language System (UMLS) and to the Medical Dictionary for Regulatory Activities (MedDRA). We present the curation process and the structure of the publicly available database SPL-ADR-200db containing 5,098 distinct ADRs. The database is available at https://bionlp.nlm.nih.gov/tac2017adversereactions/; the code for preparing and validating the data is available at https://github.com/lhncbc/fda-ars.

  16. Interdisciplinary researches for potential developments of drugs and natural products

    Directory of Open Access Journals (Sweden)

    Arunrat Chaveerach

    2017-04-01

    Full Text Available Developments of drugs or natural products from plants are possibly made, simple to use and lower cost than modern drugs. The development processes can be started with studying local wisdom and literature reviews to choose the plants which have long been used in diverse areas, such as foods, traditional medicine, fragrances and seasonings. Then those data will be associated with scientific researches, namely plant collection and identification, phytochemical screening by gas chromatography-mass spectrometry, pharmacological study/review for their functions, and finally safety and efficiency tests in human. For safety testing, in vitro cell toxicity by cell viability assessment and in vitro testing of DNA breaks by the comet assay in human peripheral blood mononuclear cells can be performed. When active chemicals and functions containing plants were chosen with safety and efficacy for human uses, then, the potential medicinal natural products will be produced. Based on these procedures, the producing cost will be cheaper and the products can be evaluated for their clinical properties. Thus, the best and lowest-priced medicines and natural products can be distributed worldwide.

  17. Interdisciplinary researches for potential developments of drugs and natural products

    Institute of Scientific and Technical Information of China (English)

    Arunrat Chaveerach; Runglawan Sudmoon; Tawatchai Tanee

    2017-01-01

    Developments of drugs or natural products from plants are possibly made,simple to use and lower cost than modern drugs.The development processes can be started with studying local wisdom and literature reviews to choose the plants which have long been used in diverse areas,such as foods,traditional medicine,fragrances and seasonings.Then those data will be associated with scientific researches,namely plant collection and identification,phytochemical screening by gas chromatography-mass spectrometry,pharmacological study/review for their functions,and finally safety and efficiency tests in human.For safety testing,in vitro cell toxicity by cell viability assessment and in vitro testing of DNA breaks by the comet assay in human peripheral blood mononuclear cells can be performed.When active chemicals and functions containing plants were chosen with safety and efficacy for human uses,then,the potential medicinal natural products will be produced.Based on these procedures,the producing cost will be cheaper and the products can be evaluated for their clinical properties.Thus,the best and lowest-priced medicines and natural products can be distributed worldwide.

  18. Natural Products as Leads in Schistosome Drug Discovery

    Directory of Open Access Journals (Sweden)

    Bruno J. Neves

    2015-01-01

    Full Text Available Schistosomiasis is a neglected parasitic tropical disease that claims around 200,000 human lives every year. Praziquantel (PZQ, the only drug recommended by the World Health Organization for the treatment and control of human schistosomiasis, is now facing the threat of drug resistance, indicating the urgent need for new effective compounds to treat this disease. Therefore, globally, there is renewed interest in natural products (NPs as a starting point for drug discovery and development for schistosomiasis. Recent advances in genomics, proteomics, bioinformatics, and cheminformatics have brought about unprecedented opportunities for the rapid and more cost-effective discovery of new bioactive compounds against neglected tropical diseases. This review highlights the main contributions that NP drug discovery and development have made in the treatment of schistosomiasis and it discusses how integration with virtual screening (VS strategies may contribute to accelerating the development of new schistosomidal leads, especially through the identification of unexplored, biologically active chemical scaffolds and structural optimization of NPs with previously established activity.

  19. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Science.gov (United States)

    2013-12-12

    ... Guidance for Industry (GFI) 209, ``The Judicious Use of Medically Important Antimicrobial Drugs in Food... of certain antimicrobial new animal drug products who are interested in revising conditions of use... Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines for stakeholders...

  20. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

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

  1. 21 CFR 330.3 - Imprinting of solid oral dosage form drug products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Imprinting of solid oral dosage form drug products... AS SAFE AND EFFECTIVE AND NOT MISBRANDED General Provisions § 330.3 Imprinting of solid oral dosage form drug products. A requirement to imprint an identification code on solid oral dosage form drug...

  2. 77 FR 71006 - Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for the Treatment...

    Science.gov (United States)

    2012-11-28

    ... poisoning and unapproved injectable drug products containing sodium thiosulfate labeled for the treatment of... for the treatment of cyanide poisoning are new drugs that require approved new drug applications (NDAs... Injection and Sodium Thiosulfate Injection drug product, labeled for treatment of acute cyanide poisoning...

  3. Scientific workflows as productivity tools for drug discovery.

    Science.gov (United States)

    Shon, John; Ohkawa, Hitomi; Hammer, Juergen

    2008-05-01

    Large pharmaceutical companies annually invest tens to hundreds of millions of US dollars in research informatics to support their early drug discovery processes. Traditionally, most of these investments are designed to increase the efficiency of drug discovery. The introduction of do-it-yourself scientific workflow platforms has enabled research informatics organizations to shift their efforts toward scientific innovation, ultimately resulting in a possible increase in return on their investments. Unlike the handling of most scientific data and application integration approaches, researchers apply scientific workflows to in silico experimentation and exploration, leading to scientific discoveries that lie beyond automation and integration. This review highlights some key requirements for scientific workflow environments in the pharmaceutical industry that are necessary for increasing research productivity. Examples of the application of scientific workflows in research and a summary of recent platform advances are also provided.

  4. 21 CFR 207.25 - Information required in registration and drug listing.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Information required in registration and drug listing. 207.25 Section 207.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufactured by a registered blood bank, a copy of all current labeling (except that only one representative...

  5. Production of drug-loaded polymeric nanoparticles by electrospraying technology.

    Science.gov (United States)

    Sosnik, Alejandro

    2014-09-01

    The pharmaceutical industry struggles with high attrition. The outbreak of pharmaceutical micro/nanotechnology has been fundamental to overcome several (bio)pharmaceutic drawbacks of drugs such as poor aqueous solubility, physicochemical instability, short half life, inappropriate biodistribution and toxicity. The spatiotemporal release of drugs directly in the site of action and the restriction of the systemic exposure by means of nanotechnology has notoriously improved drug safety ratios. At the same time, the development of production methods that are cost-effective, scalable and reproducible under industrial settings becomes crucial to ensure the clinical translation of any development. The electrospraying process, also known as electrohydrodynamic atomization (EHDA), is a single-stage technique of liquid atomization by means of electrical forces that enables the generation of micro/nanoparticles with especially narrow size distribution. EHDA is based on the ability of an electric field to deform the interface of a liquid drop and break it into smaller mono-disperse droplets. The main advantageous features over conventional methods are the possibility to produce particles without the use of surfactants, at ambient temperature and pressure and with maximum encapsulation efficiency due to the absence of an external medium that allows the migration and/or dissolution of water-soluble cargos. In addition, the mild conditions are optimal for the encapsulation of thermo-sensitive cargos. The present article overviews the applications of this technology for the production of nano-drug delivery systems and discusses its key role to support the transfer of a broad spectrum of nanomedicines to the market.

  6. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Science.gov (United States)

    2011-09-29

    ... monograph need not obtain FDA approval before marketing if their drug product meets the conditions in part... introduce into the United States an OTC drug product that had been marketed solely in a foreign country...

  7. Presenting efficacy information in direct-to-consumer prescription drug advertisements.

    Science.gov (United States)

    O'Donoghue, Amie C; Sullivan, Helen W; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J

    2014-05-01

    We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs. Published by Elsevier Ireland Ltd.

  8. Communicating during a pandemic: information the public wants about the disease and new vaccines and drugs.

    Science.gov (United States)

    Henrich, Natalie; Holmes, Bev

    2011-07-01

    To prepare for pandemics, countries are creating pandemic preparedness plans. These plans frequently include crisis communication strategies that recommend conducting pre-crisis audience research to increase the effectiveness and relevance of communication with the public. To begin understanding the communication needs of the public and health care workers, 11 focus groups were conducted in Vancouver, Canada, in 2006 and 2007 to identify what information people want to receive and how they want to receive it. In the event of a pandemic, participants want to know their risk of infection and how sick they could become if infected. To make decisions about using vaccines and drugs, they want information that enables them to assess the risks of using the products. The public prefers to receive this information from family doctors, the Internet, and schools. Health care workers prefer to receive information in e-mails and in-services.

  9. Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

    International Nuclear Information System (INIS)

    Gebran, N.; Al-Haldari, K.

    2006-01-01

    Little research has assessed the quality of manufacturer provided prescribing information or documented difference in key aspects of drug information among different marketed generic products of the same drug particularly in Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of Middle East. We assessed the correctness and completeness of information pertaining to indications, dosage cautions/contraindications, side effects and drug interactions in 37 packages inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), melformin (7 inserts) and omeprazole (9 inserts). We also described deficiencies in quality and quantity of manufacturers provided information that could be misleading to patients and prescribes. We found substantial disagreement in information between generic packages inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumulative average of 63.16% of drug information indicators were in agreement with these standard references. Section headings with the least conformity with study references were those related to dosage (57, 28%) and side effects (54+-30%). Our results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts. (author)

  10. Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis.

    Science.gov (United States)

    Sullivan, Helen W; Aikin, Kathryn J; Poehlman, Jon

    2017-11-10

    Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks' severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.

  11. Software package as an information center product

    International Nuclear Information System (INIS)

    Butler, M.K.

    1977-01-01

    The Argonne Code Center serves as a software exchange and information center for the U.S. Energy Research and Development Administration and the Nuclear Regulatory Commission. The goal of the Center's program is to provide a means for sharing of software among agency offices and contractors, and for transferring computing applications and technology, developed within the agencies, to the information-processing community. A major activity of the Code Center is the acquisition, review, testing, and maintenance of a collection of software--computer systems, applications programs, subroutines, modules, and data compilations--prepared by agency offices and contractors to meet programmatic needs. A brief review of the history of computer program libraries and software sharing is presented to place the Code Center activity in perspective. The state-of-the-art discussion starts off with an appropriate definition of the term software package, together with descriptions of recommended package contents and the Carter's package evaluation activity. An effort is made to identify the various users of the product, to enumerate their individual needs, to document the Center's efforts to meet these needs and the ongoing interaction with the user community. Desirable staff qualifications are considered, and packaging problems, reviewed. The paper closes with a brief look at recent developments and a forecast of things to come. 2 tables

  12. 76 FR 58020 - Prescription Drug User Fee Act IV Information Technology Plan

    Science.gov (United States)

    2011-09-19

    ...] Prescription Drug User Fee Act IV Information Technology Plan AGENCY: Food and Drug Administration, HHS. ACTION... information technology (IT) plan entitled ``PDUFA IV Information Technology Plan'' (updated plan) to achieve... Information Technology Plan.'' This plan will meet one of the performance goals agreed to under the 2007...

  13. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Science.gov (United States)

    2013-11-27

    ... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

  14. 75 FR 49946 - National Drug Intelligence Center: Agency Information Collection Activities: Proposed Extension...

    Science.gov (United States)

    2010-08-16

    ... DEPARTMENT OF JUSTICE [OMB Number 1105-0087] National Drug Intelligence Center: Agency Information...), National Drug Intelligence Center (NDIC), will be submitting the following information collection request... Kevin M. Walker, General Counsel, National Drug Intelligence Center, Fifth Floor, 319 Washington Street...

  15. 75 FR 12756 - Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug...

    Science.gov (United States)

    2010-03-17

    ... Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... drug advertisements. DATES: Submit written or electronic comments on the collection of information by... approval from the Office of Management and Budget (OMB) for each collection of information they conduct or...

  16. 77 FR 74827 - Working Group on Access to Information on Prescription Drug Container Labels

    Science.gov (United States)

    2012-12-18

    ... on Prescription Drug Container Labels AGENCY: Architectural and Transportation Barriers Compliance... information on prescription drug container labels accessible to people who are blind or visually impaired. The... stakeholder working group to develop best practices for making information on prescription drug container...

  17. Generic Drugs: Questions and Answers

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

  18. Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada

    Directory of Open Access Journals (Sweden)

    Thamir M. Alshammari

    2017-12-01

    Full Text Available The safety information on drug labels of a company marketing the same drugs in different countries is sometimes different. The aim of the present study is to understand the differences in the volume and content of safety information on the drug labels from the same manufacturers in three developed countries: the United States of America (USA, the United Kingdom (UK and Canada. This study involved the calculation of the proportion of total safety information (PSI and of contraindications (PCI in comparison to all information on the label and the percentage of boxed warnings (PBW among the 100 labels studied from each country. The PSI on the labels of different countries is different with USA labels bearing lesser value PSI and UK labels bearing higher value PSI. The qualitative information provided on these drug labels from each country in ‘contraindications’ sections, ‘boxed/serious warnings’ and ‘overdosage’ sections presented differences in the information provided on most of the labels. We have found distinct differences between the safety information available on drug labels in terms of volume and content. We conclude that the safety information for the same products should be standardised across all countries.

  19. Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

    Science.gov (United States)

    Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani

    2018-01-01

    The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.

  20. Patient centric drug product design in modern drug delivery as an opportunity to increase safety and effectiveness.

    Science.gov (United States)

    Stegemann, Sven

    2018-06-01

    The advances in drug delivery technologies have enabled pharmaceutical scientists to deliver a drug through various administration routes and optimize the drug release and absorption. The wide range of drug delivery systems and dosage forms represent a toolbox of technology for the development of pharmaceutical drug products but might also be a source of medication errors and nonadherence. Patient centric drug product development is being suggested as an important factor to increase therapeutic outcomes. Areas covered: Patients have impaired health and potentially disabilities and they are not medical or pharmaceutical experts but are requested to manage complex therapeutic regimens. As such the application of technology should also serve to reduce complexity, build on patients' intuition and ease of use. Patients form distinct populations based on the targeted disease, disease cluster or age group with specific characteristics or therapeutic contexts. Expert opinion: Establishing a target product and patient profile is essential to guide drug product design development. Including the targeted patient populations in the process is a prerequisite to achieve patient-centric pharmaceutical drug product design. Addressing the needs early on in the product design process, will create more universal design, avoiding the necessity for multiple product presentations to cover the different patient populations.

  1. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  2. Thermodynamics of Highly Supersaturated Aqueous Solutions of Poorly Water-Soluble Drugs-Impact of a Second Drug on the Solution Phase Behavior and Implications for Combination Products.

    Science.gov (United States)

    Trasi, Niraj S; Taylor, Lynne S

    2015-08-01

    There is increasing interest in formulating combination products that contain two or more drugs. Furthermore, it is also common for different drug products to be taken simultaneously. This raises the possibility of interactions between different drugs that may impact formulation performance. For poorly water-soluble compounds, the supersaturation behavior may be a critical factor in determining the extent of oral absorption. The goal of the current study was to evaluate the maximum achievable supersaturation for several poorly water-soluble compounds alone, and in combination. Model compounds included ritonavir, lopinavir, paclitaxel, felodipine, and diclofenac. The "amorphous solubility" for the pure drugs was determined using different techniques and the change in this solubility was then measured in the presence of differing amounts of a second drug. The results showed that "amorphous solubility" of each component in aqueous solution is substantially decreased by the second component, as long as the two drugs are miscible in the amorphous state. A simple thermodynamic model could be used to predict the changes in solubility as a function of composition. This information is of great value when developing co-amorphous or other supersaturating formulations and should contribute to a broader understanding of drug-drug physicochemical interactions in in vitro assays as well as in the gastrointestinal tract. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  3. Information delivery manuals to integrate building product information into design

    DEFF Research Database (Denmark)

    Berard, Ole Bengt; Karlshøj, Jan

    2013-01-01

    Despite continuing BIM progress, professionals in the AEC industry often lack the information they need to perform their work. Although this problem could be alleviated by information systems similar to those in other industries, companies struggle to model processes and information needs....... Traditional business process modeling languages often fail to completely cover all four perspectives. BuildingSMART has proposed Information Delivery Manuals (IDMs) to model and re-engineer processes that address the four perspectives through a collaborative methodology in order to standardize and implement...... in the manner necessary to develop information systems that support digital collaboration, workflows, and information exchange. Processes for information systems can be described from four perspectives: task sequence, information need, organizational interaction, and required logic for the specific task...

  4. Physicians' Perception of Teratogenic Risk and Confidence in Prescribing Drugs in Pregnancy-Influence of Norwegian Drug Information Centers.

    Science.gov (United States)

    Bakkebø, Tina; Widnes, Sofia Frost; Aamlid, Synnøve Stubmo; Schjøtt, Jan

    2016-05-01

    Clinical decision support provided by drug information centers is an intervention that can ensure rational drug therapy for pregnant women. We have examined whether physicians' teratogenic risk perceptions and confidence in prescribing drugs to pregnant women is altered after advice from the Norwegian drug information centers, Regional Medicines and Pharmacovigilance Centres i Norway (RELIS). Physicians who consulted RELIS for advice on patient-specific drug use in pregnancy from November 2013 to April 2014 completed questionnaires before and after receiving the advice. A scale from 1 to 7 was used to rate confidence in prescribing and perception of teratogenic risk. The lower part of the scale represented a low perception of teratogenic risk and a high confidence in prescribing a drug in pregnancy. The data were analyzed using a mixed linear model. A total of 45 physicians participated in the study and they assessed 64 drugs or categories of drugs. Advice from RELIS increased confidence in prescribing, with a statistically significant mean change on the scale from 4.1 to 2.9. The assessment of teratogenic risk was reduced after advice from RELIS, with a mean change from 3.2 to 2.5, though this was not significant. A subgroup of 26 physicians completed questionnaires both before and after advice from RELIS and assessed a total of 32 drugs or categories of drugs. In 94% of these assessments, advice from RELIS altered the physician's confidence in prescribing. Perception of teratogenic risk was altered in 78% of the assessments. Our results show that physicians' perception of teratogenic risk and confidence in prescribing drugs to pregnant women is influenced by advice from Norwegian drug information centers. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  5. Drug-Target Interaction Prediction through Label Propagation with Linear Neighborhood Information.

    Science.gov (United States)

    Zhang, Wen; Chen, Yanlin; Li, Dingfang

    2017-11-25

    Interactions between drugs and target proteins provide important information for the drug discovery. Currently, experiments identified only a small number of drug-target interactions. Therefore, the development of computational methods for drug-target interaction prediction is an urgent task of theoretical interest and practical significance. In this paper, we propose a label propagation method with linear neighborhood information (LPLNI) for predicting unobserved drug-target interactions. Firstly, we calculate drug-drug linear neighborhood similarity in the feature spaces, by considering how to reconstruct data points from neighbors. Then, we take similarities as the manifold of drugs, and assume the manifold unchanged in the interaction space. At last, we predict unobserved interactions between known drugs and targets by using drug-drug linear neighborhood similarity and known drug-target interactions. The experiments show that LPLNI can utilize only known drug-target interactions to make high-accuracy predictions on four benchmark datasets. Furthermore, we consider incorporating chemical structures into LPLNI models. Experimental results demonstrate that the model with integrated information (LPLNI-II) can produce improved performances, better than other state-of-the-art methods. The known drug-target interactions are an important information source for computational predictions. The usefulness of the proposed method is demonstrated by cross validation and the case study.

  6. A network integration approach for drug-target interaction prediction and computational drug repositioning from heterogeneous information.

    Science.gov (United States)

    Luo, Yunan; Zhao, Xinbin; Zhou, Jingtian; Yang, Jinglin; Zhang, Yanqing; Kuang, Wenhua; Peng, Jian; Chen, Ligong; Zeng, Jianyang

    2017-09-18

    The emergence of large-scale genomic, chemical and pharmacological data provides new opportunities for drug discovery and repositioning. In this work, we develop a computational pipeline, called DTINet, to predict novel drug-target interactions from a constructed heterogeneous network, which integrates diverse drug-related information. DTINet focuses on learning a low-dimensional vector representation of features, which accurately explains the topological properties of individual nodes in the heterogeneous network, and then makes prediction based on these representations via a vector space projection scheme. DTINet achieves substantial performance improvement over other state-of-the-art methods for drug-target interaction prediction. Moreover, we experimentally validate the novel interactions between three drugs and the cyclooxygenase proteins predicted by DTINet, and demonstrate the new potential applications of these identified cyclooxygenase inhibitors in preventing inflammatory diseases. These results indicate that DTINet can provide a practically useful tool for integrating heterogeneous information to predict new drug-target interactions and repurpose existing drugs.Network-based data integration for drug-target prediction is a promising avenue for drug repositioning, but performance is wanting. Here, the authors introduce DTINet, whose performance is enhanced in the face of noisy, incomplete and high-dimensional biological data by learning low-dimensional vector representations.

  7. Marketing Information Products and Services : A Primer for ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Marketing Information Products and Services : A Primer for Librarians and Information Professionals. Couverture du livre Marketing Information Products and Services : A Primer for Librarians and Information Professionals. Directeur(s) : Abhinandan K. Jain, Ashok Jambhekar, T.P.Rama Rao et S. Sreenivas Rao. Maison(s) ...

  8. Benefit and risk information in prescription drug advertising: review of empirical studies and marketing implications.

    Science.gov (United States)

    Kopp, S W; Bang, H K

    2000-01-01

    As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.

  9. Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

    Science.gov (United States)

    Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

    2015-01-01

    At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

  10. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... those not stored at the inspected establishment, must be legible, stored to prevent deterioration or...

  11. 78 FR 23273 - Determination That the OXYCONTIN (Oxycodone Hydrochloride) Drug Products Covered by New Drug...

    Science.gov (United States)

    2013-04-18

    ... mitigation strategy (REMS) http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor... Blueprint for Prescriber Education for Extended- Release and Long-Acting Opioid Analgesics'' ( http://www...

  12. Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

    Science.gov (United States)

    Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

    2018-03-01

    Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

  13. CMS Drug Spending

    Data.gov (United States)

    U.S. Department of Health & Human Services — CMS has released several information products that provide spending information for prescription drugs in the Medicare and Medicaid programs. The CMS Drug Spending...

  14. 76 FR 34086 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information...

    Science.gov (United States)

    2011-06-10

    ... Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing AGENCY: Substance Abuse and Mental... may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (oral fluid...

  15. The availability of reliable information about medicines in Serbia for health professionals summary of product characteristics

    Directory of Open Access Journals (Sweden)

    Đukić Ljiljana C.

    2015-01-01

    Full Text Available Introduction Today, there are many drugs for the treatment of a large number of indicator areas. Significant financial resources are invested in research with the aim of introducing reliable therapeutics to therapy. Therefore, it is necessary to provide health care professionals exact information about new therapies. The overall process of scientific data, ideas and information exchange is possible through numerous communications of modern IT tools. Methodology According to the Law, key information on registered drug is included in the Summary of Product Characteristics (SPC for health professionals, which is harmonized with EU directives and regulations (SmPC.Protocol content and structure of the information provided in SPC is determined in the guidelines of the EU, therefore, a unique set of data is established for all the drugs registered in Serbia. Topic This paper presents the key segments of SPC, with special reference to the description of the regulations that are required for data related to indications, mechanism of action, dosage, contraindications, side effects, interactions and other important information regarding the profile of the drug, which are standardized and harmonized with the structure of identical documents which operate at the EU level, or EMEA. Conclusions SPC is the regulatory determined technical document on medicinal products in the RS in which there are listed scientifically proven, clinical and pharmacological data and information on the profile of the drug, which are essential for health professionals - doctors and pharmacists in the implementation of pharmacotherapy in our society. This document is the starting point for the development of applied Pharmacoinformatics and it includes a range of activities important for the development of appropriate manuals and makes available data and information for monitoring indicators of the national policy on drugs and modern effective drugs treatment.

  16. Evaluation of Information Contained in Drug Advertisement and ...

    African Journals Online (AJOL)

    This was a descriptive study based on critical appraisal of drug promotional brochures and leaflets. ..... behavior of doctors in a teaching hospital in Ibadan,. Nigeria. ... Guide. Edinburgh, Churchills Living stone, 1999: 111–116. 12. Buck ML.

  17. Adoption of Dynamic Product Information: An Empirical Investigation of Supporting Purchase Decisions on Product Bundles

    OpenAIRE

    Maass, Wolfgang; Kowatsch, Tobias

    2008-01-01

    Up until now, brick-and-mortar stores provide consumers with static product information in the form of printed product labels. This kind of product information does neither adapt to consumer needs nor facilitates new business models (e.g. consumer experience or ad hoc product bundling by products itself). By contrast, dynamic product information provided by mobile recommendation agents (MRA) may leverage these limitations. In this article we formulate a Simplified Consumer Choice (SCC) model ...

  18. Evolving Product Information in Aligning Product Development Decisions across Disciplines

    NARCIS (Netherlands)

    Oude Luttikhuis, Ellen; de Lange, Jos; Lutters, Diederick; ten Klooster, Roland

    2015-01-01

    Today's product development is fragmented across various disciplines all with their own fields of expertise. Maintaining overview in consequences and implications of decisions is difficult, since many stakeholders are involved. To optimise the product development, many methods are developed based on

  19. Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor.

    Science.gov (United States)

    Gupta, Neeraj; Hanley, Michael J; Diderichsen, Paul M; Yang, Huyuan; Ke, Alice; Teng, Zhaoyang; Labotka, Richard; Berg, Deborah; Patel, Chirag; Liu, Guohui; van de Velde, Helgi; Venkatakrishnan, Karthik

    2018-02-15

    Model-informed drug development (MIDD) was central to the development of the oral proteasome inhibitor ixazomib, facilitating internal decisions (switch from body surface area (BSA)-based to fixed dosing, inclusive phase III trials, portfolio prioritization of ixazomib-based combinations, phase III dose for maintenance treatment), regulatory review (model-informed QT analysis, benefit-risk of 4 mg dose), and product labeling (absolute bioavailability and intrinsic/extrinsic factors). This review discusses the impact of MIDD in enabling patient-centric therapeutic optimization during the development of ixazomib. © 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  20. An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.

    Science.gov (United States)

    Morar-Mitrica, Sorina; Adams, Monica L; Crotts, George; Wurth, Christine; Ihnat, Peter M; Tabish, Tanvir; Antochshuk, Valentyn; DiLuzio, Willow; Dix, Daniel B; Fernandez, Jason E; Gupta, Kapil; Fleming, Michael S; He, Bing; Kranz, James K; Liu, Dingjiang; Narasimhan, Chakravarthy; Routhier, Eric; Taylor, Katherine D; Truong, Nobel; Stokes, Elaine S E

    2018-02-01

    The Biophorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals. To gain a better understanding of current industry approaches for establishing biopharmaceutical drug product (DP) robustness, the BPDG-Formulation Point Share group conducted an intercompany collaboration exercise, which included a bench-marking survey and extensive group discussions around the scope, design, and execution of robustness studies. The results of this industry collaboration revealed several key common themes: (1) overall DP robustness is defined by both the formulation and the manufacturing process robustness; (2) robustness integrates the principles of quality by design (QbD); (3) DP robustness is an important factor in setting critical quality attribute control strategies and commercial specifications; (4) most companies employ robustness studies, along with prior knowledge, risk assessments, and statistics, to develop the DP design space; (5) studies are tailored to commercial development needs and the practices of each company. Three case studies further illustrate how a robustness study design for a biopharmaceutical DP balances experimental complexity, statistical power, scientific understanding, and risk assessment to provide the desired product and process knowledge. The BPDG-Formulation Point Share discusses identified industry challenges with regard to biopharmaceutical DP robustness and presents some recommendations for best practices. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  1. Sears Home Improvement Products, Inc. Information Sheet

    Science.gov (United States)

    Sears Home Improvement Products, Inc. (the Company) is located in Longwood, Florida. The case involves renovation activities conducted at property constructed prior to 1978, located in cities across Minnesota, Wisconsin, California, Georgia, Nevada.

  2. Quality by design case study: an integrated multivariate approach to drug product and process development.

    Science.gov (United States)

    Huang, Jun; Kaul, Goldi; Cai, Chunsheng; Chatlapalli, Ramarao; Hernandez-Abad, Pedro; Ghosh, Krishnendu; Nagi, Arwinder

    2009-12-01

    To facilitate an in-depth process understanding, and offer opportunities for developing control strategies to ensure product quality, a combination of experimental design, optimization and multivariate techniques was integrated into the process development of a drug product. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Two types of analyses were performed to extract maximal information, DOE effect & response surface analysis and multivariate analysis (PCA and PLS). The DOE effect analysis was used to evaluate the interactions and effects of three design factors (water amount, wet massing time and lubrication time), on response variables (blend flow, compressibility and tablet dissolution). The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. Multivariate analysis of all variables from the DOE batches was conducted to study relationships between the variables and to evaluate the impact of material attributes/process parameters on manufacturability and final product CQAs. The integrated multivariate approach exemplifies application of QbD principles and tools to drug product and process development.

  3. Application of Geographic Information System (GIS) in Drug Logistics Management Information System (LMIS) at District Level in Malawi: Opportunities and Challenges

    Science.gov (United States)

    Chikumba, Patrick Albert

    District pharmacies in Malawi use a computerised IS to monitor the flow of products from a warehouse to health service delivery points and determine understocked or overstocked products at each health facility. Currently, all drug LMIS reports are in tabular forms. The GIS can help health and drug logistics officers to get additional spatial information, such as locations of health facilities and environmental factors, to the existing reports in the form of maps. This paper highlights some opportunities and challenges of applying the GIS in the drug LMIS, which basically involve technologies, organisation, and standards and data integration. It has been found that this idea is very good but it requires much effort, commitment and resources for successful implementation.

  4. 21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers. 200.200 Section 200.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing §...

  5. Productivity results of nuclear information systems

    International Nuclear Information System (INIS)

    Groves, J.E.

    1988-01-01

    The information necessary to manage a nuclear generation station and multiple stations is greater today than ever before. The management of the processes necessary to develop information from data requires professional management and a programmatic approach. The cost is not insignificant. But the cost of not facing this challenge squarely is greater. The San Onofre Nuclear Generation Plant has developed the Nuclear Information Services function to assist management and professionals at all levels with their information needs. Often, this is merely giving them the tools they need to do it themselves. Herein contains a selection of specific examples that urges officer and senior level management to review the concept of the Nuclear Information Services function in more depth to determine the appropriateness of such an approach within their organizations. The establishment of on line computerized systems for the majority of the work flow processes and administrative process has resulted in an estimate 190 less people needed. The Health Physics Automated Access Control System (AACS) implementation resulted in a savings of $800,000 a year. The implementation of a Site Procedures Information Network (SPIN) has saved $160,000 per year

  6. Forecasting Aggregate Productivity using Information from Firm-level Data

    NARCIS (Netherlands)

    Bartelsman, E.J.; Wolf, Z.

    2014-01-01

    In this paper, we explore whether information from firm-level data can improve forecasts of aggregate productivity growth. We generate firm-level productivity measures and aggregate them into time-series components that capture within-firm productivity and the productivity contribution of

  7. 21 CFR 335.50 - Labeling of antidiarrheal drug products.

    Science.gov (United States)

    2010-04-01

    ... problem”. (iii) “Ask a doctor or pharmacist before use if you are taking any drug for [bullet... Section 335.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... identified in § 335.10. (i) “Do not use if you have [bullet] bloody or black stool”. (ii) “Ask a doctor...

  8. Method s for Measuring Productivity in Libraries and Information Centres

    OpenAIRE

    Mohammad Alaaei

    2009-01-01

      Within Information centers, productivity is the result of optimal and effective use of information resources, service quality improvement, increased user satisfaction, pleasantness of working environment, increased motivation and enthusiasm of staff to work better. All contribute to the growth and development of information centers. Thus these centers would need to be familiar with methods employed in productivity measurement. Productivity is one of the criteria for evaluating system perfor...

  9. 3rd International Symposium on Innovative Management, Information and Production

    CERN Document Server

    Xu, Bing; Wu, Berlin

    2014-01-01

    Innovative Management in Information and Production is based on the proceedings of the Third International Symposium on Innovative Managemet, Information and Production. This symposium is held by International Society of Management Engineers. The symposium took place on October 8-10, in Ho Chi Minh City, Vietnam. This book examines recent innovative management of information and productions such as digital collection management and operations planning, scheduling and control.

  10. The value of information updating in new product development

    CERN Document Server

    Artmann, Christian

    2009-01-01

    This work shows how managing uncertainty in new product development can be improved by conducting an information update during the development process. The book details the comprehensive model needed to perform that information update.

  11. Information sought, information shared: exploring performance and image enhancing drug user-facilitated harm reduction information in online forums.

    Science.gov (United States)

    Tighe, Boden; Dunn, Matthew; McKay, Fiona H; Piatkowski, Timothy

    2017-07-21

    There is good evidence to suggest that performance and image enhancing drug (PIED) use is increasing in Australia and that there is an increase in those using PIEDs who have never used another illicit substance. Peers have always been an important source of information in this group, though the rise of the Internet, and the increased use of Internet forums amongst substance consumers to share harm reduction information, means that PIED users may have access to a large array of views and opinions. The aim of this study was to explore the type of information that PIED users seek and share on these forums. An online search was conducted to identify online forums that discussed PIED use. Three discussion forums were included in this study: aussiegymjunkies.com, bodybuildingforums.com.au, and brotherhoodofpain.com. The primary source of data for this study was the 'threads' from the online forums. Threads were thematically analysed for overall content, leading to the identification of themes. One hundred thirty-four threads and 1716 individual posts from 450 unique avatars were included in this analysis. Two themes were identified: (1) personal experiences and advice and (2) referral to services and referral to the scientific literature. Internet forums are an accessible way for members of the PIED community to seek and share information to reduce the harms associated with PIED use. Forum members show concern for both their own and others' use and, where they lack information, will recommend seeking information from medical professionals. Anecdotal evidence is given high credence though the findings from the scientific literature are used to support opinions. The engagement of health professionals within forums could prove a useful strategy for engaging with this population to provide harm reduction interventions, particularly as forum members are clearly seeking further reliable information, and peers may act as a conduit between users and the health and medical

  12. Intelligent Information Systems for Web Product Search

    NARCIS (Netherlands)

    D. Vandic (Damir)

    2017-01-01

    markdownabstractOver the last few years, we have experienced an increase in online shopping. Consequently, there is a need for efficient and effective product search engines. The rapid growth of e-commerce, however, has also introduced some challenges. Studies show that users can get overwhelmed by

  13. Exploiting Large-Scale Drug-Protein Interaction Information for Computational Drug Repurposing

    Science.gov (United States)

    2014-06-20

    studies that have reported antimalarial activities of azole compounds [39-43] lend support to our model predictions. The highest-scored non-malarial...Table 4, verapamil and cimetidine, do not have antimal- arial activities themselves but exhibit synergism when used in combination with antimalarial ... activators . Because of their high frequencies among the antimalarial drugs, according to Eq. 3, the drug-protein interactions contributing most to the

  14. Pregnancy and lactation advice: How does Australian Product Information compare with established information resources?

    Science.gov (United States)

    Brown, Emma; Hotham, Elizabeth; Hotham, Neil

    2016-09-01

    Product information is a popular medicines information resource; however, there is some evidence that its pregnancy and lactation information is overconservative, which can lead to inadequate treatment of pregnant and lactating women. A thorough analysis of pregnancy and lactation information within Australian Product Information and Consumer Medicines Information was performed. The statements within these resources were compared with established clinical resources: Australian Medicines Handbook, Therapeutic Guidelines, South Australian Perinatal Practice Guidelines, Organization of Teratology Information Specialists, LactMed, Motherisk and the Pregnancy and Breastfeeding Medicines Guide published by the Royal Women's Hospital Melbourne. Product Information was found to be the most cautious resource, with 44.5% of pregnancy recommendations and 69% of lactation recommendations reviewed being more conservative than other resources. Product Information is an imperfect and often overconservative reference for pregnant and lactating women. Health professionals are urged to review established clinical resources to inform decision making.

  15. Drug Use and Abuse: Background Information for Security Personnel

    Science.gov (United States)

    1994-05-01

    Neurotoxicity of methamphetamine : Mechanisms of action and issues related to aging. In Miller, M. A., & Kozel, N. J., (Eds.), op. cit. 99. Cox et al...lives. This presents a dilemma for clearance adjudicators. If clearance standards are too lax, security may not be protected . If standards are too...strict, many well-adjusted, adventuresome, and creative employees may be screened out. Drug use may weaken judgment and affect ability to protect

  16. Protein Complex Production from the Drug Discovery Standpoint.

    Science.gov (United States)

    Moarefi, Ismail

    2016-01-01

    Small molecule drug discovery critically depends on the availability of meaningful in vitro assays to guide medicinal chemistry programs that are aimed at optimizing drug potency and selectivity. As it becomes increasingly evident, most disease relevant drug targets do not act as a single protein. In the body, they are instead generally found in complex with protein cofactors that are highly relevant for their correct function and regulation. This review highlights selected examples of the increasing trend to use biologically relevant protein complexes for rational drug discovery to reduce costly late phase attritions due to lack of efficacy or toxicity.

  17. International benchmaking: Supplying the information for product efficiency policy makers

    NARCIS (Netherlands)

    Siderius, H.P.; Jeffcott, S.; Blok, K.

    2012-01-01

    In the development of effective product efficiency policy, the critical element for policy makers is comprehensive, independent information. However, easily accessible, reliable information on the energy performance of products and policies is often scarce within a particular market, and rarer still

  18. ROLE OF INFORMATION PHARMACEUTICAL MARKET IN PROVIDING TRAFFIC CONTROL DRUG

    Directory of Open Access Journals (Sweden)

    O. S. Solovjov

    2014-01-01

    Full Text Available The controversial questions of the pharmaceutical market informatization are considered. The main principles and legal frameworks to manage population ensure with medicines based on use of information technology are proposed. The logic and conception framework of related information automatization for hospitals and population under the current legislation are discussed.

  19. Drug pricing and reimbursement information management: processes and decision making in the global economy.

    Science.gov (United States)

    Tsourougiannis, Dimitrios

    2017-01-01

    Background : Cost-containment initiatives are re-shaping the pharmaceutical business environment and affecting market access as well as pricing and reimbursement decisions. Effective price management procedures are too complex to accomplish manually. Prior to February 2013, price management within Astellas Pharma Europe Ltd was done manually using an Excel database. The system was labour intensive, slow to update, and prone to error. An innovative web-based pricing information management system was developed to address the shortcomings of the previous system. Development : A secure web-based system for submitting, reviewing and approving pricing requests was designed to: track all pricing applications and approval status; update approved pricing information automatically; provide fixed and customizable reports of pricing information; collect pricing and reimbursement rules from each country; validate pricing and reimbursement rules monthly. Several sequential phases of development emphasized planning, time schedules, target dates, budgets and implementation of the entire system. A test system was used to pilot the electronic (e)-pricing system with three affiliates (four users) in February 2013. Outcomes : The web-based system was introduced in March 2013, currently has about 227 active users globally and comprises more than 1000 presentations of 150 products. The overall benefits of switching from a manual to an e-pricing system were immediate and highly visible in terms of efficiency, transparency, reliability and compliance. Conclusions : The e-pricing system has improved the efficiency, reliability, compliance, transparency and ease of access to multinational drug pricing and approval information.

  20. Transporter-mediated natural product-drug interactions for the treatment of cardiovascular diseases.

    Science.gov (United States)

    Zha, Weibin

    2018-04-01

    The growing use of natural products in cardiovascular (CV) patients has been greatly raising the concerns about potential natural product-CV drug interactions. Some of these may lead to unexpected cardiovascular adverse effects and it is, therefore, essential to identify or predict potential natural product-CV drug interactions, and to understand the underlying mechanisms. Drug transporters are important determinants for the pharmacokinetics of drugs and alterations of drug transport has been recognized as one of the major causes of natural product-drug interactions. In last two decades, many CV drugs (e.g., angiotensin II receptor blockers, beta-blockers and statins) have been identified to be substrates and inhibitors of the solute carrier (SLC) transporters and the ATP-binding cassette (ABC) transporters, which are two major transporter superfamilies. Meanwhile, in vitro and in vivo studies indicate that a growing number of natural products showed cardioprotective effects (e.g., gingko biloba, danshen and their active ingredients) are also substrates and inhibitors of drug transporters. Thus, to understand transporter-mediated natural product-CV drug interactions is important and some transporter-mediated interactions have already shown to have clinical relevance. In this review, we review the current knowledge on the role of ABC and SLC transporters in CV therapy, as well as transporter modulation by natural products used in CV diseases and their induced natural product-CV drug interactions through alterations of drug transport. We hope our review will aid in a comprehensive summary of transporter-mediated natural product-CV drug interactions and help public and physicians understand these type of interactions. Copyright © 2017. Published by Elsevier B.V.

  1. Inventory control with product returns : The impact of imperfect information

    NARCIS (Netherlands)

    De Brito, M.P.; Laan, E.A.

    2009-01-01

    Product returns are characterized by considerable uncertainty on time and quantity. In the literature on inventory management for product return environments best forecasts of future returns are associated with methods that use the most information regarding product return history. In practice,

  2. Multi drug resistance and β-lactamase production by Klebsiella ...

    African Journals Online (AJOL)

    SERVER

    2007-08-06

    Aug 6, 2007 ... *Corresponding author. E-mail: gnsimha123@rediffmail.com. (Rice, 1999). plasmid that can be easily spread from one organisms to another (Sirot, 1995) these enzymes are capable of inactivating a variety of β-lactam drugs (Rice,. 1999). The ESBL producing organisms often show multi- drug resistant as ...

  3. 21 CFR 341.74 - Labeling of antitussive drug products.

    Science.gov (United States)

    2010-04-01

    ... directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you... Section 341.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES..., consult a doctor.” (2) For oral and topical antitussives labeled for adults or for adults and children...

  4. Effects of emotional tone and visual complexity on processing health information in prescription drug advertising.

    Science.gov (United States)

    Norris, Rebecca L; Bailey, Rachel L; Bolls, Paul D; Wise, Kevin R

    2012-01-01

    This experiment explored how the emotional tone and visual complexity of direct-to-consumer (DTC) drug advertisements affect the encoding and storage of specific risk and benefit statements about each of the drugs in question. Results are interpreted under the limited capacity model of motivated mediated message processing framework. Findings suggest that DTC drug ads should be pleasantly toned and high in visual complexity in order to maximize encoding and storage of risk and benefit information.

  5. The Effects of the Application of Production Information Systems

    Directory of Open Access Journals (Sweden)

    Dusanka Lecic

    2014-02-01

    Full Text Available The authors show you in this paper definition and functions of information systems, information systems development methodologies and stages of development. Also, the authors will show the effects of the application of production information systems. Authors also include SWOT analysis in which show the influence of the external and internal environment on the implementation of IS in business.

  6. Statin Drugs Markedly Inhibit Testosterone Production by Rat Leydig Cells In Vitro: Implications for Men

    Science.gov (United States)

    Statin drugs lower blood cholesterol by inhibiting hepatic 3-hydroxy-3-methylglutaryl-Coenzyme-A reductase. During drug development it was shown that statins inhibit production of cholesterol in the testis. We evaluated testosterone production in vitro, using highly purified rat ...

  7. 21 CFR 349.65 - Labeling of ophthalmic emollient drug products.

    Science.gov (United States)

    2010-04-01

    ... product contains the established name of the drug(s), if any, and identifies the product as a “lubricant... the eye or to exposure to wind or sun.” (3) “For use as a protectant against further irritation or to...

  8. 21 CFR 349.60 - Labeling of ophthalmic demulcent drug products.

    Science.gov (United States)

    2010-04-01

    ... product contains the established name of the drug(s), if any, and identifies the product as a “lubricant... exposure to wind or sun.” (3) “For use as a protectant against further irritation or to relieve dryness of...

  9. National Clearinghouse for Drug Abuse Information Selected Reference Series, Series 4, No. 1.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHEW/PHS), Rockville, MD. National Clearinghouse for Drug Abuse Information.

    This bibliography, which attempts to gather the significant research on the reproductive effects of the drugs of abuse, is one in a series prepared by the National Clearinghouse for Drug Abuse Information on subjects of topical interest. Selection of literature is based on its currency, its significance in the field, and its availability in local…

  10. Trust in online prescription drug information among internet users: the impact on information search behavior after exposure to direct-to-consumer advertising.

    Science.gov (United States)

    Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew; Zinkhan, George M

    2002-01-01

    The proliferation of both manufacturer-controlled and independent medication-related websites has aroused concern among consumers and policy-makers concerning the trustworthiness of Web-based drug information. The authors examine consumers' trust in on-line prescription drug information and its influence on information search behavior. The study design involves a retrospective analysis of data from a 1998 national survey. The findings reveal that trust in drug information from traditional media sources such as television and newspapers transfers to the domain of the Internet. Furthermore, a greater trust in on-line prescription drug information stimulates utilization of the Internet for information search after exposure to prescription drug advertising.

  11. Myasthenia Gravis Medication Information Card (Drugs to be Avoided or Used with Caution in Myasthenia Gravis)

    Science.gov (United States)

    MYASTHENIA GRAVIS MEDICATION INFORMATION CARD Drugs to be Avoided or Used with Caution in MG My Name _______________________________________________ ... the MGFA web site; reference document “Medications and Myasthenia Gravis (A Reference for Health Care Professionals.” www. ...

  12. Communicating efficacy information based on composite scores in direct-to-consumer prescription drug advertising.

    Science.gov (United States)

    Williams, Pamela A; O'Donoghue, Amie C; Sullivan, Helen W; Willoughby, Jessica Fitts; Squire, Claudia; Parvanta, Sarah; Betts, Kevin R

    2016-04-01

    Drug efficacy can be measured by composite scores, which consist of two or more symptoms or other clinical components of a disease. We evaluated how individuals interpret composite scores in direct-to-consumer (DTC) prescription drug advertising. We conducted an experimental study of seasonal allergy sufferers (n=1967) who viewed a fictitious print DTC ad that varied by the type of information featured (general indication, list of symptoms, or definition of composite scores) and the presence or absence of an educational intervention about composite scores. We measured composite score recognition and comprehension, and perceived drug efficacy and risk. Ads that featured either (1) the composite score definition alone or (2) the list of symptoms or general indication information along with the educational intervention improved composite score comprehension. Ads that included the composite score definition or the educational intervention led to lower confidence in the drug's benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions. Adding composite score information to DTC print ads may improve individuals' comprehension of composite scores and affect their perceptions of the drug. Providing composite score information may lead to more informed patient-provider prescription drug decisions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  13. Curriculum and instructional methods for drug information, literature evaluation, and biostatistics: survey of US pharmacy schools.

    Science.gov (United States)

    Phillips, Jennifer A; Gabay, Michael P; Ficzere, Cathy; Ward, Kristina E

    2012-06-01

    The drug information curriculum in US colleges of pharmacy continues to evolve. The American College of Clinical Pharmacy (ACCP) Drug Information Practice and Research Network (DI PRN) published an opinion paper with specific recommendations regarding drug information education in 2009. Adoption of these recommendations has not been evaluated. To assess which recommendations made in the ACCP DI PRN opinion paper are included in US pharmacy school curricula and characterize faculty qualifications, educational methods, and recent changes in drug information education. An electronic survey was designed using the ACCP DI PRN opinion paper and the Accreditation Council for Pharmacy Education standards and guidelines for accreditation of PharmD programs in the US. Survey questions addressed curricular content within the following categories: drug information, literature evaluation, and biostatistics. A letter including the online survey link was sent via email to the dean of each US college/school of pharmacy (N = 128). Recipients were instructed to forward the email to the individual at their institution who was the most knowledgeable about the content and methodology used for didactic drug information education. Sixty-four responses were included in the final analysis. Of the 19 ACCP DI PRN minimum core concepts, 9 (47%) were included in curricula of all responding institutions; 14 of 19 (74%) were included in curricula for all but 1 institution. In contrast, 5 of 16 concepts (31%) were not formally taught by a number of institutions. Many respondents noted an increased focus on evidence-based medicine, medication safety, and informatics. Although a survey of drug information curricula documented substantial inclusion of the essential concepts presented in the ACCP DI PRN opinion paper, room for improvement remains in drug information curricula in US colleges of pharmacy.

  14. New Product Development (Npd) Process In Subsidiary: Information Perspectives

    OpenAIRE

    Firmanzah

    2008-01-01

    Information is an important resource for new product development (NPD) process in subsidiary. However, we still lack of research to analyze NPD process from information perspective in subsidiary context. This research is an exploratory research and it exploited 8 cases of NPD process in consumer goods subsidiaries operating in Indonesian market. Three types of information have been identified and analyzed NPD process; global, regional and local information. The result of this research ...

  15. Accuracy of manual entry of drug administration data into an anesthesia information management system.

    Science.gov (United States)

    Avidan, Alexander; Dotan, Koren; Weissman, Charles; Cohen, Matan J; Levin, Phillip D

    2014-11-01

    Data on drug administration are entered manually into anesthesia information management systems (AIMS). This study examined whether these data are accurate regarding drug name, dose administered, and time of administration, and whether the stage of anesthesia influences data accuracy. Real-time observational data on drug administration during elective operations were compared with computerized information on drug administration entered by anesthesiologists. A trained observer (K.D.) performed the observations. Data were collected during 57 operations which included 596 separate occasions of drug administration by 22 anesthesiologists. No AIMS records were found for 90 (15.1%) occasions of drug administration (omissions), while there were 11 (1.8%) AIMS records where drug administration was not observed. The AIMS and observer data matched for drug name on 495 of 596 (83.1%) occasions, for dose on 439 of 495 (92.5%) occasions, and for time on 476 of 495 (96.2%) occasions. Amongst the 90 omitted records, 34 (37.8%) were for vasoactive drugs with 24 (27.7%) for small doses of hypnotics. Omissions occurred mostly during maintenance: 50 of 153 (24.6%), followed by induction: 30 of 325 (9.2%) and emergence: 10 of 57 (17.5%) (P < 0.001). Time and dose inaccuracies occurred mainly during induction, followed by maintenance and emergence; time inaccuracies were 7/325 (8.3%), 10/203 (4.9%), and 0/57 (0%), respectively (P = 0.07), and dose inaccuracies were 15/325 (4.6%), 3/203 (1.5%), and 1/57 (1.7%), respectively (P = 0.11). The range of accuracy varies when anesthesiologists manually enter drug administration data into an AIMS. Charting omissions represent the largest cause of inaccuracy, principally by omissions of records for vasopressors and small doses of hypnotic drugs. Manually entered drug administration data are not without errors. Accuracy of entering drug administration data remains the responsibility of the anesthesiologist.

  16. Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.

    Science.gov (United States)

    2015-07-08

    The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

  17. ORGANIZATION OF INFORMATION INTERACTION OF AIRPORT PRODUCTION PROCESSES

    Directory of Open Access Journals (Sweden)

    Yakov Mikhajlovich Dalinger

    2017-01-01

    Full Text Available The organization of service production attributed to airports activity is analyzed. The importance and the actuality of information interaction problem solution between productive processes as a problem of organization of modern produc- tion are shown.Possibilities and features of information interaction system construction in form of multi-level hierarchical struc- ture have been shown. The airport is considered as an enterprise aimed at service production where it is necessary to analyze much in- formation in a limited time-frame. The production schedule often changes under the influence of many factors. This leads to the increase of the role of computerization and informatization of production processes what predetermines automation of production, creation of information environment and organization of information interaction needed for realization of production processes. The integrated organization form is proposed because it is oriented to the integration of different processes into a universal production system and it allows to conduct the coordination of local goals of particular processes in the context of the global purpose aimed at the improvement of the effectiveness of the airport activity. The main conditions needed for organization of information interaction between production processes and techno- logical operations are considered, and the list of the following problems is determined. The attention is paid to the necessity of compatibility of structure and organization of interaction system in the conditions of the airline and the necessity of be- ing its reflection in the information space of the airline. The usefulness of the intergrated organization form of information interaction based on information exchange between processes and service customers according to the network structure is explained. Multi-level character of this structure confirms its advantage over other items, however it also has a series of features presented

  18. Customized products and cloud service information system development research

    Directory of Open Access Journals (Sweden)

    Hung Chien-Wen

    2017-01-01

    Full Text Available This study presents a cloud service customized product information system to enable businesses to provide customized product marketing on the Internet to meet consumer demand for customized products. The cloud service of the information system development strategic framework proposed in this study contains three elements: (1 e-commerce services, (2 promotion type modules, and (3 cloud services customized promotional products. In this study, a mining cloud information system to detect customer behavior is proposed. The association rules from relational database design are utilized to mine consumer behavior to generate cross-selling proposals for customer products and marketing for a retailing mall in Taiwan. The study is composed of several parts, as follows. A market segment and application of association rules in data exploration techniques (Association Rule Mining and sequence-like exploration (Sequential Pattern Mining, efficient analysis of customers, consumer behavior, identification of candidates for promotional products, and using cloud service delivery and evaluation of targets to evaluate candidates for promotional products for production. However, in addition to cloud service customized promotional products, the quantity of promotional products sales varies for different customers. We strive to achieve increased customer loyalty and profits through the use of active cloud service customized promotional products.

  19. The Impact of Drug Trafficking on Informal Security Actors in Kenya

    Directory of Open Access Journals (Sweden)

    Moritz Schuberth

    2014-01-01

    Full Text Available The Kenyan state is currently under pressure from two sides: First, numerous non-state armed groups have taken over the provision of security in areas where the state is practically absent. Second, drug-trafficking organizations are gaining ground as the country is increasingly being used as a major transit hub for narcotics. This article investigates the relationship between drug trafficking and informal security provision in Kenya and draws analogies from comparable experiences in Latin America and West Africa. Field research in Kenya has demonstrated that profit-oriented, informal security actors in Mombasa work for drug lords, while their counterparts in Nairobi are more likely to be hired by politicians. Moreover, faith-based vigilante groups in both cities appear to be less susceptible to external manipulation by drug traffickers. The article concludes by considering the potential consequences of an expansion of the drug trade in Kenya.

  20. Plants’ Natural Products as Alternative Promising Anti-Candida Drugs

    Science.gov (United States)

    Soliman, Sameh; Alnajdy, Dina; El-Keblawy, Ali A.; Mosa, Kareem A.; Khoder, Ghalia; Noreddin, Ayman M.

    2017-01-01

    Candida is a serious life-threatening pathogen, particularly with immunocompromised patients. Candida infections are considered as a major cause of morbidity and mortality in a broad range of immunocompromised patients. Candida infections are common in hospitalized patients and elderly people. The difficulty to eradicate Candida infections is owing to its unique switch between yeast and hyphae forms and more likely to biofilm formations that render resistance to antifungal therapy. Plants are known sources of natural medicines. Several plants show significant anti-Candida activities and some of them have lower minimum inhibitory concentration, making them promising candidates for anti-Candida therapy. However, none of these plant products is marketed for anti-Candida therapy because of lack of sufficient information about their efficacy, toxicity, and kinetics. This review revises major plants that have been tested for anti-Candida activities with recommendations for further use of some of these plants for more investigation and in vivo testing including the use of nanostructure lipid system. PMID:28989245

  1. Sources of Information as Determinants of Product and Process Innovation.

    Science.gov (United States)

    Gómez, Jaime; Salazar, Idana; Vargas, Pilar

    2016-01-01

    In this paper we use a panel of manufacturing firms in Spain to examine the extent to which they use internal and external sources of information (customers, suppliers, competitors, consultants and universities) to generate product and process innovation. Our results show that, although internal sources are influential, external sources of information are key to achieve innovation performance. These results are in line with the open innovation literature because they show that firms that are opening up their innovation process and that use different information sources have a greater capacity to generate innovations. We also find that the importance of external sources of information varies depending on the type of innovation (product or process) considered. To generate process innovation, firms mainly rely on suppliers while, to generate product innovation, the main contribution is from customers. The potential simultaneity between product and process innovation is also taken into consideration. We find that the generation of both types of innovation is not independent.

  2. Sources of Information as Determinants of Product and Process Innovation.

    Directory of Open Access Journals (Sweden)

    Jaime Gómez

    Full Text Available In this paper we use a panel of manufacturing firms in Spain to examine the extent to which they use internal and external sources of information (customers, suppliers, competitors, consultants and universities to generate product and process innovation. Our results show that, although internal sources are influential, external sources of information are key to achieve innovation performance. These results are in line with the open innovation literature because they show that firms that are opening up their innovation process and that use different information sources have a greater capacity to generate innovations. We also find that the importance of external sources of information varies depending on the type of innovation (product or process considered. To generate process innovation, firms mainly rely on suppliers while, to generate product innovation, the main contribution is from customers. The potential simultaneity between product and process innovation is also taken into consideration. We find that the generation of both types of innovation is not independent.

  3. Sources of Information as Determinants of Product and Process Innovation

    Science.gov (United States)

    2016-01-01

    In this paper we use a panel of manufacturing firms in Spain to examine the extent to which they use internal and external sources of information (customers, suppliers, competitors, consultants and universities) to generate product and process innovation. Our results show that, although internal sources are influential, external sources of information are key to achieve innovation performance. These results are in line with the open innovation literature because they show that firms that are opening up their innovation process and that use different information sources have a greater capacity to generate innovations. We also find that the importance of external sources of information varies depending on the type of innovation (product or process) considered. To generate process innovation, firms mainly rely on suppliers while, to generate product innovation, the main contribution is from customers. The potential simultaneity between product and process innovation is also taken into consideration. We find that the generation of both types of innovation is not independent. PMID:27035456

  4. Drugs@FDA Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  5. Design to Robotic Production for Informed Materialization Processes

    Directory of Open Access Journals (Sweden)

    Sina Mostafavi

    2017-12-01

    Full Text Available Design to Robotic Production (D2RP establishes links between digital design and production in order to achieve informed materialization at an architectural scale. D2RP research is being discussed under the computation, automation and materialization themes, by reference to customizable digital design means, robotic fabrication setups and informed materialization strategies implemented by the Robotic Building group at Hyperbody, TU Delft.

  6. EPD--environmental product declarations for wood products : an application of life cycle information about forest products

    Science.gov (United States)

    Richard Bergman; Adam Taylor

    2011-01-01

    Transparent and credible environmental labeling of products is vital for a sustainable future. Ecolabeling shows information on the environmental performance of products, processes, and services. This article focuses on one type of ecolabeling referred to as environmental product declarations (EPDs) that provide environmental impact information based on life cycle...

  7. Antiviral Information Management System (AIMS): a prototype for operational innovation in drug development.

    Science.gov (United States)

    Jadhav, Pravin R; Neal, Lauren; Florian, Jeff; Chen, Ying; Naeger, Lisa; Robertson, Sarah; Soon, Guoxing; Birnkrant, Debra

    2010-09-01

    This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques.

  8. Leveraging management information in improving call centre productivity

    Directory of Open Access Journals (Sweden)

    Manthisana Mosese

    2016-04-01

    Objectives: This research explored the use of management information and its impact on two fundamental functions namely, improving productivity without compromising the quality of service, in the call centre of a well-known South African fashion retailer, Edcon. Following the implementation of the call centre technology project the research set out to determine how Edcon can transform their call centre to improve productivity and customer service through effective utilisation of their management information. Method: Internal documents and reports were analysed to provide the basis of evaluation between the measures of productivity prior to and post the implementation of a technology project at Edcon’s call centre. Semi-structured in-depth and group interviews were conducted to establish the importance and use of management information in improving productivity and customer service. Results: The results indicated that the availability of management information has indeed contributed to improved efficiency at the Edcon call centre. Although literature claims that there is a correlation between a call centre technology upgrade and improvement in performance, evident in the return on investment being realised within a year or two of implementation, it fell beyond the scope of this study to investigate the return on investment for Edcon’s call centre. Conclusion: Although Edcon has begun realising benefits in improved productivity in their call centre from their available management information, information will continue to play a crucial role in supporting management with informed decisions that will improve the call centre operations. [pdf to follow

  9. Influence of Information Product Quality on Informing Users: A Web Portal Context

    OpenAIRE

    Junghyun Nam

    2016-01-01

    Web portals have been used as information products to deliver personalized, feature-rich, and flexible information needs to Internet users. However, all portals are not equal. Most of them have relatively a small number of visitors, while a few capture the majority of surfers. This study seeks to uncover the factors that contribute the perceived quality of a general portal. Based on 21 factors derived from an extensive literature review on Information Product Quality (IPQ), web usage, and med...

  10. A proposal for a drug information database and text templates for generating package inserts

    Directory of Open Access Journals (Sweden)

    Okuya R

    2013-07-01

    Full Text Available Ryo Okuya,1 Masaomi Kimura,2 Michiko Ohkura,2 Fumito Tsuchiya3 1Graduate School of Engineering and Science, 2Faculty of Engineering, Shibaura Institute of Technology, Tokyo, 3School of Pharmacy, International University of Health and Welfare, Tokyo, Japan Abstract: To prevent prescription errors caused by information systems, a database to store complete and accurate drug information in a user-friendly format is needed. In previous studies, the primary method for obtaining data stored in a database is to extract drug information from package inserts by employing pattern matching or more sophisticated methods such as text mining. However, it is difficult to obtain a complete database because there is no strict rule concerning expressions used to describe drug information in package inserts. The authors' strategy was to first build a database and then automatically generate package inserts by embedding data in the database using templates. To create this database, the support of pharmaceutical companies to input accurate data is required. It is expected that this system will work, because these companies can earn merit for newly developed drugs to decrease the effort to create package inserts from scratch. This study designed the table schemata for the database and text templates to generate the package inserts. To handle the variety of drug-specific information in the package inserts, this information in drug composition descriptions was replaced with labels and the replacement descriptions utilizing cluster analysis were analyzed. To improve the method by which frequently repeated ingredient information and/or supplementary information are stored, the method was modified by introducing repeat tags in the templates to indicate repetition and improving the insertion of data into the database. The validity of this method was confirmed by inputting the drug information described in existing package inserts and checking that the method could

  11. Fisher-Renyi entropy product and information plane

    International Nuclear Information System (INIS)

    Romera, E.; Nagy, A.

    2008-01-01

    Connection between Fisher information and Renyi entropy has been established. This link allows us to define the Fisher-Renyi information plane and an entropic product in terms of these quantities. New Renyi uncertainty relations are obtained for single particle densities of many particle systems in position-momentum conjugate spaces

  12. Use of anonymous Web communities and websites by medical consumers in Japan to research drug information.

    Science.gov (United States)

    Kishimoto, Keiko; Fukushima, Noriko

    2011-01-01

    In this study, we investigated the status of researching drug information online, and the type of Internet user who uses anonymous Web communities and websites. A Web-based cross-sectional survey of 10875 male and female Internet users aged 16 and over was conducted in March 2010. Of 10282 analyzed respondents, excluding medical professionals, about 47% reported that they had previously searched the Internet for drug information and had used online resources ranging from drug information search engines and pharmaceutical industry websites to social networking sites and Twitter. Respondents who had researched drug information online (n=4861) were analyzed by two multivariable logistic regressions. In Model 1, the use of anonymous websites associated with age (OR, 0.778; 95% CI, 0.742-0.816), referring to the reputation and the narrative of other Internet users on shopping (OR, 1.640; 95% CI, 1.450-1.855), taking a prescription drug (OR, 0.806; 95% CI, 0.705-0.922), and frequent consulting with non-professionals about medical care and health (OR, 1.613; 95% CI, 1.396-1.865). In Model 2, use of only anonymous websites was associated with age (OR, 0.753; 95% CI, 0.705-0.805), using the Internet daily (OR, 0.611; 95% CI, 0.462-0.808), taking a prescription drug (OR, 0.614; 95% CI, 0.505-0.747), and experience a side effect (OR, 0.526; 95% CI, 0.421-0.658). The analysis revealed the profiles of Internet users who researched drug information on social media sites where the information providers are anonymous and do not necessarily have adequate knowledge of medicine and online information literacy.

  13. Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services.

    Science.gov (United States)

    Schaefer, Christof

    2011-03-01

    Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology. © 2011 The Author. Congenital Anomalies © 2011 Japanese Teratology Society.

  14. Opinion On Drug Information Services Provided In A Multi- Specialty Teaching Hospital

    Directory of Open Access Journals (Sweden)

    Vijayakumar TM, Poovi G & Dhanaraju MD

    2011-05-01

    Full Text Available Objective: To evaluate the various drug information queriesreceived, and to access the drug information services providedby the pharmacy practice department.Method: Drug information queries received during wardrounds, direct communication, telephone or internet etc. weredocumented in the drug information request anddocumentation forms prepared by the department over theperiod of January 2010 to June 2010. Various parameters likestatus of enquirer, their specialty, mode of receipt of query,purpose of query, type of query etc. were consider forevaluation.Results: Out of 208 queries received, major 56 (26.9% frommale medical ward. Maximum [82 (39.4 %] queries were fromthe physicians. 73 (35.0 % of the queries were about therecent advances and the updating of the information, It wasfound that mostly the mode of request was during wardrounds 85 (40.9%. Most of the queries [126 (60.6%] wereanswered by written or printout format. Majority of thequeries [195 (93.8 %] were answered directly to theenquirers through direct access. Most of the queries wereanswered through books in the department [86 (41.3 %].Conclusion: Results of the external auditing revealed thatrequestors were generally satisfied with the service provided.The drug information services provided by clinical pharmacistsat the hospital were found to be useful and beneficial to thehealthcare professionals and patients.

  15. A Product Development Decision Model for Cockpit Weather Information Systems

    Science.gov (United States)

    Sireli, Yesim; Kauffmann, Paul; Gupta, Surabhi; Kachroo, Pushkin

    2003-01-01

    There is a significant market demand for advanced cockpit weather information products. However, it is unclear how to identify the most promising technological options that provide the desired mix of consumer requirements by employing feasible technical systems at a price that achieves market success. This study develops a unique product development decision model that employs Quality Function Deployment (QFD) and Kano's model of consumer choice. This model is specifically designed for exploration and resolution of this and similar information technology related product development problems.

  16. A Product Development Decision Model for Cockpit Weather Information System

    Science.gov (United States)

    Sireli, Yesim; Kauffmann, Paul; Gupta, Surabhi; Kachroo, Pushkin; Johnson, Edward J., Jr. (Technical Monitor)

    2003-01-01

    There is a significant market demand for advanced cockpit weather information products. However, it is unclear how to identify the most promising technological options that provide the desired mix of consumer requirements by employing feasible technical systems at a price that achieves market success. This study develops a unique product development decision model that employs Quality Function Deployment (QFD) and Kano's model of consumer choice. This model is specifically designed for exploration and resolution of this and similar information technology related product development problems.

  17. Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.

    Science.gov (United States)

    Aikin, Kathryn J; Southwell, Brian G; Paquin, Ryan S; Rupert, Douglas J; O'Donoghue, Amie C; Betts, Kevin R; Lee, Philip K

    Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. These results

  18. Clinical trials information in drug development and regulation : existing systems and standards

    NARCIS (Netherlands)

    Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans

    2012-01-01

    Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and

  19. Norwegian elderly patients' need for drug information and attitudes towards medication use reviews in community pharmacies.

    Science.gov (United States)

    Mamen, Anette Vik; Håkonsen, Helle; Kjome, Reidun L S; Gustavsen-Krabbesund, Bjørn; Toverud, Else-Lydia

    2015-12-01

    Medication use review (MUR) is a community pharmacy service in several countries. Knowledge about what patients want from such a service is limited. The aim of this study was therefore to investigate Norwegian elderly patients' need for drug information and their attitudes towards MURs. In Norway's two largest cities, 162 patients (72% women; mean age: 78.9 years) who used at least one prescription drug were recruited from 18 senior centres. They were interviewed personally with a structured questionnaire (29 closed and 4 open-ended questions). The average number of prescription drugs used was 4.4. Seventy per cent also used over-the-counter drugs. The main source of drug information was the general practitioner (GP) followed by package inserts and pharmacy staff. For drug-related problems, 62% would contact the GP compared with 24% who preferred the pharmacist. Fifty per cent remembered no information when collecting prescriptions. However, 56% wanted to know more about their medication and 55% were interested in a MUR. The main topics they wished to address were effect/side effects and interactions. Lack of privacy was reported to be a major obstacle in the current situation. This study shows that community pharmacies in Norway play a minor role regarding drug information to elderly polypharmacy patients. The GP is both their main information source and whom they contact for drug-related problems. However, half of the patients would like to know more about their medication. More than half were positive towards taking part in a MUR. © 2015 Royal Pharmaceutical Society.

  20. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

    Science.gov (United States)

    Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P; McNeil, Scott; Borchard, Gerrit; Flühmann, Beat; Weinstein, Vera; Neervannan, Sesha; Griffiths, Elwyn; Jiang, Wenlei; Wolff-Holz, Elena; Crommelin, Daan J A; de Vlieger, Jon S B

    2017-11-01

    Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

  1. 21 CFR 328.50 - Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol. 328.50 Section 328.50 Food and Drugs FOOD AND DRUG... PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL Labeling § 328.50 Principal display panel of all...

  2. 21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What controls and acceptance criteria must I have... POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Finished Drug Product Controls and Acceptance § 212.70 What controls and acceptance criteria must I have for my finished PET drug products? (a) Specifications...

  3. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac. 310.528 Section 310.528 Food and Drugs FOOD AND... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean...

  4. Method s for Measuring Productivity in Libraries and Information Centres

    Directory of Open Access Journals (Sweden)

    Mohammad Alaaei

    2009-04-01

    Full Text Available   Within Information centers, productivity is the result of optimal and effective use of information resources, service quality improvement, increased user satisfaction, pleasantness of working environment, increased motivation and enthusiasm of staff to work better. All contribute to the growth and development of information centers. Thus these centers would need to be familiar with methods employed in productivity measurement. Productivity is one of the criteria for evaluating system performance. In the past decades particular emphasis has been placed on measurement and improvement of human resource, creativity, innovation and expert analysis. Contemplation and efforts made towards identification of problems and issues and new means to make more useful and better resource management is the very definition of productivity. Simply put, productivity is the relationship between system output and the elements garnered to produce these outputs. The causality between variables and factors impacting on productivity is very complex. In information centers, given the large volume of elements involved, it seems necessary to increase efficiency and productivity

  5. Low literacy and written drug information: information-seeking, leaflet evaluation and preferences, and roles for images.

    Science.gov (United States)

    van Beusekom, Mara M; Grootens-Wiegers, Petronella; Bos, Mark J W; Guchelaar, Henk-Jan; van den Broek, Jos M

    2016-12-01

    Background Low-literate patients are at risk to misinterpret written drug information. For the (co-) design of targeted patient information, it is key to involve this group in determining their communication barriers and information needs. Objective To gain insight into how people with low literacy use and evaluate written drug information, and to identify ways in which they feel the patient leaflet can be improved, and in particular how images could be used. Setting Food banks and an education institution for Dutch language training in the Netherlands. Method Semi-structured focus groups and individual interviews were held with low-literate participants (n = 45). The thematic framework approach was used for analysis to identify themes in the data. Main outcome measure Low-literate people's experience with patient information leaflets, ideas for improvements, and perceptions on possible uses for visuals. Results Patient information leaflets were considered discouraging to use, and information difficult to find and understand. Many rely on alternative information sources. The leaflet should be shorter, and improved in terms of organisation, legibility and readability. Participants thought images could increase the leaflet's appeal, help ask questions, provide an overview, help understand textual information, aid recall, reassure, and even lead to increased confidence, empowerment and feeling of safety. Conclusion Already at the stages of paying attention to the leaflet and maintaining interest in the message, low-literate patients experience barriers in the communication process through written drug information. Short, structured, visual/textual explanations can lower the motivational threshold to use the leaflet, improve understanding, and empower the low-literate target group.

  6. Production and Investigation of Controlled Drug Release Properties of Tamoxifen Loaded Alginate-Gum Arabic Microbeads

    Directory of Open Access Journals (Sweden)

    Rukiye Yavaşer

    2016-08-01

    Full Text Available The entrapment of tamoxifen onto alginate-gum arabic beads and the production of controlled drug release was investigated in this study. The polymeric system that would provide the controlled release of tamoxifen was formed using alginate and gum arabic. In the first phase of the study, the optimization of the alginate-gum arabic beads production was conducted; then the study continued with drug entrapment experiments. Tamoxifen entrapment yield was found to be approximately 90% of initial tamoxifen concentration. In vitro drug release experiments were performed in simulated gastric juice and intestinal fluid where the tamoxifen release was 20% and 53% of the initial drug present, respectively. As a result of this study, it is expected that a valuable contribution to the field of controlled drug release system production is realized.

  7. 21 CFR 310.530 - Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    Science.gov (United States)

    2010-04-01

    ... labeling or in the ingredient statement is an implied drug claim. The claim implied by the use of this term... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Topically applied hormone-containing drug products for over-the-counter (OTC) human use. 310.530 Section 310.530 Food and Drugs FOOD AND DRUG...

  8. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Packaging and Labeling § 212.80 What are the...

  9. Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products.

    Science.gov (United States)

    Sugihara, Masahisa; Takeuchi, Susumu; Sugita, Masaru; Higaki, Kazutaka; Kataoka, Makoto; Yamashita, Shinji

    2015-12-07

    high intrasubject variability in oral drug absorption. This information is of importance to design the human BE study for oral drug products containing APIs with a risk of large intrasubject variability in oral absorption.

  10. [Adverse muscle effects of a podofyllotoxin-containing cytotoxic drug product with simvastatin].

    Science.gov (United States)

    Kaipiainen-Seppänen, Oili; Savolainen, Elina; Elfving, Pia; Kononoff, Aulikki

    2009-01-01

    With the ageing population, drug interactions pose an increasing challenge to health professionals. We describe four patients, for whom concurrent administration of a podofyllotoxin-containing cytotoxic drug product and simvastatin caused severe adverse effects on muscles, including muscle pain, soreness or fatigue or weakness, and in some patients also disintegration of muscle tissue, i.e. rhabdomyolysis. The metabolism of both drugs proceeds via the common CYP3A4 enzyme pathway.

  11. Information on actual medication use and drug-related problems in older patients: questionnaire or interview?

    Science.gov (United States)

    Willeboordse, Floor; Grundeken, Lucienne H; van den Eijkel, Lisanne P; Schellevis, François G; Elders, Petra J M; Hugtenburg, Jacqueline G

    2016-04-01

    Information on medication use and drug-related problems is important in the preparation of clinical medication reviews. Critical information can only be provided by patients themselves, but interviewing patients is time-consuming. Alternatively, patient information could be obtained with a questionnaire. In this study the agreement between patient information on medication use and drug-related problems in older patients obtained with a questionnaire was compared with information obtained during an interview. General practice in The Netherlands. A questionnaire was developed to obtain information on actual medication use and drug-related problems. Two patient groups ≥65 years were selected based on general practitioner electronic medical records in nine practices; I. polypharmacy and II. ≥1 predefined general geriatric problems. Eligible patients were asked to complete the questionnaire and were interviewed afterwards. Agreement on information on medication use and drug-related problems collected with the questionnaire and interview was calculated. Ninety-seven patients participated. Of all medications used, 87.6 % (95 % CI 84.7-90.5) was reported identically in the questionnaire and interview. Agreement for the complete medication list was found for 45.4 % (95 % CI 35.8-55.3) of the patients. On drug-related problem level, agreement between questionnaire and interview was 75 %. Agreement tended to be lower in vulnerable patients characterized by ≥4 chronic diseases, ≥10 medications used and low health literacy. Information from a questionnaire showed reasonable agreement compared with interviewing. The patients reported more medications and drug-related problems in the interview than the questionnaire. Taking the limitations into account, a questionnaire seems a suitable tool for medication reviews that may replace an interview for most patients.

  12. Accuracy and completeness of drug information in Wikipedia: a comparison with standard textbooks of pharmacology.

    Directory of Open Access Journals (Sweden)

    Jona Kräenbring

    Full Text Available The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7% ± 0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8 ± 1.5% (p < 0.001. Completeness varied in-between categories, and was lowest in the category "pharmacokinetics" (68.0% ± 4.2%; p < 0.001 and highest in the category "indication" (91.3% ± 2.0% when compared to the textbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6 ± 1.6 references and 262.8 ± 37.4 edits performed by 142.7 ± 17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education.

  13. Accuracy and Completeness of Drug Information in Wikipedia: A Comparison with Standard Textbooks of Pharmacology

    Science.gov (United States)

    Gutmann, Joanna; Muehlich, Susanne; Zolk, Oliver; Wojnowski, Leszek; Maas, Renke; Engelhardt, Stefan; Sarikas, Antonio

    2014-01-01

    The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7%±0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8±1.5% (ptextbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6±1.6 references and 262.8±37.4 edits performed by 142.7±17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education. PMID:25250889

  14. Accuracy and completeness of drug information in Wikipedia: a comparison with standard textbooks of pharmacology.

    Science.gov (United States)

    Kräenbring, Jona; Monzon Penza, Tika; Gutmann, Joanna; Muehlich, Susanne; Zolk, Oliver; Wojnowski, Leszek; Maas, Renke; Engelhardt, Stefan; Sarikas, Antonio

    2014-01-01

    The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7% ± 0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8 ± 1.5% (p < 0.001). Completeness varied in-between categories, and was lowest in the category "pharmacokinetics" (68.0% ± 4.2%; p < 0.001) and highest in the category "indication" (91.3% ± 2.0%) when compared to the textbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6 ± 1.6 references and 262.8 ± 37.4 edits performed by 142.7 ± 17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education.

  15. Multidisciplinary approach to successful implementation of production information system (PRISM)

    Energy Technology Data Exchange (ETDEWEB)

    Shariff, M.R.; Gopalakrishnan, S.G.; Francis, N. [and others

    1995-12-31

    A company wide corporate and regional production database supporting all production areas was envisaged critical to the current expansion within Petronas Carigali Sdn Bhd (PCSB). A multi disciplinary project team was thus formed to analyze the requirements prior to developing, testing, implementing and training users. PCSB has currently evolved into a mature E & P company on par with other E & P companies within the region. This expansion necessitates a common Production Information System for the efficient dissemination of vital Production Information for Production Surveillance, Reservoir Management, Reserve Assessment, Special Studies and Standardized Group-wide Reporting. This paper will discuss all the phases involved in the project which includes Systems Requirement Study, Data Migration, System Development, System Implementation and Post-Implementation Plan.

  16. Influence of Information Product Quality on Informing Users: A Web Portal Context

    Directory of Open Access Journals (Sweden)

    Junghyun Nam

    2016-11-01

    Full Text Available Web portals have been used as information products to deliver personalized, feature-rich, and flexible information needs to Internet users. However, all portals are not equal. Most of them have relatively a small number of visitors, while a few capture the majority of surfers. This study seeks to uncover the factors that contribute the perceived quality of a general portal. Based on 21 factors derived from an extensive literature review on Information Product Quality (IPQ, web usage, and media use, an experimental study was conducted to identify the factors that are perceived by web portal users as most relevant. The literature categorizes quality factors of an information product in three dimensions: information, physical, and service. This experiment suggests a different clustering of factors: Content relevancy, Communication interactiveness, Information currency, and Instant gratification. The findings in this study will help developers find a more customer-oriented approach to developing high-traffic portals.

  17. Design of a RESTful web information system for drug prescription and administration.

    Science.gov (United States)

    Bianchi, Lorenzo; Paganelli, Federica; Pettenati, Maria Chiara; Turchi, Stefano; Ciofi, Lucia; Iadanza, Ernesto; Giuli, Dino

    2014-05-01

    Drug prescription and administration processes strongly impact on the occurrence of risks in medical settings for they can be sources of adverse drug events (ADEs). A properly engineered use of information and communication technologies has proven to be a promising approach to reduce these risks. In this study, we propose PHARMA, a web information system which supports healthcare staff in the secure cooperative execution of drug prescription, transcription and registration tasks. PHARMA allows the easy sharing and management of documents containing drug-related information (i.e., drug prescriptions, medical reports, screening), which is often inconsistent and scattered across different information systems and heterogeneous organization domains (e.g., departments, other hospital facilities). PHARMA enables users to access such information in a consistent and secure way, through the adoption of REST and web-oriented design paradigms and protocols. We describe the implementation of the PHARMA prototype, and we discuss the results of the usability evaluation that we carried out with the staff of a hospital in Florence, Italy.

  18. Production Planning and Planting Pattern Scheduling Information System for Horticulture

    Science.gov (United States)

    Vitadiar, Tanhella Zein; Farikhin; Surarso, Bayu

    2018-02-01

    This paper present the production of planning and planting pattern scheduling faced by horticulture farmer using two methods. Fuzzy time series method use to predict demand on based on sales amount, while linear programming is used to assist horticulture farmers in making production planning decisions and determining the schedule of cropping patterns in accordance with demand predictions of the fuzzy time series method, variable use in this paper is size of areas, production advantage, amount of seeds and age of the plants. This research result production planning and planting patterns scheduling information system with the output is recommendations planting schedule, harvest schedule and the number of seeds will be plant.

  19. 78 FR 38053 - Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug...

    Science.gov (United States)

    2013-06-25

    ... marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug...-610 were not withdrawn from sale for reasons of safety or effectiveness. This determination means that...

  20. Evaluation of In-Use Stability of Anticoagulant Drug Products: Warfarin Sodium.

    Science.gov (United States)

    Nguyenpho, Agnes; Ciavarella, Anthony B; Siddiqui, Akhtar; Rahman, Ziyaur; Akhtar, Sohail; Hunt, Robert; Korang-Yeboah, Maxwell; Khan, Mansoor A

    2015-12-01

    The objective of the study was to evaluate the stability of warfarin products during use by patients or caregivers. For evaluation, three commercial products manufactured by different processes were selected and placed at 30°C/75%RH to simulate in use condition. Samples were withdrawn up to 12 weeks and analyzed for the physicochemical changes. Scanning electron microscopy demonstrated increasing holes and craters in the tablets over the timeframe. Near-infrared chemical imaging and powder X-ray powder diffraction corroborated the change arising from conversion of crystalline to amorphous forms of the drug. Hardness and disintegration time of the tablets were found to increase progressively. With increasing time, moisture contents of the products were found to increase and consequent decrease in isopropyl alcohol content of the product. Dissolution of the tablets in media at pH 4.5 demonstrated discrimination between crystalline and amorphous drug products. Overall, percent drug dissolved in each product at 30 min was found to decrease with increasing exposure time. Dissolution of drug decreased from 54% to 38% and 82% to 54% for the two products while the third product maintained consistently high level of dissolution. These results suggest that the drug product quality attributes can change during use. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  1. Use of drugs and antibiotics in poultry production in Ghana | Turkson ...

    African Journals Online (AJOL)

    This study was designed to assess the extent of drug and antibiotic use in small and large commercial poultry producers in Ghana, and the extent of the knowledge, perceptions and practice of drug withdrawal period in poultry production. In all, 483 poultry farmers in Greater Accra, Ashanti and Central regions were ...

  2. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Science.gov (United States)

    2010-04-01

    ... for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.” (3) “Do not take this product, unless directed by a doctor, if you have a breathing problem such....50 Section 338.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  3. 75 FR 48352 - Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn...

    Science.gov (United States)

    2010-08-10

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

  4. Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements.

    Science.gov (United States)

    Betts, Kevin R; Boudewyns, Vanessa; Aikin, Kathryn J; Squire, Claudia; Dolina, Suzanne; Hayes, Jennifer J; Southwell, Brian G

    2017-08-02

    Broadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product's major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information. Examine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers' ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined. A web-based experiment was conducted in which US adults who self-reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire. The type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias-corrected scores) ranged from 63% to 70% across the three illness samples. The revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers' processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks. Published by Elsevier Inc.

  5. Product diffusion through on-demand information-seeking behaviour.

    Science.gov (United States)

    Riedl, Christoph; Bjelland, Johannes; Canright, Geoffrey; Iqbal, Asif; Engø-Monsen, Kenth; Qureshi, Taimur; Sundsøy, Pål Roe; Lazer, David

    2018-02-01

    Most models of product adoption predict S-shaped adoption curves. Here we report results from two country-scale experiments in which we find linear adoption curves. We show evidence that the observed linear pattern is the result of active information-seeking behaviour: individuals actively pulling information from several central sources facilitated by modern Internet searches. Thus, a constant baseline rate of interest sustains product diffusion, resulting in a linear diffusion process instead of the S-shaped curve of adoption predicted by many diffusion models. The main experiment seeded 70 000 (48 000 in Experiment 2) unique voucher codes for the same product with randomly sampled nodes in a social network of approximately 43 million individuals with about 567 million ties. We find that the experiment reached over 800 000 individuals with 80% of adopters adopting the same product-a winner-take-all dynamic consistent with search engine driven rankings that would not have emerged had the products spread only through a network of social contacts. We provide evidence for (and characterization of) this diffusion process driven by active information-seeking behaviour through analyses investigating (a) patterns of geographical spreading; (b) the branching process; and (c) diffusion heterogeneity. Using data on adopters' geolocation we show that social spreading is highly localized, while on-demand diffusion is geographically independent. We also show that cascades started by individuals who actively pull information from central sources are more effective at spreading the product among their peers. © 2018 The Authors.

  6. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2012-02-29

    ...] Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Size of Beads in Drug Products Labeled for... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  7. 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

    ...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  8. 49 CFR Appendix F to Part 40 - Drug and Alcohol Testing Information that C/TPAs May Transmit to Employers

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Drug and Alcohol Testing Information that C/TPAs... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. F Appendix F to Part 40—Drug and Alcohol Testing Information that C/TPAs May Transmit to Employers 1. If you...

  9. Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use; delay of compliance dates. Final rule; delay of compliance dates; request for comments.

    Science.gov (United States)

    2012-05-11

    The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

  10. OPPIDUM surveillance program: 20 years of information on drug abuse in France.

    Science.gov (United States)

    Frauger, Elisabeth; Moracchini, Christophe; Le Boisselier, Reynald; Braunstein, David; Thirion, Xavier; Micallef, Joëlle

    2013-12-01

    It is important to assess drug abuse liability in 'real life' using different surveillance systems. Some are based on specific population surveys, such as individuals with drug abuse or dependence, or under opiate maintenance treatment, because this population is very familiar with drugs and is more likely to divert or abuse them. In France, an original surveillance system based on this specific population and called 'Observation of illegal drugs and misuse of psychotropic medications (OPPIDUM) survey' was set up in 1990 as the first of its kind. The aim of this article is to describe this precursor of French drug abuse surveillance using different examples, to demonstrate its ability to effectively give health authorities and physicians interesting data on drug abuse. OPPIDUM is an annual, cross-sectional survey that anonymously collects information on abuse and dependence observed in patients recruited in specialized care centers dedicated to drug dependence. From 1990 to 2010, a total of 50,734 patients were included with descriptions of 102,631 psychoactive substance consumptions. These data have outlined emergent behaviors such as the misuse of buprenorphine by intravenous or nasal administration. It has contributed to assess abuse liability of emergent drugs such as clonazepam or methylphenidate. This surveillance system was also able to detect the decrease of flunitrazepam abuse following implementation of regulatory measures. OPPIDUM's twenty years of experience clearly demonstrate that collection of valid and useful data on drug abuse is possible and can provide helpful information for physicians and health authorities. © 2013 The Authors Fundamental and Clinical Pharmacology © 2013 Société Française de Pharmacologie et de Thérapeutique.

  11. Integrated system of production information processing for surface mines

    Energy Technology Data Exchange (ETDEWEB)

    Li, K.; Wang, S.; Zeng, Z.; Wei, J.; Ren, Z. [China University of Mining and Technology, Xuzhou (China). Dept of Mining Engineering

    2000-09-01

    Based on the concept of geological statistic, mathematical program, condition simulation, system engineering, and the features and duties of each main department in surface mine production, an integrated system for surface mine production information was studied systematically and developed by using the technology of data warehousing, CAD, object-oriented and system integration, which leads to the systematizing and automating of the information management, data processing, optimization computing and plotting. In this paper, its overall object, system design, structure and functions and some key techniques were described. 2 refs., 3 figs.

  12. Homeless drug users and information technology: a qualitative study with potential implications for recovery from drug dependence.

    Science.gov (United States)

    Neale, Joanne; Stevenson, Caral

    2014-09-01

    Having access to information and communication technologies (ICTs) is a prerequisite to meaningful participation in society. This paper seeks to: i. explore the engagement of homeless drug users (HDUs) with ICTs and ii. discuss the findings with reference to recovery from drug dependence. The study design was qualitative and longitudinal, involving data collected in 2012-13 via 52 semi-structured interviews with 30 homeless drug users (25 men; five women). Participants were recruited from 17 hostels in two English cities. Interview data were analyzed using Framework. HDUs had access to ICTs, used ICTs, and wanted to engage with them more. Experiences of digital exclusion were a function of participants' inability to afford ICTs, the relatively cheap and poor quality technology available to them, limited knowledge about ICTs, and lack of support in using them. That HDUs were often unable to take full advantage of technology because they had nobody to explain what their devices could do or to show them how they worked was ironic given that using ICTs to (re)establish and maintain relationships were functions of technology that HDUs particularly liked. The physical, human, cultural, and social capital of HDUs influenced their access to, and use of, ICTs. Equally, ICTs were themselves an important recovery resource. Services and others should endeavor to provide HDUs with easy access to good quality technology, as well as offers of support and education so that all individuals have the knowledge and confidence to make optimum use of the technology that is available to them.

  13. Sources of Information as Determinants of Product and Process Innovation

    OpenAIRE

    G?mez, Jaime; Salazar, Idana; Vargas, Pilar

    2016-01-01

    In this paper we use a panel of manufacturing firms in Spain to examine the extent to which they use internal and external sources of information (customers, suppliers, competitors, consultants and universities) to generate product and process innovation. Our results show that, although internal sources are influential, external sources of information are key to achieve innovation performance. These results are in line with the open innovation literature because they show that firms that are ...

  14. Health motivation and product design determine consumers' visual attention to nutrition information on food products.

    Science.gov (United States)

    Visschers, Vivianne H M; Hess, Rebecca; Siegrist, Michael

    2010-07-01

    In the present study we investigated consumers' visual attention to nutrition information on food products using an indirect instrument, an eye tracker. In addition, we looked at whether people with a health motivation focus on nutrition information on food products more than people with a taste motivation. Respondents were instructed to choose one of five cereals for either the kindergarten (health motivation) or the student cafeteria (taste motivation). The eye tracker measured their visual attention during this task. Then respondents completed a short questionnaire. Laboratory of the ETH Zurich, Switzerland. Videos and questionnaires from thirty-two students (seventeen males; mean age 24.91 years) were analysed. Respondents with a health motivation viewed the nutrition information on the food products for longer and more often than respondents with a taste motivation. Health motivation also seemed to stimulate deeper processing of the nutrition information. The student cafeteria group focused primarily on the other information and did this for longer and more often than the health motivation group. Additionally, the package design affected participants' nutrition information search. Two factors appear to influence whether people pay attention to nutrition information on food products: their motivation and the product's design. If the package design does not sufficiently facilitate the localization of nutrition information, health motivation can stimulate consumers to look for nutrition information so that they may make a more deliberate food choice.

  15. Overview of Skin Whitening Agents: Drugs and Cosmetic Products

    Directory of Open Access Journals (Sweden)

    Céline Couteau

    2016-07-01

    Full Text Available Depigmentation and skin lightening products, which have been in use for ages in Asian countries where skin whiteness is a major esthetic criterion, are now also highly valued by Western populations, who expose themselves excessively to the sun and develop skin spots as a consequence. After discussing the various possible mechanisms of depigmentation, the different molecules that can be used as well as the status of the products containing them will now be presented. Hydroquinone and derivatives thereof, retinoids, alpha- and beta-hydroxy acids, ascorbic acid, divalent ion chelators, kojic acid, azelaic acid, as well as diverse herbal extracts are described in terms of their efficacy and safety. Since a genuine effect (without toxic effects is difficult to obtain, prevention by using sunscreen products is always preferable.

  16. Information strategy and information products in radiation protection. A Norwegian RISKPERCOM study

    Energy Technology Data Exchange (ETDEWEB)

    Reitan, J B; Toennesen, A [Statens Straalevern, Oesteraas (Norway); Waldahl, R [Avdeling for media og kommunikasjon, Oslo Univ., Oslo (Norway)

    1998-02-01

    A short description of the national background for the radiation issue is presented together with a presentation of information strategy and analysis of the information products of the Norwegian Radiation Protection Authority. This is part of an international study. 35 refs.

  17. Information strategy and information products in radiation protection. A Norwegian RISKPERCOM study

    International Nuclear Information System (INIS)

    Reitan, J.B.; Toennesen, A.; Waldahl, R.

    1998-02-01

    A short description of the national background for the radiation issue is presented together with a presentation of information strategy and analysis of the information products of the Norwegian Radiation Protection Authority. This is part of an international study. 35 refs

  18. [Drug advertising--users want information. Report of telephone survey conducted by North-Rhine Westphalia Public Health Service on the topic of drug advertising and drug information for users].

    Science.gov (United States)

    Puteanus, U

    2000-10-01

    In Germany, drug advertising of non-prescription drugs is a controversial subject. On the one hand, consumer organisations plead for placing a ban on advertising or at least to offer a detailed description of medical risks in respect of protection. On the other hand, the pharmaceutical industry is keen on liberalizing the specific advertising law for drugs. A representative telephone survey among the population of North Rhine-Westphalia was conducted in April and May 1999. It showed consumer interest in advertising, the value of information on risks, the institution with maximum credibility in drug information for consumers, the importance of the now obligatory sentence after every advertisement: Regarding risks and side effects read the leaflet in the package and ask your physician or pharmacist, and to what extend the consumer would take advice from independent experts over the telephone about drugs. It was found that, in particular women, about 30% are occasionally interested in advertising, younger people are more open-minded about advertising than older people; and that doctors and pharmacists have the most credibility and are consulted for further information. It was also found that more than 80% of the population demanded precise information on the side effects of drugs. One-third of the consumers declared that the obligatory sentence (see above) led to greater demand for information from doctors or to read attentively the instruction leaflet. Nevertheless, there is a need for more information from more than half of the consumers, who would take advantage of an independent advice centre if this should exist.

  19. 21 CFR 352.52 - Labeling of sunscreen drug products.

    Science.gov (United States)

    2010-04-01

    ... sunburn [bullet] higher SPF gives more sunburn protection”. 1 See § 201.66(b)(4) of this chapter. (ii) For... “minimum”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin that sunburns minimally”. (ii) For products that provide an SPF of 12 to under 30...

  20. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Science.gov (United States)

    2010-04-01

    ... “pinworm treatment.” (b) Indication. The labeling of the product states, under the heading “Indication,” the following: “For the treatment of pinworms.” Other truthful and nonmisleading statements... repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire...

  1. 21 CFR 349.78 - Labeling of eyewash drug products.

    Science.gov (United States)

    2010-04-01

    ...,” “air pollutants (smog or pollen),” or “chlorinated water”). (2) “For” (select one of the following...),” or “chlorinated water”). (c) Warnings. In addition to the warnings in § 349.50, the labeling of the... products intended for use with an eyecup. Rinse cup with clean water immediately before each use. Avoid...

  2. Production of biological nanoparticles from Θ- lactalbumin for drug ...

    African Journals Online (AJOL)

    In recent years, the concept of controlled release of encapsulated ingredients at the right place and the right time has become of more interest to the food and pharmaceutical industry. Whey proteins are valuable by-products from the cheese industry. The physicochemical properties of the whey proteins suggest that they ...

  3. Drug-enhanced carbon monoxide production from heme by cytochrome P450 reductase

    Directory of Open Access Journals (Sweden)

    Dragic Vukomanovic

    2017-01-01

    Full Text Available Carbon monoxide (CO formed endogenously is considered to be cytoprotective, and the vast majority of CO formation is attributed to the degradation of heme by heme oxygenases-1 and -2 (HO-1, HO-2. Previously, we observed that brain microsomes containing HO-2 produced many-fold more CO in the presence of menadione and its congeners; herein we explored these observations further. We determined the effects of various drugs on CO production of rat brain microsomes and recombinant human cytochrome P450 reductase (CPR; CO was measured by gas chromatography with reductive detection. Brain microsomes of Sprague-Dawley rats or recombinant human cytochrome P450 reductase (CPR were incubated with NADPH and various drugs in closed vials in phosphate buffer at pH 7.4 and 37°C. After 15 minutes, the reaction was stopped by cooling in dry ice, and the headspace gas was analyzed for CO production using gas chromatography with reductive (mercuric oxide detection. We observed drug-enhanced CO production in the presence of both microsomes and recombinant CPR alone; the presence of HO was not required. A range of structurally diverse drugs were capable of amplifying this CO formation; these molecules had structures consistent with redox cycling capability. The addition of catalase to a reaction mixture, that contained activating drugs, inhibited the production of CO. Drug-enhanced CO formation can be catalyzed by CPR. The mechanism of CPR activation was not through classical drug-receptor mediation. Redox cycling may be involved in the drug-induced amplification of CO production by CPR through the production of reactive oxygen species.

  4. Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

    Science.gov (United States)

    Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

    2016-11-01

    This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

  5. Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland.

    Science.gov (United States)

    Santiago, Macarena Gonzalez; Bucher, Heiner C; Nordmann, Alain J

    2008-12-31

    New legal regulations for the marketing of pharmaceutical products were introduced in 2002 in Switzerland. We investigated whether claims in drug advertisements citing published scientific studies were justified by these studies after the introduction of these new regulations. In this cross-sectional study, two independent reviewers screened all issues of six major Swiss medical journals published in the year 2005 to identify all drug advertisements for analgesic, gastrointestinal and psychopharmacologic drugs and evaluated all drug advertisements referring to at least one publication. The pharmaceutical claim was rated as being supported, being based on a potentially biased study or not to be supported by the cited study according to pre-specified criteria. We also explored factors likely to be associated with supported advertisement claims. Of 2068 advertisements 577 (28%) promoted analgesic, psychopharmacologic or gastrointestinal drugs. Among them were 323 (56%) advertisements citing at least one reference. After excluding multiple publications of the same drug advertisement and advertisements with non-informative references, there remained 29 unique advertisements with at least one reference to a scientific study. These 29 advertisements contained 78 distinct pairs of claims of analgesic, gastrointestinal and psychopharmacologic drugs and referenced studies. Thirty-seven (47%) claims were supported, 16 (21%) claims were not supported by the corresponding reference, and 25 (32%) claims were based on potentially biased evidence, with no relevant differences between drug groups. Studies with conflict of interest and studies stating industry funding were more likely to support the corresponding claim (RR 1.52, 95% CI 1.07-2.17 and RR 1.50, 95% CI 0.98-2.28) than studies without identified conflict of interest and studies without information on type of funding. Following the introduction of new regulations for drug advertisement in Switzerland, 53% of all assessed

  6. Special forest products: species information guide for the Pacific Northwest.

    Science.gov (United States)

    Nan C. Vance; Melissa Borsting; David Pilz; Jim. Freed

    2001-01-01

    This guide is a collection of information about economically important vascular and nonvascular plants and fungi found in the Pacific Northwest that furnish special forest products. Many of these plants and fungi are also found in Alaska, northern Idaho, and western Montana. They contribute to many botanical, floral, woodcraft, and decorative industries and to the...

  7. Structural optimization for materially informed design to robotic production processes

    NARCIS (Netherlands)

    Bier, H.H.; Mostafavi, S.

    2015-01-01

    Hyperbody’s materially informed Design-to-Robotic-Production (D2RP) processes for additive and subtractive manufacturing aim to achieve performative porosity in architecture at various scales. An extended series of D2RP experiments aiming to produce prototypes at 1:1 scale wherein design materiality

  8. Some Comments on Marketing AIP Information Products and Services.

    Science.gov (United States)

    King, Donald W.; Brown, A. M.

    This study was addressed to marketing considerations for the American Institute of Physics (AIP) information products and services. The general system and its operation in a marketing environment, including promotion, channels of distribution and pricing are covered. Particular emphasis is placed on the cost/demand/price relationship for four…

  9. Product Bundling and Shared Information Goods: A Pricing Exercise

    Science.gov (United States)

    Morrison, William G.

    2016-01-01

    In this article, the author describes an exercise in which two pricing problems (product bundling and the sharing of digital information goods) can be understood using the same analytical approach. The exercise allows students to calculate the correct numerical answers with relative ease, while the teaching plan demonstrates the importance of the…

  10. Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?

    Science.gov (United States)

    Doran, Evan

    2016-01-01

    Hyosun Kim’s report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it PMID:27239884

  11. Print Advertisements for Alzheimer’s Disease Drugs: Informational and Transformational Features

    Science.gov (United States)

    Gooblar, Jonathan; Carpenter, Brian D.

    2014-01-01

    Purpose We examined print advertisements for Alzheimer’s disease drugs published in journals and magazines between January 2008 and February 2012, using an informational versus transformational theoretical framework to identify objective and persuasive features. Methods In 29 unique advertisements, we used qualitative methods to code and interpret identifying information, charts, benefit and side effect language, and persuasive appeals embedded in graphics and narratives. Results Most elements contained a mixture of informational and transformational features. Charts were used infrequently, but when they did appear the accompanying text often exaggerated the data. Benefit statements covered an array of symptoms, drug properties, and caregiver issues. Side effect statements often used positive persuasive appeals. Graphics and narrative features emphasized positive emotions and outcomes. Implications We found subtle and sophisticated attempts both to educate and to persuade readers. It is important for consumers and prescribing physicians to read print advertisements critically so that they can make informed treatment choices. PMID:23687184

  12. Enriching step-based product information models to support product life-cycle activities

    Science.gov (United States)

    Sarigecili, Mehmet Ilteris

    The representation and management of product information in its life-cycle requires standardized data exchange protocols. Standard for Exchange of Product Model Data (STEP) is such a standard that has been used widely by the industries. Even though STEP-based product models are well defined and syntactically correct, populating product data according to these models is not easy because they are too big and disorganized. Data exchange specifications (DEXs) and templates provide re-organized information models required in data exchange of specific activities for various businesses. DEXs show us it would be possible to organize STEP-based product models in order to support different engineering activities at various stages of product life-cycle. In this study, STEP-based models are enriched and organized to support two engineering activities: materials information declaration and tolerance analysis. Due to new environmental regulations, the substance and materials information in products have to be screened closely by manufacturing industries. This requires a fast, unambiguous and complete product information exchange between the members of a supply chain. Tolerance analysis activity, on the other hand, is used to verify the functional requirements of an assembly considering the worst case (i.e., maximum and minimum) conditions for the part/assembly dimensions. Another issue with STEP-based product models is that the semantics of product data are represented implicitly. Hence, it is difficult to interpret the semantics of data for different product life-cycle phases for various application domains. OntoSTEP, developed at NIST, provides semantically enriched product models in OWL. In this thesis, we would like to present how to interpret the GD & T specifications in STEP for tolerance analysis by utilizing OntoSTEP.

  13. 21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

    Science.gov (United States)

    2010-04-01

    ... PHARMACEUTICALS Production and Process Controls § 211.110 Sampling and testing of in-process materials and drug... capsule weight variation; (2) Disintegration time; (3) Adequacy of mixing to assure uniformity and... production process, e.g., at commencement or completion of significant phases or after storage for long...

  14. THE EVOLUTION OF ROMANIAN TRADE IN INFORMATION PRODUCTS AND

    Directory of Open Access Journals (Sweden)

    CECILIA IRINA RABONTU

    2015-10-01

    Full Text Available The trade in Romania has seen an increased dynamism in many areas. When it comes to food or non food products, or services are bringing into question we can say that the period of consumerism in which we are living hallmarks the commercial activities. Trade in information products and services had lately a remarkable richness, being the categories that arouses greatest interest from certain consumers becoming more and more numerous and demanding in terms of technology. In this paper we proposed to analyze how much the sales of information products and services respond to the many needs expressed by Romanian customers and to capture the dynamics in which this type of commerce evolved.

  15. Synthetic and bioengineered products in nuclear medicine and drug delivery

    International Nuclear Information System (INIS)

    Frier, M.

    1997-01-01

    Full text. The supply of radio pharmaceuticals based on pooled human blood products, for example human serum albumin (H S A) and fibrinogen, has previously met with some problems due to the possibility of donor infection A common feature of all biologicals of animal or human origin is the potential risk of viral contamination from the source material. Recombinant DNA technology provides an alternative source of biological materials that have applications throughout medicine. Micro capsules prepared from recombinant human serum albumin (r H S A) are currently under development as ultrasound contrast agents. Similar products would serve as an alternative source of material to serum albumin pooled from human donors and would offer great potential in the production of radio pharmaceuticals. There is a growing interest in the use of macromolecular carriers for therapeutic agents. When labelled with and appropriate gamma-emitter, their biodistribution can be be followed by scintigraphy. The biodistribution of a synthetic branched polypeptide, based on a poly-L-lysine backbone (average molecular mass 45 kDa) is described. The polymer was conjugated to diethylene triamine penta-acetic acid and labelled by chelation with Indium-111. Mice were injected i.v. with labelled material and imaged with a gamma camera with a pin hole collimator. Images showed the majority of tracer remaining in the blood poll, but about 35% appeared in the urinary bladder within 1.5 h

  16. Information Technology in Small Medium Enterprise: Logistic and Production Processes

    Directory of Open Access Journals (Sweden)

    Maurizio Pighin

    2017-01-01

    Full Text Available This paper presents and discuss a survey which describes how small-medium enterprises (SMEs implement and use their information system with respect to their logistic and production processes. The study first describes the rationale of the research, then it identifies the characteristics of the companies and detects their general attitude towards information technology (IT. In the following section the paper presents a set of detailed processes to verify the structure and workflow of companies and how IT supports their processes. In the last part we study the influence of some company characteristics to effective use of processes and to different technological approaches, to support defined logistic and production processes. The novelty of the study and its interest, both in academic and institutional context as in the real world, resides in the opportunity to verify and understand the different attitudes of SMEs towards information technology in defining, organizing, planning and control their processes.

  17. 76 FR 37814 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs...

    Science.gov (United States)

    2011-06-28

    ... laboratory studies with good laboratory practices, (4) name and address of each clinical investigator, (5... assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected... technology. New Animal Drugs for Investigational Uses--21 CFR Part 511 (OMB Control Number 0910-0117...

  18. The quality of Dutch hospital drug formularies : Evaluation of technical features and organisational information

    NARCIS (Netherlands)

    Fijn, R; de Vries, CS; Engles, SAG; Brouwers, JRBJ; de Blaey, CJ; de Jong-van den Berg, LTW

    Introduction: Hospital drug formularies (HDFs) are widely used tools to help influence clinicians' prescribing behaviour. Besides the therapeutic quality of HDFs, the available information and the way in which this is presented are key factors in HDFs' success or failure to influence prescribing

  19. Database dedicated to information published during the Benelux conferences on hormone and veterinary drug residue analyses

    NARCIS (Netherlands)

    Impens, S.; Brabander, H.F. de; Bergwerff, A.A.; Ginkel, L.A. van; Schilt, R.; Stephany, R.W.; Wasch, K. de; Courtheyn, D.; Peteghem, C. van

    2002-01-01

    Every other year scientists working in the field of residue analysis participate the "International Symposium on Hormone and Veterinary Drug Residue Analysis" and "Euroresidue" conferences. In each symposium a lot of innovative information is presented. In order to obtain a retrieval system for this

  20. Health information technology vendor selection strategies and total factor productivity.

    Science.gov (United States)

    Ford, Eric W; Huerta, Timothy R; Menachemi, Nir; Thompson, Mark A; Yu, Feliciano

    2013-01-01

    The aim of this study was to compare health information technology (HIT) adoption strategies' relative performance on hospital-level productivity measures. The American Hospital Association's Annual Survey and Healthcare Information and Management Systems Society Analytics for fiscal years 2002 through 2007 were used for this study. A two-stage approach is employed. First, a Malmquist model is specified to calculate hospital-level productivity measures. A logistic regression model is then estimated to compare the three HIT adoption strategies' relative performance on the newly constructed productivity measures. The HIT vendor selection strategy impacts the amount of technological change required of an organization but does not appear to have either a positive or adverse impact on technical efficiency or total factor productivity. The higher levels in technological change experienced by hospitals using the best of breed and best of suite HIT vendor selection strategies may have a more direct impact on the organization early on in the process. However, these gains did not appear to translate into either increased technical efficiency or total factor productivity during the period studied. Over a longer period, one HIT vendor selection strategy may yet prove to be more effective at improving efficiency and productivity.

  1. New information on world uranium resource, production, supply and demand

    International Nuclear Information System (INIS)

    Zhang Jianguo; Meng Jin

    2006-01-01

    New information on world uranium resource, production, supply and demand is introduced. Up to now, explored uranium resources at production cost < USD 40/kg U has 2523257 t uranium; production cost < USD 80/kg U has 5911514 t uranium; production cost < USD130/kg U has 11280488 t uranium; and cost range unassigned has 3102000 t uranium. At moment, the demand uranium of each year is about 67000 t U. After 2020, world uranium demand will rise well above 100000 t per annum with sharp revival of nuclear power plants. With three kinds of economic growth the cumulative requirement of the uranium in low demand case, middle demand case and high demand case from 2000 to 2050 is 3390000, 5394100 and 7577300 t respectively. In the world market uranium price rises from 20 years lowest 18.2 USD/kg U to 75.4 USD/kg U. In 2003, global uranium product is about 35385 t U, and 2004, global uranium product is about 40475 t U. In 2004's world uranium production underground mining, open pit, in situ, by product, and combination account for 39%, 27%, 19%, 11% and 4% respectively. (authors)

  2. Drug Development Process

    Science.gov (United States)

    ... Preclinical Research Preclinical Research Drugs undergo laboratory and animal testing to answer basic questions about safety. More Information ... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  3. Investigation of drug products received for analysis in the Swedish STRIDA project on new psychoactive substances.

    Science.gov (United States)

    Bäckberg, Matilda; Jönsson, Karl-Henrik; Beck, Olof; Helander, Anders

    2018-02-01

    The web-based open sale of unregulated new psychoactive substances (NPS) has shown a steady increase in recent years. Analysis of drug products sold as NPS is useful to confirm the true chemical contents, for comparison with the substances detected in corresponding body fluids, but also to study drug trends. This work describes the examination of 251 drug products that were randomly submitted for analysis in 173 cases of suspected NPS-related intoxications in the Swedish STRIDA project in 2010-2015. Of the products, 39% were powders/crystals, 32% tablets/capsules, 16% herbal materials, 8% liquids, 1% blotters, and 4% others. The analysis involved tandem mass spectrometry and nuclear magnetic resonance spectroscopy. In 88 products (35%), classic psychoactive substances, prescription pharmaceuticals, dietary supplements, or doping agents were found; however, in none of these cases had an NPS-related intoxication been indicated from product markings or patient self-reports. Another 12 products tested negative for psychoactive substances. The remaining 151 products contained 86 different NPS (30% contained ≥2 substances). In 104 drug products, a specific NPS ingredient was indicated based on labelling (69%) or patient self-report; in 92 cases this was also analytically confirmed to be correct. Overall, the NPS products submitted for analysis in the STRIDA project showed a high degree of consistency between suspected and actual content (88%). The results of related urine and/or blood analysis further demonstrated that the patients commonly (89%) tested positive for the indicated NPS, but also revealed that polysubstance intoxication was common (83%), indicating use of additional drug products. Copyright © 2017 John Wiley & Sons, Ltd.

  4. Sample preparation composite and replicate strategy for assay of solid oral drug products.

    Science.gov (United States)

    Harrington, Brent; Nickerson, Beverly; Guo, Michele Xuemei; Barber, Marc; Giamalva, David; Lee, Carlos; Scrivens, Garry

    2014-12-16

    In pharmaceutical analysis, the results of drug product assay testing are used to make decisions regarding the quality, efficacy, and stability of the drug product. In order to make sound risk-based decisions concerning drug product potency, an understanding of the uncertainty of the reportable assay value is required. Utilizing the most restrictive criteria in current regulatory documentation, a maximum variability attributed to method repeatability is defined for a drug product potency assay. A sampling strategy that reduces the repeatability component of the assay variability below this predefined maximum is demonstrated. The sampling strategy consists of determining the number of dosage units (k) to be prepared in a composite sample of which there may be a number of equivalent replicate (r) sample preparations. The variability, as measured by the standard error (SE), of a potency assay consists of several sources such as sample preparation and dosage unit variability. A sampling scheme that increases the number of sample preparations (r) and/or number of dosage units (k) per sample preparation will reduce the assay variability and thus decrease the uncertainty around decisions made concerning the potency of the drug product. A maximum allowable repeatability component of the standard error (SE) for the potency assay is derived using material in current regulatory documents. A table of solutions for the number of dosage units per sample preparation (r) and number of replicate sample preparations (k) is presented for any ratio of sample preparation and dosage unit variability.

  5. A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design.

    Science.gov (United States)

    Martin-Moe, Sheryl; Lim, Fredric J; Wong, Rita L; Sreedhara, Alavattam; Sundaram, Jagannathan; Sane, Samir U

    2011-08-01

    Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more controls in the drug manufacturing processes, especially for biological therapeutics, and it has recently launched an initiative for Pharmaceutical Quality for the 21st Century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have been mainly focused on active pharmaceutical ingredient processes with little emphasis on drug product development. We present a systematic approach to biopharmaceutical drug product development using a monoclonal antibody as an example. The approach presented herein leverages scientific understanding of products and processes, risk assessments, and rational experimental design to deliver processes that are consistent with QbD philosophy without excessive incremental effort. Data generated using these approaches will not only strengthen data packages to support specifications and manufacturing ranges but hopefully simplify implementation of postapproval changes. We anticipate that this approach will positively impact cost for companies, regulatory agencies, and patients, alike. Copyright © 2011 Wiley-Liss, Inc.

  6. 78 FR 72840 - Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B...

    Science.gov (United States)

    2013-12-04

    ... reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product'' (section 503A... because it included restrictions on the advertising or promotion of the compounding of any particular drug... effect on the safety or effectiveness of that drug product. In addition, the DQSA adds a new section 503B...

  7. 21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Science.gov (United States)

    2010-04-01

    ... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...

  8. 21 CFR 310.548 - Drug products containing colloidal silver ingredients or silver salts offered over-the-counter...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing colloidal silver... Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease. (a) Colloidal silver ingredients and silver salts have...

  9. Commercial products that convey personal health information in emergencies.

    Science.gov (United States)

    Potini, Vishnu C; Weerasuriya, Dilani N; Lowery-North, Douglas W; Kellermann, Arthur L

    2011-12-01

    Describe commercially available products and services designed to convey personal health information in emergencies. The search engine Google®, supplemented by print ads, was used to identify companies and organizations that offer relevant products and services to the general market. Disease-specific, health system, and health plan-specific offerings were excluded. Vendor web sites were the primary sources of information, supplemented by telephone and e-mail queries to sales representatives. Perfect inter-rater agreement was achieved. Thirty-nine unique vendors were identified. Eight sell engraved jewelry. Three offer an embossed card or pamphlet. Twelve supply USB drives with various features. Eleven support password-protected web sites. Five maintain national call centers. Available media differed markedly with respect to capacity and accessibility. Quoted prices ranged from a one-time expenditure of $3.50 to an annual fee of $200. Associated features and annual fees varied widely. A wide range of products and services exist to help patients convey personal health information. Health care providers should be familiar with their features, so they can access the information in a disaster or emergency.

  10. Real time information management for improving productivity in metallurgical complexes

    International Nuclear Information System (INIS)

    Bascur, O.A.; Kennedy, J.P.

    1999-01-01

    Applying the latest information technologies in industrial plants has become a serious challenge to management and technical teams. The availability of real time and historical operations information to identify the most critical part of the processing system from mechanical integrity is a must for global plant optimization. Expanded use of plant information on the desktop is a standard tool for revenue improvement, cost reduction, and adherence to production constraints. The industrial component desktop supports access to information for process troubleshooting, continuous improvement and innovation by plant and staff personnel. Collaboration between groups enables the implementation of an overall process effectiveness index based on losses due to equipment availability, production and product quality. The key to designing technology is to use the Internet based technologies created by Microsoft for its marketplace-office automation and the Web. Time derived variables are used for process analysis, troubleshooting and performance assessment. Connectivity between metallurgical complexes, research centers and their business system has become a reality. Two case studies of large integrated mining/metallurgical complexes are highlighted. (author)

  11. The Use of Economic Evidence to Inform Drug Pricing Decisions in Jordan.

    Science.gov (United States)

    Hammad, Eman A

    2016-01-01

    Drug pricing is an example of a priority setting in a developing country with official requirements for the use of cost-effectiveness (CE) evidence. To describe the role of economic evidence in drug pricing decisions in Jordan. A prospective review of all applications submitted between November 2013 and May 2015 to the Jordan Food and Drug Association's drug pricing committee was carried out. All applications that involved requests for CE evidence were reviewed. Details on the type of study, the extent, and whether the evidence submitted was part of the formal deliberations were extracted and summarized. The committee reviewed a total of 1608 drug pricing applications over the period of the study. CE evidence was requested in only 11 applications. The submitted evidence was of limited use to the committee due to concerns about quality, relevance of studies, and lack of pharmacoeconomic expertise. There were also no clear rules describing how CE would inform pricing decisions. Limited local data and health economic experience were the main barriers to the use of economic evidence in drug pricing decisions in Jordan. In addition, there are no official rules describing the elements and process by which the CE evidence would inform drug pricing decisions. This study summarized accumulated observations for the current use of economic evaluations and evidence-based decision making in Jordan. Recommendations have been proposed to applicants and key decision makers to enhance the role of economic evidence in influencing health policies and evidence-based decision making across priority settings. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  12. Microvesicle formulations used in topical drugs and cosmetics affect product efficiency, performance and allergenicity

    DEFF Research Database (Denmark)

    Madsen, Jakob Torp; Ejner Andersen, Klaus

    2010-01-01

    transdermal delivery more efficient for a number of drugs. Vesicular systems may also allow a more precise drug delivery to the site of action (ie, the hair follicles) and thereby minimize the applied drug concentration, reducing potential side effects. On the other hand, this may increase the risk of other......Attempts to improve the formulations of topical products are continuing processes (ie, to increase cosmetic performance, enhance effects, and protect ingredients from degradation). The development of micro- and nanovesicular systems has led to the marketing of topical drugs and cosmetics that use...... these technologies. Several articles have reported improved clinical efficacy by the encapsulation of pharmaceuticals in vesicular systems, and the numbers of publications and patents are rising. Some vesicular systems may deliver the drug deeper in the skin as compared to conventional vehicles, or even make...

  13. Stability of Reconstituted Telavancin Drug Product in Frozen Intravenous Bags.

    Science.gov (United States)

    Gu, Zhengtian; Wong, Anissa; Raquinio, Elvira; Nguyen, Alice

    2015-07-01

    Intravenous (IV) infusions of telavancin for injection are generally administered in-hospital, but in some circumstances they may be administered in an outpatient environment. In that setting, antibiotics may be premixed and frozen. This study determined the chemical stability of nonpreserved telavancin in various commonly used reconstitution diluents stored in IV bags (polyvinyl chloride [PVC] and PVC-free) at -20°C (-4°F) without light. Telavancin (750 mg/vial) was reconstituted with 5% dextrose injection USP (D5W) or 0.9% sodium chloride injection USP (NS) to obtain drug solutions at approximately 15 mg/mL. Infusion solutions of telavancin at diluted concentrations of 0.6 mg/mL and 8.0 mg/mL covering the range utilized in clinical practice were prepared in both PVC and PVC-free IV bags using D5W or NS solutions. The infusion solutions were stored under frozen conditions (-20°C ± 5°C [-4°F ± 41°F]) and the chemical stability was evaluated for up to 32 days. Telavancin concentration, purity, and degradant levels were determined using a stability-indicating high-performance liquid chromatography (HPLC) method. Telavancin IV infusion solutions in D5W or NS at 0.6 mg/mL and 8 mg/mL and stored at -20°C (-4°F) met the chemical stability criteria when tested on days 0, 7, 14, and 32. The assayed telavancin concentration at each time point was within 97% to 103% of the initial mean assay value. The total degradants quantified by the HPLC stability-indicating method did not show any significant change over the 32-day study period. Telavancin IV infusion solutions (in D5W or NS) in both PVC and PVC-free IV bags were stable for at least 32 days when stored at -20°C (-4°F) without light. These results provide prolonged frozen stability data further to that previously established for 7 days under refrigerated conditions (2°C-8°C [36°F -46°F]), and for 12 hours at room temperature when diluted into IV bags containing D5W, NS, or lactated Ringer's solution.

  14. Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

    Science.gov (United States)

    Uppal, Navjeet K; Dupuis, Lee L; Parshuram, Christopher S

    2008-01-01

    To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs. We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada. A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary. We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.

  15. Characterization of Complementary and Alternative Medicine-Related Consultations in an Academic Drug Information Service.

    Science.gov (United States)

    Gregory, Philip J; Jalloh, Mohamed A; Abe, Andrew M; Hu, James; Hein, Darren J

    2016-12-01

    To characterize requests received through an academic drug information consultation service related to complementary and alternative medicines. A retrospective review and descriptive analysis of drug information consultations was conducted. A total of 195 consultations related to complementary and alternative medicine were evaluated. All consultation requests involved questions about dietary supplements. The most common request types were related to safety and tolerability (39%), effectiveness (38%), and therapeutic use (34%). Sixty-eight percent of the requests were from pharmacists. The most frequent consultation requests from pharmacists were questions related to drug interactions (37%), therapeutic use (37%), or stability/compatibility/storage (34%). Nearly 60% of complementary and alternative medicine-related consultation requests were able to be completely addressed using available resources. Among review sources, Natural Medicines Comprehensive Database, Clinical Pharmacology, Micromedex, and Pharmacist's Letter were the most common resources used to address consultations. Utilization of a drug information service may be a viable option for health care professionals to help answer a complementary and alternative medicine-related question. Additionally, pharmacists and other health care professionals may consider acquiring resources identified to consistently answering these questions. © The Author(s) 2015.

  16. Ethnic hair care products may increase false positives in hair drug testing.

    Science.gov (United States)

    Kidwell, David A; Smith, Frederick P; Shepherd, Arica R

    2015-12-01

    The question of why different races appear more susceptible to hair contamination by external drugs remains controversial. This research studied susceptibility of head hair to external cocaine and methamphetamine when hair products have been applied. Three different chemical classes of ethnic hair products were applied to Caucasian, Asian, and African hair. Some products increased the methamphetamine and cocaine concentrations in all hair types. A unique finding of this research is that certain ethnic hair products can replace moisture as a diffusion medium, thereby increasing the susceptibility to contamination over 100-fold compared to petroleum-based products. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Harnessing the potential of natural products in drug discovery from a cheminformatics vantage point.

    Science.gov (United States)

    Rodrigues, Tiago

    2017-11-15

    Natural products (NPs) present a privileged source of inspiration for chemical probe and drug design. Despite the biological pre-validation of the underlying molecular architectures and their relevance in drug discovery, the poor accessibility to NPs, complexity of the synthetic routes and scarce knowledge of their macromolecular counterparts in phenotypic screens still hinder their broader exploration. Cheminformatics algorithms now provide a powerful means of circumventing the abovementioned challenges and unlocking the full potential of NPs in a drug discovery context. Herein, I discuss recent advances in the computer-assisted design of NP mimics and how artificial intelligence may accelerate future NP-inspired molecular medicine.

  18. Combinative Particle Size Reduction Technologies for the Production of Drug Nanocrystals

    Directory of Open Access Journals (Sweden)

    Jaime Salazar

    2014-01-01

    Full Text Available Nanosizing is a suitable method to enhance the dissolution rate and therefore the bioavailability of poorly soluble drugs. The success of the particle size reduction processes depends on critical factors such as the employed technology, equipment, and drug physicochemical properties. High pressure homogenization and wet bead milling are standard comminution techniques that have been already employed to successfully formulate poorly soluble drugs and bring them to market. However, these techniques have limitations in their particle size reduction performance, such as long production times and the necessity of employing a micronized drug as the starting material. This review article discusses the development of combinative methods, such as the NANOEDGE, H 96, H 69, H 42, and CT technologies. These processes were developed to improve the particle size reduction effectiveness of the standard techniques. These novel technologies can combine bottom-up and/or top-down techniques in a two-step process. The combinative processes lead in general to improved particle size reduction effectiveness. Faster production of drug nanocrystals and smaller final mean particle sizes are among the main advantages. The combinative particle size reduction technologies are very useful formulation tools, and they will continue acquiring importance for the production of drug nanocrystals.

  19. Evaluation and appraisal of drug information services in a rural secondary level care hospital, Anantapur, AP

    Directory of Open Access Journals (Sweden)

    Rohit Bhavsar

    2012-01-01

    Full Text Available Background: Drug Information Center (DIC is an information center which provides drug information (DI to healthcare professionals. The aim was to evaluate the performance of DIC for improving the quality and quantity of information services provided to the healthcare professionals. The service was provided free of cost to the customers. Materials and Methods: This descriptive study was conducted for the period of 6 months from February to August 2011 excluding May due to vacation. Customers were asked: how did they find the service provided to them? Was it good, satisfactory, or need improvement? There were written feedback forms to be filled by the customers, including customer satisfaction questions. The official publication of the DIC, RIPER PDIC Bulletin was screened for its types of articles/number of drug news published. The bulletin is circulated for free to the healthcare professionals electronically. Results and Discussion: A total of 232 queries were obtained during the study period of 6 months. Average number of queried received to the DIC was 39 per month. Most preferred mode of queries was personal access (89%. Majority of queries were received from nurses, i.e., 162 (70% queries and 81% of all queries were drug oriented for improving knowledge. There were only 19% of the queries for individual patients; doctors asked most of those queries. Only 3% queries answered were rated as need improvement by the healthcare professionals. Rest were considered as either Good (56% or satisfactory (49%. Range of drug news published in each bulletin was 3-4 and most of the other articles include expert opinion to improve practice or training. Conclusion: The DI services were satisfactorily used for academic interests. Nurses used the service for the highest compared to other health care professionals. Future studies should plan to establish the usefulness of DI to improve healthcare practice.

  20. 78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

    Science.gov (United States)

    2013-11-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1038... information on the formulation, manufacturing, and labeling of currently marketed over- the-counter (OTC... hearing will be held on March 7, 2014, from 9 a.m. to 5 p.m. Submit electronic or written requests to make...

  1. 49 CFR 40.321 - What is the general confidentiality rule for drug and alcohol test information?

    Science.gov (United States)

    2010-10-01

    ... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Confidentiality and Release of Information § 40.321 What is the general confidentiality rule for drug and alcohol test... DOT drug or alcohol testing process, you are prohibited from releasing individual test results or...

  2. 49 CFR 40.323 - May program participants release drug or alcohol test information in connection with legal...

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false May program participants release drug or alcohol... the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING... information pertaining to an employee's drug or alcohol test without the employee's consent in certain legal...

  3. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] 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...

  4. Transit and lifespan in neutrophil production: implications for drug intervention.

    Science.gov (United States)

    Câmara De Souza, Daniel; Craig, Morgan; Cassidy, Tyler; Li, Jun; Nekka, Fahima; Bélair, Jacques; Humphries, Antony R

    2018-02-01

    A comparison of the transit compartment ordinary differential equation modelling approach to distributed and discrete delay differential equation models is studied by focusing on Quartino's extension to the Friberg transit compartment model of myelosuppression, widely relied upon in the pharmaceutical sciences to predict the neutrophil response after chemotherapy, and on a QSP delay differential equation model of granulopoiesis. An extension to the Quartino model is provided by considering a general number of transit compartments and introducing an extra parameter that allows for the decoupling of the maturation time from the production rate of cells. An overview of the well established linear chain technique, used to reformulate transit compartment models with constant transit rates as distributed delay differential equations (DDEs), is then given. A state-dependent time rescaling of the Quartino model is performed to apply the linear chain technique and rewrite the Quartino model as a distributed DDE, yielding a discrete DDE model in a certain parameter limit. Next, stability and bifurcation analyses are undertaken in an effort to situate such studies in a mathematical pharmacology context. We show that both the original Friberg and the Quartino extension models incorrectly define the mean maturation time, essentially treating the proliferative pool as an additional maturation compartment. This misspecification can have far reaching consequences on the development of future models of myelosuppression in PK/PD.

  5. Drug Facts

    Medline Plus

    Full Text Available ... Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used Drugs in the Past Drug Use ... Videos Information About Drugs Alcohol ...

  6. Sample preparation composite and replicate strategy case studies for assay of solid oral drug products.

    Science.gov (United States)

    Nickerson, Beverly; Harrington, Brent; Li, Fasheng; Guo, Michele Xuemei

    2017-11-30

    Drug product assay is one of several tests required for new drug products to ensure the quality of the product at release and throughout the life cycle of the product. Drug product assay testing is typically performed by preparing a composite sample of multiple dosage units to obtain an assay value representative of the batch. In some cases replicate composite samples may be prepared and the reportable assay value is the average value of all the replicates. In previously published work by Harrington et al. (2014) [5], a sample preparation composite and replicate strategy for assay was developed to provide a systematic approach which accounts for variability due to the analytical method and dosage form with a standard error of the potency assay criteria based on compendia and regulatory requirements. In this work, this sample preparation composite and replicate strategy for assay is applied to several case studies to demonstrate the utility of this approach and its application at various stages of pharmaceutical drug product development. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

    Science.gov (United States)

    Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

    2018-01-01

    Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

  8. Concurrent Use of Conventional Drugs with Chinese Herbal Products in Taiwan: A Population-based Study

    Directory of Open Access Journals (Sweden)

    Ming-Chen Chen

    2013-10-01

    Full Text Available The increased use of Chinese herbal products (CHPs worldwide has raised the concern of herb–drug interactions. The aim of this study was to determine the prevalence and utilization patterns of concurrent use of conventional drugs and CHPs in Taiwan. The usage and frequency of services in the co-prescription of a CHP and a conventional drug were evaluated. Subjects were recruited from a simple random sample of 1,000,000 subjects from over 22 million beneficiaries of the National Health Insurance in 2007. The logistic regression method was employed to estimate the odds ratios (ORs for the co-prescription of a CHP and a conventional drug (CH+D and a conventional drug alone (D-alone. The prevalence of the CH+D was 14.1%. Females, regular salary earners, and elderly (65 years and above were more likely to consume a CHP and a conventional drug concurrently. Painkillers, especially acetaminophen, and anti-cough medicines were the top two conventional drugs that were most frequently co-prescribed with a CHP. Anti-cough medication is the most common conventional drug co-prescribed with CHP, after painkillers. We recommend that safety issues be investigated in future research and integrating both healthcare technologies may be beneficial for the overall health and quality of life of patients.

  9. Dynamic products shaping information to engage and persuade

    CERN Document Server

    Colombo, Sara

    2016-01-01

    This book explores how dynamic changes in products' sensory features can be used to convey information to the user in an effective and engaging way. The aim is to supply the reader with a clear understanding of an important emerging area of research and practice in product design, referred to as dynamic products, which is opening up new possibilities for the integration of product design with digital and smart technologies and offering an alternative to the use of digital interfaces. Dynamic products are artifacts displaying sensory characteristics – visual, tactile, auditory, or olfactory – that change in a proactive and reversible way over time, addressing one or more of the user's senses. The reader will learn why and how to communicate by means of such dynamic products. Their potential advantages and limitations are identified and design tools are proposed to support the design activity. It is hoped that the book will stimulate the design community to reflect upon the ever more compelling need to merg...

  10. Predicting visual attention to nutrition information on food products: the influence of motivation and ability.

    Science.gov (United States)

    Turner, Monique Mitchell; Skubisz, Christine; Pandya, Sejal Patel; Silverman, Meryl; Austin, Lucinda L

    2014-09-01

    Obesity is linked to numerous diseases including heart disease, diabetes, and cancer. To address this issue, food and beverage manufacturers as well as health organizations have developed nutrition symbols and logos to be placed on the front of food packages to guide consumers to more healthful food choices. In 2010, the U.S. Food and Drug Administration requested information on the extent to which consumers notice, use, and understand front-of-package nutrition symbols. In response, this study used eye-tracking technology to explore the degree to which people pay visual attention to the information contained in food nutrition labels and front-of-package nutrition symbols. Results indicate that people with motivation to shop for healthful foods spent significantly more time looking at all available nutrition information compared to people with motivation to shop for products on the basis of taste. Implications of these results for message design, food labeling, and public policy are discussed.

  11. Production and transfer of energy and information in Hamiltonian systems.

    Directory of Open Access Journals (Sweden)

    Chris G Antonopoulos

    Full Text Available We present novel results that relate energy and information transfer with sensitivity to initial conditions in chaotic multi-dimensional Hamiltonian systems. We show the relation among Kolmogorov-Sinai entropy, Lyapunov exponents, and upper bounds for the Mutual Information Rate calculated in the Hamiltonian phase space and on bi-dimensional subspaces. Our main result is that the net amount of transfer from kinetic to potential energy per unit of time is a power-law of the upper bound for the Mutual Information Rate between kinetic and potential energies, and also a power-law of the Kolmogorov-Sinai entropy. Therefore, transfer of energy is related with both transfer and production of information. However, the power-law nature of this relation means that a small increment of energy transferred leads to a relatively much larger increase of the information exchanged. Then, we propose an "experimental" implementation of a 1-dimensional communication channel based on a Hamiltonian system, and calculate the actual rate with which information is exchanged between the first and last particle of the channel. Finally, a relation between our results and important quantities of thermodynamics is presented.

  12. Student and faculty perspective toward the role and value of integration of natural product information into the pharmacy curriculum.

    Science.gov (United States)

    Kostka-Rokosz, Maria D; Dvorkin-Camiel, Lana; Asabigi, Amina-Louise

    2011-03-01

    Consumer use of natural products is a mainstay in our society and continues to grow in prevalence. As pharmacists are viewed as drug experts and are easily accessible to patients, it is important for them to have basic knowledge of natural products. Students and faculty members participating in a natural product elective were surveyed upon completion of the course about their perspectives regarding incorporation of covered information into the required curriculum. The majority of students and faculty members agree with the necessity of natural product content in the pharmacy curriculum. Their ideas for ways of incorporating this information, however, differ. Healthcare students and faculty are beginning to recognize the need for incorporation of Natural Product information into the curriculum and healthcare programs in the country should begin to rise to the occasion.

  13. Informed Design to Robotic Production Systems; Developing Robotic 3D Printing System for Informed Material Deposition

    NARCIS (Netherlands)

    Mostafavi, S.; Bier, H.; Bodea, S.; Anton, A.M.

    2015-01-01

    This paper discusses the development of an informed Design-to-Robotic-Production (D2RP) system for additive manufacturing to achieve performative porosity in architecture at various scales. An extended series of experiments on materiality, fabrication and robotics were designed and carried out

  14. Information to Improve Public Perceptions of the Food and Drug Administration (FDA’s Tobacco Regulatory Role

    Directory of Open Access Journals (Sweden)

    Amira Osman

    2018-04-01

    Full Text Available While the Food and Drug Administration (FDA has had regulatory authority over tobacco products since 2009, public awareness of this authority remains limited. This research examines several broad types of information about FDA tobacco regulatory mission that may improve the perceptions of FDA as a tobacco regulator. Using Amazon Mechanical Turk, 1766 adults, smokers and non-smokers, were randomly assigned to view a statement about FDA regulatory authority that varied three information types in a 2 × 2 × 2 between subjects experimental design: (1 FDA’s roles in regulating tobacco (yes/no; (2 The scientific basis of regulations (yes/no; and (3 A potential protective function of regulations (yes/no. Using factorial ANOVA, we estimated the main and interactive effects of all three types of information and of smoking status on the perceptions of FDA. Participants that were exposed to information on FDA roles reported higher FDA credibility and a greater perceived knowledge of FDA than those who did not. Exposure to information about the scientific basis of regulations led to more negative views of the tobacco industry. Participants who learned of the FDA’s commitment to protecting the public reported higher FDA credibility and more positive attitudes toward regulations than those who did not learn of this commitment. We observed no significant interaction effects. The findings suggest that providing information about the regulatory roles and protective characterization of the FDA’s tobacco regulatory mission positively influence public perceptions of FDA and tobacco regulations.

  15. Prescription painkillers and controlled substances: an appraisal of drug information provided by six US pharmacies

    Directory of Open Access Journals (Sweden)

    Gill PS

    2013-02-01

    Full Text Available Preetinder S GillCollege of Technology, Eastern Michigan University, Ypsilanti, MI, USABackground: Health literacy impacts health outcomes. Health literacy is a measure of a person's competence to find, access, contextualize, and understand the information needed to make health decisions. Low levels of health literacy have been associated with poor health status. Health literacy can be enhanced by improving the readability of health literature. Misuse and abuse of prescription medicines and controlled substances is rising. It could be argued that improving the readability of the drug-information documents associated with these medicines could serve to alleviate this situation in a small, albeit incremental, manner. This paper provides a readability assessment of 71 such documents.Methods: The readability of drug-information documents associated with 12 commonly misused and abused painkiller medicines and controlled substances published by the top six US pharmacies was assessed. The Flesch-Kincaid Grade Level, Flesch Reading Ease, and Simple Measure of Gobbledygook (SMOG indices were used to assess the readability of these drug-information documents. One-way analysis of variance (ANOVA was used to compare the readability of the documents.Results: The average Flesch-Kincaid Grade Level index score was found to be 11.16. The average Flesch Reading Ease index score was found to be 45.94. The average SMOG index score was found to be 13.60. Pharmacies C and E had the best average readability scores, whereas pharmacies A and B had the worst average readability scores.Conclusion: Access, contents, and formatting of the documents were qualitatively analyzed to make recommendations to improve readability. Pharmacies C and E were used as benchmarks to identify the seven best practices. Good drug-information documents should have: (1 clear purpose, (2 limited scope, (3 summary/brief review, (4 well-placed graphics, (5 informative illustrations, (6 clean

  16. Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2016-07-01

    We have systematically identified medicinal products withdrawn worldwide because of adverse drug reactions, assessed the level of evidence used for making the withdrawal decisions, and explored the patterns of withdrawals over time. We searched PubMed, the WHO database of withdrawn products, and selected texts. We included products that were withdrawn after launch from 1950 onwards, excluding non-human and over-the-counter medicines. We assessed the levels of evidence on which withdrawals were based using the Oxford Center for Evidence Based Medicine Levels of Evidence. Of 353 medicinal products withdrawn from any country, only 40 were withdrawn worldwide. Anecdotal reports were cited as evidence for withdrawal in 30 (75%) and deaths occurred in 27 (68%). Hepatic, cardiac, and nervous system toxicity accounted for over 60% of withdrawals. In 28 cases, the first withdrawal was initiated by the manufacturer. The median interval between the first report of an adverse drug reaction that led to withdrawal and the first withdrawal was 1 year (range 0-43 years). Worldwide withdrawals occurred within 1 year after the first withdrawal in any country. In conclusion, the time it takes for drugs to be withdrawn worldwide after reports of adverse drug reactions has shortened over time. However, there are inconsistencies in current withdrawal procedures when adverse drug reactions are suspected. A uniform method for establishing worldwide withdrawal of approved medicinal products when adverse drug reactions are suspected should be developed, to facilitate global withdrawals. Rapid synthesis of the evidence on harms should be a priority when serious adverse reactions are suspected.

  17. 21 CFR 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic...

    Science.gov (United States)

    2010-04-01

    ... requirements for human drug products held by the Strategic National Stockpile. 201.26 Section 201.26 Food and... drug products held by the Strategic National Stockpile. (a) The appropriate FDA Center Director may... safety, effectiveness, or availability of such product that is or will be included in the Strategic...

  18. The effects of four different drugs administered through catheters on slime production in coagulase negative Staphylococci

    Directory of Open Access Journals (Sweden)

    J. Sedef Göçmen

    2012-12-01

    Full Text Available Objectives: Higher rate of slime production has been found in pathogen bacteria strains. Accordingly, the factors thatcontribute to higher slime production rate increase the infection risk, while the factors that reduce the slime productionrate will reduce the infection risk. The effect of some drugs that are administered through catheters in intensive careunits on slime production with coagulase negative Staphylococci was investigated.Materials and methods: In this study, the effect of four different preparations containing Glyceryl trinitrate (Perlinganit®, Dexmedetomidine (Precedex®, Esmolol (Brevibloc®, and Propofol (Propofol® on slime production of 24Staphylococcus epidermidis strains isolated from blood cultures of patients, and reference strain were investigated. Slimeproduction was determined using ‘the quantitative microdilution plaque test’ described by Christensen.Results: Under controlled medium, eight strains formed slimes, and in the media containing esmolol, glyceryl trinitrate,dexmedetomidine, and propofol slimes were positive for five, 21, 15, and 18 strains, respectively. The rate of slime productionin glyceryl trinitrate, dexmedetomidine, and propofol containing media were higher than that of the controls.Conclusions: In the light of the results of this study, it is concluded that the drugs and/or additives increase the rate ofslime production. The effects of the preparations administered through catheters on slime production should be investigated,and these effects should be kept in mind during their use. J Microbiol Infect Dis 2012; 2(4: 150-154Key words: Slime Production, Coagulase Negative Staphyloccoci, Parenteral drugs

  19. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Science.gov (United States)

    2010-10-01

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary...

  20. 40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

    Science.gov (United States)

    2010-07-01

    ... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of a...

  1. Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label.

    Science.gov (United States)

    Baldrick, Paul

    2018-01-01

    Juvenile animal testing has become an established part of drug development to support safe clinical use in the human pediatric population and for eventual drug product label use. A review of European Paediatric Investigation Plan decisions showed that from 2007 to mid-2017, 229 drugs had juvenile animal work requested, almost exclusively incorporating general toxicology study designs, in rat (57.5%), dog (8%), mouse (4.5%), monkey (4%), pig (2%), sheep (1%), rabbit (1%), hamster (0.5%), and species not specified (21.5%). A range of therapeutic areas were found, but the most common areas were infectious diseases (15%), endocrinology (13.5%), oncology (13%), neurology (11%), and cardiovascular diseases (10%). Examination of major clinical indications within these therapeutic areas showed some level of consistency in the species of choice for testing and the pediatric age that required support. Examination of juvenile animal study findings presented in product labels raises questions around how useful the data are to allow prescribing the drug to a child. It is hopeful that the new ICH S11 guideline "Nonclinical Safety Testing in Support of Development of Pediatric Medicines" currently in preparation will aid drug developers in clarifying the need for juvenile animal studies as well as in promoting a move away from toxicology studies with a conventional design. This would permit more focused testing to examine identified areas of toxicity or safety concerns and clarify the presentation/interpretation of juvenile animal study findings for proper risk assessment by a drug prescriber.

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

    Science.gov (United States)

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

    2015-08-01

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

  3. Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy.

    Science.gov (United States)

    Narhi, Linda O; Corvari, Vincent; Ripple, Dean C; Afonina, Nataliya; Cecchini, Irene; Defelippis, Michael R; Garidel, Patrick; Herre, Andrea; Koulov, Atanas V; Lubiniecki, Tony; Mahler, Hanns-Christian; Mangiagalli, Paolo; Nesta, Douglas; Perez-Ramirez, Bernardo; Polozova, Alla; Rossi, Mara; Schmidt, Roland; Simler, Robert; Singh, Satish; Spitznagel, Thomas M; Weiskopf, Andrew; Wuchner, Klaus

    2015-06-01

    Measurement and characterization of subvisible particles (defined here as those ranging in size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information generated is applied depends on the particular product development stage, the amount of material, and the time available for the analysis. In order to compare results across laboratories and products, it is important to harmonize nomenclature, experimental protocols, data analysis, and interpretation. In this manuscript on perspectives on subvisible particles in protein therapeutic drug products, we focus on the tools available for detection, characterization, and quantification of these species and the strategy around their application. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  4. Nature is the best source of anticancer drugs: Indexing natural products for their anticancer bioactivity.

    Science.gov (United States)

    Rayan, Anwar; Raiyn, Jamal; Falah, Mizied

    2017-01-01

    Cancer is considered one of the primary diseases that cause morbidity and mortality in millions of people worldwide and due to its prevalence, there is undoubtedly an unmet need to discover novel anticancer drugs. However, the traditional process of drug discovery and development is lengthy and expensive, so the application of in silico techniques and optimization algorithms in drug discovery projects can provide a solution, saving time and costs. A set of 617 approved anticancer drugs, constituting the active domain, and a set of 2,892 natural products, constituting the inactive domain, were employed to build predictive models and to index natural products for their anticancer bioactivity. Using the iterative stochastic elimination optimization technique, we obtained a highly discriminative and robust model, with an area under the curve of 0.95. Twelve natural products that scored highly as potential anticancer drug candidates are disclosed. Searching the scientific literature revealed that few of those molecules (Neoechinulin, Colchicine, and Piperolactam) have already been experimentally screened for their anticancer activity and found active. The other phytochemicals await evaluation for their anticancerous activity in wet lab.

  5. Nature is the best source of anticancer drugs: Indexing natural products for their anticancer bioactivity.

    Directory of Open Access Journals (Sweden)

    Anwar Rayan

    Full Text Available Cancer is considered one of the primary diseases that cause morbidity and mortality in millions of people worldwide and due to its prevalence, there is undoubtedly an unmet need to discover novel anticancer drugs. However, the traditional process of drug discovery and development is lengthy and expensive, so the application of in silico techniques and optimization algorithms in drug discovery projects can provide a solution, saving time and costs. A set of 617 approved anticancer drugs, constituting the active domain, and a set of 2,892 natural products, constituting the inactive domain, were employed to build predictive models and to index natural products for their anticancer bioactivity. Using the iterative stochastic elimination optimization technique, we obtained a highly discriminative and robust model, with an area under the curve of 0.95. Twelve natural products that scored highly as potential anticancer drug candidates are disclosed. Searching the scientific literature revealed that few of those molecules (Neoechinulin, Colchicine, and Piperolactam have already been experimentally screened for their anticancer activity and found active. The other phytochemicals await evaluation for their anticancerous activity in wet lab.

  6. Vaccination of chickens against coccidiosis ameliorates drug resistance in commercial poultry production

    Directory of Open Access Journals (Sweden)

    H. David Chapman

    2014-12-01

    Full Text Available Drug resistance is a problem wherever livestock are raised under intensive conditions and drugs are used to combat parasitic infections. This is particularly true for the anticoccidial agents used for the prevention of coccidiosis caused by protozoa of the apicomplexan genus Eimeria in poultry. Resistance has been documented for all the dozen or so drugs approved for use in chickens and varying levels of resistance is present for those currently employed. A possible solution may be the introduction of drug-sensitive parasites into the houses where poultry are raised so that they may replace such drug-resistant organisms. This can be achieved by utilizing live vaccines that contain strains of Eimeria that were isolated before most anticoccidial compounds were introduced. Such strains are inherently drug-sensitive. Practical proposals to achieve this objective involve the alternation of vaccination with medication (known as rotation programs in successive flocks reared in the same poultry house. A proposal for a yearly broiler production cycle involving chemotherapy and vaccination is presented. There are few, if any, examples in veterinary parasitology where it has proved possible to restore sensitivity to drugs used to control a widespread parasite. Further research is necessary to ascertain whether this can result in sustainable and long-term control of Eimeria infections in poultry.

  7. Vaccination of chickens against coccidiosis ameliorates drug resistance in commercial poultry production

    Science.gov (United States)

    Chapman, H. David; Jeffers, Thomas K.

    2014-01-01

    Drug resistance is a problem wherever livestock are raised under intensive conditions and drugs are used to combat parasitic infections. This is particularly true for the anticoccidial agents used for the prevention of coccidiosis caused by protozoa of the apicomplexan genus Eimeria in poultry. Resistance has been documented for all the dozen or so drugs approved for use in chickens and varying levels of resistance is present for those currently employed. A possible solution may be the introduction of drug-sensitive parasites into the houses where poultry are raised so that they may replace such drug-resistant organisms. This can be achieved by utilizing live vaccines that contain strains of Eimeria that were isolated before most anticoccidial compounds were introduced. Such strains are inherently drug-sensitive. Practical proposals to achieve this objective involve the alternation of vaccination with medication (known as rotation programs) in successive flocks reared in the same poultry house. A proposal for a yearly broiler production cycle involving chemotherapy and vaccination is presented. There are few, if any, examples in veterinary parasitology where it has proved possible to restore sensitivity to drugs used to control a widespread parasite. Further research is necessary to ascertain whether this can result in sustainable and long-term control of Eimeria infections in poultry. PMID:25516830

  8. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

    Science.gov (United States)

    Kesselheim, A S

    2010-06-01

    In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

  9. 78 FR 58311 - Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop...

    Science.gov (United States)

    2013-09-23

    ... public workshop must register online by December 20, 2013. Early registration is recommended because...; however, it does not alter the statutory standards for marketing approval. To gain approval, all drugs must demonstrate substantial evidence of effectiveness, safety, and product quality for the treatment...

  10. 75 FR 4973 - Registration Requirements for Importers and Manufacturers of Prescription Drug Products...

    Science.gov (United States)

    2010-02-01

    ... diverted to the clandestine manufacture of a controlled substance. Most of the ephedrine, pseudoephedrine... for-profit. Other: Not-for-profit, government agencies. Abstract: The Domestic Chemical Diversion... may be diverted in the United States for the production of illicit drugs must register with DEA...

  11. 76 FR 45267 - Determination That INVERSINE (Mecamylamine Hydrochloride) Tablet and Six Other Drug Products Were...

    Science.gov (United States)

    2011-07-28

    ... products that have been discontinued from marketing for reasons other than safety or effectiveness... From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION... listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This...

  12. 76 FR 11488 - Determination That MEGACE (Megestrol Acetate) Tablets and Nine Other Drug Products Were Not...

    Science.gov (United States)

    2011-03-02

    ... products that have been discontinued from marketing for reasons other than safety or effectiveness... for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice... document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that...

  13. 77 FR 59403 - Determination That ENDURON (methyclothiazide) Tablets and Six Other Drug Products Were Not...

    Science.gov (United States)

    2012-09-27

    ... products that have been discontinued from marketing for reasons other than safety or effectiveness... for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice... document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that...

  14. The Role of Natural Products in Drug Discovery and Development against Neglected Tropical Diseases

    Directory of Open Access Journals (Sweden)

    Peter Mubanga Cheuka

    2016-12-01

    Full Text Available Endemic in 149 tropical and subtropical countries, neglected tropical diseases (NTDs affect more than 1 billion people annually, including 875 million children in developing economies. These diseases are also responsible for over 500,000 deaths per year and are characterized by long-term disability and severe pain. The impact of the combined NTDs closely rivals that of malaria and tuberculosis. Current treatment options are associated with various limitations including widespread drug resistance, severe adverse effects, lengthy treatment duration, unfavorable toxicity profiles, and complicated drug administration procedures. Natural products have been a valuable source of drug regimens that form the cornerstone of modern pharmaceutical care. In this review, we highlight the potential that remains untapped in natural products as drug leads for NTDs. We cover natural products from plant, marine, and microbial sources including natural-product-inspired semi-synthetic derivatives which have been evaluated against the various causative agents of NTDs. Our coverage is limited to four major NTDs which include human African trypanosomiasis (sleeping sickness, leishmaniasis, schistosomiasis and lymphatic filariasis.

  15. 75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

    Science.gov (United States)

    2010-11-30

    ... the program expansion including the availability of appropriate staff and sufficient funding. 4. The...] Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product Surveillance... expansion of its Conference Cooperative Agreement Program (U13), awarded to the Engelberg Center for Health...

  16. 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

  17. Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm.

    Science.gov (United States)

    Kesisoglou, Filippos; Mitra, Amitava

    2015-09-01

    Physiologically based absorption models can be an important tool in understanding product performance and hence implementation of Quality by Design (QbD) in drug product development. In this report, we show several case studies to demonstrate the potential application of absorption modeling in rational design of drug product under the QbD paradigm. The examples include application of absorption modeling—(1) prior to first-in-human studies to guide development of a formulation with minimal sensitivity to higher gastric pH and hence reduced interaction when co-administered with PPIs and/or H2RAs, (2) design of a controlled release formulation with optimal release rate to meet trough plasma concentrations and enable QD dosing, (3) understanding the impact of API particle size distribution on tablet bioavailability and guide formulation design in late-stage development, (4) assess impact of API phase change on product performance to guide specification setting, and (5) investigate the effect of dissolution rate changes on formulation bioperformance and enable appropriate specification setting. These case studies are meant to highlight the utility of physiologically based absorption modeling in gaining a thorough understanding of the product performance and the critical factors impacting performance to drive design of a robust drug product that would deliver the optimal benefit to the patients.

  18. Cytotoxic Drugs Departments as a precondition for high-quality product

    Directory of Open Access Journals (Sweden)

    Katarzyna Głuszek

    2014-06-01

    Full Text Available Cancer control is a tremendous challenge not only for the ill patient and physicians, but also for the whole health care system. For the first time, during the European Conference of Oncology Pharmacists, the highest standards of pharmaceutical care were proposed for cancer patients. Undoubtedly, the lifestyle and prophylaxis which would enable the detection of cancer at an early stage exert an effect on the development of the disease. Cytostatics show toxic, mutagenic, oncogenic and immunosuppressive effects; therefore, their preparation should be handled by the Central Cytotoxic Drugs Department, because the majority of the drugs prepared belong to Register A. Drugs are manufactured in accordance with GMP principles. All-Polish Standards adopted by the Polish Pharmaceutical Association delineate the direction to be developed by every hospital with respect to its own procedures and instructions. The Master of Pharmacy is responsible for the preparation of cytotoxic drugs. At one bench should work an operator and an assistant. The recommended working time should not exceed 2 h without break, and 5 h daily. The person who collects cytotoxic drugs from the Central Department should use a legible sign and a stamp including the hour and date of collection. While manufacturing cytostatics for patients in daily doses it is recommended to use concentrates in the form of solutions rather than lyophilised powders, which results in the shortening of the stage of production of the drug and reduces the possibility of forming aerosols; in the case of closed infusion systems (containers for infusion liquids which are used for the production of daily doses, the cabinet should be equipped in two tight docks for dispensing. Needleless connection of the LUER-LOCK type – a recommendation of the ISOPP – guarantees a tight connection with the drug transfer port even in the case of an increase in pressure during the manufacture of drugs. To a certain extent

  19. The sources and popularity of online drug information: an analysis of top search engine results and web page views.

    Science.gov (United States)

    Law, Michael R; Mintzes, Barbara; Morgan, Steven G

    2011-03-01

    The Internet has become a popular source of health information. However, there is little information on what drug information and which Web sites are being searched. To investigate the sources of online information about prescription drugs by assessing the most common Web sites returned in online drug searches and to assess the comparative popularity of Web pages for particular drugs. This was a cross-sectional study of search results for the most commonly dispensed drugs in the US (n=278 active ingredients) on 4 popular search engines: Bing, Google (both US and Canada), and Yahoo. We determined the number of times a Web site appeared as the first result. A linked retrospective analysis counted Wikipedia page hits for each of these drugs in 2008 and 2009. About three quarters of the first result on Google USA for both brand and generic names linked to the National Library of Medicine. In contrast, Wikipedia was the first result for approximately 80% of generic name searches on the other 3 sites. On these other sites, over two thirds of brand name searches led to industry-sponsored sites. The Wikipedia pages with the highest number of hits were mainly for opiates, benzodiazepines, antibiotics, and antidepressants. Wikipedia and the National Library of Medicine rank highly in online drug searches. Further, our results suggest that patients most often seek information on drugs with the potential for dependence, for stigmatized conditions, that have received media attention, and for episodic treatments. Quality improvement efforts should focus on these drugs.

  20. DEVELOPMENT OF INFORMATION SERVICES AND PRODUCTS IN UZBEKISTAN DURING GLOBALIZATION

    Directory of Open Access Journals (Sweden)

    Feruza Khayrullaevna Sidikova

    2014-10-01

    Full Text Available The main purpose of the article is investigation of the issues of development of information services and products in Uzbekistan during globalization role of information and communicative technologies in development international business and trade. As the results of the research there revealed a connection of introducing electronic commerce and business in practice of firms, corporation and banks there conducted changes in the character of carrying out commercial and financial transactions, interrelations with partners and clients, elaborations and introduction business strategies and competition itself. In the conclusion there offered the suggestions of joining and adjusting to each other varying legislation of different countries and developing international system of taxation of Internet commerce satisfying all participants of electronic trading transactions.

  1. High availability based on production information systems research and practice

    International Nuclear Information System (INIS)

    Lu Weiping

    2010-01-01

    Through the presentation of the production information system application deployment in Qinshan Nuclear Power Co., Ltd., combined with CEAS failure to deal with, respectively, in the server (operating system), database and application software on-going monitoring and tuning of the actual cases are discussed: For the system to maintain a high availability, performance and security, not only on the server (operating system) for rational allocation and deployment, but also the need for database and application software to optimize the well-designed and sustained. (authors)

  2. Functional and Behavioral Product Information Representation and Consistency Validation for Collaboration in Product Lifecycle Activities

    Science.gov (United States)

    Baysal, Mehmet Murat

    2012-01-01

    Information models that represent the function, assembly and behavior of artifacts are critical in the conceptual development of a product and its evaluation. Much research has been conducted in this area; however, existing models do not relate function, behavior and structure in a comprehensive and consistent way. In this work, NIST's Core…

  3. Information for physicians and pharmacists about drugs that might cause dry mouth: a study of monographs and published literature.

    Science.gov (United States)

    Nguyen, Caroline T; MacEntee, Michael I; Mintzes, Barbara; Perry, Thomas L

    2014-01-01

    Over three-quarters of the older population take medications that can potentially cause dry mouth. Physicians or pharmacists rarely inform patients about this adverse effect and its potentially severe damage to the teeth, mouth and general health. The objectives of this study were to (1) identify warnings in the literature about dry mouth associated with the most frequently prescribed pharmaceutical products in Canada; and (2) consider how this information might be obtained by physicians, pharmacists and patients. Monographs on the 72 most frequently prescribed medications during 2010 were retrieved from the Compendium of Pharmaceuticals and Specialties (CPS, a standard drug information reference for physicians and pharmacists), the National Library of Medicine's 'DailyMed' database, directly from the manufacturers, and from a systematic search of biomedical journals. The CPS provided monographs for 43% of the medications, and requests to manufacturers produced the remaining monographs. Mentions of dry mouth were identified in 61% of the products (43% amongst CPS monographs; an additional 43% amongst manufacturers' monographs; 7% in the DailyMed database and 7% from biomedical journals); five medications had contradictory reports in different monographs. Nearly two-thirds (61%) of the most commonly prescribed medications can cause dry mouth, yet warnings about this adverse effect and its potentially serious consequences are not readily available to physicians, pharmacists, dentists or patients.

  4. Reforming the Regulation of Therapeutic Products in Canada: The Protecting of Canadians from Unsafe Drugs Act (Vanessa’s Law

    Directory of Open Access Journals (Sweden)

    Katherine Fierlbeck

    2016-11-01

    Full Text Available Enacted November 2014, Vanessa’s Law amends the Food and Drugs Act to give Health Canada greater powers to compel the disclosure of information, recall drugs and devices, impose fines and injunctions, and collect post-market safety information. The Act amends seriously outdated legislation that had been in place since 1954. While the explicit goals of the Act are to improve patient safety and provide transparency, it also establishes a regulatory framework that facilitates investment in the burgeoning field of biotechnology. While regulatory reform was already on the public agenda, public awareness of litigation against large pharmaceutical firms combined with the championing of the legislation by Conservative MP Terence Young, whose daughter Vanessa died from an adverse drug reaction, pushed the legislation through to implementation. Many key aspects of the Act depend upon the precise nature of supporting regulations that are still to be implemented. Despite the new powers conferred by the legislation on the Minister of Health, there is some concern that these discretionary powers may not be exercised, and that Health Canada may not have sufficient resources to take advantage of these new powers. Given experience to date since enactment, the new legislation, designed to provide greater transparency vis-à-vis therapeutic products, may actually have a chilling effect on independent scrutiny.

  5. Associations of gender and age groups on the knowledge and use of drug information resources by American pharmacists

    Directory of Open Access Journals (Sweden)

    Carvajal MJ

    2013-06-01

    Full Text Available Objectives: To explore knowledge and use of drug information resources by pharmacists and identify patterns influenced by gender and age-group classification. Methods: A survey questionnaire was mailed nationwide to 1,000 practitioners working in community (n = 500 and hospital (n = 500 settings who answer drug information questions as part of their expected job responsibilities. Responses pertaining to drug information resource use and knowledge of different types of drug-related queries, resource media preferences, and perceived adequacy of resources maintained in the pharmacy were analyzed by gender and age group. The t statistic was used to test for significant differences of means and percentages between genders and between age groups. Descriptive statistics were used to characterize other findings.Results: Gender and age group classification influenced patterns of knowledge and use of drug information resources by pharmacists. They also affected pharmacists’ perceptions of the most common types of questions prompting them to consult a drug information reference, as well as the resources consulted. Micromedex, exclusively available in electronic format, was the most commonly consulted resource overall by pharmacists. Lexi-Comp Online was the leading choice by women, preferred over Micromedex, but was not one of the top two resources selected by men. Conclusion: This study successfully identified the influence of gender and age-group classification in assessing drug information resource knowledge and use of general and specific types of drug-related queries.

  6. Associations of gender and age groups on the knowledge and use of drug information resources by American pharmacists.

    Science.gov (United States)

    Carvajal, Manuel J; Clauson, Kevin A; Gershman, Jennifer; Polen, Hyla H

    2013-04-01

    To explore knowledge and use of drug information resources by pharmacists and identify patterns influenced by gender and age-group classification. A survey questionnaire was mailed nationwide to 1,000 practitioners working in community (n = 500) and hospital (n = 500) settings who answer drug information questions as part of their expected job responsibilities. Responses pertaining to drug information resource use and knowledge of different types of drug-related queries, resource media preferences, and perceived adequacy of resources maintained in the pharmacy were analyzed by gender and age group. The t statistic was used to test for significant differences of means and percentages between genders and between age groups. Descriptive statistics were used to characterize other findings. Gender and age group classification influenced patterns of knowledge and use of drug information resources by pharmacists. They also affected pharmacists' perceptions of the most common types of questions prompting them to consult a drug information reference, as well as the resources consulted. Micromedex, exclusively available in electronic format, was the most commonly consulted resource overall by pharmacists. Lexi-Comp Online was the leading choice by women, preferred over Micromedex, but was not one of the top two resources selected by men. This study successfully identified the influence of gender and age-group classification in assessing drug information resource knowledge and use of general and specific types of drug-related queries.

  7. Development of Analytical Method and Monitoring of Veterinary Drug Residues in Korean Animal Products.

    Science.gov (United States)

    Song, Jae-Sang; Park, Su-Jeong; Choi, Jung-Yun; Kim, Jin-Sook; Kang, Myung-Hee; Choi, Bo-Kyung; Hur, Sun Jin

    2016-01-01

    This study was conducted to determine the residual amount of veterinary drugs such as meloxicam, flunixin, and tulathromycin in animal products (beef, pork, horsemeat, and milk). Veterinary drugs have been widely used in the rearing of livestock to prevent and treat diseases. A total of 152 samples were purchased from markets located in major Korean cities (Seoul, Busan, Incheon, Daegu, Daejeon, Gwangju, Ulsan and Jeju), including Jeju. Veterinary drugs were analyzed by liquid chromatography-tandem mass spectrometry according to the Korean Food Standards Code. The resulting data, which are located within 70-120% of recovery range and less than 20% of relative standard deviations, are in compliance with the criteria of CODEX. A total of five veterinary drugs were detected in 152 samples, giving a detection rate of approximately 3.3%; and no food source violated the guideline values. Our result indicated that most of the veterinary drug residues in animal products were below the maximum residue limits specified in Korea.

  8. 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

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  9. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...; (ii) Is prominently placed on the package; and (iii) Is so placed that it will be unaffected if the... product or, if the petition seeks an exemption for a drug class, the name of the drug class, and a list of...

  10. 21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What actions must I take to control the... POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) Distribution § 212.90 What actions must I take to control the distribution of PET drug products? (a) Written distribution procedures. You must establish...

  11. Czech Teratology Information Service: comparison of treatments by psychotropic and antiepileptic drugs.

    Science.gov (United States)

    Manáková, Eva; Hubicková-Heringová, Lucie; Jelínek, Richard

    2006-12-01

    Care, treatment and follow-up in psychiatric and epileptic pregnant women were compared with women inquiring Czech Teratology Information Service (CZTIS) due to other exposure to drugs during pregnancy. Data were collected by CZTIS, member of European Network of Teratology Information Services from 1996. Exposed groups were compared with pregnant women exposed to drugs which were not classified as major teratogens or hyperthermia. Groups do not vary in age, reproductive history and other parameters. We observed higher frequency of miscarriage and voluntary termination of pregnancy in the group of psychiatric patients. The number of malformation in prospective follow-up cases was lower than in control group. Chronic diseases as epilepsy or psychiatric disorders have to be treated during pregnancy. Women should obtain accurate information about possible risk before pregnancy. Co-operation is needed in these cases. Physicians should keep in mind that appropriate information is to be given to the patient according to her disease, education and comprehension of the problem. If there is any doubt they should organize help for their patients.

  12. Functional evaluation of healthcare products such as cosmetics, drugs, and foods

    International Nuclear Information System (INIS)

    Hatta, Ichiro

    2008-01-01

    The present paper surveys analytical methods recently employed in the field of healthcare products such as cosmetics, drugs, and foods by using Spring-8 facility which delivers high-intensity X-ray beams from electron cyclotron accelerator. These X-ray beams can be used to analyze atoms and their chemical state in human tissues such as skin, hair, whisker, teeth, and new developed products. Thus, a variety of products related with medical supplies, health food products, health maintenance, and preventive medicine concern this research group. Here, the results on colloidal states, such as lipid-molecule aggregates and lamellar structure type, generally present in cosmetic products and food substances, are focused and reported, specifically focusing on hair cuticle and honey cell layer of the skin regarding to cosmetic and pharmaceutical products. (S. Ohno)

  13. Trends in Deaths Involving Heroin and Synthetic Opioids Excluding Methadone, and Law Enforcement Drug Product Reports, by Census Region - United States, 2006-2015.

    Science.gov (United States)

    O'Donnell, Julie K; Gladden, R Matthew; Seth, Puja

    2017-09-01

    Opioid overdose deaths quadrupled from 8,050 in 1999 to 33,091 in 2015 and accounted for 63% of drug overdose deaths in the United States in 2015. During 2010-2015, heroin overdose deaths quadrupled from 3,036 to 12,989 (1). Sharp increases in the supply of heroin and illicitly manufactured fentanyl (IMF) are likely contributing to increased deaths (2-6). CDC examined trends in unintentional and undetermined deaths involving heroin or synthetic opioids excluding methadone (i.e., synthetic opioids)* by the four U.S. Census regions during 2006-2015. Drug exhibits (i.e., drug products) obtained by law enforcement and reported to the Drug Enforcement Administration's (DEA's) National Forensic Laboratory Information System (NFLIS) that tested positive for heroin or fentanyl (i.e., drug reports) also were examined. All U.S. Census regions experienced substantial increases in deaths involving heroin from 2006 to 2015. Since 2010, the South and West experienced increases in heroin drug reports, whereas the Northeast and Midwest experienced steady increases during 2006-2015. † In the Northeast, Midwest, and South, deaths involving synthetic opioids and fentanyl drug reports increased considerably after 2013. These broad changes in the U.S. illicit drug market highlight the urgent need to track illicit drugs and enhance public health interventions targeting persons using or at high risk for using heroin or IMF.

  14. Drug Familiarization and Therapeutic Misconception Via Direct-to-Consumer Information.

    Science.gov (United States)

    Bélisle-Pipon, Jean-Christophe; Williams-Jones, Bryn

    2015-06-01

    Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising (DTCA). However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information (DTCI) campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA.

  15. Drug information, misinformation, and disinformation on social media: a content analysis study.

    Science.gov (United States)

    Al Khaja, Khalid A J; AlKhaja, Alwaleed K; Sequeira, Reginald P

    2018-05-24

    Dissemination of misleading drug information through social media can be detrimental to the health of the public. This study, carried out in Bahrain, evaluated the truthfulness of 22 social media claims about drugs (72.7%), dietary supplements (22.7%), and toxic bisphenol-A (4.5%). They circulated on WhatsApp platform, as case studies. We categorized claims as objectively true, false, or potentially misleading. The content analysis revealed that "potentially misleading" claims were the most frequent messages (59.1%). They tend to exaggerate the efficacy or safety without sufficient evidence to substantiate claims. False claims (27.3%) were likely due to unfair competition or deception. Overall, 13.6% of the messages were objectively true claims that could withstand regulatory scrutiny. Majority of the drug-related messages on social media were potentially misleading or false claims that lacked credible evidence to support them. In the public interest, regulatory authorities should monitor such information disseminated via social media platforms.

  16. Hybrid combinations containing natural products and antimicrobial drugs that interfere with bacterial and fungal biofilms.

    Science.gov (United States)

    Zacchino, Susana A; Butassi, Estefanía; Cordisco, Estefanía; Svetaz, Laura A

    2017-12-15

    Biofilms contribute to the pathogenesis of many chronic and difficult-to eradicate infections whose treatment is complicated due to the intrinsic resistance to conventional antibiotics. As a consequence, there is an urgent need for strategies that can be used for the prevention and treatment of biofilm-associated infections. The combination therapy comprising an antimicrobial drug with a low molecular weight (MW) natural product and an antimicrobial drug (antifungal or antibacterial) appeared as a good alternative to eradicate biofilms. The aims of this review were to perform a literature search on the different natural products that have showed the ability of potentiating the antibiofilm capacity of antimicrobial drugs, to analyze which are the antimicrobial drugs most used in combination, and to have a look on the microbial species most used to prepare biofilms. Seventeen papers, nine on combinations against antifungal biofilms and eight against antibacterial biofilms were collected. Within the text, the following topics have been developed: breaf history of the discovery of biofilms; stages in the development of a biofilm; the most used methodologies to assess antibiofilm-activity; the natural products with capacity of eradicating biofilms when acting alone; the combinations of low MW natural products with antibiotics or antifungal drugs as a strategy for eradicating microbial biofilms and a list of the low MW natural products that potentiate the inhibition capacity of antifungal and antibacterial drugs against biofilms. Regarding combinations against antifungal biofilms, eight over the nine collected works were carried out with in vitro studies while only one was performed with in vivo assays by using Caenorhabditis elegans nematode. All studies use biofilms of the Candida genus. A 67% of the potentiators were monoterpenes and sesquiterpenes and six over the nine works used FCZ as the antifungal drug. The activity of AmpB and Caspo was enhanced in one and two

  17. Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.

    Science.gov (United States)

    Jenke, Dennis; Egert, Thomas; Hendricker, Alan; Castner, James; Feinberg, Tom; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank; Markovic, Ingrid

    2017-01-01

    A simulating leaching (migration) study was performed on a model container-closure system relevant to parenteral and ophthalmic drug products. This container-closure system consisted of a linear low-density polyethylene bottle (primary container), a polypropylene cap and an elastomeric cap liner (closure), an adhesive label (labeling), and a foil overpouch (secondary container). The bottles were filled with simulating solvents (aqueous salt/acid mixture at pH 2.5, aqueous buffer at pH 9.5, and 1/1 v/v isopropanol/water), a label was affixed to the filled and capped bottles, the filled bottles were placed into the foil overpouch, and the filled and pouched units were stored either upright or inverted for up to 6 months at 40 °C. After storage, the leaching solutions were tested for leached substances using multiple complementary analytical techniques to address volatile, semi-volatile, and non-volatile organic and inorganic extractables as potential leachables.The leaching data generated supported several conclusions, including that (1) the extractables (leachables) profile revealed by a simulating leaching study can qualitatively be correlated with compositional information for materials of construction, (2) the chemical nature of both the extracting medium and the individual extractables (leachables) can markedly affect the resulting profile, and (3) while direct contact between a drug product and a system's material of construction may exacerbate the leaching of substances from that material by the drug product, direct contact is not a prerequisite for migration and leaching to occur. LAY ABSTRACT: The migration of container-related extractables from a model pharmaceutical container-closure system and into simulated drug product solutions was studied, focusing on circumstances relevant to parenteral and ophthalmic drug products. The model system was constructed specifically to address the migration of extractables from labels applied to the outside of the

  18. Health care providers' use of a drug information service for pregnancy-related inquiries.

    Science.gov (United States)

    Patil, Avinash S; Patil, Neelima P; Lewis, Ashley N; Swamy, Geeta K; Murtha, Amy P

    2014-01-01

    To characterize pregnancy and lactation-related medication inquiries to a drug information center to identify classes of medications of most concern to providers. A secondary objective was to identify any trends in provider inquiries over the study period. A retrospective descriptive study of pregnancy and lactation-related inquiries to the University of North Carolina Health Care System Drug Information Center database between January 2001 and December 2010. University of North Carolina Health Care System Drug Information Center. Provider inquiries and responses were extracted and characterized by indication for treatment and reason for inquiry. Comparison of the first and second 5-year periods was performed to delineate trends. Descriptive statistics, Fisher's Exact and χ2 tests were used for analysis. Inquiry origin, time, and subject. 433 inquiries were retrieved over the study period from physicians (50%), pharmacists (21%), and nurses (18%). Inquiries were most often made during the antepartum period (34%), followed by the postpartum (28%) and preconception (22%) periods. The most frequent indications for inquiry were psychiatry (15%) and infectious diseases (14%), which remained constant throughout the study period. Safety was the most common reason for inquiry (52%). The responses provided to callers were limited due to lack of information availability 37% of the time. Psychiatry and infectious disease-related indications are the most frequent subjects of provider inquiry regarding medication use in pregnancy. Rates of inquiry remained constant throughout the past decade in most therapeutic areas. These findings are consistent with previous observations in other developed countries and suggest high-yield areas for pharmacist education.

  19. Analyses of marketplace tacrolimus drug product quality: bioactivity, NMR and LC-MS.

    Science.gov (United States)

    Sommers, Cynthia D; Pang, Eric S; Ghasriani, Houman; Berendt, Robert T; Vilker, Vincent L; Keire, David A; Boyne, Michael T

    2013-11-01

    Tacrolimus (FK506) is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Recent clinical reports suggested a significant reduction in the tacrolimus concentration/dose ratio in the plasma of liver and kidney recipients when the reference listed drug was substituted with a generic drug. In response to these concerns about switching between tacrolimus from different approved manufacturers during treatment, the FDA initiated purity, potency and quality studies of the innovator and generic tacrolimus products available in the US marketplace. A combination of analytical methods, including mass spectrometry (LC-MS), nuclear magnetic resonance (NMR) and bioactivity assay were developed and validated to assess the quality of tacrolimus. These tests measured the identity, impurities and activity of tacrolimus from active pharmaceutical ingredient (API) sources and with formulated drug product from five different approved manufactures. In addition, some testing was performed on tacrolimus capsules obtained from a non US approved Indian source. The data obtained showed no discernible difference in the impurity profiles and potency between the generic and innovator tacrolimus products. Copyright © 2013. Published by Elsevier B.V.

  20. Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015

    Directory of Open Access Journals (Sweden)

    Hsin-Chun Lee

    2018-04-01

    Full Text Available Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and eggs from food-producing animals, governments and relevant agencies established laws and regulations for the use of veterinary drugs. It is, therefore, necessary to monitor the content of residual drugs in livestock products at regular intervals to assess whether the regulations have resulted in the effective management of food product safety, and to prevent and manage sudden problems related to this issue. A 2011–2015 livestock product post-marketing monitoring program launched by the Taiwan Food and Drug Administration (TFDA inspected 1487 livestock products. Over the past 5 years, there were 34 samples identified that did not conform to the regulations; these samples included residue drugs such as β-agonists, chloramphenicols, β-lactam antibiotics, sulfa drugs, enrofloxacin, and lincomycin. Inspections of commercial livestock products with the consistent cooperation of agricultural authorities did not detect the drugs that were banned by the government, whereas the detection of other drugs decreased annually with an increase in the post-market monitoring sample size. In the future, the TFDA will continue to monitor the status of residual veterinary drugs in commercial livestock products, adjust the sampling of food products annually according to monitoring results, and closely cooperate with agricultural authorities on source management. Keywords: Agricultural authorities, Livestock products, Post-market monitoring, Veterinary drug residues

  1. Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

    Science.gov (United States)

    Seifert, Harry A; Malik, Raleigh E; Bhattacharya, Mondira; Campbell, Kevin R; Okun, Sally; Pierce, Carrie; Terkowitz, Jeffrey; Turner, J Rick; Krucoff, Mitchell W; Powell, Gregory E

    2017-12-01

    This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Testimonials and Informational Videos on Branded Prescription Drug Websites: Experimental Study to Assess Influence on Consumer Knowledge and Perceptions.

    Science.gov (United States)

    Sullivan, Helen W; O'Donoghue, Amie C; Gard Read, Jennifer; Amoozegar, Jacqueline B; Aikin, Kathryn J; Rupert, Douglas J

    2018-01-23

    Direct-to-consumer (DTC) promotion of prescription drugs can affect consumer behaviors and health outcomes, and Internet drug promotion is growing rapidly. Branded drug websites often capitalize on the multimedia capabilities of the Internet by using videos to emphasize drug benefits and characteristics. However, it is unknown how such videos affect consumer processing of drug information. This study aimed to examine how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions. We conducted an experimental study in which online panel participants with acid reflux (n=1070) or high blood pressure (n=1055) were randomly assigned to view 1 of the 10 fictitious prescription drug websites and complete a short questionnaire. On each website, we manipulated the type of video (patient testimonial, mechanism of action animation, or none) and whether the video mentioned drug risks. Participants who viewed any video were less likely to recognize drug risks presented only in the website text (P≤.01). Including risk information in videos increased participants' recognition of the risks presented in the videos (P≤.01). However, in some cases, including risk information in videos decreased participants' recognition of the risks not presented in the videos (ie, risks presented in text only; P≤.04). Participants who viewed a video without drug risk information thought that the website placed more emphasis on benefits, compared with participants who viewed the video with drug risk information (P≤.01). Compared with participants who viewed a video without drug risk information, participants who viewed a video with drug risk information thought that the drug was less effective in the high blood pressure sample (P=.03) and thought that risks were more serious in the acid reflux sample (P=.01). There were no significant differences between risk and nonrisk video conditions on other perception

  3. Internet application: production-technical information system MoNET

    International Nuclear Information System (INIS)

    Tomiga, J.

    2004-01-01

    MoNET is the production-technical information system supporting engineering, operational and maintenance processes of distribution network administrator. It utilizes the model of distribution network that is situated in the geo-space relational database. The geo-space database represents an information base of operational-technical processes. It contains elements and equipment s of the distribution network, failures, operational events, maintenance records, but also, parcels, reference planimetry, e.g. and other subjects for which is relevant the positional datum - geo-space information. MoNET is typically exploited in the fields: - evidence of the subjects and equipment of network, technical documentation; - property administration; - planning of network development, support of designing and construction; - technical calculation; - breakdown controller centre; - maintenance management. MoNET can be implemented as the desktop application, however its first benefit is derived from its usage as the intranet application MoNET WEB for the whole enterprise or organisation. This version enables an unrestricted number of end-users to enter this system. The end-users don't need any special software to enter the data of MoNet WEB application, the pre-installed Internet Explorer will do. (author)

  4. Multifaceted determinants of online non-prescription drug information seeking and the impact on consumers' use of purchase channels.

    Science.gov (United States)

    Holtgräfe, Catherine; Zentes, Joachim

    2012-06-01

    The growing importance of the Internet as an information and purchasing channel is drawing widespread attention from marketing decision makers. Nevertheless, the relevance of the Internet to the so-called self-medication market in Germany has been paid barely enough attention. Our study aims to contribute insights concerning the penetration of the Internet in this market, as well as to give an overview of the critical determinants of Internet use for non-prescription drug information seeking, such as the accessibility of professional information, trust in health professionals' opinion and the ability to search online, as well as the perceived usefulness and credibility of online non-prescription drug information. Furthermore, we demonstrate that the preferred use of the Internet as a non-prescription drug information source positively influences the choice of unconventional purchase channels for non-prescription drugs and negatively affects the use of stationary pharmacies.

  5. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ...] Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers... Solvents in Animal Drug Products; Questions and Answers.'' The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human...

  6. Product Knowledge and Product Involvement as Moderators of the Effects of Information on Purchase Decisions: A Case Study Using the Perfect Information Frontier Approach.

    Science.gov (United States)

    Bei, Lien-Ti; Widdows, Richard

    1999-01-01

    Using a 2x2x2 factorial design, data from 282 respondents illustrate that people with more product knowledge ("experts") are more likely to be persuaded by complex than simple product information. "Novices" reacted similarly to simple and complex information. The type of information provided influences purchasing decisions. (SK)

  7. Clinical efficacy and health implications of inconsistency in different production batches of antimycotic drugs in a developing country.

    Science.gov (United States)

    Ogunshe, Adenike A O; Adepoju, Adedayo A; Oladimeji, Modupe E

    2011-01-01

    This study aimed at evaluating the in vitro efficacy and health implications of inconsistencies in different production batches of antimycotic drugs. in vitro susceptibility profiles of 36 Candida spp. - C. albicans (19.4%), C. glabrata (30.6%), C. tropicalis (33.3%), and C. pseudotropicalis (16.7%) - obtained from human endocervical and high vaginal swabs (ECS/HVS) to two different batches (B1 and B2) of six antimycotic drugs (clotrimazole, doxycycline, iconazole, itraconazole, metronidazole and nystatin) was determined using modified agar well-diffusion method. None of the Candida strains had entirely the same (100%) susceptibility / resistance profiles in both batches of corresponding antimycotic drugs; while, different multiple antifungal susceptibility (MAS) rates were also recorded in batches 1 and 2 for corresponding antifungals. Only 14.3%, 27.3%, 16.7-33.3%, and 8.3-25.0% of C. albicans, C. glabrata, C. pseudotropicalis, and C. tropicalis strains, respectively, had similar susceptibility/resistance profiles toward coressponding antifungal agents in both batches; while up to 57.1% of C. albicans, 45.5% of C. glabrata, 66.7% of C. pseudotropicalis, and 50.0% of C. tropicalis strains were susceptible to one batch of antifungals but resistant to corresponding antifungals in the second batch. As high as 71.4% (C. albicans), 73.0% (C. glabrata), 50.0% (C. pseudotropicalis), and 66.74% (C. tropicalis) strains had differences of ≥ 10.0 mm among corresponding antimycotic agents. Candida strains exhibited different in vitro susceptibility / resistance patterns toward two batches of corresponding antimycotic agents, which has clinical implications on the efficacy of the drugs and treatment of patients. The findings of the present study will be of benefit in providing additional information in support of submission of drugs for registration to appropriate regulatory agencies.

  8. An introduction to the new Productivity Information Management System (PIMS)

    Science.gov (United States)

    Hull, R.

    1982-01-01

    The productivity information management system (PIMS), is described. The main objective of this computerized system is to enable management scientists to interactively explore data concerning DSN operations, maintenance and repairs, to develop and verify models for management planning. The PIMS will provide a powerful set of tools for iteratively manipulating data sets in a wide variety of ways. The initial version of PIMS will be a small scale pilot system. The following topics are discussed: (1) the motivation for developing PIMS; (2) various data sets which will be integrated by PIMS; (3) overall design of PIMS; and (4) how PIMS will be used. A survey of relevant databases concerning DSN operations at Goldstone is also included.

  9. Solar energy; Product information. Zonne-energie; Produktinformatie

    Energy Technology Data Exchange (ETDEWEB)

    Kruisheer, N

    1992-03-20

    In five brief articles product information is given on solar energy applications with special attention to the Netherlands. After an introduction on solar energy availability in the Netherlands the developments in solar boiler techniques are dealt with. Solar water heaters have advantages for the environment, and government subsidies stimulate different uses of such water heaters. Also the developments of solar cells show good prospects, not only for developing countries, but also for the industrialized countries. In brief the developments in solar energy storage and the connection of solar equipment to the grid are discussed. Finally attention is paid to the applications of passive solar energy in the housing construction, the use of transparent thermal insulation and the developments of translucent materials. 18 figs., 18 ills.

  10. Review on research of suppression male fertility and male contraceptive drug development by natural products.

    Science.gov (United States)

    Bajaj, Vijay Kumar; Gupta, Radhey S

    2013-08-01

    Male contraceptive development in the present scenario is most viable aspect of research due to uncontrolled population growth in the world. In this respect investigators are busy to find out a safe male contraceptive drug. Researchers have started their finding for a suitable drug from natural sources because these are safe and easily acceptable for common man, most of natural sources are plants and their products. In this review 137 plants and their effects on reproduction and reproductive physiology are summarized. Some of them have intense effect on male reproductive system and do not produce any side effects. Reproductive toxicological studies are also important aspects of these kinds of researches, so it is important that drugs are safe and widely acceptable. An ideal male contraceptive can influence semen, testes, hormone level, accessory reproductive organs and general physiology of animals and produced some alterations. Many plants in this review are showing antifertility as well as antispermatogenic effects, so these may be used for further study for contraceptives development but it is important to find out the mechanism of reaction and further laboratory and clinical research on some plants are needed for final male contraceptive drug development. In conclusion this review will help for finding suitable plant products for male contraceptive clinical and laboratory studies.

  11. Essential Drugs Production in Brazil, Russia, India, China and South Africa (BRICS: Opportunities and Challenges

    Directory of Open Access Journals (Sweden)

    Zoheir Ezziane

    2014-12-01

    Full Text Available The objective of this work is to elucidate various essential drugs in the Brazil, Russia, India, China and South Africa (BRICS countries. It discusses the opportunities and challenges of the existing biotech infrastructure and the production of drugs and vaccines in member states of the BRICS. This research is based on a systematic literature review between the years 2000 and 2014 of documents retrieved from the databases Embase, PubMed/Medline, Global Health, and Google Scholar, and the websites of relevant international organizations, research institutions and philanthropic organizations. Findings vary from one member state to another. These include useful comparison between the BRICS countries in terms of pharmaceuticals expenditure versus total health expenditure, local manufacturing of drugs/vaccines using technology and know-how transferred from developed countries, and biotech entrepreneurial collaborations under the umbrella of the BRICS region. This study concludes by providing recommendations to support more of inter collaborations among the BRICS countries as well as between BRICS and many developing countries to shrink drug production costs. In addition, this collaboration would also culminate in reaching out to poor countries that are not able to provide their communities and patients with cost-effective essential medicines.

  12. Comparison of Clobetasol Propionate Generics Using Simplified in Vitro Bioequivalence Method for Topical Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; de Souza, Weidson Carlos; de Souza Texeira, Leonardo; da Cunha-Filho, Marcilio Sergio Soares; Gelfuso, Guilherme Martins; Gratieri, Tais

    2017-11-20

    The aim of this paper is to propose a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or post-approval after changes to the product. Twelve clobetasol propionate (CP) formulations (six creams and six ointments) from the local market were used as a model to challenge the proposed methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction. To support the results, physicochemical tests for pH, viscosity, density and assay, as well as in vitro release were performed. Both protocols, extracting the drug from the skin using the tape-stripping technique or extracting from the full skin were capable of differentiating CP formulations. Only one formulation did not present statistical difference from the reference drug product in penetration tests and only other two oitments presented equivalent release to the reference. The proposed protocol is straightforward and reproducible. Results suggest the bioinequavalence of tested CP formulations reinforcing the necessity of such evaluations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  13. Essential drugs production in Brazil, Russia, India, China and South Africa (BRICS): opportunities and challenges.

    Science.gov (United States)

    Ezziane, Zoheir

    2014-12-01

    The objective of this work is to elucidate various essential drugs in the Brazil, Russia, India, China and South Africa (BRICS) countries. It discusses the opportunities and challenges of the existing biotech infrastructure and the production of drugs and vaccines in member states of the BRICS. This research is based on a systematic literature review between the years 2000 and 2014 of documents retrieved from the databases Embase, PubMed/Medline, Global Health, and Google Scholar, and the websites of relevant international organizations, research institutions and philanthropic organizations. Findings vary from one member state to another. These include useful comparison between the BRICS countries in terms of pharmaceuticals expenditure versus total health expenditure, local manufacturing of drugs/vaccines using technology and know-how transferred from developed countries, and biotech entrepreneurial collaborations under the umbrella of the BRICS region. This study concludes by providing recommendations to support more of inter collaborations among the BRICS countries as well as between BRICS and many developing countries to shrink drug production costs. In addition, this collaboration would also culminate in reaching out to poor countries that are not able to provide their communities and patients with cost-effective essential medicines.

  14. Descriptive Analysis of Recorded Phone Calls to Iran Drug and Poison Information Centers during 2011-2012

    Directory of Open Access Journals (Sweden)

    Talat Ghane

    2013-06-01

    Full Text Available Background: Poisoning is one of the main causes of visits to emergency departments and hospitals in Iran. Drug and Poison Information Centers (DPIC are reliable sources to guide poisoned patients and provide information about pharmaceutical agents. This study was designed to analyze recorded phone calls to Iran DPICs during 2011-2012.Methods: This was a retrospective study on phone calls to DPIC in Tehran between January 2011 and November 2012. Data including demographic features, type of poison (in case of poisoning and intention of poisoning were collected by reviewing the reported phone calls to central division of Iran DPICs in Tehran.Results: It was found that 98.5% of the phone calls were inquiries about pharmaceutical products and only 1.5% of them were associated with poisoning. 49% of poisonings reported from the DPICs in 2011was intentional, while this rate increased to 67% in 2012. Regarding toxic agents responsible for poisonings, pharmaceuticals were the most common consisting of 68.6% and 70.9% of cases in 2011 and 2012, respectively.Conclusion: Pharmaceutical products are the main causes of poisonings in Iran. Public education on safety and storage issues and also strict terms of sale should be implemented. In addition, the majority of poisonings occurred intentionally while the rate showed an increasing trend. Predisposing factors of this high rate should be studied.

  15. Analysis of the data on pregnancy and lactation provided by patient information leaflets of anti-rheumatic drugs in Argentina.

    Science.gov (United States)

    Sabando, Miguel Ormaza; Saavedra, Maira Arias; Sequeira, Gabriel; Kerzberg, Eduardo

    2018-04-01

    To analyse the level of consistency and updating of the information on pregnancy and lactation provided by patient information leaflets (PILs) of the antirheumatic drugs approved in Argentina. Inconsistencies between the 2016 EULAR Task Force recommendations on the use of anti-rheumatic drugs during pregnancy and lactation and the information provided by PILs of the same drugs approved in Argentina were analysed along with inconsistencies within the PILs of different registered trademarks of these drugs. Eighty-eight PILs of 32 drugs were analysed. Out of the 88 PILs, 50% presented information inconsistencies as to pregnancy. Medications comprised in this group were: hydroxychloroquine, sulfasalazine, azathioprine, tacrolimus, cyclosporine, NSAIDs (during the first two trimesters), celecoxib, some glucocorticoids, colchicine, and some anti-TNF drugs (etanercept, adalimumab and infliximab) during part of the pregnancy. As for lactation, 56% had information inconsistencies. Medications encompassed in this group were: hydroxychloroquine, chloroquine, sulfasalazine, azathioprine, tacrolimus, cyclosporine, NSAIDs, celecoxib, meprednisone, prednisone, colchicine, and anti-TNF drugs. Out of 17 drugs that had more than one registered trademark, information inconsistencies on pregnancy were found in the PILs of sulfasalazine, diclofenac, ibuprofen and methylprednisolone. Concerning lactation, inconsistencies were present in the PILs of hydroxychloroquine, sulfasalazine, diclofenac, ibuprofen, meprednisone, and colchicine. At least half of the PILs of anti-rheumatic drugs analysed in this study had information inconsistencies on pregnancy and lactation. This is a serious state of affairs because the consensual decision-making process between patient and professional may be compromised, which, in turn, may give rise to medical-legal issues.

  16. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' and to set timelines... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' (GFI 209) and (2) the...

  17. Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015.

    Science.gov (United States)

    Lee, Hsin-Chun; Chen, Chi-Min; Wei, Jen-Ting; Chiu, Hsiu-Yi

    2018-04-01

    Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and eggs from food-producing animals, governments and relevant agencies established laws and regulations for the use of veterinary drugs. It is, therefore, necessary to monitor the content of residual drugs in livestock products at regular intervals to assess whether the regulations have resulted in the effective management of food product safety, and to prevent and manage sudden problems related to this issue. A 2011-2015 livestock product post-marketing monitoring program launched by the Taiwan Food and Drug Administration (TFDA) inspected 1487 livestock products. Over the past 5 years, there were 34 samples identified that did not conform to the regulations; these samples included residue drugs such as β-agonists, chloramphenicols, β-lactam antibiotics, sulfa drugs, enrofloxacin, and lincomycin. Inspections of commercial livestock products with the consistent cooperation of agricultural authorities did not detect the drugs that were banned by the government, whereas the detection of other drugs decreased annually with an increase in the post-market monitoring sample size. In the future, the TFDA will continue to monitor the status of residual veterinary drugs in commercial livestock products, adjust the sampling of food products annually according to monitoring results, and closely cooperate with agricultural authorities on source management. Copyright © 2017. Published by Elsevier B.V.

  18. Accelerated approval of oncology products: the food and drug administration experience.

    Science.gov (United States)

    Johnson, John R; Ning, Yang-Min; Farrell, Ann; Justice, Robert; Keegan, Patricia; Pazdur, Richard

    2011-04-20

    We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations allowed accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. Failure to complete postapproval trials to confirm clinical benefit with due diligence could result in removal of the accelerated approval indication from the market. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in postapproval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8-12.6 years) and the mean time was 4.7 years, representing a substantial time savings in terms of earlier availability of drugs to cancer patients. Three new indications did not show clinical benefit when confirmatory postapproval trials were completed and were subsequently removed from the market or had restricted distribution plans implemented. Confirmatory trials were not completed for 14 new indications. The five longest intervals from receipt of accelerated approval to July 1, 2010, without completion of trials to confirm clinical benefit were 10.5, 6.4, 5.5, 5.5, and 4.7 years. The five longest intervals between accelerated approval and successful conversion to regular approval were 12.6, 9.7, 8.1, 7.5, and 7.4 years. Trials to confirm clinical benefit should be part of the drug development plan and should be in progress at the time of an application seeking accelerated approval to prevent an ineffective drug from remaining on the market for an unacceptable time.

  19. A workshop series using peer-grading to build drug information, writing, critical-thinking, and constructive feedback skills.

    Science.gov (United States)

    Davis, Lindsay E

    2014-12-15

    To utilize a skills-based workshop series to develop pharmacy students' drug information, writing, critical-thinking, and evaluation skills during the final didactic year of training. A workshop series was implemented to focus on written (researched) responses to drug information questions. These workshops used blinded peer-grading to facilitate timely feedback and strengthen assessment skills. Each workshop was aligned to the didactic coursework content to complement and extend learning, while bridging and advancing research, writing, and critical thinking skills. Attainment of knowledge and skills was assessed by rubric-facilitated peer grades, faculty member grading, peer critique, and faculty member-guided discussion of drug information responses. Annual instructor and course evaluations consistently revealed favorable student feedback regarding workshop value. A drug information workshop series using peer-grading as the primary assessment tool was successfully implemented and was well received by pharmacy students.

  20. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... increases FDA's authorities and responsibilities to address issues such as drug shortages, drug supply chain... and describes new standards and processes affecting drug and biologics approvals, drug supply chain... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD...

  1. Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products.

    Science.gov (United States)

    Jenke, Dennis; Castner, James; Egert, Thomas; Feinberg, Tom; Hendricker, Alan; Houston, Christopher; Hunt, Desmond G; Lynch, Michael; Shaw, Arthur; Nicholas, Kumudini; Norwood, Daniel L; Paskiet, Diane; Ruberto, Michael; Smith, Edward J; Holcomb, Frank

    2013-01-01

    Polymeric and elastomeric materials are commonly encountered in medical devices and packaging systems used to manufacture, store, deliver, and/or administer drug products. Characterizing extractables from such materials is a necessary step in establishing their suitability for use in these applications. In this study, five individual materials representative of polymers and elastomers commonly used in packaging systems and devices were extracted under conditions and with solvents that are relevant to parenteral and ophthalmic drug products (PODPs). Extraction methods included elevated temperature sealed vessel extraction, sonication, refluxing, and Soxhlet extraction. Extraction solvents included a low-pH (pH = 2.5) salt mixture, a high-pH (pH = 9.5) phosphate buffer, a 1/1 isopropanol/water mixture, isopropanol, and hexane. The resulting extracts were chemically characterized via spectroscopic and chromatographic means to establish the metal/trace element and organic extractables profiles. Additionally, the test articles themselves were tested for volatile organic substances. The results of this testing established the extractables profiles of the test articles, which are reported herein. Trends in the extractables, and their estimated concentrations, as a function of the extraction and testing methodologies are considered in the context of the use of the test article in medical applications and with respect to establishing best demonstrated practices for extractables profiling of materials used in PODP-related packaging systems and devices. Plastic and rubber materials are commonly encountered in medical devices and packaging/delivery systems for drug products. Characterizing the extractables from these materials is an important part of determining that they are suitable for use. In this study, five materials representative of plastics and rubbers used in packaging and medical devices were extracted by several means, and the extracts were analytically

  2. Regulatory Notes on Impact of Excipients on Drug Products and the Maillard Reaction.

    Science.gov (United States)

    Chowdhury, Dipak K; Sarker, Haripada; Schwartz, Paul

    2018-02-01

    In general, it is an important criterion that excipients remain inert throughout the shelf life of the formulated pharmaceutical product. However, depending on the functionality in chemical structure of active drug and excipients, they may undergo interaction. The well-known Maillard reaction occurs between a primary amine with lactose at high temperature to produce brown pigments. The reactivity of Maillard reaction may vary depending on the concentration as well as other conditions. Commercially, there are products where the active pharmaceutical ingredient is a primary amine and contains less than 75% lactose along with inactive excipients. This product does not show Maillard reaction during its shelf life of around 2 years at ambient conditions. However, when the same type of product contains more than 95 % lactose as an excipient, then there is a possibility of interactions though it is not visible in the initial year. Therefore, this regulatory note discusses involvement of different factors of a known drug-excipient interactions with case studies and provides an overview on how the concentration of lactose in the pharmaceutical product is important in addition to temperature and moisture in Maillard reaction.

  3. Batch-to-Batch Quality Consistency Evaluation of Botanical Drug Products Using Multivariate Statistical Analysis of the Chromatographic Fingerprint

    OpenAIRE

    Xiong, Haoshu; Yu, Lawrence X.; Qu, Haibin

    2013-01-01

    Botanical drug products have batch-to-batch quality variability due to botanical raw materials and the current manufacturing process. The rational evaluation and control of product quality consistency are essential to ensure the efficacy and safety. Chromatographic fingerprinting is an important and widely used tool to characterize the chemical composition of botanical drug products. Multivariate statistical analysis has showed its efficacy and applicability in the quality evaluation of many ...

  4. Lean Production and information technology : Connection or contradiction?

    NARCIS (Netherlands)

    Riezebos, Jan; Klingenberg, Warse; Hicks, Christian

    The principles of Lean Production have enabled organisations in the manufacturing and service sectors to significantly improve their competitiveness. The application of Lean principles, derived from the Toyota Production System has enabled many organisations to Simultaneously improve productivity,

  5. Ensuring and Improving Information Quality for Earth Science Data and Products: Role of the ESIP Information Quality Cluster

    Science.gov (United States)

    Ramapriyan, Hampapuram; Peng, Ge; Moroni, David; Shie, Chung-Lin

    2016-01-01

    Quality of products is always of concern to users regardless of the type of products. The focus of this paper is on the quality of Earth science data products. There are four different aspects of quality - scientific, product, stewardship and service. All these aspects taken together constitute Information Quality. With increasing requirement on ensuring and improving information quality, there has been considerable work related to information quality during the last several years. Given this rich background of prior work, the Information Quality Cluster (IQC), established within the Federation of Earth Science Information Partners (ESIP) has been active with membership from multiple organizations. Its objectives and activities, aimed at ensuring and improving information quality for Earth science data and products, are discussed briefly.

  6. Ensuring and Improving Information Quality for Earth Science Data and Products Role of the ESIP Information Quality Cluster

    Science.gov (United States)

    Ramapriyan, H. K. (Rama); Peng, Ge; Moroni, David; Shie, Chung-Lin

    2016-01-01

    Quality of products is always of concern to users regardless of the type of products. The focus of this paper is on the quality of Earth science data products. There are four different aspects of quality scientific, product, stewardship and service. All these aspects taken together constitute Information Quality. With increasing requirement on ensuring and improving information quality, there has been considerable work related to information quality during the last several years. Given this rich background of prior work, the Information Quality Cluster (IQC), established within the Federation of Earth Science Information Partners (ESIP) has been active with membership from multiple organizations. Its objectives and activities, aimed at ensuring and improving information quality for Earth science data and products, are discussed briefly.

  7. Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.

    Science.gov (United States)

    Capati, Vincent C; Kesselheim, Aaron S

    2016-04-01

    A "product hop" involves the substitution of a new formulation of a prescription drug by a pharmaceutical manufacturer for an old version to forestall generic competition. In 2015, for example, Forest Laboratories, the brand-name drug manufacturer of memantine, an Alzheimer's disease treatment, introduced an extended-release version and tried to restrict patient access to the previous version. Product hops can lead to useful incremental innovation but can also have major public health implications by disrupting patients on stable treatment regimens and increasing costs for patients and payers. This commentary reviews alleged anticompetitive product hopping in the case of memantine, which involved proposed conduct that would have left Alzheimer's disease patients with no effective choice but to transition to memantine XR. Policy solutions that can limit anticompetitive product hops include raising the bar for obtaining patents on new drug product formulations and changing automatic generic substitution laws. No outside funding supported this research. To support his work at PORTAL in the summer of 2015, Capati was the recipient of the University of New Hampshire School of Law Rudman Center Public Service Fellowship. Kesselheim's research was supported by Greenwall Faculty Scholars program, the Laura and John Arnold Foundation, and the Harvard Program in Therapeutic Science. In 2013, Kesselheim served as an expert on behalf of a class of individual plaintiffs against Warner Chilcott regarding potential antitrust violations Kesselheim was responsible for concept and design of this commentary. Capati took the lead in data collection and analysis, along with Kesselheim. Capati wrote the manuscript, which was revised by primarily by Kesselheim, along with Capati.

  8. [HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

    Science.gov (United States)

    Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

    2017-04-01

    In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

  9. Natural products against cancer: A comprehensive bibliometric study of the research projects, publications, patents and drugs

    Directory of Open Access Journals (Sweden)

    Jian Du

    2014-01-01

    Full Text Available Objectives: To analyze multi-source data including awards, publications, patents and drugs, and try to draw the whole landscape of the research and development community in the area of natural products (NPs against cancer. Materials and Methods: Awards, publications, patents and drugs data from National Institute of Health/Natural Science Foundation of China (NIH/NSFC, PubMed, Derwent Innovation Index and Cortellis were collected. Bibliometric methodologies and technology are used to investigate publications/patents/drugs, their contents and relationships. Results: NIH and NSFC respectively demonstrated a stable and sustained expenditure growth in this area. The number of publications is continuously increasing. Yet the annual patent applications worldwide and FDA drug approvals were little changed or not obviously fluctuated in 2003-2013. USA and several Asia-pacific countries/territories are important contributing powers. We described the evolution of major research topics by those MeSH Major Topics indexed in PubMed with the largest growth range in three intervals, and analyzed hot research topics in the recent 10 years which include NPs or NPs derivatives, cell line/animal model, laboratory technologies and activation mechanisms. Conclusions: China published the most publications and received the most patent applications, but drug discovery performance is no better than USA and Japan. Research on anti-neoplastic structures and compounds originated from Chinese traditional medicine (TCM, medicinal plants, herbal medicine and marine NPs are major research topics in the recent 10 years. There still exits translational gap between basic research and drug discovery. Translational research should be undertaken to strengthen the applicability of NPs.

  10. Provisional in-silico biopharmaceutics classification (BCS) to guide oral drug product development.

    Science.gov (United States)

    Wolk, Omri; Agbaria, Riad; Dahan, Arik

    2014-01-01

    The main objective of this work was to investigate in-silico predictions of physicochemical properties, in order to guide oral drug development by provisional biopharmaceutics classification system (BCS). Four in-silico methods were used to estimate LogP: group contribution (CLogP) using two different software programs, atom contribution (ALogP), and element contribution (KLogP). The correlations (r(2)) of CLogP, ALogP and KLogP versus measured LogP data were 0.97, 0.82, and 0.71, respectively. The classification of drugs with reported intestinal permeability in humans was correct for 64.3%-72.4% of the 29 drugs on the dataset, and for 81.82%-90.91% of the 22 drugs that are passively absorbed using the different in-silico algorithms. Similar permeability classification was obtained with the various in-silico methods. The in-silico calculations, along with experimental melting points, were then incorporated into a thermodynamic equation for solubility estimations that largely matched the reference solubility values. It was revealed that the effect of melting point on the solubility is minor compared to the partition coefficient, and an average melting point (162.7 °C) could replace the experimental values, with similar results. The in-silico methods classified 20.76% (± 3.07%) as Class 1, 41.51% (± 3.32%) as Class 2, 30.49% (± 4.47%) as Class 3, and 6.27% (± 4.39%) as Class 4. In conclusion, in-silico methods can be used for BCS classification of drugs in early development, from merely their molecular formula and without foreknowledge of their chemical structure, which will allow for the improved selection, engineering, and developability of candidates. These in-silico methods could enhance success rates, reduce costs, and accelerate oral drug products development.

  11. AIDSinfo Drug Database

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content Drugs Home Drugs Find information on FDA-approved HIV/ ... infection drugs and investigational HIV/AIDS drugs. Search Drugs Search drug Search Icon What's this? Close Popup ...

  12. Application of the Technology Web 2.0 in a drug information centre.

    Science.gov (United States)

    Juárez Giménez, J C; Puyal González, C; Valdivia Vadell, C; Palacio Lacambra, M E; Vidal Otero, J; Cerqueira Dapena, M J

    2011-01-01

    To develop a Web 2.0 resource map and select those that may be useful in a Drug Information Centre at a Hospital Pharmacy Department (CIMSF). A multidisciplinary working group under the Biomedical Information Commission selected some of the Web 2.0 resources included in the Guía d'usos i estil a les xarxes Socials guide of the Catalonian Government. Six resources were selected: Netvibes, Delicious, Google groups, Google Docs, Slideshare and Twitter. These tools were used for 5 months to manage biomedical information for the medical staff, and to provide external visibility by providing information to other health professionals. More than a thousand hits were recorded on the portal Netvibes and more than 100 professionals followed CIMSF on Twitter. The Web 2.0 offers useful, user-friendly and cost-efficient tools which could be implemented in a CIMSF, while also enabling participation in external networks of pharmacotherapeutic interest, increasing its visibility to other professionals. Copyright © 2011 SEFH. Published by Elsevier Espana. All rights reserved.

  13. 77 FR 14022 - Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation-Derived...

    Science.gov (United States)

    2012-03-08

    ...] Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for... to submit to support the CMC information for fermentation-derived intermediates, drug substances, and...

  14. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    Science.gov (United States)

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

  15. SAFE USE OF DRUGS DURING PREGNANCY IN FOCUS OF INTERNATIONAL PRACTICE OF PHARMACOVIGILANCE SYSTEM AND TERATOLOGICAL INFORMATION SERVICE ORGANIZATION

    Directory of Open Access Journals (Sweden)

    K. A. Lutsevich

    2012-01-01

    Full Text Available The safe use of drugs during pregnancy is essential to optimize the health of both pregnant woman and her future child. At the same time obstetrician-gynecologists often face the lack of evidence-based information on the use of drugs and leave the issue to the woman herself — whether the treatment benefit to the mother outweighs risks to the unborn child — relying on the limited amount of scientific data. Preconception discussion of actual risks and safe treatment reduces patient fears and maximizes the emphasis on the therapy safety. At the same time, the lack of adequate information on safety for the majority of drugs used by pregnant women combined with the need to make appropriate treatment decisions and communicate drug risk information to a potentially vulnerable population is the most challenging and critical issue of pregnant women's health.

  16. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Science.gov (United States)

    2010-05-24

    ... consumer product incident reports involving a description of incidents related to the use of consumer... consumer product must include a word or phrase sufficient to distinguish a product identified in a report... consumer product; or understand the relationship between the submitter of a report of harm and the victim...

  17. Information Sharing In Shipbuilding based on the Product State Model

    DEFF Research Database (Denmark)

    Larsen, Michael Holm

    1999-01-01

    The paper provides a review of product modelling technologies and the overall architecture for the Product State Model (PSM) environment as a basis for how dynamically updated product data can improve control of production activities. Especially, the paper focuses on the circumstances prevailing...

  18. Spatial scaling of net primary productivity using subpixel landcover information

    Science.gov (United States)

    Chen, X. F.; Chen, Jing M.; Ju, Wei M.; Ren, L. L.

    2008-10-01

    Gridding the land surface into coarse homogeneous pixels may cause important biases on ecosystem model estimations of carbon budget components at local, regional and global scales. These biases result from overlooking subpixel variability of land surface characteristics. Vegetation heterogeneity is an important factor introducing biases in regional ecological modeling, especially when the modeling is made on large grids. This study suggests a simple algorithm that uses subpixel information on the spatial variability of land cover type to correct net primary productivity (NPP) estimates, made at coarse spatial resolutions where the land surface is considered as homogeneous within each pixel. The algorithm operates in such a way that NPP obtained from calculations made at coarse spatial resolutions are multiplied by simple functions that attempt to reproduce the effects of subpixel variability of land cover type on NPP. Its application to a carbon-hydrology coupled model(BEPS-TerrainLab model) estimates made at a 1-km resolution over a watershed (named Baohe River Basin) located in the southwestern part of Qinling Mountains, Shaanxi Province, China, improved estimates of average NPP as well as its spatial variability.

  19. Mathematical analysis of the impact mechanism of information platform on agro-product supply chain and agro-product competitiveness

    Directory of Open Access Journals (Sweden)

    Jiang Qi-Jie

    2017-04-01

    Full Text Available How to optimize agro-product supply chain to promote its operating efficiency so as to enhance the competitiveness of regional agricultural products has posed a problem to academic circles, business circles and governments of various levels. One way to solve this problem is to introduce an information platform into the supply chain, which this essay focuses on. Firstly, a review of existing research findings concerning the agro-product competitiveness, agro-product supply chain (ASC and information platform was given. Secondly, we constructed a mathematical model to analyze the impact of information platform on the bullwhip effect in ASC. Thirdly, another mathematical model was constructed to help compare and analyze the impact of information platform on information acquisition of members in ASC. The research results show that the implantation of information platform can mitigate the bullwhip effect in ASC, and members can determine order amount or production more close to the actual market demand. And also the information platform can reduce the time for members in ASC to get information from other members. Besides, information platform can help ASC to alleviate information asymmetry among upstream and downstream members. Furthermore, researches about the operating mechanism and pattern, technical feature and running structure of the information platform, along with their impacts on agro-product supply chain and the competitiveness of agricultural products need to be advanced.

  20. Mathematical analysis of the impact mechanism of information platform on agro-product supply chain and agro-product competitiveness

    Science.gov (United States)

    Jiang, Qi-Jie; Jin, Mao-Zhu; Ren, Pei-Yu

    2017-04-01

    How to optimize agro-product supply chain to promote its operating efficiency so as to enhance the competitiveness of regional agricultural products has posed a problem to academic circles, business circles and governments of various levels. One way to solve this problem is to introduce an information platform into the supply chain, which this essay focuses on. Firstly, a review of existing research findings concerning the agro-product competitiveness, agro-product supply chain (ASC) and information platform was given. Secondly, we constructed a mathematical model to analyze the impact of information platform on the bullwhip effect in ASC. Thirdly, another mathematical model was constructed to help compare and analyze the impact of information platform on information acquisition of members in ASC. The research results show that the implantation of information platform can mitigate the bullwhip effect in ASC, and members can determine order amount or production more close to the actual market demand. And also the information platform can reduce the time for members in ASC to get information from other members. Besides, information platform can help ASC to alleviate information asymmetry among upstream and downstream members. Furthermore, researches about the operating mechanism and pattern, technical feature and running structure of the information platform, along with their impacts on agro-product supply chain and the competitiveness of agricultural products need to be advanced.

  1. Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System.

    Science.gov (United States)

    Jenke, Dennis

    2012-01-01

    An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered. Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

  2. Activation of Antibiotic Production in Bacillus spp. by Cumulative Drug Resistance Mutations.

    Science.gov (United States)

    Tojo, Shigeo; Tanaka, Yukinori; Ochi, Kozo

    2015-12-01

    Bacillus subtilis strains produce a wide range of antibiotics, including ribosomal and nonribosomal peptide antibiotics, as well as bacilysocin and neotrehalosadiamine. Mutations in B. subtilis strain 168 that conferred resistance to drugs such as streptomycin and rifampin resulted in overproduction of the dipeptide antibiotic bacilysin. Cumulative drug resistance mutations, such as mutations in the mthA and rpsL genes, which confer low- and high-level resistance, respectively, to streptomycin, and mutations in rpoB, which confer resistance to rifampin, resulted in cells that overproduced bacilysin. Transcriptional analysis demonstrated that the enhanced transcription of biosynthesis genes was responsible for the overproduction of bacilysin. This approach was effective also in activating the cryptic genes of Bacillus amyloliquefaciens, leading to actual production of antibiotic(s). Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  3. Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015

    OpenAIRE

    Hsin-Chun Lee; Chi-Min Chen; Jen-Ting Wei; Hsiu-Yi Chiu

    2018-01-01

    Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and egg...

  4. 75 FR 55676 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-09-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and...; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE 68127; and Feed Service Co., Inc., 303 Lundin Blvd... 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for 21 CFR part 520 continues to...

  5. 76 FR 17776 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-31

    ...'s Sponsor (established name of drug) drug labeler code) Roche Vitamins, Inc., 45 Waterview Blvd.... Medicator TS-40 Premix (tylosin phosphate/ sulfamethazine). Pegasus Laboratories, Inc., 8809 Ely Rd., NADA... Laboratories, Inc., 100 Nancy Dr., NADA 108-487, DEC Tabs 520.622a (015579). Belle Plaine, MN 56011...

  6. Principal component analysis as a tool for library design: a case study investigating natural products, brand-name drugs, natural product-like libraries, and drug-like libraries.

    Science.gov (United States)

    Wenderski, Todd A; Stratton, Christopher F; Bauer, Renato A; Kopp, Felix; Tan, Derek S

    2015-01-01

    Principal component analysis (PCA) is a useful tool in the design and planning of chemical libraries. PCA can be used to reveal differences in structural and physicochemical parameters between various classes of compounds by displaying them in a convenient graphical format. Herein, we demonstrate the use of PCA to gain insight into structural features that differentiate natural products, synthetic drugs, natural product-like libraries, and drug-like libraries, and show how the results can be used to guide library design.

  7. Applying the evaluability principle to nutrition table information. How reference information changes people's perception of food products.

    Science.gov (United States)

    Visschers, Vivianne H M; Siegrist, Michael

    2009-04-01

    Consumers often neglect or misinterpret nutrition table information. We argue in this paper that this can be explained by the evaluability principle, which posits that people's evaluation of a product corresponds to a greater degree with the product's actual value when people receive reference information about the product than when they do not get this information. We tested this assumption concerning nutrition table information in two studies. In Study 1, respondents received one of six nutrition tables that differed on reference and summary information about either yogurt or chocolate. In the second study, we compared three nutrition tables from the previous study, as applied to either a low nutritional value yogurt or a high nutritional value yogurt. Participants were asked to rate the attractiveness and perceived healthiness of the product in both studies. Results indicated that reference information can change people's product perception. This seems to depend, however, on the product's nutritional value and on people's primary connotation for the product. In sum, the evaluability principle can explain people's perception of a food product. A nutrition table that is adapted to this principle appears to influence people's product perception so that it becomes more in line with its nutritional value. Implications for practice and further research are given.

  8. Natural products as promising drug candidates for the treatment of Alzheimer's disease: molecular mechanism aspect.

    Science.gov (United States)

    Ansari, Niloufar; Khodagholi, Fariba

    2013-07-01

    Alzheimer's disease (AD) is the most common neurodegenerative disorder to date, with no curative or preventive therapy. Histopathological hallmarks of AD include deposition of β-amyloid plaques and formation of neurofibrillary tangles. Extent studies on pathology of the disease have made important discoveries regarding mechanism of disease and potential therapeutic targets. Many cellular changes including oxidative stress, disruption of Ca2+ homeostasis, inflammation, metabolic disturbances, and accumulation of unfolded/misfolded proteins can lead to programmed cell death in AD. Despite intensive research, only five approved drugs are available for the management of AD. Hence, there is a need to look at alternative therapies. Use of natural products and culinary herbs in medicine has gained popularity in recent years. Several natural substances with neuroprotective effects have been widely studied. Most of these compounds have remarkable antioxidant properties and act mainly by scavenging free radical species. Some of them increase cell survival and improve cognition by directly affecting amyloidogenesis and programmed cell death pathways. Further studies on these natural products and their mechanism of action, parallel with the use of novel pharmaceutical drug design and delivery techniques, enable us to offer an addition to conventional medicine. This review discussed some natural products with potential neuroprotective properties against Aβ with respect to their mechanism of action.

  9. Virtual target screening to rapidly identify potential protein targets of natural products in drug discovery

    Directory of Open Access Journals (Sweden)

    Yuri Pevzner

    2014-05-01

    Full Text Available Inherent biological viability and diversity of natural products make them a potentially rich source for new therapeutics. However, identification of bioactive compounds with desired therapeutic effects and identification of their protein targets is a laborious, expensive process. Extracts from organism samples may show desired activity in phenotypic assays but specific bioactive compounds must be isolated through further separation methods and protein targets must be identified by more specific phenotypic and in vitro experimental assays. Still, questions remain as to whether all relevant protein targets for a compound have been identified. The desire is to understand breadth of purposing for the compound to maximize its use and intellectual property, and to avoid further development of compounds with insurmountable adverse effects. Previously we developed a Virtual Target Screening system that computationally screens one or more compounds against a collection of virtual protein structures. By scoring each compound-protein interaction, we can compare against averaged scores of synthetic drug-like compounds to determine if a particular protein would be a potential target of a compound of interest. Here we provide examples of natural products screened through our system as we assess advantages and shortcomings of our current system in regards to natural product drug discovery.

  10. Virtual target screening to rapidly identify potential protein targets of natural products in drug discovery

    Directory of Open Access Journals (Sweden)

    Yuri Pevzner

    2015-08-01

    Full Text Available Inherent biological viability and diversity of natural products make them a potentially rich source for new therapeutics. However, identification of bioactive compounds with desired therapeutic effects and identification of their protein targets is a laborious, expensive process. Extracts from organism samples may show desired activity in phenotypic assays but specific bioactive compounds must be isolated through further separation methods and protein targets must be identified by more specific phenotypic and in vitro experimental assays. Still, questions remain as to whether all relevant protein targets for a compound have been identified. The desire is to understand breadth of purposing for the compound to maximize its use and intellectual property, and to avoid further development of compounds with insurmountable adverse effects. Previously we developed a Virtual Target Screening system that computationally screens one or more compounds against a collection of virtual protein structures. By scoring each compound-protein interaction, we can compare against averaged scores of synthetic drug-like compounds to determine if a particular protein would be a potential target of a compound of interest. Here we provide examples of natural products screened through our system as we assess advantages and shortcomings of our current system in regards to natural product drug discovery.

  11. On-chip microreactor system for the production of nano-emulsion loaded liposomes: towards targeted delivery of lipophilic drugs

    NARCIS (Netherlands)

    Langelaan, M.L.P.; Emmelkamp, J.; Segers, M.J.A.; Lenting, H.B.M.

    2011-01-01

    An on-chip microreactor system for the production of novel nano-biodevices is presented. This nano-biodevice consists of a nano-emulsion loaded with lipophilic drugs, entrapped in liposomes. These nano-biodevices can be equipped with targeting molecules for higher drug efficiency. The microreactor

  12. Declaration of nutrition information on and nutritional quality of Thai ready-to-eat packaged food products.

    Science.gov (United States)

    Pongutta, Suladda; Chongwatpol, Pitipa; Tantayapirak, Parwin; Vandevijvere, Stefanie

    2018-06-01

    The present study assessed the nutrition information displayed on ready-to-eat packaged foods and the nutritional quality of those food products in Thailand. In March 2015, the nutrition information panels and nutrition and health claims on ready-to-eat packaged foods were collected from the biggest store of each of the twelve major retailers, using protocols developed by the International Network for Food and Obesity/Non-communicable Diseases Research, Monitoring and Action Support (INFORMAS). The Thai Nutrient Profile Model was used to classify food products according to their nutritional quality as 'healthier' or 'less healthy'. In total, information from 7205 food products was collected across five broad food categories. Out of those products, 5707 (79·2 %), 2536 (35·2 %) and 1487 (20·6 %) carried a nutrition facts panel, a Guideline Daily Amount (GDA) label and health-related claims, respectively. Only 4691 (65·1 %) and 2484 (34·5 %) of the products that displayed the nutrition facts or a GDA label, respectively, followed the guidelines of the Thai Food and Drug Administration. In total, 4689 products (65·1 %) could be classified according to the Thai Nutrient Profile Model, of which 432 products (9·2 %) were classified as healthier. Moreover, among the 1487 products carrying health-related claims, 1219 (82·0 %) were classified as less healthy. Allowing less healthy food products to carry claims could mislead consumers and result in overconsumption of ready-to-eat food products. The findings suggest effective policies should be implemented to increase the relative availability of healthier ready-to-eat packaged foods, as well as to improve the provision of nutrition information on labels in Thailand.

  13. Information 2.0 new models of information production, distribution and consumption

    CERN Document Server

    Saulles, Martin De

    2015-01-01

    This textbook provides an overview of the digital information landscape and explains the implications of the technological changes for the information industry, from publishers and broadcasters to the information professionals who manage information in all its forms.

  14. Illicit Drug Users in the Tanzanian Hinterland: Population Size Estimation Through Key Informant-Driven Hot Spot Mapping.

    Science.gov (United States)

    Ndayongeje, Joel; Msami, Amani; Laurent, Yovin Ivo; Mwankemwa, Syangu; Makumbuli, Moza; Ngonyani, Alois M; Tiberio, Jenny; Welty, Susie; Said, Christen; Morris, Meghan D; McFarland, Willi

    2018-02-12

    We mapped hot spots and estimated the numbers of people who use drugs (PWUD) and who inject drugs (PWID) in 12 regions of Tanzania. Primary (ie, current and past PWUD) and secondary (eg, police, service providers) key informants identified potential hot spots, which we visited to verify and count the number of PWUD and PWID present. Adjustments to counts and extrapolation to regional estimates were done by local experts through iterative rounds of discussion. Drug use, specifically cocaine and heroin, occurred in all regions. Tanga had the largest numbers of PWUD and PWID (5190 and 540, respectively), followed by Mwanza (3300 and 300, respectively). Findings highlight the need to strengthen awareness of drug use and develop prevention and harm reduction programs with broader reach in Tanzania. This exercise provides a foundation for understanding the extent and locations of drug use, a baseline for future size estimations, and a sampling frame for future research.

  15. Urban runoff management information/education products. Version 1

    International Nuclear Information System (INIS)

    1993-02-01

    The catalog contains information and education material related to urban runoff, stormwater and construction activities. The material has been categorized by information media. The purpose of the catalog is to showcase existing efforts, transfer information, attempt to avoid duplication and to provide a resource list for future activity. Also, it can be used as an educational guide for school systems

  16. Insomnia From Drug Treatments: Evidence From Meta-analyses of Randomized Trials and Concordance With Prescribing Information.

    Science.gov (United States)

    Doufas, Anthony G; Panagiotou, Orestis A; Panousis, Periklis; Wong, Shane Shucheng; Ioannidis, John P A

    2017-01-01

    To determine whether drugs used to treat diverse conditions cause insomnia symptoms and whether their prescription information is concordant with this evidence. We conducted a survey of meta-analyses (Cochrane Database of Systematic Reviews) and comparisons with package inserts compiled in the Physicians' Desk Reference (PDR). We identified randomized controlled trials (RCTs) in which any drug had been evaluated vs placebo and sleep had been assessed. We collectively referred to insomnia-related outcomes as sleep disturbance. We also searched the PDR to identify any insomnia symptoms listed for drugs with RCT evidence available. Seventy-four Cochrane systematic reviews corresponding to 274 RCTs assessed 88 drugs in 27 different conditions, providing evidence on 109 drug-condition pairs. Of these 88 drugs, 5 decreased sleep problems and 19 increased sleep problems; 64 drugs had no nominally statistically significant effect on sleep. Acetylcholinesterase inhibitors, dopamine agonists, and selective serotonin reuptake inhibitors were the drug classes most importantly associated with sleep disturbance. Of 35 drugs that included disturbed sleep as an adverse effect in the PDR, only 14 had RCT evidence supporting such effect, and 2 had evidence of increasing and decreasing sleep problems in RCTs, although this was not shown in the PDR. We identified weak concordance between the PDR and RCTs (weighted κ=0.31; P<.001). The RCTs offer substantial evidence about the common effects of drugs on the risk of sleep disturbance; currently, prescription information only partially agrees with the available randomized evidence. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  17. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.

    Science.gov (United States)

    Köhler, Michael; Haag, Susanne; Biester, Katharina; Brockhaus, Anne Catharina; McGauran, Natalie; Grouven, Ulrich; Kölsch, Heike; Seay, Ulrike; Hörn, Helmut; Moritz, Gregor; Staeck, Kerstin; Wieseler, Beate

    2015-02-26

    When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug's added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The "dossier assessment" is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics ("approved subpopulations"). To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources-that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. Retrospective analysis. All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment reports, journal publications, and registry reports

  18. Batch-to-batch quality consistency evaluation of botanical drug products using multivariate statistical analysis of the chromatographic fingerprint.

    Science.gov (United States)

    Xiong, Haoshu; Yu, Lawrence X; Qu, Haibin

    2013-06-01

    Botanical drug products have batch-to-batch quality variability due to botanical raw materials and the current manufacturing process. The rational evaluation and control of product quality consistency are essential to ensure the efficacy and safety. Chromatographic fingerprinting is an important and widely used tool to characterize the chemical composition of botanical drug products. Multivariate statistical analysis has showed its efficacy and applicability in the quality evaluation of many kinds of industrial products. In this paper, the combined use of multivariate statistical analysis and chromatographic fingerprinting is presented here to evaluate batch-to-batch quality consistency of botanical drug products. A typical botanical drug product in China, Shenmai injection, was selected as the example to demonstrate the feasibility of this approach. The high-performance liquid chromatographic fingerprint data of historical batches were collected from a traditional Chinese medicine manufacturing factory. Characteristic peaks were weighted by their variability among production batches. A principal component analysis model was established after outliers were modified or removed. Multivariate (Hotelling T(2) and DModX) control charts were finally successfully applied to evaluate the quality consistency. The results suggest useful applications for a combination of multivariate statistical analysis with chromatographic fingerprinting in batch-to-batch quality consistency evaluation for the manufacture of botanical drug products.

  19. Women with epilepsy in childbearing age: Pregnancy-related knowledge, information sources, and antiepileptic drugs.

    Science.gov (United States)

    Friedrich, Latica; Sruk, Ana; Bielen, Ivan

    2018-03-01

    Pregnancy-related issues in epilepsy (PRIE) are essential for management of epilepsy in women. We conducted a study among women with epilepsy (WWE) aged 15-45years about their knowledge, sources, and needs for information regarding PRIE, which included their current antiepileptic drugs (AEDs) usage. Women with epilepsy, visitors of Croatian Association for Epilepsy webpage, were offered an online questionnaire, and 200 responses were analyzed. The mean number of correct answers about PRIE was 3.5 out of 5. Main predictors of knowledge on PRIE were a prior consultation with a neurologist and higher usage of books/brochures. A prior neurologist consultation on PRIE was stated by 45% of subjects. As the preferred future mode of being informed on PRIE, majority of women (61%) chooses their neurologist, 22% written materials distributed by a neurologist, and only 13% Internet. Levetiracetam was the most commonly used AED (34.5%). Valproate was used by 26%, and of those 59% stated no previous consultation on PRIE with their neurologist. In summary, we believe our study shows that knowledge of PRIE among WWE in their childbearing age is unsatisfactory, as are the neurologist consultation rates about PRIE. Our results demonstrate that, despite modern technologies, educational activities should be based on neurologist consultations and providing the patients with appropriate written materials. This is especially true for the relatively large proportion of women still taking valproate. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

    Science.gov (United States)

    Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

    2014-04-11

    Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

  1. Symbiotic Microbes from Marine Invertebrates: Driving a New Era of Natural Product Drug Discovery

    Directory of Open Access Journals (Sweden)

    Alix Blockley

    2017-10-01

    Full Text Available Invertebrates account for more than 89% of all extant organisms in the marine environment, represented by over 174,600 species (recorded to date. Such diversity is mirrored in (or more likely increased by the microbial symbionts associated with this group and in the marine natural products (or MNPs that they produce. Since the early 1950s over 20,000 MNPs have been discovered, including compounds produced by symbiotic bacteria, and the chemical diversity of compounds produced from marine sources has led to them being referred to as "blue gold" in the search for new drugs. For example, 80% of novel antibiotics stemming from the marine environment have come from Actinomycetes, many of which can be found associated with marine sponges, and compounds with anti-tumorigenic and anti-diabetic potential have also been isolated from marine symbionts. In fact, it has been estimated that marine sources formed the basis of over 50% of FDA-approved drugs between 1981 and 2002. In this review, we explore the diversity of marine microbial symbionts by examining their use as the producers of novel pharmaceutical actives, together with a discussion of the opportunities and constraints offered by “blue gold” drug discovery.

  2. Can Brazil play a more important role in global tuberculosis drug production? An assessment of current capacity and challenges.

    Science.gov (United States)

    Gemal, Andre; Keravec, Joel; Menezes, Alexandre; Trajman, Anete

    2013-03-27

    Despite the existence of effective treatment, tuberculosis is still a global public health issue. The World Health Organization recommends a six-month four-drug regimen in fixed-dose combination formulation to treat drug sensitive tuberculosis, and long course regimens with several second-line drugs to treat multi-drug resistant tuberculosis. To achieve the projected tuberculosis elimination goal by 2050, it will be essential to ensure a non-interrupted supply of quality-assured tuberculosis drugs. However, quality and affordable tuberculosis drug supply is still a significant challenge for National Tuberculosis Programs. Quality drug production requires a combination of complex steps. The first challenge is to guarantee the quality of tuberculosis active pharmaceutical ingredients, then ensure an adequate manufacturing process, according to international standards, to guarantee final product's safety, efficacy and quality. Good practices for storage, transport, distribution and quality control procedures must follow. In contrast to other high-burden countries, Brazil produces tuberculosis drugs through a strong network of public sector drug manufacturers regulated by a World Health Organization-certified national sanitary authority. The installed capacity for production surpasses the 71,000 needed treatments in the country. However, in order to be prepared to act as a global supplier, important bottlenecks are to be overcome. This article presents an in-depth analysis of the current status of production of tuberculosis drugs in Brazil and the bottlenecks and opportunities for the country to sustain national demand and play a role as a potential global supplier. Raw material and drug production, quality control, international certification and pre-qualification, political commitment and regulatory aspects are discussed, as well recommendations for tackling these bottlenecks. This discussion becomes more important as new drugs and regimens to treat tuberculosis are

  3. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2011-03-02

    ... Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the.... * * * * * (b) * * * (6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses. * * * * * PART 558--NEW...

  4. Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan.

    Science.gov (United States)

    Lee, Shin Haeng; Shin, Ju-Young; Park, Mi-Ju; Park, Byung-Joo

    2014-04-01

    Drug label is a common source of information; however, the content varies widely. This study aims to evaluate label information on cardiovascular drugs regarding pregnancy for their similarities in Korea, USA, UK, and Japan. Study drugs were selected as following (1) cardiovascular drugs according to the WHO ATC code (C01-C09) and (2) drugs currently marketed in all four countries were included. Evidence level was classified into five categories ('Definite', 'Probable', 'Possible', 'Unlikely', and 'Unclassified') and recommendation level was classified into four categories ('Contraindicated', 'Cautious', 'Compatible', and 'Unclassified'). Frequency and proportion were presented. Percent agreement and kappa coefficient with 95% confidence interval (CI) were calculated using SAS ver. 9.3. Total of 50 cardiovascular drugs were included. 'Unclassified' was represented the most in Korea, followed by Japan and UK (58%, 54%, and 46%, pdrugs in all four countries were classified as 'contraindicated' or 'cautious'. Japanese labels had the largest proportion of 'contraindicated' level (62%), and Korea and UK followed (58%, 44%, pdrugs were 'compatible' whereas, there were none in Korea, UK, and Japan (pdrugs in pregnancy differed widely. Reliable safety information in pregnancy should be provided through regular updates. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Modifying release characteristics from 3D printed drug-eluting products

    DEFF Research Database (Denmark)

    Boetker, Johan; Water, Jorrit; Aho, Johanna

    2016-01-01

    Abstract This work describes an approach to modify the release of active compound from a 3D printed model drug product geometry intended for flexible dosing and precision medication. The production of novel polylactic acid and hydroxypropyl methylcellulose based feed materials containing...... nitrofurantoin for 3D printing purposes is demonstrated. Nitrofurantoin, Metolose® and polylactic acid were successfully co-extruded with up to 40% Metolose® content, and subsequently 3D printed into model disk geometries (ø10 mm, h = 2 mm). Thermal analysis with differential scanning calorimetry and solid phase...... identification with Raman spectroscopy showed that nitrofurantoin remained in its original solid form during both hot-melt extrusion and subsequent 3D printing. Rheological measurements of the different compositions showed that the flow properties were sensitive to the amount of undissolved particles present...

  6. A Diffusion Model Incorporating Product Benefits, Price, Income and Information

    OpenAIRE

    Dan Horsky

    1990-01-01

    We start by assuming that a major benefit of many new durable products such as dishwashers and microwave ovens is time savings. Others, such as VCRs, also enhance the value of our leisure time. Using a household production framework we demonstrate that a utility maximizing individual will have a reservation price for the product which is a function of the product benefits and his wage rate. By assuming that the wage rate has an extreme value distribution across the population, we are able to ...

  7. Do MincerianWage Equations Inform How Schooling Influences Productivity?

    DEFF Research Database (Denmark)

    Groth, Christian; Growiec, Jakub

    2017-01-01

    We study the links between the Mincerian wage equation (the cross-sectional relationship between wages and years of schooling) and the human capital production function (the causal effect of schooling on labor productivity). Based on a stylized Mincerian general equilibrium model with imperfect...... substitutability across skill types and ex ante identical workers, we demonstrate that the mechanism of compensating wage differentials renders the Mincerian wage equation uninformative for the human capital production function. Proper identification of the human capital production function should take...... into account the equilibrium allocation of individuals across skill types....

  8. Drug advertising directed to pharmacists in Brazil: information or sales promotion?

    Directory of Open Access Journals (Sweden)

    Jussara Calmon Reis de Souza Soares

    2011-12-01

    Full Text Available Analyses of drug advertising reveal important social and cultural values and attitudes at a certain point in history. The purpose of this paper was to investigate how pharmaceutical industry communicates with pharmacists in Brazil, using drug promotion as a valuable tool. The point of departure was the analysis of a series of drug advertisements published in three Brazilian technical journals targeted at pharmacists and other health professionals. For the present study, the focus was on the content of the messages directed to pharmacists, in order to critically analyze the role attributed to these professionals as portrayed by the ads, and to discuss it in the context of pharmaceutical care. The collection and analysis of the data followed Anvisa's methodology. Pharmacists' social responsibility includes the reduction of preventable drug-related morbidity and mortality, but the information provided by the ads only refers to sales growth and profitability. Pharmacists are portrayed as salesmen, rather than health professionals, and encouraged to sell pharmaceutical drugs which are being heavily advertised to medical doctors. Consequences for pharmaceutical care are discussed.Análises de propaganda de medicamentos revelam importantes valores socioculturais e atitudes em um determinado contexto histórico. O objetivo deste trabalho foi analisar como a indústria farmacêutica se comunica com os farmacêuticos no Brasil, tendo a promoção farmacêutica como instrumento. O ponto de partida foi a análise de uma série de propagandas de medicamentos publicadas em três revistas técnicas dirigidas a farmacêuticos e outros profissionais de saúde. Para o presente estudo, o foco foi no conteúdo linguístico das mensagens, a fim de possibilitar uma reflexão crítica sobre o papel dos farmacêuticos no contexto da assistência farmacêutica, a partir das mensagens veiculadas pelos anúncios. A coleta e análise dos dados seguiu metodologia proposta

  9. Study on Product Lines for Digital Information Products%数字信息产品生产线研究

    Institute of Scientific and Technical Information of China (English)

    毛凌翔; 程慧平

    2014-01-01

    在数字信息逐渐从“资源观”向“产品观”转换的背景下,从数字信息产品的角度分析数字信息产品生产过程与模型,提出基于人工构件变异和组件重用的数字信息产品生产线理论,并应用于地理信息产品中进行实证,有望提高数字信息产品的生产效率并节约生产成本。%With the development of digital information technology and market-driven economy, user needs become diversified and customized today, and digital information is increasingly turning toward product-perspective direction from the resource-perspective. From the perspective of digital information products, digital information production process and model has been analyzed, and a digital information product lines theory based on artifacts variation and component reuse has been proposed. Then using instance to prove the correctness of the theory, practical use of digital information production line mode can greatly improve production efficiency of digital information products and significantly save production costs.

  10. 75 FR 77906 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Drug...

    Science.gov (United States)

    2010-12-14

    ... Collection Activities: Proposed Collection; Comments Requested: Drug Questionnaire DEA Form 341 ACTION: 60...: Extension of a currently approved collection. (2) Title of the Form/Collection: Drug Questionnaire (DEA Form... specific questions about their personal history, if any, of illegal drug use. (5) An estimate of the total...

  11. Natural products to improve quality of life targeting for colon drug delivery.

    Science.gov (United States)

    Kim, Hyunjo

    2012-03-01

    The colon is largely being investigated as a site for administration of protein and peptides, which are degraded by digestive enzymes in the upper GIT. Also for local diseases of the colon such as inflammatory bowel disease, colorectal cancer and ameobiasis, drug administration to the site of action can not only reduce the dose to be administered, but also decrease the side effects. Inflammatory Bowel Disease (IBD) such as Ulcerative colitis and Crohn's disease are characterized by chronic intestinal inflammation. Intestinal bacteria initiate the activation of intestinal inflammatory processes, which are mediated by pro-inflammatory cytokines and chemokine. Increased chemokine expression has also been observed in epithelial cells, endothelial cells, and smooth muscle cells. Future trials of specific agents capable of inhibiting chemokine synthesis and secretion or blocking chemokine-chemokine receptor interaction will be important to study in patients with ulcerative colitis and Crohn's disease. Many important bioactive compounds have been discovered from natural sources using bioactivity directed fractionation and isolation (BDFl) Continuing discovery has also been facilitated by the recent development of new bioassay methods. These bioactive compounds are mostly plant secondary metabolites, and many naturally occurring pure compounds have become medicines, dietary supplements, and other useful commercial products. The present review includes various approaches investigated for colon drug delivery and their site specificity. To achieve successful colonic delivery, a drug needs to be protected from absorption and the environment of the upper gastrointestinal tract and then be abruptly released into the proximal colon, which is considered the optimum site for colon targeted delivery of drugs.

  12. Direct-to-consumer advertising skepticism and the use and perceived usefulness of prescription drug information sources.

    Science.gov (United States)

    DeLorme, Denise E; Huh, Jisu; Reid, Leonard N

    2009-01-01

    This study investigates advertising skepticism in the context of consumers' prescription drug information seeking behavior. Results of a telephone survey found that: (a) the overall level of direct-to-consumer advertising (DTCA) skepticism among consumers was neutral; (b) DTCA skepticism was unrelated to age, positively related to education and income, and varied by race; (c) however, when all the antecedent variables were considered concurrently, only education emerged as a significant predictor (consumers with higher education were more skeptical of DTCA); (d) DTCA skepticism was not significantly related to perceived importance of prescription drug information; (e) DTCA skepticism was not associated with use of advertising and interpersonal sources of prescription drug information; and (f) DTCA skepticism was negatively related to perceived usefulness of advertising sources but unrelated to perceived usefulness of professional interpersonal sources (i.e., physicians and pharmacists). The article concludes with a discussion of findings and directions for future research.

  13. Meaningful use of health information technology and declines in in-hospital adverse drug events.

    Science.gov (United States)

    Furukawa, Michael F; Spector, William D; Rhona Limcangco, M; Encinosa, William E

    2017-07-01

    Nationwide initiatives have promoted greater adoption of health information technology as a means to reduce adverse drug events (ADEs). Hospital adoption of electronic health records with Meaningful Use (MU) capabilities expected to improve medication safety has grown rapidly. However, evidence that MU capabilities are associated with declines in in-hospital ADEs is lacking. Data came from the 2010-2013 Medicare Patient Safety Monitoring System and the 2008-2013 Healthcare Information and Management Systems Society (HIMSS) Analytics Database. Two-level random intercept logistic regression was used to estimate the association of MU capabilities and occurrence of ADEs, adjusting for patient characteristics, hospital characteristics, and year of observation. Rates of in-hospital ADEs declined by 19% from 2010 to 2013. Adoption of MU capabilities was associated with 11% lower odds of an ADE (95% confidence interval [CI], 0.84-0.96). Interoperability capability was associated with 19% lower odds of an ADE (95% CI, 0.67- 0.98). Adoption of MU capabilities explained 22% of the observed reduction in ADEs, or 67,000 fewer ADEs averted by MU. Concurrent with the rapid uptake of MU and interoperability, occurrence of in-hospital ADEs declined significantly from 2010 to 2013. MU capabilities and interoperability were associated with lower occurrence of ADEs, but the effects did not vary by experience with MU. About one-fifth of the decline in ADEs from 2010 to 2013 was attributable to MU capabilities. Findings support the contention that adoption of MU capabilities and interoperability spurred by the Health Information Technology for Economic and Clinical Health Act contributed in part to the recent decline in ADEs. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the United States.

  14. Seniors' perceptions of prescription drug advertisements: a pilot study of the potential impact on informed decision making.

    Science.gov (United States)

    Grenard, Jerry L; Uy, Visith; Pagán, José A; Frosch, Dominick L

    2011-10-01

    To conduct a pilot study exploring seniors' perceptions of direct-to-consumer advertising (DTCA) of prescription drugs and how the advertisements might prepare them for making informed decisions with their physicians. We interviewed 15 seniors (ages 63-82) individually after they each watched nine prescription drug advertisements recorded from broadcast television. Grounded Theory methods were used to identify core themes related to the research questions. Four themes emerged from the interviews about DTCA: (1) awareness of medications was increased, (2) information was missing or misleading and drugs were often perceived as more effective than clinical evidence would suggest, (3) most seniors were more strongly influenced by personal or vicarious experience with a drug - and by their physician - than by DTCA, and (4) most seniors were circumspect about the information in commercial DTCA. DTCA may have some limited benefit for informed decision making by seniors, but the advertisements do not provide enough detailed information and some information is misinterpreted. Physicians should be aware that many patients may misunderstand DTCA, and that a certain amount of time may be required during consultations to correct these misconceptions until better advertising methods are employed by the pharmaceutical industry. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  15. Particle shedding from peristaltic pump tubing in biopharmaceutical drug product manufacturing.

    Science.gov (United States)

    Saller, Verena; Matilainen, Julia; Grauschopf, Ulla; Bechtold-Peters, Karoline; Mahler, Hanns-Christian; Friess, Wolfgang

    2015-04-01

    In a typical manufacturing setup for biopharmaceutical drug products, the fill and dosing pump is placed after the final sterile filtration unit in order to ensure adequate dispensing accuracy and avoid backpressure peaks. Given the sensitivity of protein molecules, peristaltic pumps are often preferred over piston pumps. However, particles may be shed from the silicone tubing employed. In this study, particle shedding and a potential turbidity increase during peristaltic pumping of water and buffer were investigated using three types of commercially available silicone tubing. In the recirculates, mainly particles of around 200 nm next to a very small fraction of particles in the lower micrometer range were found. Using 3D laser scanning microscopy, surface roughness of the inner tubing surface was found to be a determining factor for particle shedding from silicone tubing. As the propensity toward particle shedding varied between tubing types and also cannot be concluded from manufacturer's specifications, individual testing with the presented methods is recommended during tubing qualification. Choosing low abrasive tubing can help to further minimize the very low particle counts to be expected in pharmaceutical drug products. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  16. A bibliometric analysis of scientific production on atypical antipsychotic drugs from Italy

    Science.gov (United States)

    López-Muñoz, Francisco; De Berardis, Domenico; Fornaro, Michele; Vellante, Federica; di Giannantonio, Massimo; Povedano-Montero, Francisco J; Póveda Fernández-Martín, Maria; Rubio, Gabriel; Álamo, Cecilio

    2017-01-01

    A bibliometric study of peer-reviewed scientific publications on atypical antipsychotic drugs (AADs) from Italy is herein presented. We selected the documents from Scopus database. We applied several bibliometric indicators of production and dispersion, including Price’s Law about the increase of scientific literature, and Bradford’s Law. We also calculated the participation index across different countries. The bibliometric data have also been correlated with some social and health data sourcing in Italy, such as total per capita expenditure on health and gross domestic expenditure. A total of 2949 original documents were published within the period 1972-2015. Our results state fulfilment of Price’s Law, with scientific production showing exponential growth (r=0.901, as against an r=0.838 after linear adjustment). The drugs most widely studied were clozapine (257 documents), risperidone (179), and olanzapine (172). Stratification into Bradford zones yielded a nucleus represented by the Journal of Clinical Psychopharmacology and Rivista di Psichiatria (58 articles, each one). A total of 1091 different journals were evaluated. The publications on AADs in Italy have undergone exponential growth over the studied period, which is in line with the progressively burgeoning on novel AAD releases. No evidence of saturation point was observed.

  17. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

    Science.gov (United States)

    Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

    2008-07-01

    The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

  18. Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

    Science.gov (United States)

    Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

    2018-02-05

    A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Supply Disruptions, Asymmetric Information, and a Backup Production Option

    OpenAIRE

    Zhibin (Ben) Yang; Göker Ayd{\\i}n; Volodymyr Babich; Damian R. Beil

    2009-01-01

    We study a manufacturer that faces a supplier privileged with private information about supply disruptions. We investigate how risk-management strategies of the manufacturer change and examine whether risk-management tools are more or less valuable in the presence of such asymmetric information. We model a supply chain with one manufacturer and one supplier, in which the supplier's reliability is either high or low and is the supplier's private information. On disruption, the supplier chooses...

  20. Determinants of the accessibility of regional-product information

    NARCIS (Netherlands)

    Ittersum, van K.; Meulenberg, M.T.G.; Trijp, van J.C.M.

    2003-01-01

    In an era being characterized by globalization, the importance of product differentiation grows. Marketing products based on the region-of-origin (within-country area) is one of the strategies applied (i.e., Washington apples). Most place-of-origin research focuses on the effect of the

  1. Information paths within the new product development process

    DEFF Research Database (Denmark)

    Jespersen, Kristina Risom

    2007-01-01

    collection platform to obtain measurements from within the NPD process. 42 large, international companies participated in the data collecting simulation. Results revealed five different information paths that were not connecting all stages of the NPD process. Moreover, results show that the front......-end is not driving the information acquisition through the stages of the NPD process, and that environmental turbulence disconnects stages from the information paths in the NPD process. This implies that information is at the same time a key to success and a key to entrapment in the NPD process....

  2. A proposal for a pharmacokinetic interaction significance classification system (PISCS) based on predicted drug exposure changes and its potential application to alert classifications in product labelling.

    Science.gov (United States)

    Hisaka, Akihiro; Kusama, Makiko; Ohno, Yoshiyuki; Sugiyama, Yuichi; Suzuki, Hiroshi

    2009-01-01

    Pharmacokinetic drug-drug interactions (DDIs) are one of the major causes of adverse events in pharmacotherapy, and systematic prediction of the clinical relevance of DDIs is an issue of significant clinical importance. In a previous study, total exposure changes of many substrate drugs of cytochrome P450 (CYP) 3A4 caused by coadministration of inhibitor drugs were successfully predicted by using in vivo information. In order to exploit these predictions in daily pharmacotherapy, the clinical significance of the pharmacokinetic changes needs to be carefully evaluated. The aim of the present study was to construct a pharmacokinetic interaction significance classification system (PISCS) in which the clinical significance of DDIs was considered with pharmacokinetic changes in a systematic manner. Furthermore, the classifications proposed by PISCS were compared in a detailed manner with current alert classifications in the product labelling or the summary of product characteristics used in Japan, the US and the UK. A matrix table was composed by stratifying two basic parameters of the prediction: the contribution ratio of CYP3A4 to the oral clearance of substrates (CR), and the inhibition ratio of inhibitors (IR). The total exposure increase was estimated for each cell in the table by associating CR and IR values, and the cells were categorized into nine zones according to the magnitude of the exposure increase. Then, correspondences between the DDI significance and the zones were determined for each drug group considering the observed exposure changes and the current classification in the product labelling. Substrate drugs of CYP3A4 selected from three therapeutic groups, i.e. HMG-CoA reductase inhibitors (statins), calcium-channel antagonists/blockers (CCBs) and benzodiazepines (BZPs), were analysed as representative examples. The product labelling descriptions of drugs in Japan, US and UK were obtained from the websites of each regulatory body. Among 220

  3. Sources of product information used by consumers when purchasing kitchen cabinets.

    Science.gov (United States)

    Geoffrey H. Donovan; David L. Nicholls; Joseph. Roos

    2004-01-01

    Survey data from home shows in Seattle, Washington and Anchorage, Alaska were used to determine the sources of product information used by consumers when buying kitchen cabinets. Results show that in-store sales staff are the most common source of product information, and that consumers' favorite wood species, age, and gender can influence the source of product...

  4. Natural products, an important resource for discovery of multitarget drugs and functional food for regulation of hepatic glucose metabolism.

    Science.gov (United States)

    Li, Jian; Yu, Haiyang; Wang, Sijian; Wang, Wei; Chen, Qian; Ma, Yanmin; Zhang, Yi; Wang, Tao

    2018-01-01

    Imbalanced hepatic glucose homeostasis is one of the critical pathologic events in the development of metabolic syndromes (MSs). Therefore, regulation of imbalanced hepatic glucose homeostasis is important in drug development for MS treatment. In this review, we discuss the major targets that regulate hepatic glucose homeostasis in human physiologic and pathophysiologic processes, involving hepatic glucose uptake, glycolysis and glycogen synthesis, and summarize their changes in MSs. Recent literature suggests the necessity of multitarget drugs in the management of MS disorder for regulation of imbalanced glucose homeostasis in both experimental models and MS patients. Here, we highlight the potential bioactive compounds from natural products with medicinal or health care values, and focus on polypharmacologic and multitarget natural products with effects on various signaling pathways in hepatic glucose metabolism. This review shows the advantage and feasibility of discovering multicompound-multitarget drugs from natural products, and providing a new perspective of ways on drug and functional food development for MSs.

  5. Adulteration of proprietary Chinese medicines and health products with undeclared drugs: experience of a tertiary toxicology laboratory in Hong Kong.

    Science.gov (United States)

    Ching, Chor Kwan; Chen, Sammy Pak Lam; Lee, Hencher Han Chih; Lam, Ying Hoo; Ng, Sau Wah; Chen, Mo Lung; Tang, Magdalene Huen Yin; Chan, Suzanne Suk San; Ng, Candy Wai Yan; Cheung, Jana Wing Lan; Chan, Tina Yee Ching; Lau, Nike Kwai Cheung; Chong, Yeow Kuan; Mak, Tony Wing Lai

    2018-01-01

    Proprietary Chinese medicines (pCMs) and health products, generally believed to be natural and safe, are gaining popularity worldwide. However, the safety of pCMs and health products has been severely compromised by the practice of adulteration. The current study aimed to examine the problem of adulteration of pCMs and health products in Hong Kong. The present study was conducted in a tertiary referral clinical toxicology laboratory in Hong Kong. All cases involving the use of pCMs or health products, which were subsequently confirmed to contain undeclared adulterants, from 2005 to 2015 were reviewed retrospectively. A total of 404 cases involving the use of 487 adulterated pCMs or health products with a total of 1234 adulterants were identified. The adulterants consisted of approved drugs, banned drugs, drug analogues and animal thyroid tissue. The six most common categories of adulterants detected were nonsteroidal anti-inflammatory drugs (17.7%), anorectics (15.3%), corticosteroids (13.8%), diuretics and laxatives (11.4%), oral antidiabetic agents (10.0%) and erectile dysfunction drugs (6.0%). Sibutramine was the most common adulterant (n = 155). The reported sources of these illicit products included over-the-counter drug stores, the internet and Chinese medicine practitioners. A significant proportion of patients (65.1%) had adverse effects attributable to these illicit products, including 14 severe and two fatal cases. Psychosis, iatrogenic Cushing syndrome and hypoglycaemia were the three most frequently encountered adverse effects. Adulteration of pCMs and health products with undeclared drugs poses severe health hazards. Public education and effective regulatory measures are essential to address the problem. © 2017 The British Pharmacological Society.

  6. On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs).

    Science.gov (United States)

    Méthot, Julie; Brisson, Diane; Gaudet, Daniel

    2012-04-01

    Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.

  7. Drug Facts

    Science.gov (United States)

    ... Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol ...

  8. 75 FR 76831 - Publicly Available Consumer Product Safety Information Database

    Science.gov (United States)

    2010-12-09

    ... information as evidenced by their verification that they have done so. We also note that reports of harm... ``Others'' file reports of harm with us using our online incident reporting form by self-reporting as... requirements for verification of information it intends to make public. Response--Congress provided a clear...

  9. Information provision for sustainable agricultural production in the ...

    African Journals Online (AJOL)

    The study sought to identify the methods of information provision to farmers and to evaluate how information is made accessible to farmers as well as the constraints farmers face in the Tolon-Kumbungu District of the Northern Region. Six communities were used for the study. Data was collected from one hundred and fifty ...

  10. Roles and responsibilities of pharmacists with respect to natural health products: key informant interviews.

    Science.gov (United States)

    Olatunde, Shade; Boon, Heather; Hirschkorn, Kristine; Welsh, Sandy; Bajcar, Jana

    2010-03-01

    Although many pharmacies sell natural health products (NHPs), there is no clear definition as to the roles and responsibilities (if any) of pharmacists with respect to these products. The purpose of this study was to explore pharmacy and stakeholder leaders' perceptions of pharmacists' professional NHP roles and responsibilities. Semi-structured key informant interviews were conducted with pharmacy leaders (n=17) and stakeholder (n=18) leaders representing consumers, complementary and alternative medicine practitioners, conventional health care practitioners, and industry across Canada. All participants believed a main NHP responsibility for pharmacists was in safety monitoring, although a one challenge identified in the interviews was pharmacists' general lack of NHP knowledge; however, stakeholder leaders did not expect pharmacists to be experts, but should have a basic level of knowledge about NHPs. Participants described pharmacists' professional roles and responsibilities for NHPs as similar to those for over-the-counter drugs; more awareness of existing NHP-related pharmacy policies is needed, and pharmacy owners/managers should provide additional training to ensure front-line pharmacists have appropriate knowledge of NHPs sold in the pharmacy. Copyright 2010 Elsevier Inc. All rights reserved.

  11. Fate and antibacterial potency of anticoccidial drugs and their main abiotic degradation products

    International Nuclear Information System (INIS)

    Hansen, Martin; Krogh, Kristine A.; Brandt, Asbjorn; Christensen, Jan H.; Halling-Sorensen, Bent

    2009-01-01

    The antibacterial potency of eight anticoccidial drugs was tested in a soil bacteria bioassay (pour plate method), EC 50 -values between 2.4 and 19.6 μM were obtained; however, one compound, nicarbazin exhibited an EC 50 -value above the maximum tested concentration (21 μM, 9.1 mg L -1 ). The potency of mixtures of two of the compounds, narasin and nicarbazin, was synergistic (more than additive) with 10-fold greater antibacterial potency of the mixture than can be explained by their individual EC 50 -values. The influence of pH, temperature, oxygen concentration and light on the transformation of robenidine and salinomycin was investigated. Robenidine was transformed by photolysis (DT 50 of 4.1 days) and was unstable at low pH (DT 50 of approximately 4 days); salinomycin was merely transformed at low pH, the latter into an unknown number of products. The antibacterial potency of the mixtures of transformation products of robenidine after photolysis and at low pH was comparable with that of the parent compound. Finally five photo-transformation products of robenidine were structural elucidated by accurate mass measurements, i-FIT values (isotopic pattern fit) and MS/MS fragmentation patterns. - Five photo-transformation products of robenidine were structural elucidated. This mixture was found to have similar antibacterial potency as the parent compound

  12. Fate and antibacterial potency of anticoccidial drugs and their main abiotic degradation products

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, Martin [Section of Toxicology and Environmental Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen (Denmark)], E-mail: mah@farma.ku.dk; Krogh, Kristine A. [Section of Toxicology and Environmental Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen (Denmark); Brandt, Asbjorn [Section of Veterinary Medicines, Danish Medicines Agency, Axel Heides Gade 1, DK-2300 Copenhagen (Denmark); Christensen, Jan H. [Section of Soil and Environmental Chemistry, Department of Basic Sciences and Environment, Faculty of Life Sciences, University of Copenhagen, Thorvaldsensvej 40, DK-1871 Frederiksberg (Denmark); Halling-Sorensen, Bent [Section of Toxicology and Environmental Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen (Denmark)

    2009-02-15

    The antibacterial potency of eight anticoccidial drugs was tested in a soil bacteria bioassay (pour plate method), EC{sub 50}-values between 2.4 and 19.6 {mu}M were obtained; however, one compound, nicarbazin exhibited an EC{sub 50}-value above the maximum tested concentration (21 {mu}M, 9.1 mg L{sup -1}). The potency of mixtures of two of the compounds, narasin and nicarbazin, was synergistic (more than additive) with 10-fold greater antibacterial potency of the mixture than can be explained by their individual EC{sub 50}-values. The influence of pH, temperature, oxygen concentration and light on the transformation of robenidine and salinomycin was investigated. Robenidine was transformed by photolysis (DT{sub 50} of 4.1 days) and was unstable at low pH (DT{sub 50} of approximately 4 days); salinomycin was merely transformed at low pH, the latter into an unknown number of products. The antibacterial potency of the mixtures of transformation products of robenidine after photolysis and at low pH was comparable with that of the parent compound. Finally five photo-transformation products of robenidine were structural elucidated by accurate mass measurements, i-FIT values (isotopic pattern fit) and MS/MS fragmentation patterns. - Five photo-transformation products of robenidine were structural elucidated. This mixture was found to have similar antibacterial potency as the parent compound.

  13. Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

    Science.gov (United States)

    Arguello, Blanca; Salgado, Teresa M; Fernandez-Llimos, Fernando

    2015-01-01

    Aims To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). Methods SmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing ‘conclusive’ or ‘ambiguous’ information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Results Of the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. Conclusions Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. PMID:25224071

  14. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

    Science.gov (United States)

    Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer

    2016-06-01

    To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.

  15. Electrosynthesis methods and approaches for the preparative production of metabolites from parent drugs

    NARCIS (Netherlands)

    Gül, Turan; Bischoff, Rainer; Permentier, Hjalmar

    2015-01-01

    Identification of potentially toxic metabolites is important for drug discovery and development. Synthesis of drug metabolites is typically performed by organic synthesis or enzymatic methods, but is not always straightforward. Electrochemical (EC) methods are increasingly used to study drug

  16. Information on the quality of substance for the preparation of pharmaceutical drugs in terms of hospital pharmacy

    Directory of Open Access Journals (Sweden)

    Jovović Marija Đ.

    2015-01-01

    Full Text Available Explanation the topic The pharmaceutical activity is the activity of public or social and special interest, because it is a direct function of health care. Topic positioning and discussion The aim of this paper is to highlight the importance of ensuring the quality of pharmaceutical substances that supplies hospitals, which are used for production of galenic and magistral drugs. Conclusion Compliance with national legislation, as well as establishing compliance prescribed by the European legislation in the field of drug development is binding. Therefore, all manufacturers of drugs and/or active pharmaceutical ingredients must apply quality standards prescribed by the European Pharmacopoeia in order to develop, manufacture and sales of medicines. When it comes to the quality of pharmaceutical ingredients for the production of drugs in the pharmacy, pharmacies especially in residential institutions in our country is permanently done by harmonizing national legislation in order to improve conditions for the preparation and production of galenic drugs in terms of inpatient health institutions performed in a manner that is prescribed by international regulations. This requires the adaptation of institutions, including fundamental changes in competence as national professional and administrative and regulatory rules that apply to state- and private sectors.

  17. Scaffold architecture and pharmacophoric properties of natural products and trade drugs: application in the design of natural product-based combinatorial libraries.

    Science.gov (United States)

    Lee, M L; Schneider, G

    2001-01-01

    Natural products were analyzed to determine whether they contain appealing novel scaffold architectures for potential use in combinatorial chemistry. Ring systems were extracted and clustered on the basis of structural similarity. Several such potential scaffolds for combinatorial chemistry were identified that are not present in current trade drugs. For one of these scaffolds a virtual combinatorial library was generated. Pharmacophoric properties of natural products, trade drugs, and the virtual combinatorial library were assessed using a self-organizing map. Obviously, current trade drugs and natural products have several topological pharmacophore patterns in common. These features can be systematically explored with selected combinatorial libraries based on a combination of natural product-derived and synthetic molecular building blocks.

  18. Report: More Information Is Needed On Toxaphene Degradation Products

    Science.gov (United States)

    Report #2006-P-00007, Dec 16, 2005. Toxaphene in the environment changes, or degrades. The degradation products are different from the original toxaphene in chemical composition and how they appear to testing instruments, so they could go unreported.

  19. DNA sequence analyses of blended herbal products including synthetic cannabinoids as designer drugs.

    Science.gov (United States)

    Ogata, Jun; Uchiyama, Nahoko; Kikura-Hanajiri, Ruri; Goda, Yukihiro

    2013-04-10

    In recent years, various herbal products adulterated with synthetic cannabinoids have been distributed worldwide via the Internet. These herbal products are mostly sold as incense, and advertised as not for human consumption. Although their labels indicate that they contain mixtures of several potentially psychoactive plants, and numerous studies have reported that they contain a variety of synthetic cannabinoids, their exact botanical contents are not always clear. In this study, we investigated the origins of botanical materials in 62 Spice-like herbal products distributed on the illegal drug market in Japan, by DNA sequence analyses and BLAST searches. The nucleotide sequences of four regions were analyzed to identify the origins of each plant species in the herbal mixtures. The sequences of "Damiana" (Turnera diffusa) and Lamiaceae herbs (Mellissa, Mentha and Thymus) were frequently detected in a number of products. However, the sequences of other plant species indicated on the packaging labels were not detected. In a few products, DNA fragments of potent psychotropic plants were found, including marijuana (Cannabis sativa), "Diviner's Sage" (Salvia divinorum) and "Kratom" (Mitragyna speciosa). Their active constituents were also confirmed using gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS), although these plant names were never indicated on the labels. Most plant species identified in the products were different from the plants indicated on the labels. The plant materials would be used mainly as diluents for the psychoactive synthetic compounds, because no reliable psychoactive effects have been reported for most of the identified plants, with the exception of the psychotropic plants named above. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  20. Open-label extension studies: do they provide meaningful information on the safety of new drugs?

    Science.gov (United States)

    Day, Richard O; Williams, Kenneth M

    2007-01-01

    The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the