WorldWideScience

Sample records for drug industry

  1. New Zealand’s Drug Development Industry

    Directory of Open Access Journals (Sweden)

    Christopher Carswell

    2013-09-01

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

  2. An assessment of drug testing within the construction industry.

    Science.gov (United States)

    Gerber, Jonathan K; Yacoubian, George S

    2002-01-01

    Drug testing in the workplace has gone from virtual nonexistence to widespread employer acceptance during the past two decades. This growth is particularly significant for the construction industry. High rates of alcohol and other drug use, coupled with the high-risk, safety-sensitive nature of the industry, have prompted the development of a variety of drug surveillance and prevention strategies. Despite this growing vigilance, no scholarly works have examined the impact of drug-related policies in the construction industry. To address this limitation, we investigate the efficacy of workplace drug-testing programs in reducing injury incident rates and workers' compensation experience-rating modification factors (MODs) within the construction industry. Analyses indicate that companies with drug-testing programs experienced a 51 percent reduction in incident rates within two years of implementation. Moreover, companies that drug test their employees experienced a significant reduction in their MODs. Policy implications are discussed in light of the current findings.

  3. 76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

    Science.gov (United States)

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

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

    OpenAIRE

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

    2016-01-01

    Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs - Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers - A well–considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in ass...

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

    Science.gov (United States)

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

    2009-01-01

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

  6. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Science.gov (United States)

    2010-04-29

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

  7. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

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

    Directory of Open Access Journals (Sweden)

    Bălan Emilia

    2017-01-01

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

  9. Industry perspectives on market access of innovative drugs

    Directory of Open Access Journals (Sweden)

    Kim ePauwels

    2016-06-01

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

  10. Redactions in protocols for drug trials: what industry sponsors concealed.

    Science.gov (United States)

    Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

    2018-04-01

    Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

  11. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...

  12. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

  13. 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...

  14. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ...] Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm...

  15. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-10-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  16. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process... for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of...

  17. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

  18. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Science.gov (United States)

    2012-02-23

    ...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

  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. THE ROLE OF PROMOTION ON MARKETING IN TURKISH DRUG INDUSTRY

    Directory of Open Access Journals (Sweden)

    Emrah Bilgener

    2004-08-01

    Full Text Available Abstract\tMarketing has an important role in modern life. Marketing provides economical and social bene-fits with correleating between producers and consumers.\tPromotional activities are necessary for better marketing strategies. Therefore, firms have to give more importance to promotional activities. Promotional activities are marketing instruments that an-nounced all the knowledges about the products and services to their consumers, for surviving and de-veloping the firms.\tNowadays drug producers are marketing their products all arround the world. But, drugs are not ordinary products, for this reason more importance must be given to drug marketing andpromotion.\tThe purpose of this study is to determine the role of promotion within the marketing in Turkish Drug Industry. The material of this study is an uniform questionnaire with 41 questions applied to about 190-200 medical representatives who work in Çorum, Yozgat, Amasya and Tokat cities for 37 firms which are the members of Federation of Employer’s Organization in Pharmaceutical Industry and 14 firms which are profited by the services of this federation.\tIn this study, SPSS program (ver7.5 has been used for evaluation of the data. According to the re-sults, medical represantatives think that the drug sales will increase and wait the data of IMS (Inform Medicines Statistics will rise about 60-80%. 90% of the medical represantatives believe that the pa-ramedical activities are effective and 73% of them carry out paramedical studies.\tÖzet\tPazarlama modern yasantida önemli bir role sahiptir. Pazarlama üreticiler ve tüketiciler arasinda bir iliski kurarak, ekonomik ve sosyal faydalar saglar. Tanitim faaliyetleri daha iyi bir pazarlama stratejisi için gereklidir. Bu nedenle sirketler daha iyi bir pazarlama stratejisi için tanitim faaliyetlerine önem vermelidir. Tanitim faaliyetleri, isletmenin ürettigi mal ve hizmetleri tüketicilere duyuran, isletmenin gelisimini ve yasamasini

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

    Science.gov (United States)

    2011-07-21

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

  2. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-02

    .... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0971...

  3. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Science.gov (United States)

    2013-03-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0168] Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  4. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...

  5. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  6. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Science.gov (United States)

    2011-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  7. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Science.gov (United States)

    2011-01-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  8. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Science.gov (United States)

    2011-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  9. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Science.gov (United States)

    2013-03-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  10. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0076] (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS...

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

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  12. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

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

    Science.gov (United States)

    2012-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1161] Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  14. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

  15. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Science.gov (United States)

    2011-03-15

    ...] Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...

  16. 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...

  17. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Science.gov (United States)

    2012-02-24

    ...] Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment... Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (c...

  18. Work-related injuries in a state trauma registry: relationship between industry and drug screening.

    Science.gov (United States)

    Bunn, Terry L; Slavova, Svetla; Bernard, Andrew C

    2014-08-01

    Work-related injuries exert a great financial and economic burden on the US population. The study objectives were to identify the industries and occupations associated with worker injuries and to determine the predictors for injured worker drug screening in trauma centers. Work-related injury cases were selected using three criteria (expected payer source of workers' compensation, industry-related e-codes, and work-related indicator) from the Kentucky Trauma Registry data set for years 2008 to 2012. Descriptive analyses and multiple logistic regression were performed on the work-related injury cases. The "other services" and construction industry sectors accounted for the highest number of work-related cases. Drugs were detected in 55% of all drug-screened work-related trauma cases. Higher percentages of injured workers tested positive for drugs in the natural resources and mining, transportation and public utilities, and construction industries. In comparison, higher percentages of injured workers in the other services as well as transportation and public utilities industries were drug screened. Treatment at Level I trauma centers and Glasgow Coma Scale (GCS) scores indicating a coma or severe brain injury were both significant independent predictors for being screened for drugs; industry was not a significant predictor for being drug screened. The injured worker was more likely to be drug screened if the worker had a greater than mild injury, regardless of whether the worker was an interfacility transfer. These findings indicate that there may be elevated drug use or abuse in natural resources and mining, transportation and public utilities, as well as construction industry workers; improved identification of the specific drug types in positive drug screen results of injured workers is needed to better target prevention efforts. Epidemiologic study, level III.

  19. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Science.gov (United States)

    2010-04-29

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for... the Internet. To receive ``Draft Guidance for Industry and Food and Drug Administration Staff; User... and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and...

  20. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Science.gov (United States)

    2013-12-04

    ... information technology. Under the draft guidance, outsourcing facilities that elect to register should submit... guidance provides information on how an outsourcing facility should submit facility registration...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under...

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

    Science.gov (United States)

    2013-02-26

    ... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

  2. 75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

    Science.gov (United States)

    2010-03-29

    ...] Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical... industry entitled ``Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for... the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.'' In the...

  3. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  4. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2010-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0459] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori; Availability AGENCY: Food...

  5. Vertical Integration Heats Up in Drug Industry: Will Medication Price Hikes Cool Down as a Result?

    Science.gov (United States)

    Barlas, Stephen

    2018-01-01

    Is industry consolidation a response to President Donald Trump's repeated denunciation of high drug prices and congressional hearings on the issue? The author considers whether any of this corporate collaboration will get at some of the significant, underlying problems in the drug-pricing space.

  6. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Science.gov (United States)

    2011-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...

  7. The year's new drugs & biologics, 2017, part II - News that shaped the industry in 2017.

    Science.gov (United States)

    Graul, A I; Dulsat, C; Pina, P; Tracy, M; D'Souza, P

    2018-02-01

    This eagle's-eye overview of the drug industry in 2017 provides insight into some of last year's top stories, including the growing opioid crisis affecting the U.S. and other developed countries and the 2017-2018 influenza epidemic, with a spotlight on the need for a universal flu vaccine. As in previous years, we also review orphan drug development, new agency-supported programs such as PRIME and RMAT, pipeline attrition and drug pricing, as well as pharma/biotech mergers and acquisitions of note. Finally, we take a glimpse into the crystal ball to anticipate the new drugs that will be approved in 2018. Copyright 2018 Clarivate Analytics.

  8. When technological discontinuities and disruptive business models challenge dominant industry logics: insights from the drugs industry

    OpenAIRE

    Sabatier , Valérie; Kennard , Adrienne; Mangematin , Vincent

    2012-01-01

    Working paper serie RMT (WPS 12-04) - 39 p; International audience; An industry's dominant logic is the general scheme of value creation and capture shared by its actors. In high technology fields, technological discontinuities are not enough to disrupt an industry's dominant logic. Identifying the factors that might trigger change in that logic can help companies develop strategies to enable them to capture greater value from their innovations by disrupting that logic. Based on analyzing the...

  9. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  10. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Science.gov (United States)

    2010-06-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...

  11. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  12. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Science.gov (United States)

    2011-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological... appropriate, and other forms of information technology. Draft Guidance for Industry and Food and Drug...

  13. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals... Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for...

  14. 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...

  15. 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...

  16. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information...

  17. 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...

  18. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2011-08-17

    ... a larger amount of the drug substance than what is intended to be delivered to the patient. This... patient, but also to others, including family members, caregivers, children, and pets. For example...

  19. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    .... 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1983-07-01

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

  1. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  2. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Science.gov (United States)

    2011-02-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  3. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  4. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Science.gov (United States)

    2012-08-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  5. [Drugs in veterinary medicine. The role of the veterinary drug industry].

    Science.gov (United States)

    Baars, J C

    1984-02-01

    Veterinary medicines constitute an unescapable element in the scheme of animal health and welfare. Nowadays, they are used more and more to improve health and productivity in farm animals. When a veterinary medicine is prescribed it must not only be effective but must also be safe for both animals and humans. Due to ever changing regulations and constant improvements in residue detection techniques it is necessary to conduct new investigations with existing products. It therefore costs a great deal of time and money to introduce, and maintain, a product in the market. In future, therefore, fewer medicines with more limited indications will be introduced and these will be to combat important production disorders in the more significant species only. In view of the above, research and production will be restricted to large, international, concerns. Due to our well structured agricultural industry and the existence of well organized and equipped veterinary research institutions, and practitioners, Holland is able to play an important role in the development of veterinary medicines. Close co-operation between all involved parties coupled with an efficient registration procedure is not ony of benefit to the veterinary pharmaceutical industry but also for international recognition of our national animal husbandry industry, ancillary industries and veterinary and other consultants. In this scheme of things the accent is not upon qualifications but upon the skills of veterinarians - wherever placed - who are involved in the administration of veterinary medicines.

  6. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Science.gov (United States)

    2012-07-03

    ...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...

  7. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Science.gov (United States)

    2013-09-25

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

  8. Perception of various stakeholders regarding clinical drug trial industry in India

    Directory of Open Access Journals (Sweden)

    Rakesh M Parikh

    2011-01-01

    Full Text Available Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010. Aims: There is an urgent need for introspection and corrective actions. Materials and Methods: An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc. Results: Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles. Conclusions: Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations.

  9. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Science.gov (United States)

    2013-06-07

    ... adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail... and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION... June 2013. FDA is providing this final guidance document to assist industry in developing technical and...

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

    Directory of Open Access Journals (Sweden)

    Tom L. Blundell

    2017-07-01

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

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

    Science.gov (United States)

    Blundell, Tom L

    2017-07-01

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

  12. Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries.

    Science.gov (United States)

    Onishi, Taku; Tsukamoto, Katsura; Matsumaru, Naoki; Waki, Takashi

    2018-01-01

    Efforts to promote the development of pediatric pharmacotherapy include regulatory frameworks and close collaboration between the US Food and Drug Administration and the European Medicines Agency. We characterized the current status of pediatric clinical trials conducted in the United States by the pharmaceutical industry, focusing on the involvement of the European Union member countries, to clarify the industry perspective. Data on US pediatric clinical trials were obtained from ClinicalTrials.gov . Binary regression analysis was performed to identify what factors influence the likelihood of involvement of European Union countries. A total of 633 US pediatric clinical trials that met inclusion criteria were extracted and surveyed. Of these, 206 (32.5%) involved a European Union country site(s). The results of binary regression analysis indicated that attribution of industry, phase, disease area, and age of pediatric participants influenced the likelihood of the involvement of European Union countries in US pediatric clinical trials. Relatively complicated or large pediatric clinical trials, such as phase II and III trials and those that included a broad age range of participants, had a significantly greater likelihood of the involvement of European Union countries ( P European Union countries, and (3) feasibility of clinical trials is mainly concerned by pharmaceutical industry for pediatric drug development. Additional incentives for high marketability may further motivate pharmaceutical industry to develop pediatric drugs.

  13. Alcohol and drug policy model for the Canadian upstream petroleum industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-09-15

    This alcohol and drug policy model was developed to help employers manage and reduce the risks associated with drug and alcohol use in the workplace. The policy model outlined guidelines for establishing and implementing drug and alcohol policies, and discussed treatment programs and opportunities for re-employment. The model was developed by Enform, the upstream petroleum industry's safety and training arm, who used a previous guide developed by the Construction Owner's Association of Alberta (COAA) as a model. Enform's model provided a summary of key accountabilities across all levels of industry as well as the accepted minimum criteria for developing alcohol and drug policies. The model included guidelines and recommendations for employees, supervisors, and owners, employers, and contractors. The responsibilities of associations, organizations, and private companies were also outlined. An overview of recommended implementation plans was provided, as well as details of alcohol and drug use education programs and workplace rules. A supervisor's guide to implementation provided outlines of the causes of drug use among employees. tabs.

  14. The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

    Science.gov (United States)

    Stanley, A G; Jackson, D; Barnett, D B

    2005-04-01

    Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

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

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic...

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

    Science.gov (United States)

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

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. Academic-industrial partnerships in drug discovery in the age of genomics.

    Science.gov (United States)

    Harris, Tim; Papadopoulos, Stelios; Goldstein, David B

    2015-06-01

    Many US FDA-approved drugs have been developed through productive interactions between the biotechnology industry and academia. Technological breakthroughs in genomics, in particular large-scale sequencing of human genomes, is creating new opportunities to understand the biology of disease and to identify high-value targets relevant to a broad range of disorders. However, the scale of the work required to appropriately analyze large genomic and clinical data sets is challenging industry to develop a broader view of what areas of work constitute precompetitive research. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

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

  19. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-06-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  20. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

  1. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

  2. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

  3. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  4. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  5. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0642] Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  6. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  7. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

  8. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Science.gov (United States)

    2012-07-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0524] Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  9. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0367] Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  10. 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...

  11. 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...

  12. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Science.gov (United States)

    2011-08-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

  13. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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

    Science.gov (United States)

    2013-11-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1279] Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

  16. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Science.gov (United States)

    2012-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0094] Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  17. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Science.gov (United States)

    2011-04-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  18. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  19. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Science.gov (United States)

    2011-12-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  20. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

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

    Science.gov (United States)

    2011-09-27

    ...] Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products..., Reductions, and Refunds for Drug and Biological Products.'' This guidance provides recommendations to... ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This guidance provides...

  2. Lowering industry firewalls: pre-competitive informatics initiatives in drug discovery.

    Science.gov (United States)

    Barnes, Michael R; Harland, Lee; Foord, Steven M; Hall, Matthew D; Dix, Ian; Thomas, Scott; Williams-Jones, Bryn I; Brouwer, Cory R

    2009-09-01

    Pharmaceutical research and development is facing substantial challenges that have prompted the industry to shift funding from early- to late-stage projects. Among the effects is a major change in the attitude of many companies to their internal bioinformatics resources: the focus has moved from the vigorous pursuit of intellectual property towards exploration of pre-competitive cross-industry collaborations and engagement with the public domain. High-quality, open and accessible data are the foundation of pre-competitive research, and strong public-private partnerships have considerable potential to enhance public data resources, which would benefit everyone engaged in drug discovery. In this article, we discuss the background to these changes and propose new areas of collaboration in computational biology and chemistry between the public domain and the pharmaceutical industry.

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

    Science.gov (United States)

    Kinch, Michael S; Moore, Ryan

    2016-06-23

    The way new medicines are discovered and brought to market has fundamentally changed over the last 30 years. Our previous analysis showed that biotechnology companies had contributed significantly to the US Food and Drug Administration approval of new molecular entities up to the mid-1980s, when the trends started to decline. Although intriguing, the focus on biotechnology necessarily precluded the wider question of how the biopharmaceutical industry has been delivering on its goals to develop new drugs. Here, we present a comprehensive analysis of all biopharmaceutical innovators and uncover unexpected findings. The present biopharmaceutical industry grew steadily from 1800 to 1950 and then stagnated for two decades, before a burst of growth attributable to the biotechnology revolution took place; but consolidation has reduced the number of active and independent innovators to a level not experienced since 1945. The trajectories and trends we observe raise fundamental questions about biopharmaceutical innovators and the sustainability of the drug-development enterprise. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

    Science.gov (United States)

    Löfgren, Hans

    2007-06-01

    This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

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

    Science.gov (United States)

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

    2016-01-01

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

  6. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

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

    Science.gov (United States)

    2011-05-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-D-0102] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and...

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

    Science.gov (United States)

    2011-08-09

    ... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

  9. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2010-09-28

    ... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

  10. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Science.gov (United States)

    2012-02-21

    ... industry entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and... data analysis in the context of identifying potential drug interactions. The guidance also addresses... Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling.'' Comments were received...

  11. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0090] Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability... familiar and less familiar approaches. As more experience is obtained with the less familiar designs...

  12. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Science.gov (United States)

    2010-11-12

    ... annually from approximately 25 application holders. FDA professionals familiar with Dear Health Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0319] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters...

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

    Science.gov (United States)

    2013-02-08

    ...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA... trials that are specifically focused on the treatment of patients with established Alzheimer's disease...

  14. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Science.gov (United States)

    2013-12-04

    ...] Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers... the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked... issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and...

  15. 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...

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

    Directory of Open Access Journals (Sweden)

    S Satyanarayan

    2011-10-01

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

  17. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Science.gov (United States)

    2010-08-03

    ... drug substance than what is intended to be delivered to the patient. This excess amount of drug... issue not only to the patient, but also to others including family members, caregivers, children, and...

  18. 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...

  19. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-09

    ... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0375...

  20. Drug-disease modeling in the pharmaceutical industry - where mechanistic systems pharmacology and statistical pharmacometrics meet.

    Science.gov (United States)

    Helmlinger, Gabriel; Al-Huniti, Nidal; Aksenov, Sergey; Peskov, Kirill; Hallow, Karen M; Chu, Lulu; Boulton, David; Eriksson, Ulf; Hamrén, Bengt; Lambert, Craig; Masson, Eric; Tomkinson, Helen; Stanski, Donald

    2017-11-15

    Modeling & simulation (M&S) methodologies are established quantitative tools, which have proven to be useful in supporting the research, development (R&D), regulatory approval, and marketing of novel therapeutics. Applications of M&S help design efficient studies and interpret their results in context of all available data and knowledge to enable effective decision-making during the R&D process. In this mini-review, we focus on two sets of modeling approaches: population-based models, which are well-established within the pharmaceutical industry today, and fall under the discipline of clinical pharmacometrics (PMX); and systems dynamics models, which encompass a range of models of (patho-)physiology amenable to pharmacological intervention, of signaling pathways in biology, and of substance distribution in the body (today known as physiologically-based pharmacokinetic models) - which today may be collectively referred to as quantitative systems pharmacology models (QSP). We next describe the convergence - or rather selected integration - of PMX and QSP approaches into 'middle-out' drug-disease models, which retain selected mechanistic aspects, while remaining parsimonious, fit-for-purpose, and able to address variability and the testing of covariates. We further propose development opportunities for drug-disease systems models, to increase their utility and applicability throughout the preclinical and clinical spectrum of pharmaceutical R&D. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective.

    Science.gov (United States)

    Vahle, John L; Anderson, Ulf; Blomme, Eric A G; Hoflack, Jean-Christophe; Stiehl, Daniel P

    2018-04-18

    Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the impact of the discipline on pharmaceutical nonclinical safety assessment. To understand the current state of toxicogenomics in the sector, an industry group surveyed companies to determine the frequency of toxicogenomics use in in vivo studies at various stages of drug discovery and development and to assess how toxicogenomics use has evolved over time. Survey data were compiled during 2016 from thirteen pharmaceutical companies. Toxicogenomic analyses were infrequently conducted in the development phase and when performed were done to address specific mechanistic questions. Prior to development, toxicogenomics use was more frequent; however, there were significant differences in approaches among companies. Across all phases, gaining mechanistic insight was the most frequent reason cited for pursing toxicogenomics with few companies using toxicogenomics to predict toxicities. These data were consistent with the commentary submitted in response to survey questions asking companies to describe the evolution of their toxicogenomics strategy. Overall, these survey data indicate that toxicogenomics is not widely used as a predictive tool in the pharmaceutical industry but is used regularly by some companies and serves a broader role in mechanistic investigations and as a complement to other technologies. Copyright © 2018. Published by Elsevier Inc.

  2. The exploitation of "sicko-chatting" by the pharmaceutical industry : a strategy for the normalization of drug use

    OpenAIRE

    Niquette , Manon

    2012-01-01

    International audience; The Exploitation of 'sicko-chatting' by the Pharmaceutical industry: a strategy for the Normalization of drug use Pharmaceutical drugs are consumer goods. As such, they inscribe the transition from normality to pathology within the ambit of health marketing (Duclos, 2008, p. 109). It is now widely acknowledged that this pathology is not just a mere quantitative modification of the normal state, but that it also implies the patient's qualitative assessment of his or her...

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

    Science.gov (United States)

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

    2015-06-01

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

  4. 78 FR 100 - Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s...

    Science.gov (United States)

    2013-01-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0523] Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  5. 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

  6. Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

    Science.gov (United States)

    Keinonen, Tuija; Keränen, Tapani; Klaukka, Timo; Saano, Veijo; Ylitalo, Pauli; Enlund, Hannes

    2003-09-01

    The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.

  7. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Science.gov (United States)

    2012-07-27

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

  8. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Science.gov (United States)

    2012-02-27

    ... proposed information collected is necessary for the proper performance of FDA's functions, including... the draft guidance for industry entitled: ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products'' (Absenteeism Draft Guidance) published in the Federal...

  9. Industry

    International Nuclear Information System (INIS)

    Schindler, I.; Wiesenberger, H.

    2001-01-01

    This chapter of the environmental control report deals with the environmental impact of the industry in Austria. It gives a review of the structure and types of the industry, the legal framework and environmental policy of industrial relevance. The environmental situation of the industry in Austria is analyzed in detail, concerning air pollution (SO 2 , NO x , CO 2 , CO, CH 4 , N 2 O, NH 3 , Pb, Cd, Hg, dioxin, furans), waste water, waste management and deposit, energy and water consumption. The state of the art in respect of the IPPC-directives (European Integrated Pollution Prevention and Control Bureau) concerning the best available techniques of the different industry sectors is outlined. The application of European laws and regulations in the Austrian industry is described. (a.n.)

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

    Science.gov (United States)

    van der Hoogte, Arjo Roersch; Pieters, Toine

    2010-01-01

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

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

    Science.gov (United States)

    Twine, Richard

    2013-12-01

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

  12. 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...

  13. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Science.gov (United States)

    2011-06-21

    ... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act... the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug... statutory definitions for these terms set forth in sections 201(g) and 201(h) of the Federal Food, Drug, and...

  14. Industrialization

    African Journals Online (AJOL)

    Lucy

    . African states as ... regarded as the most important ingredients that went to add value to land and labour in order for countries ... B. Sutcliffe Industry and Underdevelopment (Massachusetts Addison – Wesley Publishing Company. 1971), pp.

  15. Industrialization

    African Journals Online (AJOL)

    Lucy

    scholar, Walt W. Rostow presented and supported this line of thought in his analysis of ... A Brief Historical Background of Industrialization in Africa ... indicative) The western model allowed for the political economy to be shaped by market.

  16. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Science.gov (United States)

    2011-06-22

    .... FDA-2011-D-0404] Guidance for Industry on Topical Acne Drug Products for Over-the- Counter Human Use... entities entitled ``Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and... recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug...

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

    Science.gov (United States)

    Watkins, Elizabeth Siegel

    2012-08-01

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

  18. Industry

    Energy Technology Data Exchange (ETDEWEB)

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

    2007-12-01

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

  19. 78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

    Science.gov (United States)

    2013-02-25

    ...--Implementing the Physician Labeling Rule Content and Format Requirements; Availability AGENCY: Food and Drug...--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological...

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

    NARCIS (Netherlands)

    Broekhof, Martijn

    2002-01-01

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

  1. 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

  2. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Science.gov (United States)

    2012-10-01

    ... bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft... infection caused by bacterial pathogens that show resistance to most antibacterial drugs on in vitro...

  3. Evolution of camel CYP2E1 and its associated power of binding toxic industrial chemicals and drugs.

    Science.gov (United States)

    Kandeel, Mahmoud; Altaher, Abdullah; Kitade, Yukio; Abdelaziz, Magdi; Alnazawi, Mohamed; Elshazli, Kamal

    2016-10-01

    Camels are raised in harsh desert environment for hundreds of years ago. By modernization of live and the growing industrial revolution in camels rearing areas, camels are exposed to considerable amount of chemicals, industrial waste, environmental pollutions and drugs. Furthermore, camels have unique gene evolution of some genes to withstand living in harsh environments. In this work, the camel cytochrome P450 2E1 (CYP2E1) is compromised to detect its evolution rate and its power to bind with various chemicals, protoxins, procarcinogens, industrial toxins and drugs. In comparison with human CYP2E1, camel CYP2E1 more efficiently binds to small toxins as aniline, benzene, catechol, amides, butadiene, toluene and acrylamide. Larger compounds were more preferentially bound to the human CYP2E1 in comparison with camel CYP2E1. The binding of inhalant anesthetics was almost similar in both camel and human CYP2E1 coinciding with similar anesthetic effect as well as toxicity profiles. Furthermore, evolutionary analysis indicated the high evolution rate of camel CYP2E1 in comparison with human, farm and companion animals. The evolution rate of camel CYP2E1 was among the highest evolution rate in a subset of 57 different organisms. These results indicate rapid evolution and potent toxin binding power of camel CYP2E1. Copyright © 2016. Published by Elsevier Ltd.

  4. Direct-to-consumer advertising of prescription drugs: European Commission persists in putting industry's interests first.

    Science.gov (United States)

    2013-01-01

    In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.

  5. The Drug Discovery and Development Industry in India-Two Decades of Proprietary Small-Molecule R&D.

    Science.gov (United States)

    Differding, Edmond

    2017-06-07

    This review provides a comprehensive survey of proprietary drug discovery and development efforts performed by Indian companies between 1994 and mid-2016. It is based on the identification and detailed analysis of pharmaceutical, biotechnology, and contract research companies active in proprietary new chemical entity (NCE) research and development (R&D) in India. Information on preclinical and clinical development compounds was collected by company, therapeutic indication, mode of action, target class, and development status. The analysis focuses on the overall pipeline and its evolution over two decades, contributions by type of company, therapeutic focus, attrition rates, and contribution to Western pharmaceutical pipelines through licensing agreements. This comprehensive analysis is the first of its kind, and, in our view, represents a significant contribution to the understanding of the current state of the drug discovery and development industry in India. © 2017 The Author. Published by Wiley-VCH Verlag GmbH & Co. KGaA.

  6. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Science.gov (United States)

    2012-03-13

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.

  7. Spurious and counterfeit drugs: a growing industry in the developing world.

    Science.gov (United States)

    Gautam, C S; Utreja, A; Singal, G L

    2009-05-01

    Spread of spurious/counterfeit/substandard drugs is a modern day menace which has been recognised internationally, especially so in developing countries. The problem assumes added significance in view of rapid globalisation. The market of spurious and counterfeit drugs is a well-organised, white collar crime. Poverty, high cost of medicines, lack of an official supply chain, legislative lacunae, easy accessibility to computerised printing technology, ineffective law enforcement machinery, and light penalties provide the counterfeiters with an enormous economic incentive without much risk. The consequences of the use of such medicines may vary from therapeutic failure to the occurrence of serious adverse events and even death. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance on part of all stakeholders can help tackle this problem.

  8. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry

    Science.gov (United States)

    Bourdette, Dennis N.; Ahmed, Sharia M.; Whitham, Ruth H.

    2015-01-01

    Objective: To examine the pricing trajectories in the United States of disease-modifying therapies (DMT) for multiple sclerosis (MS) over the last 20 years and assess the influences on rising prices. Methods: We estimated the trend in annual drug costs for 9 DMTs using published drug pricing data from 1993 to 2013. We compared changes in DMT costs to general and prescription drug inflation during the same period. We also compared the cost trajectories for first-generation MS DMTs interferon (IFN)–β-1b, IFN-β-1a IM, and glatiramer acetate with contemporaneously approved biologic tumor necrosis factor (TNF) inhibitors. Results: First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%–60% higher than existing DMTs. Significant increases in the cost trajectory of the first-generation DMTs occurred following the Food and Drug Administration approvals of IFN-β-1a SC (2002) and natalizumab (reintroduced 2006) and remained high following introduction of fingolimod (2010). Similar changes did not occur with TNF inhibitor biologics during these time intervals. DMT costs in the United States currently are 2 to 3 times higher than in other comparable countries. Conclusions: MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class. There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs. PMID:25911108

  9. 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...

  10. Screening for mental illness: the merger of eugenics and the drug industry.

    Science.gov (United States)

    Sharav, Vera Hassner

    2005-01-01

    The implementation of a recommendation by the President's New Freedom Commission (NFC) to screen the entire United States population--children first--for presumed, undetected, mental illness is an ill-conceived policy destined for disastrous consequences. The "pseudoscientific" methods used to screen for mental and behavioral abnormalities are a legacy from the discredited ideology of eugenics. Both eugenics and psychiatry suffer from a common philosophical fallacy that undermines the validity of their theories and prescriptions. Both are wed to a faith-based ideological assumption that mental and behavioral manifestations are biologically determined, and are, therefore, ameliorated by biological interventions. NFC promoted the Texas Medication Algorithm Project (TMAP) as a "model" medication treatment plan. The impact of TMAP is evident in the skyrocketing increase in psychotropic drug prescriptions for children and adults, and in the disproportionate expenditure for psychotropic drugs. The New Freedom Commission's screening for mental illness initiative is, therefore, but the first step toward prescribing drugs. The escalating expenditure for psychotropic drugs since TMAP leaves little doubt about who the beneficiaries of TMAP are. Screening for mental illness will increase their use.

  11. Drug repurposing in pharmaceutical industry and its impact on market access: market access implications

    Science.gov (United States)

    Murteira, Susana; Millier, Aurélie; Toumi, Mondher

    2014-01-01

    Background Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination. Objective This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe. Methods The case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses. Results A total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were ‘change in administration setting to hospital’ (374%, ptarget product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in

  12. Drug repurposing in pharmaceutical industry and its impact on market access: market access implications.

    Science.gov (United States)

    Murteira, Susana; Millier, Aurélie; Toumi, Mondher

    2014-01-01

    Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination. This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe. The case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses. A total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, ptarget product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change

  13. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Science.gov (United States)

    2013-01-22

    ... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...

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

    Science.gov (United States)

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

    2005-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Nazrul Haq

    2017-02-01

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

  16. THE GENERIC DRUGS LAUNCH AND THEIR IMPACT ON THE COMPETITIVE STRATEGIES OF THE BRAZILIAN PHARMACEUTICAL INDUSTRY

    OpenAIRE

    FELIPE DAVID COHEN

    2004-01-01

    O propósito deste estudo é analisar o advento dos genéricos e verificar seu impacto nas estratégias competitivas implementadas por empresas da indústria farmacêutica brasileira. Este trabalho adota como base o estudo de Michael Porter sobre tipologias, identificando as estratégias relevantes e os grupamentos existentes nesse segmento industrial, buscando também relacionar o posicionamento estratégico assumido pelos laboratórios ao desempenho observado. O método ...

  17. The drugs industry and peasant self-defence in a Peruvian cocaine enclave.

    Science.gov (United States)

    van Dun, Mirella

    2012-11-01

    This article gives a detailed account of the cocaine industry and the related violence in the Peruvian Upper Huallaga. It is argued that in this cocaine producing region violence increased during state-led forced eradication operations of the coca plants. Most of the violent incidents were closely related to the diminishing cocaine industry, but they were also related to the actions of the state security forces. Instead of receiving support from the state's security apparatus, the population mobilized its own forces to fight the violence. As will be argued, the causes of violence in this cocaine enclave are part of a dynamic interaction amongst many factors - an interaction that is influenced by the local context, a partial state vacuum, and the social utility and the economic advantages of violence. One needs to be aware that motivations of those who engage in the violent behaviour can change over time, as underlying power structures are influenced by changes in local conditions. The study covers an in-depth account of events taking place in the Upper Huallaga during the years 2003-2007. The research material was collected by several ethnographical fieldwork methods. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. [Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

    Science.gov (United States)

    Curcio, Pasqualina Curcio

    2008-10-01

    The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

  19. The mutual extraction industry: drug use and the normative structure of social capital in the Russian far north.

    Science.gov (United States)

    Pilkington, Hilary; Sharifullina, El'vira

    2009-05-01

    The article contributes to the literature on the role of social networks and social capital in young people's drug use. It considers the structural and cultural dimensions of the 'risk environment' of post-Soviet Russia, the micro risk-environment of a de-industrializing city in the far north of the country and the kind of social capital that circulates in young people's social networks there. Its focus is thus on social capital at the micro-level, the 'bridging' networks of peer friendship groups and the norms that govern them. The research is based on a small ethnographic study of the friendship groups and social networks of young people in the city of Vorkuta in 2006-2007. It draws on data from 32 respondents aged 17-27 in the form of 17 semi-structured audio and video interviews and field diaries. Respondents were selected from friendship groups in which drug use was a regular and symbolically significant practice. The risk environment of the Russian far north is characterised by major de-industrialization, poor health indicators, low life expectancy and limited educational and employment opportunities. It is also marked by a 'work hard, play hard' cultural ethos inherited from the Soviet period when risk-laden manual labour was well-rewarded materially and symbolically. However, young people today often rely on informal economic practices to generate the resource needed to fulfil their expectations. This is evident from the social networks among respondents which were found to be focused around a daily routine of generating and spending income, central to which is the purchase, sale and use of drugs. These practices are governed by norms that often invert those normally ascribed to social networks: reciprocity is replaced by mutual exploitation and trust by cheating. Social networks are central to young people's management of the risk environment associated with post-Soviet economic transformation. However, such networks are culturally as well as structurally

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

    Directory of Open Access Journals (Sweden)

    Lončar Irma M.

    2013-01-01

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

  1. Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

    Science.gov (United States)

    Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee

    2018-05-01

    Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.

  2. Opportunities for Data Science in the Pharmaceutical Industry: The Use of Data to Find Efficiencies in Drug Development Can?t Come Too Soon.

    Science.gov (United States)

    Keshava, Nirmal

    2017-01-01

    By the numbers, 2016 was not a good year for the U.S. pharmaceutical industry. As of early December, only 19 new drugs had been approved by the Food and Drug Administration (FDA), fewer than half of those approved in 2015 and the lowest number since 2007. Further, the FDA approved only 61% of submissions in 2016, compared to 95% in 2015 [1]. And, among the largest companies, the return on investment for research and development (R&D) fell to 3.7% [2].

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

    Science.gov (United States)

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

    2013-05-01

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

  4. Nasal-to-CNS drug delivery: where are we now and where are we heading? An industrial perspective.

    Science.gov (United States)

    Landis, Margaret S; Boyden, Tracey; Pegg, Simon

    2012-02-01

    Delivery of drug therapeutics across the blood-brain barrier is a challenging task for pharmaceutical scientists. Nasal-to-CNS drug delivery has shown promising results in preclinical efficacy models and investigatory human clinical trials. The further development of this technology with respect to the establishment of valid, predictable preclinical species models, translatable pharmacokinetic-pharmacodynamic relationships and definition of toxicology impact will help attract additional pharmaceutical investment in this drug-delivery approach. Further discoveries in nasal nanotechnology, targeted delivery devices and diagnostic olfactory imaging will serve to fuel the advancements in this area of drug delivery.

  5. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Science.gov (United States)

    2013-04-17

    ... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...

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

    Science.gov (United States)

    2011-05-05

    ... are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug... overdoses that can result from the use of dosage delivery devices with markings that are inconsistent or... because of ongoing concerns about potentially serious accidental drug overdoses that can result from the...

  7. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring... promote global supply chain transparency. The information provided through self-identification will enable... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...

  8. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Science.gov (United States)

    2011-04-13

    ... Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to... exploration and verification of drug effects under epidemic and pandemic conditions. A draft notice of...

  9. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-14

    ..., 301-796-2483; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM- 17), Food and Drug... information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; and the...

  10. The innovative use of a large-scale industry biomedical consortium to research the genetic basis of drug induced serious adverse events.

    Science.gov (United States)

    Holden, Arthur L

    2007-01-01

    The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical

  11. Method for manufacturing carrier containing e.g. proteins for human during oral drug delivery operation for food and drug administration application in pharmaceutical industry, involves providing active ingredient to core layer

    DEFF Research Database (Denmark)

    2015-01-01

    NOVELTY - The method involves preparing a multi-layered film comprising a core layer and a barrier layer, where the core layer comprises active ingredient. The multi-layered film is subjected to a hot embossing step using an embossing stamp including protrusions that allows for generation...... delivery operation for a food and drug administration (FDA) application in a pharmaceutical industry. ADVANTAGE - The method enables allowing an individual micro-structure stuck in an embossing stamp to be demolded under the conditions such that demolding operation is done by treating elastically...

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

    Science.gov (United States)

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

    2017-01-01

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

  13. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Science.gov (United States)

    2010-03-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0143... confer any rights for or on any person and does not operate to bind FDA or the public. An alternative... is to discuss the most current information and thinking about clinical and basic aspects of the still...

  14. 77 FR 72869 - Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug...

    Science.gov (United States)

    2012-12-06

    ... fluid, breast milk, urine, and serum. Data from the National Health and Nutrition Examination Survey... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1135...) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP...

  15. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0432... Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to... other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major...

  16. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Science.gov (United States)

    2011-01-31

    ... of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville... harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand.'' The guidance discusses the meaning of the term ``harmful and...

  17. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0226...) audit report provides FDA a degree of assurance of compliance with basic and fundamental quality management system requirements for medical devices. \\1\\ The GHTF founding members auditing systems include...

  18. 78 FR 63220 - Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for...

    Science.gov (United States)

    2013-10-23

    ... assist sponsors in the development of new antibacterial drugs to treat acute bacterial skin and skin..., rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office... Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center...

  19. Practical guidelines for the characterization and quality control of pure drug nanoparticles and nano-cocrystals in the pharmaceutical industry.

    Science.gov (United States)

    Peltonen, Leena

    2018-06-16

    The number of poorly soluble drug candidates is increasing, and this is also seen in the research interest towards drug nanoparticles and (nano-)cocrystals; improved solubility is the most important application of these nanosystems. In order to confirm the functionality of these nanoparticles throughout their lifecycle, repeatability of the formulation processes, functional performance of the formed systems in pre-determined way and system stability, a thorough physicochemical understanding with the aid of necessary analytical techniques is needed. Even very minor deviations in for example particle size or size deviation in nanoscale can alter the product bioavailability, and the effect is even more dramatic with the smallest particle size fractions. Also, small particle size sets special requirements for the analytical techniques. In this review most important physicochemical properties of drug nanocrystals and nano-cocrystals are presented, suitable analytical techniques, their pros and cons, are described with the extra input on practical point of view. Copyright © 2018. Published by Elsevier B.V.

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

    Science.gov (United States)

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

    2013-03-05

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

  1. Microbial conversion of sulfur dioxide in flue gas to sulfide using bulk drug industry wastewater as an organic source by mixed cultures of sulfate reducing bacteria

    International Nuclear Information System (INIS)

    Rao, A. Gangagni; Ravichandra, P.; Joseph, Johny; Jetty, Annapurna; Sarma, P.N.

    2007-01-01

    Mixed cultures of sulfate reducing bacteria (SRB) were isolated from anaerobic cultures and enriched with SRB media. Studies on batch and continuous reactors for the removal of SO 2 with bulk drug industry wastewater as an organic source using isolated mixed cultures of SRB revealed that isolation and enrichment methodology adopted in the present study were apt to suppress the undesirable growth of anaerobic bacteria other than SRB. Studies on anaerobic reactors showed that process was sustainable at COD/S ratio of 2.2 and above with optimum sulfur loading rate (SLR) of 5.46 kg S/(m 3 day), organic loading rate (OLR) of 12.63 kg COD/(m 3 day) and at hydraulic residence time (HRT) of 8 h. Free sulfide (FS) concentration in the range of 300-390 mg FS/l was found to be inhibitory to mixed cultures of SRB used in the present studies

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Gerson Rosenberg

    2010-04-01

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

  4. Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

    Science.gov (United States)

    Wright, Curtis; Schnoll, Sidney; Bernstein, David

    2008-10-01

    Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.

  5. Drug Facts

    Medline Plus

    Full Text Available ... Why Is It So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug ... Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug ...

  6. Pharmacist-industry relationships.

    Science.gov (United States)

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

    2017-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Cristiane Quental

    2008-04-01

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

  8. Drug Facts

    Medline Plus

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

  9. Drug Facts

    Medline Plus

    Full Text Available ... Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, ... Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug Use and Kids ...

  10. Drug Facts

    Medline Plus

    Full Text Available ... People Drug Use and Families Drug Use and Kids Drug Use and Unborn Children Drug Use and ... Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used ...

  11. An ecological perspective on U.S. industrial poultry production: the role of anthropogenic ecosystems on the emergence of drug-resistant bacteria from agricultural environments.

    Science.gov (United States)

    Davis, Meghan F; Price, Lance B; Liu, Cindy Meng-Hsin; Silbergeld, Ellen K

    2011-06-01

    The industrialization of food animal production, specifically the widespread use of antimicrobials, not only increased pressure on microbial populations, but also changed the ecosystems in which antimicrobials and bacteria interact. In this review, we argue that industrial food animal production (IFAP) is appropriately defined as an anthropogenic ecosystem. This paper uses an ecosystem perspective to frame an examination of these changes in the context of U.S. broiler chicken production. This perspective emphasizes multiple modes by which IFAP has altered microbiomes and also suggests a means of generating hypotheses for understanding and predicting the ecological impacts of IFAP in terms of the resistome and the flow of resistance within and between microbiomes. Copyright © 2011 Elsevier Ltd. All rights reserved.

  12. Environmental pollution with antimicrobial agents from bulk drug manufacturing industries in Hyderabad, South India, is associated with dissemination of extended-spectrum beta-lactamase and carbapenemase-producing pathogens.

    Science.gov (United States)

    Lübbert, Christoph; Baars, Christian; Dayakar, Anil; Lippmann, Norman; Rodloff, Arne C; Kinzig, Martina; Sörgel, Fritz

    2017-08-01

    High antibiotic and antifungal concentrations in wastewater from anti-infective drug production may exert selection pressure for multidrug-resistant (MDR) pathogens. We investigated the environmental presence of active pharmaceutical ingredients and their association with MDR Gram-negative bacteria in Hyderabad, South India, a major production area for the global bulk drug market. From Nov 19 to 28, 2016, water samples were collected from the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River, and habitats in Hyderabad and nearby villages. Samples were analyzed for 25 anti-infective pharmaceuticals with liquid chromatography-tandem mass spectrometry and for MDR Gram-negative bacteria using chromogenic culture media. In addition, specimens were screened with PCR for bla VIM , bla KPC , bla NDM , bla IMP-1 , and bla OXA-48 resistance genes. All environmental specimens from 28 different sampling sites were contaminated with antimicrobials. High concentrations of moxifloxacin, voriconazole, and fluconazole (up to 694.1, 2500, and 236,950 µg/L, respectively) as well as increased concentrations of eight other antibiotics were found in sewers in the Patancheru-Bollaram industrial area. Corresponding microbiological analyses revealed an extensive presence of extended-spectrum beta-lactamase and carbapenemase-producing Enterobacteriaceae and non-fermenters (carrying mainly bla OXA-48 , bla NDM , and bla KPC ) in more than 95% of the samples. Insufficient wastewater management by bulk drug manufacturing facilities leads to unprecedented contamination of water resources with antimicrobial pharmaceuticals, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens. The development and global spread of antimicrobial resistance present a major challenge for pharmaceutical producers and regulatory agencies.

  13. 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 ...

  14. Drug Allergy

    Science.gov (United States)

    ... Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days or ... you take the drug. Drugs commonly linked to allergies Although any drug can cause an allergic reaction, ...

  15. Estratégias mercadológicas da indústria farmacêutica e o consumo de medicamentos Marketing strategies of the pharmaceutical industry and drug consumption

    Directory of Open Access Journals (Sweden)

    José Augusto C. Barros

    1983-10-01

    Full Text Available Dentro do processo de ampliação crescente do âmbito de intervenção da Medicina (a chamada "medicalização", o uso abusivo de medicamentos industrializados assume papel de destaque. Entre as diversas práticas mercadológicas de que a Indústria Farmacêutica se vale para incrementar os seus lucros - via estímulo ao consumo - sobressai-se a propaganda, particularmente junto ao médico. A despeito da automedicação, dependente, por sua vez, em grande parte, da influência inclusive "legitimadora" do médico, é sobre esse profissional que recai, direta ou indiretamente, através da prescrição medicamentosa, a responsibilidade por ação significativa do consumo. Propõe-se, com base em diversos estudos já realizados, a análise crítica do papel da propaganda, com ênfase no papel do propagandista de laboratório e na sua eficácia como instrumento preferencial de que lançam mão os produtores de medicamentos para influenciar os hábitos de prescrição dos médicos, dirigindo-os prioritariamente à satisfação dos interesses dos produtores, em detrimento daqueles dos consumidores.The overuse of manufactured drugs plays an important role in the process of the growing intervention of Medicine (the phenomenon called "medicalization". Among the different promotional practices used by pharmaceutical manufacturers to increase their profits - by means of the stimulation of the use of drugs advertising directed specially at physicians is particularly prominent. Notwithstanding drugs sold "over the counter", the use of which also depends, in great measure, in the last analysis, on the legitimation given them by physicians, these latter are responsible, through their prescriptions, for the larger part of all drug consumption. An attempt is made a critical analysis of the role of advertising, highlighting the role of drug companies' representatives and their efficacy as the means favored by manufacturers in their attempts to influence

  16. Industry sponsorship and research outcome

    DEFF Research Database (Denmark)

    Lundh, Andreas; Sismondo, Sergio; Lexchin, Joel

    2012-01-01

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

  17. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  18. Drug Abuse

    Science.gov (United States)

    ... Cocaine Heroin Inhalants Marijuana Prescription drugs, including opioids Drug abuse also plays a role in many major social problems, such as drugged driving, violence, stress, and child abuse. Drug abuse can lead to ...

  19. Drug Facts

    Medline Plus

    Full Text Available ... Use and Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Kids Drug Use and Unborn Children Drug Use and Your Health Other Effects on ... Someone Find Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids ...

  1. Club Drugs

    Science.gov (United States)

    ... uses. Other uses of these drugs are abuse. Club drugs are also sometimes used as "date rape" drugs, to make someone unable to say no to or fight back against sexual assault. Abusing these drugs can ...

  2. Industrial recovery capability. Final report

    International Nuclear Information System (INIS)

    Gregg, D.W.

    1984-12-01

    This report provides an evaluation of the vulnerability - to a nuclear strike, terrorist attack, or natural disaster - of our national capacity to produce chlorine, beryllium, and a particular specialty alumina catalyst required for the production of sulfur. All of these industries are of critical importance to the United States economy. Other industries that were examined and found not to be particularly vulnerable are medicinal drugs and silicon wafers for electronics. Thus, only the three more vulnerable industries are addressed in this report

  3. Industrial Engineering

    DEFF Research Database (Denmark)

    Karlsson, Christer

    2015-01-01

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

  4. Farmaceutische industrie

    NARCIS (Netherlands)

    Ros JPM; van der Poel P; Etman EJ; Montfoort JA; LAE

    1995-01-01

    Dit rapport over de farmaceutische industrie is gepubliceerd binnen het Samenwerkingsproject Procesbeschrijvingen Industrie Nederland (SPIN). In het kader van dit project is informatie verzameld over industriele bedrijven of industriele processen ter ondersteuning van het overheidsbeleid op het

  5. Quality Performance of Drugs Analyzed in the Drug Analysis and ...

    African Journals Online (AJOL)

    ICT TEAM

    performance of drug samples analyzed therein. Previous reports have ... wholesalers, non-governmental organizations, hospitals, analytical ..... a dispute concerning discharge of waste water ... Healthcare Industry in Kenya, December. 2008.

  6. Industrial electrification

    International Nuclear Information System (INIS)

    Melvin, J.G.

    1983-03-01

    The technical and economic scope for industrial process electrification in Canada is assessed in the light of increasing costs of combustion fuels relative to electricity. It is concluded that electricity is capable of providing an increasing share of industrial energy, eventually aproaching 100 percent. The relatively low cost of electricity in Canada offers industry the opportunity of a head start in process electrification with consequent advantages in world markets both for industrial products and for electrical process equipment and technology. A method is described to promote the necessary innovation by providing access to technology and financing. The potential growth of electricity demand due to industrial electrification is estimated

  7. Industrial guide to chemical and drug safety

    National Research Council Canada - National Science Library

    Diwan, Prakash V; Dikshith, T. S. S

    2003-01-01

    ... References 51 Chapter 3 Heavy Metals 59 Introduction 59 Metals and Toxicity Aluminum Arsenic Barium Beryllium Cadmium Chromium Cobalt Lead Manganese Mercury and Methyl Mercury Nickel Zinc 61 62 63 65...

  8. DRUG COSTS UPDATE ON THE PHARMACEUTICAL INDUSTRY

    African Journals Online (AJOL)

    Enrique

    The Sunday Times Business Times published a supplement ... take place before marketing of the new medication. Once the patent has .... with other risks facing the business. It is clearly ... HIV/AIDS (SABCOHA) will be launching an HIV/AIDS.

  9. Drug allergies

    Science.gov (United States)

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The first time ...

  10. Study Drugs

    Science.gov (United States)

    ... to quit, they may have withdrawal symptoms like depression, thoughts of suicide, intense drug cravings, sleep problems, and fatigue. The health risks aren't the only downside to study drugs. Students caught with illegal prescription drugs may get suspended ...

  11. Drug Facts

    Medline Plus

    Full Text Available ... symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen ... to prescription drugs. The addiction slowly took over his life. I need different people around me. To ...

  13. Drug Reactions

    Science.gov (United States)

    ... problem is interactions, which may occur between Two drugs, such as aspirin and blood thinners Drugs and food, such as statins and grapefruit Drugs and supplements, such as ginkgo and blood thinners ...

  14. 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 ...

  15. Pharmacogenetics of psychotropic drugs

    National Research Council Canada - National Science Library

    Lerer, Bernard

    2002-01-01

    ... of pharmacogenetics with substance dependence and brain imaging, and consider the impact of pharmacogenetics on the biotechnology and pharmaceutical industries. This book defines the young field of pharmacogenetics as it applies to psychotropic drugs and is, therefore, an essential reference for all clinicians and researchers working in this findings field. Bernard ...

  16. Process industry properties in nuclear industry

    International Nuclear Information System (INIS)

    Zheng Hualing

    2005-01-01

    In this article the writer has described the definition of process industry, expounded the fact classifying nuclear industry as process industry, compared the differences between process industry and discrete industry, analysed process industry properties in nuclear industry and their important impact, and proposed enhancing research work on regularity of process industry in nuclear industry. (authors)

  17. Nuclear imaging drug development tools

    International Nuclear Information System (INIS)

    Buchanan, L.; Jurek, P.; Redshaw, R.

    2007-01-01

    This article describes the development of nuclear imaging as an enabling technology in the pharmaceutical industry. Molecular imaging is maturing into an important tool with expanding applications from validating that a drug reaches the intended target through to market launch of a new drug. Molecular imaging includes anatomical imaging of organs or tissues, computerized tomography (CT), magnetic resonance imaging (MRI) and ultrasound.

  18. Orphan drugs: trends and issues in drug development.

    Science.gov (United States)

    Rana, Proteesh; Chawla, Shalini

    2018-04-12

    Research in rare diseases has contributed substantially toward the current understanding in the pathophysiology of the common diseases. However, medical needs of patients with rare diseases have always been neglected by the society and pharmaceutical industries based on their small numbers and unprofitability. The Orphan Drug Act (1983) was the first serious attempt to address the unmet medical needs for patients with rare diseases and to provide impetus for the pharmaceutical industry to promote orphan drug development. The process of drug development for rare diseases is no different from common diseases but involves significant cost and infrastructure. Further, certain aspect of drug research may not be feasible for the rare diseases. The drug-approving authority must exercise their scientific judgment and ensure due flexibility while evaluating data at various stages of orphan drug development. The emergence of patent cliff combined with the government incentives led the pharmaceutical industry to realize the good commercial prospects in developing an orphan drug despite the small market size. Indeed, many drugs that were given orphan designation ended up being blockbusters. The orphan drug market is projected to reach $178 billion by 2020, and the prospects of research and development in rare diseases appears to be quite promising and rewarding.

  19. Discontinued drugs in 2012: cardiovascular drugs.

    Science.gov (United States)

    Zhao, Hong-Ping; Jiang, Hong-Min; Xiang, Bing-Ren

    2013-11-01

    The continued high rate of cardiovascular morbidity and mortality has attracted wide concern and great attention of pharmaceutical industry. In order to reduce the attrition of cardiovascular drug R&D, it might be helpful recapitulating previous failures and identifying the potential factors to success. This perspective mainly analyses the 30 cardiovascular drugs dropped from clinical development in 2012. Reasons causing the termination of the cardiovascular drugs in the past 5 years are also tabulated and analysed. The analysis shows that the attrition is highest in Phase II trials and financial and strategic factors and lack of clinical efficacy are the principal reasons for these disappointments. To solve the four problems (The 'better than the Beatles' problem, the 'cautious regulator' problem, the 'throw money at it' tendency and the 'basic researchbrute force' bias) is recommended as the main measure to increase the number and quality of approvable products.

  20. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  1. Drug Facts

    Medline Plus

    Full Text Available ... 4357) at any time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from drugs. But she's afraid ...

  2. Industrial Robots.

    Science.gov (United States)

    Reed, Dean; Harden, Thomas K.

    Robots are mechanical devices that can be programmed to perform some task of manipulation or locomotion under automatic control. This paper discusses: (1) early developments of the robotics industry in the United States; (2) the present structure of the industry; (3) noneconomic factors related to the use of robots; (4) labor considerations…

  3. Industrial symbiosis

    DEFF Research Database (Denmark)

    Sacchi, Romain; Remmen, Arne

    2017-01-01

    This study examines the development of industrial symbiosis through a practical model for physical, organizational, and social interactions in six different cases from around the world. The results provide a framework that can be used by industrial symbiosis practitioners to facilitate the creation...

  4. 2001 Industry Studies: Services Industry

    National Research Council Canada - National Science Library

    Cervone, Michael

    2001-01-01

    .... has maintained its economic strength in traditional services industries such as transportation, tourism, public utilities, finance and insurance, accounting, engineering, architecture, medical, legal...

  5. Industry sponsorship and research outcome

    DEFF Research Database (Denmark)

    Lundh, Andreas; Lexchin, Joel; Mintzes, Barbara

    2017-01-01

    BACKGROUND: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared...... on the association between sponsorship and research outcome. OBJECTIVES: To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. SEARCH METHODS: In this update we searched MEDLINE (2010......, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. DATA COLLECTION AND ANALYSIS: Two assessors screened abstracts and identified...

  6. Industrial garnet

    Science.gov (United States)

    Olson, D.W.

    2000-01-01

    The state of the global industrial garnet industry in 1999 is discussed. Industrial garnet mined in the U.S., which accounts for approximately one-third of the world's total, is usually a solid-solution of almandine and pyrope. The U.S. is the largest consumer of industrial garnet, using an estimated 47,800 st in 1999 as an abrasive and as a filtration medium in the petroleum industry, filtration plants, aircraft and motor vehicle manufacture, shipbuilding, wood furniture finishing operations, electronic component manufacture, ceramics manufacture, and glass production. Prices for crude concentrates ranged from approximately $50 to $110/st and refined garnet from $50 to $215/st in 1999, depending on type, source, quantity purchased, quality, and application.

  7. Industry honoured

    CERN Multimedia

    2008-01-01

    CERN has organised a day to thank industry for its exceptional contributions to the LHC project. Lucio Rossi addresses CERN’s industrial partners in the Main Auditorium.The LHC inauguration provided an opportunity for CERN to thank all those who have contributed to transforming this technological dream into reality. Industry has been a major player in this adventure. Over the last decade it has lent its support to CERN’s teams and participating institutes in developing, building and assembling the machine, its experiments and the computing infrastructure. CERN involved its industrial partners in the LHC inauguration by organising a special industry prize-giving day on 20 October. Over 70 firms accepted the invitation. The firms not only made fundamental contributions to the project, but some have also supported LHC events in 2008 and the inauguration ceremony through generous donations, which have been coordinated by Carmen Dell’Erba, who is responsible for secu...

  8. Industrial Waste

    DEFF Research Database (Denmark)

    Christensen, Thomas Højlund

    2011-01-01

    generation rates and material composition as well as determining factors are discussed in this chapter. Characterizing industrial waste is faced with the problem that often only a part of the waste is handled in the municipal waste system, where information is easily accessible. In addition part...... of the industrial waste may in periods, depending on market opportunities and prices, be traded as secondary rawmaterials. Production-specificwaste from primary production, for example steel slag, is not included in the current presentation. In some countries industries must be approved or licensed and as part...... of the system industry has to inform at the planning stage and afterwards in yearly reports on their waste arising and how the waste is managed. If available such information is very helpful in obtaining information about that specific industry. However, in many countries there is very little information...

  9. Industrial ecology.

    Science.gov (United States)

    Patel, C K

    1992-01-01

    Industrial ecology addresses issues that will impact future production, use, and disposal technologies; proper use of the concept should reduce significantly the resources devoted to potential remediation in the future. This cradle-to-reincarnation production philosophy includes industrial processes that are environmentally sound and products that are environmentally safe during use and economically recyclable after use without adverse impact on the environment or on the net cost to society. This will require an industry-university-government round table to set the strategy and agenda for progress. PMID:11607254

  10. Substance use - prescription drugs

    Science.gov (United States)

    Substance use disorder - prescription drugs; Substance abuse - prescription drugs; Drug abuse - prescription drugs; Drug use - prescription drugs; Narcotics - substance use; Opioid - substance use; Sedative - substance ...

  11. Industrial practices

    International Nuclear Information System (INIS)

    Velasquez Torrez, Patricia Irma

    1999-01-01

    This document reports the industrial practices carried out by the author viewing the requirements fulfilled for obtention the academic degree in chemical engineering of the San Andres University - Bolivia

  12. Electronics Industry

    National Research Council Canada - National Science Library

    Ginter, Michael J; Andersen, James L; Becker, John A; Belliveau, Gerald E; Eppich, Frank J; Awai, Herman T; Hanko, David J; Hughes, Bob; Jones, Douglas; Larson, Kelly J

    2007-01-01

    .... area, New York State, Silicon Valley (California), Taiwan, and China. This approach provides a wide range of perspectives from which to examine the selected industry's current condition, outlook, and challenges...

  13. Industrial radiography

    International Nuclear Information System (INIS)

    1994-01-01

    This Health and Safety Executive Information Sheet on industrial radiography aims to inform directors and managers of industrial radiography companies on the safety precautions necessary to ensure that their personnel do not exceed dose guidelines for exposure to ionizing radiation. The Ionising Radiations Regulations 1985 (IRR85) require that exposure doses for radiographers are kept as low reasonably practicable. Equipment maintenance, and the employment of proper emergency procedures will help to ensure personnel safety. (UK)

  14. Industrial ceramics

    International Nuclear Information System (INIS)

    Mengelle, Ch.

    1999-04-01

    After having given the definition of the term 'ceramics', the author describes the different manufacturing processes of these compounds. These materials are particularly used in the fields of 1)petroleum industry (in primary and secondary reforming units, in carbon black reactors and ethylene furnaces). 2)nuclear industry (for instance UO 2 and PuO 2 as fuels; SiC for encapsulation; boron carbides for control systems..)

  15. 78 FR 35117 - Orphan Drug Regulations

    Science.gov (United States)

    2013-06-12

    ..., ``This [framework] affects the plasma protein therapeutics industry significantly because various drugs... orphan designated.'' Because many plasma protein therapies lack orphan-drug designation, they are... change in delivery system from intravenous (IV) to oral may, in some cases and for some drugs, constitute...

  16. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Science.gov (United States)

    2011-01-07

    ...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...

  17. Drug Facts

    Medline Plus

    Full Text Available ... abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can ...

  18. Prescription Drugs

    Science.gov (United States)

    ... different competition is going on: the National Football League (NFL) vs. drug use. Read More » 92 Comments ... Future survey highlights drug use trends among the Nation’s youth for marijuana, alcohol, cigarettes, e-cigarettes (e- ...

  19. Drug Facts

    Medline Plus

    Full Text Available ... abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth ... 662-HELP (4357) at any time to find drug treatment centers near you. I want my daughter ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts ... addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain ...

  1. Drug Facts

    Medline Plus

    Full Text Available ... Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of ... Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1- ...

  2. Drug Control

    Science.gov (United States)

    Leviton, Harvey S.

    1975-01-01

    This article attempts to assemble pertinent information about the drug problem, particularily marihuana. It also focuses on the need for an educational program for drug control with the public schools as the main arena. (Author/HMV)

  3. Drug Facts

    Medline Plus

    Full Text Available ... Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs ... Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... Nicotine Facts Other Drugs of Abuse What is Addiction? What are some signs and symptoms of someone ... use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted ...

  5. Drug Facts

    Medline Plus

    Full Text Available ... Numbers and Websites Search Share Listen English Español Information about this page Click on the button that ... about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana ...

  6. Drug Facts

    Medline Plus

    Full Text Available ... Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) ... treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice ( ...

  7. Drug Facts

    Medline Plus

    Full Text Available ... call 1-800-662-HELP (4357) at any time to find drug treatment centers near you. I ... The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH) , the ...

  8. Orphan drugs

    OpenAIRE

    Goločorbin-Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojša; Mikov, Momir

    2013-01-01

    Introduction. Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in ”adopting” them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of ...

  9. Drug Testing

    Science.gov (United States)

    ... testing, substance abuse testing, toxicology screen, tox screen, sports doping tests What is it used for? Drug screening is used to find out whether or not a person has taken a certain drug or drugs. It ... Sports organizations. Professional and collegiate athletes usually need to ...

  10. Drug Facts

    Medline Plus

    Full Text Available ... to main content Easy-to-Read Drug Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts ... Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page ...

  11. Drug Facts

    Medline Plus

    Full Text Available ... can call 1-800-662-HELP (4357) at any time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... the computer will read the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos ... I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from ...

  13. Drug Facts

    Medline Plus

    Full Text Available ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs ... adicción. English Español About the National Institute on Drug Abuse (NIDA) | About This Website Tools and Resources | Contact ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  15. Drug Facts

    Medline Plus

    Full Text Available ... 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 ...

  16. Industrial gases

    International Nuclear Information System (INIS)

    Hunter, D.; Jackson, D.; Coeyman, M.

    1993-01-01

    Industrial gas companies have fought hard to boost sales and hold margins in the tough economic climate, and investments are well down from their 1989-'91 peak. But 'our industry is still very strong long term' says Alain Joly, CEO of industry leader L'Air Liquide (AL). By 1994, if a European and Japanese recovery follows through on one in the U.S., 'we could see major [investment] commitments starting again,' he says. 'Noncryogenic production technology is lowering the cost of gas-making possible new applications, oxygen is getting plenty of attention in the environmental area, and hydrogen also fits into the environmental thrust,' says Bob Lovett, executive v.p./gases and equipment with Air Products ampersand Chemicals (AP). Through the 1990's, 'Industrial gases could grow even faster than in the past decade,' he says. Virtually a new generation of new gases applications should become reality by the mid-1990s, says John Campbell, of industry consultants J.R. Campbell ampersand Associates (Lexington, MA). Big new oxygen volumes will be required for powder coal injection in blast furnaces-boosting a steel mill's requirement as much as 40% and coal gasification/combined cycle (CGCC). Increased oil refinery hydroprocessing needs promise hydrogen requirements

  17. WAr on DrugS

    African Journals Online (AJOL)

    2009-04-12

    Apr 12, 2009 ... ABStrAct. Since drugs became both a public and social issue in Nigeria, fear about both the real and .... drugs as being morally reprehensible, and ..... tice system (see for instance, Shaw, 1995; ..... A cut throat business:.

  18. Energy industry

    Science.gov (United States)

    Staszak, Katarzyna; Wieszczycka, Karolina

    2018-04-01

    The potential sources of metals from energy industries are discussed. The discussion is organized based on two main metal-contains wastes from power plants: ashes, slags from combustion process and spent catalysts from selective catalytic NOx reduction process with ammonia, known as SCR. The compositions, methods of metals recovery, based mainly on leaching process, and their further application are presented. Solid coal combustion wastes are sources of various compounds such as silica, alumina, iron oxide, and calcium. In the case of the spent SCR catalysts mainly two metals are considered: vanadium and tungsten - basic components of industrial ones.

  19. Industrial sector

    International Nuclear Information System (INIS)

    Ainul Hayati Daud; Hazmimi Kasim

    2010-01-01

    The industrial sector is categorized as related to among others, the provision of technical and engineering services, supply of products, testing and troubleshooting of parts, systems and industrial plants, quality control and assurance as well as manufacturing and processing. A total of 161 entities comprising 47 public agencies and 114 private companies were selected for the study in this sector. The majority of the public agencies, 87 %, operate in Peninsular Malaysia. The remainders were located in Sabah and Sarawak. The findings of the study on both public agencies and private companies are presented in subsequent sections of this chapter. (author)

  20. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Science.gov (United States)

    2011-08-24

    ...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug...

  1. 76 FR 54473 - Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Science.gov (United States)

    2011-09-01

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

  2. Fermentation Industry.

    Science.gov (United States)

    Grady, C. P. L., Jr.; Grady, J. K.

    1978-01-01

    Presents a literature review of wastes from the fermentation industry, covering publications of 1976-77. This review focuses on: (1) alcoholic beverage production; (2) pharmaceuticals and biochemicals production; and (3) biomass production. A list of 62 references is also presented. (HM)

  3. Industrial radiography

    International Nuclear Information System (INIS)

    Aloni, A.; Magal, O.

    1992-02-01

    This publication is meant to be a manual for industrial radiography. As such the manual concentrates on the practical aspects, presenting existing radiographic system and techniques of operation to satisfy specified quality requirements. The manual also reviews the safety aspect of performing radiographic work. (author) systems

  4. Education Industry

    Science.gov (United States)

    2007-01-01

    themes: No Child Left Behind Act reauthorization, international competitiveness, and recruiting and retention of quality teachers. The US education ...industry stakeholders and require difficult choices. A more centralized education system has many advantages , and the US should move in that direction...between math and science skills, innovation and creativity, and international education , as all these areas are integral to future success. Finally

  5. Industrial garnet

    Science.gov (United States)

    Olson, D.W.

    2013-01-01

    Garnet has been used as a gemstone since the Bronze Age. However, garnet’s angular fractures, relatively high hardness and specific gravity, chemical inertness and nontoxicity make it ideal for many industrial applications. It is also free of crystalline silica and can be recycled.

  6. 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...

  7. Quantitative decisions in drug development

    CERN Document Server

    Chuang-Stein, Christy

    2017-01-01

    This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support dru...

  8. 76 FR 9028 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2011-02-16

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire... to provide the following: (1) Firsthand exposure to industry's drug development processes and (2) a...

  9. 75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2010-03-09

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration... to provide the following: (1) First hand exposure to industry's drug development processes and (2) a...

  10. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Science.gov (United States)

    2012-11-23

    ...] Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

  11. 77 FR 10538 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2012-02-22

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave...) Firsthand exposure to industry's drug development processes and (2) a venue for sharing information about...

  12. 78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2013-02-06

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... to industry's drug development processes and (2) a venue for sharing information about project...

  13. COPD - control drugs

    Science.gov (United States)

    Chronic obstructive pulmonary disease - control drugs; Bronchodilators - COPD - control drugs; Beta agonist inhaler - COPD - control drugs; Anticholinergic inhaler - COPD - control drugs; Long-acting inhaler - COPD - control drugs; ...

  14. 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 ...

  15. [Orphan drugs].

    Science.gov (United States)

    Golocorbin Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojsa; Mikov, Momir

    2013-01-01

    Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in "adopting" them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of drugs meant to treat diseases whose pathogenesis has not yet been clarified in majority of cases. The aim of this paper is to present previous and present status of orphan drugs in Serbia and other countries. THE BEGINNING OF ORPHAN DRUGS DEVELOPMENT: This problem was first recognized by Congress of the United States of America in January 1983, and when the "Orphan Drug Act" was passed, it was a turning point in the development of orphan drugs. This law provides pharmaceutical companies with a series of reliefs, both financial ones that allow them to regain funds invested into the research and development and regulatory ones. Seven years of marketing exclusivity, as a type of patent monopoly, is the most important relief that enables companies to make large profits. There are no sufficient funds and institutions to give financial support to the patients. It is therefore necessary to make health professionals much more aware of rare diseases in order to avoid time loss in making the right diagnosis and thus to gain more time to treat rare diseases. The importance of discovery, development and production of orphan drugs lies in the number of patients whose life quality can be improved significantly by administration of these drugs as well as in the number of potential survivals resulting from the treatment with these drugs.

  16. Industrial system for producing iodine-123

    International Nuclear Information System (INIS)

    Brantley, J.C.

    1985-01-01

    An industrial system to produce iodine-123 required a complex set of steps involving new approaches by the Food and Drug Administration, difficult distribution procedures, and evidence from potential users that either very pure iodine-123 or inexpensive iodine-123 is needed. Industry has shown its willingness to invest in new radionuclides but needs strong evidence as to product potential to justify those investments

  17. The industrial applications of ionizing radiations

    International Nuclear Information System (INIS)

    1992-10-01

    This report presents all industrial applications of ionizing radiations in France, for food preservation, radiosterilization of drugs, medical materials and cosmetic products, for radiation chemistry of polymers. This report also describes the industrial plants of irradiation (electron, cobalt 60). Finally, it explains the legal and safety aspects

  18. 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 ...

  19. Rubber industry

    Science.gov (United States)

    Staszak, Maciej

    2018-03-01

    Following chapter presents short introductory description of rubber and rubber industry. The main problem of rubber industry is the way of the usage of spent tires. Furthermore very important group of problems arise considering the metal and nonmetal additives which are significant component of the vulcanized rubber. The key attention is dedicated to typical ways of rubber usage in utilization and recovery of metals from spent rubber materials concentrating specifically on used tires processing. The method of recovery of rare metals from rubber tires was described. The rubber debris finds widest use in the field of waste metal solutions processing. The environmental pollution caused by metals poses serious threat to humans. Several applications of the use of waste rubber debris to remove metals from environmental waters were described. Moreover, the agriculture usage of waste tire rubber debris is described, presenting systems where the rubber material can be useful as a soil replacement.

  20. Industry Matters

    DEFF Research Database (Denmark)

    Tran, Angie Ngoc; Jeppesen, Søren

    2018-01-01

    This chapter draws on a study investigating what corporate social responsibility (CSR) means to Vietnam’s small- and medium-size enterprise (SME) owner/managers and workers, using Scott’s three-pillar (norms, regulation, cognition) institutional framework. The findings are based on factory visits...... and interviews with 40 managers/owners and 218 workers conducted in two sectors—textile/garment/footwear (TGF) and food/beverage processing (FBP)—around Ho Chi Minh City in 2011. Scott’s framework is useful in highlighting similarities and differences between these two sectors. We found more stringent state...... regulation and greater industry pressure with regard to quality and safety of products than to labour standards in both sectors. Most factories in the TGF sector assembled products for global supply chains and were under pressure by industry norms, while most companies in the FBP sector produced...

  1. Industrious Landscaping

    DEFF Research Database (Denmark)

    Brichet, Nathalia Sofie; Hastrup, Frida

    2018-01-01

    This article has a twofold ambition. It offers a history of landscaping at Søby brown coal beds—a former mining site in western Denmark—and a methodological discussion of how to write such a study. Exploring this specific industrial landscape through a series of projects that have made different...... natural resources appear, we show that even what is recognized as resources shifts over time according to radically different and unpredictable agendas. This indicates that the Søby landscape is fundamentally volatile, as its resourcefulness has been seen interchangeably to shift between the brown coal...... business, inexpensive estates for practically savvy people, pasture for grazing, and recreational forest, among other things. We discuss these rifts in landscape history, motivated by what we refer to as industriousness, to show that, at sites such as Søby, both natural resources and historical...

  2. Industrial vision

    DEFF Research Database (Denmark)

    Knudsen, Ole

    1998-01-01

    This dissertation is concerned with the introduction of vision-based application s in the ship building industry. The industrial research project is divided into a natural seq uence of developments, from basic theoretical projective image generation via CAD and subpixel analysis to a description...... is present ed, and the variability of the parameters is examined and described. The concept of using CAD together with vision information is based on the fact that all items processed at OSS have an associated complete 3D CAD model that is accessible at all production states. This concept gives numerous...... possibilities for using vision in applications which otherwise would be very difficult to automate. The requirement for low tolerances in production is, despite the huge dimensions of the items involved, extreme. This fact makes great demands on the ability to do robust sub pixel estimation. A new method based...

  3. Industry trends

    International Nuclear Information System (INIS)

    Anon.

    1993-01-01

    This section discusses the US energy supply and demand situation including projections for energy use, the clean coal industry (constraints of regulation on investment in new technologies, technology trends, and current pollution control efficiency), opportunities in clean coal technology (Phase 2 requirements of Title 4 of the Clean Air Act, scrubber demand for lime and limestone, and demand for low sulfur coal), and the international market of clean coal technologies

  4. Industrial melanism

    Energy Technology Data Exchange (ETDEWEB)

    Ford, E B

    1969-01-01

    Certain species of Lepidoptera have undergone a mutation in pigment color from white to black in order to be more concealing when in soot discolored environments in polluted industrial areas in England. In less polluted areas the original white variety continues to prosper. The two forms result from alleles of a color-controlling gene. The black variety is inconspicuous to insects when it settles on trees and rocks which are covered with soot.

  5. Agribusiness Industry

    Science.gov (United States)

    2007-01-01

    sheer enormity of this ultra modernized industry. Hybridized or biotech corn seeds are now nearly impervious to pesticides and herbicides. From...efficient routes of commerce of many thousands of miles - a fresh head of broccoli and lettuce lands in the chilled and computer controlled misting...cumulatively, seemingly minor and insignificant changes in food production methods (i.e. packaged precut lettuce ), society (desire for convenience foods

  6. Industrial garnet

    Science.gov (United States)

    Olson, D.W.

    2007-01-01

    World production of industrial garnet was about 326 kt in 2006, with the U.S. producing about 11 percent of this total. U.S. consumption, imports, and exports were estimated at 74.3 kt, 52.3 kt, and 13.2 kt, respectively. The most important exporters are Australia, China, and India. Although demand is expected to rise over the next 5 years, prices are expected to remain low in the short term.

  7. 76 FR 45268 - Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop

    Science.gov (United States)

    2011-07-28

    ...] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop AGENCY... Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and..., and to gain additional insight from, professional societies, patient advocates, industry, consumer...

  8. Drug Facts

    Medline Plus

    Full Text Available ... Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of Abuse What ... Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1-800- ...

  9. Drug Facts

    Medline Plus

    Full Text Available ... Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of Abuse What is Addiction? ... Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1-800-662- ...

  10. Antineoplastic Drugs

    Science.gov (United States)

    Sadée, Wolfgang; El Sayed, Yousry Mahmoud

    The limited scope of therapeutic drug-level monitoring in cancer chemotherapy results from the often complex biochemical mechanisms that contribute to antineoplastic activity and obscure the relationships among drug serum levels and therapeutic benefits. Moreover, new agents for cancer chemotherapy are being introduced at a more rapid rate than for the treatment of other diseases, although the successful application of therapeutic drug-level monitoring may require several years of intensive study of the significance of serum drug levels. However, drug level monitoring can be of considerable value during phase I clinical trials of new antineoplastic agents in order to assess drug metabolism, bioavailability, and intersubject variability; these are important parameters in the interpretation of clinical studies, but have no immediate benefit to the patient. High performance liquid chromatography (HPLC) probably represents the most versatile and easily adaptable analytical technique for drug metabolite screening (1). HPLC may therefore now be the method of choice during phase I clinical trials of antineoplastic drugs. For example, within a single week we developed an HPLC assay—using a C18 reverse-phase column, UV detection, and direct serum injection after protein precipitation—for the new radiosensitizer, misonidazole (2).

  11. Drugged Driving

    Science.gov (United States)

    ... Survey Results Synthetic Cannabinoids (K2/Spice) Unpredictable Danger Drug and Alcohol Use in College-Age Adults in 2016 Monitoring the Future 2016 Survey Results Drug and Alcohol Use in College-Age Adults in 2015 View All NIDA Home ...

  12. Drug Policy in Cyprus

    Directory of Open Access Journals (Sweden)

    George Charalambous

    2012-01-01

    Full Text Available Background: The provision of pharmaceutical drugs is of enormous significance in our lives. Notable progress made inthe domain of Public Health, combined with a general increase in the standard of living, has had a direct impact on thediscovery of new drugs and cures and has shifted pharmaceutical policies further in line with the current needs of boththe country’s health system and, its population.Aim: This research aims to both shed light on and analyse the current state of pharmaceutical policy in Cyprus, as well asto try to seek out its weaknesses, making suggestions, where possible, as to how to keep these to the minimum.Results, and Conclusions: The lack of both high level research and major industrial facilities relating to the discovery ofnew pharmaceutical drugs in Cyprus, has hindered the effectiveness of pharmaceutical policy in general domains such ascontrol over the circulation and production of pharmaceutical products in the country, their pricing and distribution andthe monitoring of our drug supplies. The lack of transparency in a number of pharmaceutical procedures, and ofinformation on drugs does not enhance the industry’s reliability, but rather exacerbates an underlying feeling of insecurityrelating to it among the population.

  13. Orphan drug: Development trends and strategies

    Directory of Open Access Journals (Sweden)

    Aarti Sharma

    2010-01-01

    Full Text Available The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model - niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases.

  14. Industrial goals

    International Nuclear Information System (INIS)

    Martin, P.

    2005-01-01

    The aim of the third seminar on pellet-clad interaction, which held at Aix en Provence (France) from 9-11 march 2004, was to draw a comprehensive picture of current understanding of pellet clad interaction and its impact on the fuel rod under the widest possible conditions. This document provides the summaries of the five sessions: opening and industrial goals, fuel material behaviour in PCI situation, cladding behaviour relevant to PCI, in-pile rod behaviour, modelling of the mechanical interaction between pellet and cladding. (A.L.B.)

  15. Industrial ventilation

    Science.gov (United States)

    Goodfellow, H. D.

    Industrial ventilation design methodology, using computers and using fluid dynamic models, is considered. It is noted that the design of a ventilation system must be incorporated into the plant design and layout at the earliest conceptual stage of the project. A checklist of activities concerning the methodology for the design of a ventilation system for a new facility is given. A flow diagram of the computer ventilation model shows a typical input, the initialization and iteration loop, and the output. The application of the fluid dynamic modeling techniques include external and internal flow fields, and individual sources of heat and contaminants. Major activities for a ventilation field test program are also addressed.

  16. Drug repurposing based on drug-drug interaction.

    Science.gov (United States)

    Zhou, Bin; Wang, Rong; Wu, Ping; Kong, De-Xin

    2015-02-01

    Given the high risk and lengthy procedure of traditional drug development, drug repurposing is gaining more and more attention. Although many types of drug information have been used to repurpose drugs, drug-drug interaction data, which imply possible physiological effects or targets of drugs, remain unexploited. In this work, similarity of drug interaction was employed to infer similarity of the physiological effects or targets for the drugs. We collected 10,835 drug-drug interactions concerning 1074 drugs, and for 700 of them, drug similarity scores based on drug interaction profiles were computed and rendered using a drug association network with 589 nodes (drugs) and 2375 edges (drug similarity scores). The 589 drugs were clustered into 98 groups with Markov Clustering Algorithm, most of which were significantly correlated with certain drug functions. This indicates that the network can be used to infer the physiological effects of drugs. Furthermore, we evaluated the ability of this drug association network to predict drug targets. The results show that the method is effective for 317 of 561 drugs that have known targets. Comparison of this method with the structure-based approach shows that they are complementary. In summary, this study demonstrates the feasibility of drug repurposing based on drug-drug interaction data. © 2014 John Wiley & Sons A/S.

  17. [Club drugs].

    Science.gov (United States)

    Guerreiro, Diogo Frasquilho; Carmo, Ana Lisa; da Silva, Joaquim Alves; Navarro, Rita; Góis, Carlos

    2011-01-01

    Club drugs are the following substances: Methylenedioxymethamphetamine (MDMA); Methamphetamine; Lysergic Acid Diethylamide (LSD); Ketamine; Gamma-hydroxybutyrate (GHB) and Flunitrazepam. These substances are mainly used by adolescents and young adults, mostly in recreational settings like dance clubs and rave parties. These drugs have diverse psychotropic effects, are associated with several degrees of toxicity, dependence and long term adverse effects. Some have been used for several decades, while others are relatively recent substances of abuse. They have distinct pharmacodynamic and pharmacokinetic properties, are not easy to detect and, many times, the use of club drugs is under diagnosed. Although the use of these drugs is increasingly common, few health professionals feel comfortable with the diagnosis and treatment. The authors performed a systematic literature review, with the goal of synthesising the existing knowledge about club drugs, namely epidemiology, mechanism of action, detection, adverse reactions and treatment. The purpose of this article is creating in Portuguese language a knowledge data base on club drugs, that health professionals of various specialties can use as a reference when dealing with individual with this kind of drug abuse.

  18. Rational drug design paradigms: the odyssey for designing better drugs.

    Science.gov (United States)

    Kellici, Tahsin; Ntountaniotis, Dimitrios; Vrontaki, Eleni; Liapakis, George; Moutevelis-Minakakis, Panagiota; Kokotos, George; Hadjikakou, Sotiris; Tzakos, Andreas G; Afantitis, Antreas; Melagraki, Georgia; Bryant, Sharon; Langer, Thierry; Di Marzo, Vincenzo; Mavromoustakos, Thomas

    2015-01-01

    Due to the time and effort requirements for the development of a new drug, and the high attrition rates associated with this developmental process, there is an intense effort by academic and industrial researchers to find novel ways for more effective drug development schemes. The first step in the discovery process of a new drug is the identification of the lead compound. The modern research tendency is to avoid the synthesis of new molecules based on chemical intuition, which is time and cost consuming, and instead to apply in silico rational drug design. This approach reduces the consumables and human personnel involved in the initial steps of the drug design. In this review real examples from our research activity aiming to discover new leads will be given for various dire warnings diseases. There is no recipe to follow for discovering new leads. The strategy to be followed depends on the knowledge of the studied system and the experience of the researchers. The described examples constitute successful and unsuccessful efforts and reflect the reality which medicinal chemists have to face in drug design and development. The drug stability is also discussed in both organic molecules and metallotherapeutics. This is an important issue in drug discovery as drug metabolism in the body can lead to various toxic and undesired molecules.

  19. Superoxide dismutase: an industrial perspective.

    Science.gov (United States)

    Bafana, Amit; Dutt, Som; Kumar, Sanjay; Ahuja, Paramvir S

    2011-03-01

    The application of enzyme technologies to industrial research, development, and manufacturing has become a very important field. Since the production of crude rennet in 1874, several enzymes have been commercialized, and used for therapeutic, supplementary, and other applications. Recent advancements in biotechnology now allow companies to produce safer and less expensive enzymes with enhanced potency and specificity. Antioxidant enzymes are emerging as a new addition to the pool of industrial enzymes and are surpassing all other enzymes in terms of the volume of research and production. In the 1990s, an antioxidant enzyme--superoxide dismutase (SOD)--was introduced into the market. Although the enzyme initially showed great promise in therapeutic applications, it did not perform up to expectations. Consequently, its use was limited to non-drug applications in humans and drug applications in animals. This review summarizes the rise and fall of SOD at the industrial level, the reasons for this, and potential future thrust areas that need to be addressed. The review also focuses on other industrially relevant aspects of SOD such as industrial importance, enzyme engineering, production processes, and process optimization and scale-up.

  20. Bioinformatics in translational drug discovery.

    Science.gov (United States)

    Wooller, Sarah K; Benstead-Hume, Graeme; Chen, Xiangrong; Ali, Yusuf; Pearl, Frances M G

    2017-08-31

    Bioinformatics approaches are becoming ever more essential in translational drug discovery both in academia and within the pharmaceutical industry. Computational exploitation of the increasing volumes of data generated during all phases of drug discovery is enabling key challenges of the process to be addressed. Here, we highlight some of the areas in which bioinformatics resources and methods are being developed to support the drug discovery pipeline. These include the creation of large data warehouses, bioinformatics algorithms to analyse 'big data' that identify novel drug targets and/or biomarkers, programs to assess the tractability of targets, and prediction of repositioning opportunities that use licensed drugs to treat additional indications. © 2017 The Author(s).

  1. Industrial Biotechnology: Discovery to Delivery

    Science.gov (United States)

    Chotani, Gopal K.; Dodge, Timothy C.; Gaertner, Alfred L.; Arbige, Michael V.

    Fermentation products have penetrated almost every sector of our daily lives. They are used in ethical and generic drugs, clinical and home diagnostics, defense products, nutritional supplements, personal care products, food and animal feed ingredients, cleaning and textile processing, and in industrial applications such as fuel ethanol production. Even before knowing about the existence of microorganisms, for thousands of years ancient people routinely used them for making cheese, soy sauces, yogurt, and bread. Although humans have used fermentation as the method of choice for manufacturing for a long time, it is only now being recognized for its potential towards sustainable industrial development.

  2. Industrial chemistry engineering

    International Nuclear Information System (INIS)

    1993-01-01

    This book on industrial chemistry engineering is divided in two parts. The first part deals with industrial chemistry, inorganic industrial chemistry, organic industrial chemistry, analytical chemistry and practical questions. The last parts explain the chemical industry, a unit parts and thermodynamics in chemical industry and reference. It reveals the test subjects for the industrial chemistry engineering with a written examination and practical skill.

  3. Drug Facts

    Medline Plus

    Full Text Available ... MDMA (Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco ... Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA ( ... Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/ ...

  5. Drug Facts

    Medline Plus

    Full Text Available ... Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth ( ... Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine ...

  6. Drug Facts

    Medline Plus

    Full Text Available ... Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain ... About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other ...

  7. Drug Metabolism

    Indian Academy of Sciences (India)

    Home; Journals; Resonance – Journal of Science Education; Volume 19; Issue 3. Drug Metabolism: A Fascinating Link Between Chemistry and Biology. Nikhil Taxak Prasad V Bharatam. General Article Volume 19 Issue 3 March 2014 pp 259-282 ...

  8. Drugged Driving

    Science.gov (United States)

    ... Alcohol Club Drugs Cocaine Fentanyl Hallucinogens Inhalants Heroin Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Over-the-Counter Medicines Prescription Medicines Steroids (Anabolic) Synthetic Cannabinoids (K2/Spice) Synthetic Cathinones (Bath Salts) Tobacco/ ...

  9. Club Drugs

    Science.gov (United States)

    ... Alcohol Club Drugs Cocaine Fentanyl Hallucinogens Inhalants Heroin Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Over-the-Counter Medicines Prescription Medicines Steroids (Anabolic) Synthetic Cannabinoids (K2/Spice) Synthetic Cathinones (Bath Salts) Tobacco/ ...

  10. Drug Metabolism

    Indian Academy of Sciences (India)

    IAS Admin

    behind metabolic reactions, importance, and consequences with several ... required for drug action. ... lism, which is catalyzed by enzymes present in the above-men- ... catalyze the transfer of one atom of oxygen to a substrate produc-.

  11. Drug Facts

    Medline Plus

    Full Text Available ... Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and ... Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... 800-662-HELP (4357) at any time to find drug treatment centers near you. I want my ... is making positive changes in her life. She finds support from family and friends who don't ...

  13. Drug Facts

    Medline Plus

    Full Text Available ... That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, ... Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? ... of Health (NIH) , the principal biomedical and behavioral research agency of the United States Government. NIH is ...

  15. Drug Reactions

    Science.gov (United States)

    ... Kids and Teens Pregnancy and Childbirth Women Men Seniors Your Health Resources Healthcare Management End-of-Life Issues Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & Devices Over-the- ...

  16. Drug Facts

    Medline Plus

    Full Text Available ... prescription drugs. The addiction slowly took over his life. I need different people around me. To stop ... marijuana, "Cristina" is making positive changes in her life. She finds support from family and friends who ...

  17. Drug Resistance

    Science.gov (United States)

    ... Drug-resistance testing is also recommended for all pregnant women with HIV before starting HIV medicines and also in some pregnant women already taking HIV medicines. Pregnant women will work with their health ...

  18. Drug Facts

    Medline Plus

    Full Text Available ... Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth (Crank, ... Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine ...

  19. Drug Addiction

    Science.gov (United States)

    ... as hearing colors Impulsive behavior Rapid shifts in emotions Permanent mental changes in perception Rapid heart rate ... Drug use can negatively affect academic performance and motivation to excel in school. Legal issues. Legal problems ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana ( ... Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) ...

  1. Industrial irradiation

    International Nuclear Information System (INIS)

    Stirling, Andrew

    1995-01-01

    Production lines for rubber gloves would not appear to have much in common with particle physics laboratories, but they both use accelerators. Electron beam irradiation is often used in industry to improve the quality of manufactured goods or to reduce production cost. Products range from computer disks, shrink packaging, tyres, cables, and plastics to hot water pipes. Some products, such as medical goods, cosmetics and certain foodstuffs, are sterilized in this way. In electron beam irradiation, electrons penetrate materials creating showers of low energy electrons. After many collisions these electrons have the correct energy to create chemically active sites. They may either break molecular bonds or activate a site which promotes a new chemical linkage. This industrial irradiation can be exploited in three ways: breaking down a biological molecule usually renders it useless and kills the organism; breaking an organic molecule can change its toxicity or function; and crosslinking a polymer can strengthen it. In addition to traditional gamma irradiation using isotopes, industrial irradiation uses three accelerator configurations, each type defining an energy range, and consequently the electron penetration depth. For energies up to 750 kV, the accelerator consists of a DC potential applied to a simple wire anode and the electrons extracted through a slot in a coaxially mounted cylindrical cathode. In the 1-5 MeV range, the Cockcroft-Walton or Dynamitron( R ) accelerators are normally used. To achieve the high potentials in these DC accelerators, insulating SF6 gas and large dimension vessels separate the anode and cathode; proprietary techniques distinguish the various commercial models available. Above 5 MeV, the size of DC accelerators render them impractical, and more compact radiofrequency-driven linear accelerators are used. Irradiation electron beams are actually 'sprayed' over the product using a magnetic deflection system. Lower energy beams of

  2. Drug promotion practices: A review.

    Science.gov (United States)

    Jacob, Nilan T

    2018-01-18

    Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from preclinical studies to multicentric clinical trials and postmarketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved, which puts pressure on the manufacturers to maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role. The World Health Organization defines drug promotion as "all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs". With its humble intent of creating awareness among healthcare professionals and updating their knowledge on recent advances in treatment options, drug promotion has been an important tool, but gradually it has evolved to embrace aggressive marketing strategies and sometimes unethical business and scientific practices where the need for profit-making eclipses commitment to patient care and scientific exploration. In this review, we discuss the evolution of drug promotion practices, the various types, its merits and demerits, the influence of drug promotion on physician prescribing behaviour, the role of regulatory bodies, unethical promotional practices and finally summarize with future directions. © 2018 The British Pharmacological Society.

  3. Obesity and Pediatric Drug Development.

    Science.gov (United States)

    Vaughns, Janelle D; Conklin, Laurie S; Long, Ying; Zheng, Panli; Faruque, Fahim; Green, Dionna J; van den Anker, John N; Burckart, Gilbert J

    2018-05-01

    There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population. © 2018, The American College of Clinical Pharmacology.

  4. In Touch With Industry: ICAF Industry Studies, 1997

    Science.gov (United States)

    1997-01-01

    Analysis and Critical Control Program ( HACCP ) food safety system will allow both the Food and Drug Administration and Food Safety and Inspection...actively prevent food safety problems. The HACCP system is a scientific, process-based analysis of potential hazards, a determination of where those...Figure 2.—U.S. Primary Production (Quadrillion Btu) jam . The energy industry is a highly aggregated construct that stretches the definition of

  5. Industrial robot

    Science.gov (United States)

    Prakashan, A.; Mukunda, H. S.; Samuel, S. D.; Colaco, J. C.

    1992-11-01

    This paper addresses the design and development of a four degree of freedom industrial manipulator, with three liner axes in the positioning mechanism and one rotary axis in the orientation mechanism. The positioning mechanism joints are driven with dc servo motors fitted with incremental shaft encoders. The rotary joint of the orientation mechanism is driven by a stepping motor. The manipulator is controlled by an IBM 386 PC/AT. Microcomputer based interface cards have been developed for independent joint control. PID controllers for dc motors have been designed. Kinematic modeling, dynamic modeling, and path planning have been carried out to generate the control sequence to accomplish a given task with reference to source and destination state constraints. This project has been sponsored by the Department of Science and Technology, Government of India, New Delhi, and has been executed in collaboration with M/s Larsen & Toubro Ltd, Mysore, India.

  6. Industrial radiography

    International Nuclear Information System (INIS)

    1992-01-01

    Industrial radiography is a non-destructive testing (NDT) method which allows components to be examined for flaws without interfering with their usefulness. It is one of a number of inspection methods which are commonly used in industry to control the quality of manufactured products and to monitor their performance in service. Because of its involvement in organizing training courses in all the common NDT methods in regional projects in Asia and the Pacific and Latin America and the Caribbean and in many country programmes, the Agency is aware of the importance of standardizing as far as possible the syllabi and training course notes used by the many experts who are involved in presenting the training courses. IAEA-TECDOC-628 ''Training Guidelines in Non-destructive Testing'' presents syllabi which were developed by an Agency executed UNDP project in Latin America and the Caribbean taking into account the developmental work done by the International Committee for Non-destructive Testing. Experience gained from using the radiography syllabi from TECDOC-628 at national and regional radiography training courses in the Agency executed UNDP project in Asia and the Pacific (RAS/86/073) showed that some guidance needed to be given to radiography experts engaged in teaching at these courses on the material which should be covered. The IAEA/UNDP Asia and Pacific Project National NDT Coordinators therefore undertook to prepare Radiography Training Course Notes which could be used by experts to prepare lectures for Level 1,2 and 3 radiography personnel. The notes have been expanded to cover most topics in a more complete manner than that possible at a Level 1, 2 or 3 training course and can now be used as source material for NDT personnel interested in expanding their knowledge of radiography. Refs, figs and tabs

  7. Economic Aspects of the Chemical Industry

    Science.gov (United States)

    Koleske, Joseph V.

    Within the formal disciplines of science at traditional universities, through the years, chemistry has grown to have a unique status because of its close correspondence with an industry and with a branch of engineering—the chemical industry and chemical engineering. There is no biology industry, but aspects of biology have closely related disciplines such as fish raising and other aquaculture, animal cloning and other facets of agriculture, ethical drugs of pharmaceutical manufacture, genomics, water quality and conservation, and the like. Although there is no physics industry, there are power generation, electricity, computers, optics, magnetic media, and electronics that exist as industries. However, in the case of chemistry, there is a named industry. This unusual correspondence no doubt came about because in the chemical industry one makes things from raw materials—chemicals—and the science, manufacture, and use of chemicals grew up together during the past century or so.

  8. Expanding lysine industry: industrial biomanufacturing of lysine and its derivatives.

    Science.gov (United States)

    Cheng, Jie; Chen, Peng; Song, Andong; Wang, Dan; Wang, Qinhong

    2018-04-13

    L-Lysine is widely used as a nutrition supplement in feed, food, and beverage industries as well as a chemical intermediate. At present, great efforts are made to further decrease the cost of lysine to make it more competitive in the markets. Furthermore, lysine also shows potential as a feedstock to produce other high-value chemicals for active pharmaceutical ingredients, drugs, or materials. In this review, the current biomanufacturing of lysine is first presented. Second, the production of novel derivatives from lysine is discussed. Some chemicals like L-pipecolic acid, cadaverine, and 5-aminovalerate already have been obtained at a lab scale. Others like 6-aminocaproic acid, valerolactam, and caprolactam could be produced through a biological and chemical coupling pathway or be synthesized by a hypothetical pathway. This review demonstrates an active and expansive lysine industry, and these green biomanufacturing strategies could also be applied to enhance the competitiveness of other amino acid industry.

  9. Drug policy in United States of America

    OpenAIRE

    Stahl, Edmundo G.; Médico internista, President and Chief Executive Officer, LatAmScience. Florida, USA.

    2009-01-01

    The USA federal prescription drug policies are inconsistent. The federal government regulates the development, production, marketing and safety of prescription drugs in the country through various legal mechanisms as well as private and governmental institutions. Patent laws also play an important role in this process protecting the pharmaceutical industry. The government has no direct mechanism to control prices of prescription drugs nor does it have a policy to cover the whole US popula...

  10. Industrial radiographies

    CERN Multimedia

    2005-01-01

    The Radiation Protection group wishes to remind CERN staff responsible for contractors performing X-ray inspections on the CERN sites that the firms must apply the legislation in force in their country of origin, in particular with regard to the prevention of risks relating to ionizing radiation. Industrial radiography firms called on to work on the CERN sites must also comply with the rules laid down in CERN's Radiation Safety Manual and be registered in the relevant CERN database. Since CERN is responsible for safety on its own site, a number of additional rules have been laid down for this kind of work, as set out in Radiation Protection Procedure PRP30 https://edms.cern.ch/file/346848/LAST_RELEASED/PRP30.pdf The CERN Staff Member responsible for the contract shall register the company and issue notification that an X-ray inspection is to be performed via the web interface at the following address: http://cern.ch/rp-radio

  11. Training industry needs & Technology Industry needs

    NARCIS (Netherlands)

    Klemke, Roland; Kuula, Timo; Helin, Kaj; Wild, Fridolin

    2017-01-01

    This deliverable joins D1.1 (User Industry Needs) and D1.2 (Technology Industry Needs and Affordances) and reports on the outcomes of Tasks T1.1 (Training Industry Assessment) and T1.2 (Technology Industry Assessment). We merged the deliverables for the following reasons: For readability ease we

  12. Legal Drugs Are Good Drugs and Illegal Drugs Are Bad Drugs

    OpenAIRE

    Indrati, Dina; Prasetyo, Herry

    2011-01-01

    ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing s...

  13. The Economic Side Effects of Dangerous Drug Announcements.

    OpenAIRE

    Dranove, David; Olsen, Chris

    1994-01-01

    Immediately prior to the passage of the 1962 Food and Drug Administration Amendments, there were a number of drugs recalled from markets worldwide. Announcements about the dangerous side effects of these drugs were associated with lower-share prices for their manufacturers and the industry as a whole. We perform several analyses to sort out alternative explanations for the observed declines. We find that dangerous drug announcements had no effect on the sales of other drugs and didn't affect ...

  14. 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 ...

  15. Study Drugs

    OpenAIRE

    Lam, Stephanie Phuong; Roosta, Natalie; Nielsen, Mikkel Fuhr; Meyer, Maria Holmgaard; Friis, Katrine Birk

    2016-01-01

    In recent years, students around the world, started to use preparations as Ritalin and Modafinil,also known as study drugs, to improve their cognitive abilities1. It is a common use among thestudents in United States of America, but it is a new tendency in Denmark. Our main focus is tolocate whether study drugs needs to be legalized in Denmark or not. To investigate this ourstarting point is to understand central ethical arguments in the debate. We have chosen twoarguments from Nick Bostrom a...

  16. Biomarkers of adverse drug reactions.

    Science.gov (United States)

    Carr, Daniel F; Pirmohamed, Munir

    2018-02-01

    Adverse drug reactions can be caused by a wide range of therapeutics. Adverse drug reactions affect many bodily organ systems and vary widely in severity. Milder adverse drug reactions often resolve quickly following withdrawal of the casual drug or sometimes after dose reduction. Some adverse drug reactions are severe and lead to significant organ/tissue injury which can be fatal. Adverse drug reactions also represent a financial burden to both healthcare providers and the pharmaceutical industry. Thus, a number of stakeholders would benefit from development of new, robust biomarkers for the prediction, diagnosis, and prognostication of adverse drug reactions. There has been significant recent progress in identifying predictive genomic biomarkers with the potential to be used in clinical settings to reduce the burden of adverse drug reactions. These have included biomarkers that can be used to alter drug dose (for example, Thiopurine methyltransferase (TPMT) and azathioprine dose) and drug choice. The latter have in particular included human leukocyte antigen (HLA) biomarkers which identify susceptibility to immune-mediated injuries to major organs such as skin, liver, and bone marrow from a variety of drugs. This review covers both the current state of the art with regard to genomic adverse drug reaction biomarkers. We also review circulating biomarkers that have the potential to be used for both diagnosis and prognosis, and have the added advantage of providing mechanistic information. In the future, we will not be relying on single biomarkers (genomic/non-genomic), but on multiple biomarker panels, integrated through the application of different omics technologies, which will provide information on predisposition, early diagnosis, prognosis, and mechanisms. Impact statement • Genetic and circulating biomarkers present significant opportunities to personalize patient therapy to minimize the risk of adverse drug reactions. ADRs are a significant heath issue

  17. Drug Facts

    Medline Plus

    Full Text Available ... Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the button ... sobre el abuso de drogas, y adicción. English Español About the National Institute on Drug Abuse (NIDA) | ...

  18. Drugs reviews

    African Journals Online (AJOL)

    Angel_D

    tests (LFTs) to monitor hepatotoxicity (liver [hepatic] damage) is uncommon in many resource-poor ... cholesterol ester storage disease. ... The problem with many patients is that they are taking several drugs often ... Urine, saliva and other body fluids may be coloured orange-red: this can be very alarming to patients.

  19. Drug resistance

    NARCIS (Netherlands)

    Gorter, J.A.; Potschka, H.; Noebels, J.L.; Avoli, M.; Rogawski, M.A.; Olsen, R.W.; Delgado-Escueta, A.V.

    2012-01-01

    Drug resistance remains to be one of the major challenges in epilepsy therapy. Identification of factors that contribute to therapeutic failure is crucial for future development of novel therapeutic strategies for difficult-to-treat epilepsies. Several clinical studies have shown that high seizure

  20. Capping Drugs

    Indian Academy of Sciences (India)

    preventing disease in human beings or in animals. In the process ... of requirement. In the process, they may cause toxic side effects. .... the liver to release the physiologically active drug. Similarly ... patients addicted to alcohol. However, it is a ...

  1. Drug Facts

    Medline Plus

    Full Text Available ... Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the ... información sobre el abuso de drogas, y adicción. English Español About the National Institute on Drug Abuse ( ...

  2. 78 FR 20325 - 2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2013-04-04

    ... foundations, emerging technologies and innovations in regulatory science, as well as the current quality and... strategies, while industry professionals from some of today's leading pharmaceutical companies present case.... Drug Safety. Emerging Active Pharmaceutical Ingredients (API) Regulations. Investigations. Emerging API...

  3. Drug abuse first aid

    Science.gov (United States)

    ... use of these drugs is a form of drug abuse. Medicines that are for treating a health problem ... about local resources. Alternative Names Overdose from drugs; Drug abuse first aid References Myck MB. Hallucinogens and drugs ...

  4. 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.

  5. Drug Safety: Managing Multiple Drugs

    Science.gov (United States)

    ... This series is produced by Consumers Union and Consumer Reports Best Buy Drugs , a public information project sup- ported by grants from the Engelberg Foundation and the National Library of Medicine of ... Consumer and Prescriber Education Grant Program which is funded ...

  6. Organizational adoption of preemployment drug testing.

    Science.gov (United States)

    Spell, C S; Blum, T C

    2001-04-01

    This study explored the adoption of preemployment drug testing by 360 organizations. Survival models were developed that included internal organizational and labor market factors hypothesized to affect the likelihood of adoption of drug testing. Also considered was another set of variables that included social and political variables based on institutional theory. An event history analysis using Cox regressions indicated that both internal organizational and environmental variables predicted adoption of drug testing. Results indicate that the higher the proportion of drug testers in the worksite's industry, the more likely it would be to adopt drug testing. Also, the extent to which an organization uses an internal labor market, voluntary turnover rate, and the extent to which management perceives drugs to be a problem were related to likelihood of adoption of drug testing.

  7. Legal Drugs Are Good Drugs And Illegal Drugs Are Bad Drugs

    Directory of Open Access Journals (Sweden)

    Dina Indrati

    2011-07-01

    Full Text Available ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing setting and dual diagnosis.Key words: Legal, good drugs, illegal, bad drugs.

  8. DYNAMICS OF THE ROMANIAN ILLEGAL DRUG MARKETS

    Directory of Open Access Journals (Sweden)

    Irina Caunic

    2011-06-01

    Full Text Available Globalization has led to an increase in commercial activities running on the illegal markets, its dynamics being largely determined by the balance between profitability and the major risks involved. Revenuesare significant, one example being those obtained from drug industry. In recent years, illicit drug trafficking has seen in Romania an unprecedented escalation, as a result of market liberalization and the movement of per sons and because of the extending the phenomenon both among producers and consumers. This article examines the size of the Romanian illegal drug markets, the countries of origin and drugtransit routes, as well as the profits made by the drug trafficking networks.

  9. Chemicals Industry Vision

    Energy Technology Data Exchange (ETDEWEB)

    none,

    1996-12-01

    Chemical industry leaders articulated a long-term vision for the industry, its markets, and its technology in the groundbreaking 1996 document Technology Vision 2020 - The U.S. Chemical Industry. (PDF 310 KB).

  10. Problems with drugs in Croatia.

    Science.gov (United States)

    Vrhovac, B

    1997-01-01

    Croatia has 4.8 million inhabitants, 11,800 physicians, 2000 pharmacists, two now shareholding, pharmaceutical companies (about 6500 employees, total sales of about 350 million US dollars). There are a number of problems due to the war (GNP fell from 3800 to about 1500 US dollars), occupation of 25% of its territory, 0.5 million refugees and lack of resources (139 US dollars/capita for health, about 40 US dollars i.e. 30%!! for drugs)--about three times less than before the aggression. The drug situation is controlled with the help of: (1) donations (approximate value of 600 million US dollars since 1991 from Europe and US), (2) (essential) drug formularies--250 for outpatients, and 580 generic names for various levels of hospital use, (3) special efforts to purchase drugs of good quality at a reasonable price (a kind of tender), (4) control of prescribing (prescriptions, specialists referral) especially by GPs. A new Medicines Act is in preparation and about 1000 generic names are on the market. DRUG EDUCATION: Pharmaca: the Croatian journal of pharmacotherapy has been published since 1962, there are several Drug bulletins (one published since 1975); special chapters on clinical pharmacology in textbooks, translation of three editions of Laurence's textbook with special commentary and adaptation to local needs; ADR spontaneous and intensive monitoring (WHO programme) with a personal feedback to the reporters and regular articles on drug use in a number of periodicals. Data on drug consumption indicates that there is room for improvement of prescribing. There is an enthusiasm for 'vasoactive drugs'--after dipirydamole came oxpentifylline and antimicrobials are always overprescribed. All these problems will hopefully decrease when the war finally stops and when industry (especially tourism) starts being fruitful again. In any case the importance of teaching of pharmacotherapy at the under- and postgraduate level should be recognized. Copyright 1997 by John Wiley

  11. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Science.gov (United States)

    2013-06-05

    ... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... 20852. FOR FURTHER INFORMATION CONTACT: Jeffrey Murray, Center for Drug Evaluation and Research, Food...

  12. 76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

    Science.gov (United States)

    2011-01-25

    ... and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug...] Guidance for Industry on Process Validation: General Principles and Practices; Availability AGENCY: Food... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

  13. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Science.gov (United States)

    2010-06-22

    ... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

  14. In defense of industry-physician relationships.

    Science.gov (United States)

    Nakayama, Don K

    2010-09-01

    The objective was to examine the economic, ethical, and legal foundations for conflict of interest restrictions between physicians and pharmaceutical and medical device industries ("industry"). Recently academic medical centers and professional organizations have adopted policies that restrict permissible interactions between industry and physicians. The motive is to avoid financial conflicts of interest that compromise core values of altruism and fiduciary relationships. Productive relationships between industry and physicians provide novel drugs and devices of immense benefit to society. The issues are opposing views of medical economics, profit motives, medical professionalism, and extent to which interactions should be lawfully restricted. Industry goals are congruent with those of physicians: patient welfare, safety, and running a profitable business. Profits are necessary to develop drugs and devices. Physician collaborators invent products, refine them, and provide feedback and so are appropriately paid. Marketing is necessary to bring approved products to patients. Economic realities limit the extent to which physicians treat their patients altruistically and as fiduciaries. Providing excellent service to patients may be a more realistic standard. Statements from industry and the American College of Surgeons appropriately guide professional behavior. Preservation of industry-physician relationships is vital to maintain medical innovation and progress.

  15. INDUSTRI KREATIF INDONESIA: PENDEKATAN ANALISIS KINERJA INDUSTRI

    Directory of Open Access Journals (Sweden)

    Ahmad Kamil

    2015-10-01

    Full Text Available In 2008, the Department of Commerce of the Republic of Indonesia has launched a creative economic development documents interpreted the 2025 Indonesia became the starting point and guide the development of the creative economy in Indonesia. With the existence of this document, the industry and its stakeholders or other stakeholders can readily develop the creative economy in Indonesia. Economic development in the direction of the creative industries is one manifestation of optimism aspiration to support the Master Plan for the Acceleration and Expansion of Indonesia's Economic Development in realizing the vision of Indonesia are being developed nation. The main objective of this study is the first to analyze the role of the creative industries in Indonesia for labor, value added and productivity, secondly, to analyze the performance trend of the creative industries sector, and third, to analyze the factors affecting the performance of the creative industries sector in Indonesia. Under Indonesia Standard Industrial Classification (ISIC and codes 151-372 (manufacturing industries category identified 18 industry groups belonging to the creative industries, showed that the performance of the national creative industries has been relatively high (in terms of trend analysis of the performance of the industrial creative. Furthermore, regression analysis of panel data (econometrics indicates that company size (SIZE, wages for workers (WAGE and the content of local inputs (LOCAL has a significant impact on the performance of Indonesia's creative industry. Meanwhile, the concentration ratio (CR4 no consequences but have koresi significantly positive effect on the performance of Indonesia’s creative industry.

  16. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  18. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  19. National Drug Code Directory

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured,...

  20. Other Drugs of Abuse

    Science.gov (United States)

    ... People Abuse » Other Drugs of Abuse Other Drugs of Abuse Listen There are many other drugs of abuse, ... and Rehab Resources About the National Institute on Drug Abuse (NIDA) | About This Website Tools and Resources | Contact ...

  1. Urine drug screen

    Science.gov (United States)

    Drug screen - urine ... detect the presence of illegal and some prescription drugs in your urine. Their presence may indicate that you recently used these drugs. Some drugs may remain in your system for ...

  2. Translational informatics: an industry perspective.

    Science.gov (United States)

    Cantor, Michael N

    2012-01-01

    Translational informatics (TI) is extremely important for the pharmaceutical industry, especially as the bar for regulatory approval of new medications is set higher and higher. This paper will explore three specific areas in the drug development lifecycle, from tools developed by precompetitive consortia to standardized clinical data collection to the effective delivery of medications using clinical decision support, in which TI has a major role to play. Advancing TI will require investment in new tools and algorithms, as well as ensuring that translational issues are addressed early in the design process of informatics projects, and also given higher weight in funding or publication decisions. Ultimately, the source of translational tools and differences between academia and industry are secondary, as long as they move towards the shared goal of improving health.

  3. Incentivos y desincentivos de la industria farmacéutica privada para la I+D de nuevos medicamentos Incentives and disincentives for research and development of new drugs by the pharmaceutical industry

    Directory of Open Access Journals (Sweden)

    Pasqualina Curcio Curcio

    2008-10-01

    Full Text Available En el trabajo se desarrolló un modelo con los factores que influyen sobre la decisión de I+D de la industria farmacéutica. Los factores son el riesgo de contagio y la posibilidad de controlarlo; la letalidad y la presencia de curas o tratamientos; el ingreso; el número de personas que demandan y los costos de oportunidad de la empresa. Las empresas invertirán en mercados con demandas más inelásticas (enfermedades muy contagiosas sin posibilidad de controlar la transmisión y/o muy letales sin curas o tratamientos y/o donde los demandantes tienen elevados ingresos y/o son numerosos. No invertirá en mercados donde sus costos marginales son superiores a sus ingresos marginales, particularmente cuando sus costos incrementan permanentemente como consecuencia del aumento del costo de oportunidad generado por lo que dejaría de ganar en otros mercados. Para estos casos, las políticas de subsidio de la I+D no son efectivas, por lo tanto, éstas deben orientarse al fortalecimiento de las investigaciones, tanto básica como aplicada, realizadas por las instituciones públicas o sin fines de lucro.The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and

  4. Liposome Technology for Industrial Purposes

    Directory of Open Access Journals (Sweden)

    Andreas Wagner

    2011-01-01

    Full Text Available Liposomes, spherical vesicles consisting of one or more phospholipid bilayers, were first described in the mid 60s by Bangham and coworkers. Since then, liposomes have made their way to the market. Today, numerous lab scale but only a few large-scale techniques are available. However, a lot of these methods have serious limitations in terms of entrapment of sensitive molecules due to their exposure to mechanical and/or chemical stress. This paper summarizes exclusively scalable techniques and focuses on strengths, respectively, limitations in respect to industrial applicability. An additional point of view was taken to regulatory requirements concerning liposomal drug formulations based on FDA and EMEA documents.

  5. Understanding drugs and behaviour

    National Research Council Canada - National Science Library

    Parrott, Andrew

    2004-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix xi Part I Drugs and Their Actions . . . . . . . . . . . . . . . . . . . . . . 1 Psychoactive drugs: introduction and overview . . . . . . . . 2 The brain...

  6. Identifying Adverse Drug Events by Relational Learning.

    Science.gov (United States)

    Page, David; Costa, Vítor Santos; Natarajan, Sriraam; Barnard, Aubrey; Peissig, Peggy; Caldwell, Michael

    2012-07-01

    The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task , related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events.

  7. Sustained Release Drug Delivery Applications of Polyurethanes

    Directory of Open Access Journals (Sweden)

    Michael B. Lowinger

    2018-05-01

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

  8. Prescription Drug Abuse

    Science.gov (United States)

    ... drug abuse. And it's illegal, just like taking street drugs. Why Do People Abuse Prescription Drugs? Some people abuse prescription drugs ... common risk of prescription drug abuse is addiction . People who abuse ... as if they were taking street drugs. That's one reason most doctors won't ...

  9. Drug abuse

    International Nuclear Information System (INIS)

    Simon, T.R.; Seastrunk, J.W.; Malone, G.; Knesevich, M.A.; Hickey, D.C.

    1991-01-01

    This paper reports that this study used SPECT to examine patients who have abused drugs to determine whether SPECT could identify abnormalities and whether these findings have clinical importance. Fifteen patients with a history of substance abuse (eight with cocaine, six with amphetamine, and one with organic solvent) underwent SPECT performed with a triple-headed camera and Tc-99m HMPAO both early for blood flow and later for functional information. These images were then processed into a 3D videotaped display used in group therapy. All 15 patients had multiple areas of decreased tracer uptake peppered throughout the cortex but mainly affecting the parietal lobes, expect for the organic solvent abuser who had a large parietal defect. The videotapes were subjectively described by a therapist as an exceptional tool that countered patient denial of physical damage from substance abuse. Statistical studies of recidivism between groups is under way

  10. From a Music Industry to Sound Industries

    OpenAIRE

    Thor Magnusson

    2013-01-01

    Commodification has been an inherent aspect of music for many centuries. The aggregation of the diverse commodification practices could be described as an "industry," but this is an industry that has always been in a state of transition. New technologies, media formats, and practices appear regularly, requiring swift responses by the incumbent music industry. Although periods of relative stabil- ity have existed, where economic structures become established, the field has always been ch...

  11. Petroleum industry of Korea seen from industry

    Energy Technology Data Exchange (ETDEWEB)

    Kim, H.P. [SK Co, Seoul (Korea, Republic of)

    1998-05-01

    The domestic petroleum industry faced with outward opening and exchange crisis is put under the most difficult period so far, and costs reduction and securing international competitive power in software field are emerging as important assignments on which the life and death of national key industries depends not only as a restructuring issue of each petroleum company. Required strategy of petroleum industry to solve this effectively this year must be the thorough revamping through restructuring and reform of management standards not the survival exercise through price competition. For this, each petroleum company and distributor should open a new petroleum industry in which fair rules of the game are developed as well as costs reduction through joint efforts and value creation in overall industry. For this, government should support the domestic petroleum industry to stand up straight as a keeper of domestic energy industry by helping it to arm with international competitive power within a short period of time through overall needed system and legal scheme. It is because nobody can deny that energy industry is the key industry on which national existence is at stake.

  12. Cyclodextrins in drug carrier systems.

    Science.gov (United States)

    Uekama, K; Otagiri, M

    1987-01-01

    One of the important characteristics of cyclodextrins is the formation of an inclusion complex with a variety of drug molecules in solution and in the solid state. As a consequence of intensive basic research, exhaustive toxic studies, and realization of industrial production during the past decade, there seem to be no more barriers for the practical application of natural cyclodextrins in the biomedical field. Recently, a number of cyclodextrin derivatives and cyclodextrin polymers have been prepared to obtain better inclusion abilities than parent cyclodextrins. The natural cyclodextrins and their synthetic derivatives have been successfully utilized to improve various drug properties, such as solubility, dissolution and release rates, stability, or bioavailability. In addition, the enhancement of drug activity, selective transfer, or the reduction of side effects has been achieved by means of inclusion complexation. The drug-cyclodextrin complex is generally formed outside of the body and, after administration, it dissociates, releasing the drug into the organism in a fast and nearly uniform manner. In the biomedical application of cyclodextrins, therefore, particular attention should be directed to the magnitude of the stability constant of the inclusion complex. In the case of parenteral application, a rather limited amount of work has been done because the cyclodextrins in the drug carrier systems have to be more effectively designed to compete with various biological components in the circulatory system. However, the works published thus far apparently indicate that the inclusion phenomena of cyclodextrin analogs may allow the rational design of drug formulation and that the combination of molecular encapsulation with other carrier systems will become a very effective and valuable method for the development of a new drug delivery system in the near future.

  13. Qualitative Phenomenological Examination of IT Project Management in Pharmaceutical Industry

    Science.gov (United States)

    Ly, Phil

    2013-01-01

    The purpose of this study was to examine what caused IT projects to fail at a high rate in the pharmaceutical industry. IT projects failures delayed development of new drugs that can help save lives. It was imperative to evaluate what caused project failures because the collateral damage was delay in drug development. This qualitative…

  14. Industrial initiatives in the wind industry

    International Nuclear Information System (INIS)

    Edworthy, J.

    1992-01-01

    Industrial initiatives are methods of lobbying and marketing to increase the activity, revenues, profits, and commercial viability of an industry. They may be undertaken by industry individuals or firms, industry groups, government agencies, or combinations of all these. In Canada, one example of an industrial initiative is the Canadian Wind Energy Association. Other initiatives relevant to the wind power industry include Technology Inflow Programs sponsored by External Affairs Canada, used for visiting foreign firms with the view to licensing foreign technology, and Industrial Research Assistance Programs to develop or adapt new technologies in partnership with government. The Conservation/Renewable Energy Council, Small Power Producers of Alberta, and Independent Power Producers Society of Ontario are also active in supporting wind energy initiatives. In other countries, notable initiatives for wind energy include the Danish wind turbine warranty guarantee program. The Western Wind Industry Network of Canada conducts regional lobbying. It is suggested that in Canada, more such networks are needed, as well as joint ventures with utilities and governments, and more work with the regulatory agencies, to promote wind energy

  15. Industrial zones and Arab industrialization in Israel

    NARCIS (Netherlands)

    Sofer, Michael; Schnell, Izhak; Drori, Israel

    1996-01-01

    Since the 1970s there has been increased integration of the Arab sector into the Israeli economy. This integration has been characterized by the increase in industrial entrepreneurship in the Arab settlements. Critical to the industrialization process are factors related to the availability of

  16. Dutch industry, smart(est) industry

    NARCIS (Netherlands)

    Sol, E.J.; Steinbuch, M.; Keulen, F. van; Houten, F.J.A.M.; Horst, T.J.J. van der

    2015-01-01

    Digitalisering verandert onze samenleving. De combinatie van opkomende technologieën, zoals het Internet, micro-sensoren, 3D-printing en big data maakt volledig nieuwe producten en diensten mogelijk. In de industrie wordt niet voor niets gesproken over een vierde industriële revolutie. Het is voor

  17. Personality, Drug Preference, Drug Use, and Drug Availability

    Science.gov (United States)

    Feldman, Marc; Boyer, Bret; Kumar, V. K.; Prout, Maurice

    2011-01-01

    This study examined the relationship between drug preference, drug use, drug availability, and personality among individuals (n = 100) in treatment for substance abuse in an effort to replicate the results of an earlier study (Feldman, Kumar, Angelini, Pekala, & Porter, 2007) designed to test prediction derived from Eysenck's (1957, 1967)…

  18. Biosimilar Drugs

    Directory of Open Access Journals (Sweden)

    Muradiye Nacak

    2012-04-01

    Full Text Available Biotechnological (biopharmaceutical products are complex macromolecules created through the genetic manipulation of living organisms using recombinant DNA technology, monocolonal antibodies and gene therapy. The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. These new biotechnology medicines are known as %u201Cbiosimilars%u201D. Due to the complex method of production of biological medicines, biosimilar medicines are only similar in composition to a reference product, but may not be identical. Comparative quality, pre-clinical and clinical studies have to be provided by the biosimilar manufacturer to substantiate the similarity of structure/composition, quality, safety and efficacy between the new biosimilar and the chosen reference medicinal product. With a suitable regulatory process, biosimilars have the potential to provide considerable cost savings to both patients and healthcare providers. But, a comprehensive understanding of new products, including manufacturing process, prescribing habits, marketing practices, patent terms, and clinical use needs to be addressed with regulatory authorities, scientists and pharmaceutical industry before the future of biosimilars becomes a reality.

  19. The worldwide trend of using botanical drugs and strategies for developing global drugs.

    Science.gov (United States)

    Ahn, Kyungseop

    2017-03-01

    Natural product drugs, or botanical drugs, are drugs composed of natural substances which have constituents with healthenhancing or medicinal activities. In Korea, government-led projects brought attention to botanical drugs invigorating domestic botanical drug industry. Foreign markets, as well, are growing bigger as the significance of botanical drugs stood out. To follow along with the tendency, Korea puts a lot of effort on developing botanical drugs suitable for global market. However, standards for approving drug sales vary by countries. And also, thorough standardization, certification, clinical studies and data of these will be required as well as data confirming safety and effectiveness. Meanwhile, as an international exchange in botanical drug market continues, the importance of plant resources was emphasized. Thus countries' ownership of domestic natural resources became vital. Not only establishing a systematic method to secure domestic plant resources, but also cooperation with other countries on sharing natural resources is essential to procure natural resources effectively. Korea started to show visible results with botanical drugs, and asthma/COPD treatment made out of speedwell is one example. Sufficient investment and government's active support for basic infrastructure for global botanical drugs will bring Korea to much higher level of botanical drug development. [BMB Reports 2017; 50(3): 111-116].

  20. From academy to industry

    International Nuclear Information System (INIS)

    Chatal, J.F.

    2015-01-01

    Full text of publication follows. Clinical efficacy of radioimmunotherapy (RIT) has been clearly documented in the consolidation situation, such as first line treatment of indolent Non Hodgkin Lymphoma after induction chemotherapy [1] or after salvage resection of liver metastases from colon carcinoma [2], when tumor targets have a small, preferably microscopic, size. In this favorable situation RIT, which is a targeted therapy with toxicity limited to hematological toxicity, has a great potential and could be competitive with chemotherapy in particular for solid tumors. Such potential has been recently demonstrated in prostate cancer [3]. A lot of academic preclinical studies have been performed using multiple antibodies and antibody formats labeled with varied beta-emitting and more recently alpha particle-emitting radionuclides. With regard to other targeted therapies, the efficacy of RIT has been fully recognized and academic preclinical studies have been extended to a lot of clinical phase I/II studies but a limited number of phase II studies. Paradoxically, despite quite encouraging results, the number of industrially implemented phase III studies has been limited to the fingers of one hand illustrating a gap between academy and industry. For the last ten years only 2 ARCs (Antibody Radio Conjugates) (Zevalin and Bexxar) have been approved. The reasons for such a gap are complex and multiple but they could be summarized in one word: Money. The cost for a phase III study, enrolling hundreds of patients, exceeds the financial capabilities of most radiopharmaceutical companies and, up to now, Big Pharmas did not dare to invest in this field of RIT in part because they are not familiar with the use of radionuclides and prefer to develop ADCs (Antibody Drug Conjugates) even if they are generally more toxic and no more efficient than ARCs. For the future of RIT it is crucial to succeed in convincing Big Pharmas to invest in this field of ARCs. For this purpose it

  1. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

  2. 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, ...

  3. Drugs and lactation

    International Nuclear Information System (INIS)

    Kelssering, G.; Aguiar, L.F.; Ribeiro, R.M.; Souza, A.Z. de

    1988-01-01

    Different kinds of drugs who can be transferred through the mother's milk to the lactant and its effects are showed in this work. A list of them as below: cardiotonics, diuretics, anti-hypertensives, beta-blockings, anti-arrythmics, drugs with gastrintestinal tract action, hormones, antibiotics and chemotherapeutics, citostatic drugs, central nervous system action drugs and anticoagulants drugs. (L.M.J.) [pt

  4. A vision of the pharmaceutical industry.

    Science.gov (United States)

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing.

  5. The Industry That Can.

    Science.gov (United States)

    Aguirre, Edward

    This speech by the U.S. Commissioner of Education reviews the education industry and education-industry relations. Examples illustrate the effective partnership that can be created to fashion and achieve successful vocational and career education programs. (MML)

  6. An Industrial Physics Toolkit

    Science.gov (United States)

    Cummings, Bill

    2004-03-01

    Physicists possess many skills highly valued in industrial companies. However, with the exception of a decreasing number of positions in long range research at large companies, job openings in industry rarely say "Physicist Required." One key to a successful industrial career is to know what subset of your physics skills is most highly valued by a given industry and to continue to build these skills while working. This combination of skills from both academic and industrial experience becomes your "Industrial Physics Toolkit" and is a transferable resource when you change positions or companies. This presentation will describe how one builds and sells your own "Industrial Physics Toolkit" using concrete examples from the speaker's industrial experience.

  7. Electronics Industry Study Report

    National Research Council Canada - National Science Library

    Belt, David; Fellows, John R; Kameru, Philip; Nazaroff, Boris-Frank A; Pauroso, Anthony; Schulz, Frederick; Ballew, Bob; Bond, Thomas; Demers, Stephy; Kirkpatrick, Steve

    2005-01-01

    This paper provides a national strategy for the US electronics industry. Electronics is one of the largest industries in the US and plays a critical role in almost every aspect of national security...

  8. Localisation for industrial development

    CSIR Research Space (South Africa)

    Bhugwandin, Ashley

    2017-10-01

    Full Text Available This presentation focuses on localisation for industrial development, and is presented by Ashley Bhugwandin at The 6th CSIR Conference: Ideas that work for industrial development, 5-6 October 2017, CSIR International Convention Centre, Pretoria...

  9. Conditions for industrial production

    DEFF Research Database (Denmark)

    Jensen, Karsten Ingerslev; Schultz, Jørgen Munthe; Brauer, H.

    1996-01-01

    The possibility of an industrial aerogel glazing production is discussed with respect to sample size, sales volume and prices. Different ways of an industrial assembling line is outlined and the total costs of a 1 square meter aerogel glazing is calculated.......The possibility of an industrial aerogel glazing production is discussed with respect to sample size, sales volume and prices. Different ways of an industrial assembling line is outlined and the total costs of a 1 square meter aerogel glazing is calculated....

  10. Industry recession to persist

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    This paper reports that the depressed U.S. oil and gas industry is not likely to recover soon, witnesses told the Texas Railroad Commission's state of the petroleum industry hearing. Major companies and independent operators agreed the U.S. petroleum industry is near a state of collapse. Many the producers are despairing about the chances of surviving the latest economic downturn

  11. FOSSIL FUEL INDUSTRIES

    Science.gov (United States)

    The chapter focuses on methane emissions from the coal and natural gas industries. The petroleum industry is not addressed because of the lack of related quality data. Emission points are identified for each industry, and a discussion of factors affecting emissions is presented. ...

  12. Benchmarking and industry performance

    NARCIS (Netherlands)

    Ten Raa, T.

    2011-01-01

    In this paper I interrelate productivity analysis and the theory of industrial organization. A proposition proves that an industrial organization is efficient if and only if it is supportable in the entry-proofness sense. Industrial performance is decomposed in efficiency and technical change terms

  13. Robotics and Industrial Arts.

    Science.gov (United States)

    Edmison, Glenn A.; And Others

    Robots are becoming increasingly common in American industry. By l990, they will revolutionize the way industry functions, replacing hundreds of workers and doing hot, dirty jobs better and more quickly than the workers could have done them. Robotics should be taught in high school industrial arts programs as a major curriculum component. The…

  14. Spring 2008 Industry Study: Financial Services Industry

    National Research Council Canada - National Science Library

    Calderon, Juan; Collins, Thomas W; Devinney, Edward; Driggers, Gene J; Dunmyer, Valrica; Flood, Paul; Gallant, Robin; Kekauoha, Stanford K; Krawietz, Anthony B; Kumashiro, Patrick T; LaDue, Paul W; LaFalce, John; Larson, Steven W; Lawrence, Steven J; Nettleton, John; Ostrowski, John A

    2008-01-01

    The extensive media coverage of the 2008 subprime crisis, both domestically and abroad, drives home the crucial role that the financial services industry plays for not only individual Americans, but for U.S. national security...

  15. INDUSTRI KREATIF INDONESIA: PENDEKATAN ANALISIS KINERJA INDUSTRI

    OpenAIRE

    Ahmad Kamil

    2015-01-01

    In 2008, the Department of Commerce of the Republic of Indonesia has launched a creative economic development documents interpreted the 2025 Indonesia became the starting point and guide the development of the creative economy in Indonesia. With the existence of this document, the industry and its stakeholders or other stakeholders can readily develop the creative economy in Indonesia. Economic development in the direction of the creative industries is one manifestation of optimism aspiration...

  16. Drug Retention Times

    Energy Technology Data Exchange (ETDEWEB)

    Center for Human Reliability Studies

    2007-05-01

    The purpose of this monograph is to provide information on drug retention times in the human body. The information provided is based on plausible illegal drug use activities that might be engaged in by a recreational drug user.

  17. Drug Reactions - Multiple Languages

    Science.gov (United States)

    ... PDF Drug Interactions - HIV medicines, part 6 - English MP3 Drug Interactions - HIV medicines, part 6 - 简体中文 (Chinese, Simplified (Mandarin dialect)) MP3 Drug Interactions - HIV medicines, part 6 - English MP4 ...

  18. Teenagers and drugs

    Science.gov (United States)

    Teenagers and drugs; Symptoms of drug use in teenagers; Drug abuse - teenagers; Substance abuse - teenagers ... for a specialist who has experience working with teenagers. Do not hesitate, get help right away. The ...

  19. Drug Interaction API

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Interaction API is a web service for accessing drug-drug interactions. No license is needed to use the Interaction API. Currently, the API uses DrugBank for its...

  20. in OECD countries concerning biological drugs

    African Journals Online (AJOL)

    Jane

    2011-08-22

    Aug 22, 2011 ... the pharmaceutical sector about biological drugs come under the umbrella of innovation system of each country. ... The cost of biotechnology R and D within public research centres and ... Existence of a suitable system to protect intellectual property ... biotechnology that provide the capital for industry and.

  1. Sequencing: Targeting Insurgents and Drugs in Colombia

    Science.gov (United States)

    2007-03-01

    p. 73. 24 initiated by previous administrations coupled with declining prices in the late 1990s for coffee and oil—two of Colombia’s major...whose involvement in the illicit drug industry gained them notoriety in the 1970s with the production of cannabis . In the 1980s, Colombia became the

  2. African Journal of Drug and Alcohol Studies

    African Journals Online (AJOL)

    The African Journal of Drug & Alcohol Studies is an international scientific journal published by the African Centre for Research and Information on Substance ... Anywhere, everywhere: alcohol industry promotion strategies in Nigeria and their influence on young people · EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT

  3. Kinase-Centric Computational Drug Development

    NARCIS (Netherlands)

    Kooistra, Albert J.; Volkamer, Andrea

    2017-01-01

    Kinases are among the most studied drug targets in industry and academia, due to their involvement in a majority of cellular processes and, upon dysregulation, in a variety of diseases including cancer, inflammation, and autoimmune disorders. The high interest in this druggable protein family

  4. Carbon Nanotubes in Drug and Gene Delivery

    Science.gov (United States)

    Karimi, Mahdi; Ghasemi, Amir; Mirkiani, Soroush; Moosavi Basri, Seyed Masoud; Hamblin, Michael R.

    2017-10-01

    Recent important discoveries and developments in nanotechnology have had a remarkable and ever-increasing impact on many industries, especially materials science, pharmaceuticals, and biotechnology. Within this book, the authors describe different features of carbon nanotubes, survey the properties of both the multi-walled and single-walled varieties, and cover their applications in drug and gene delivery.

  5. Minerals industry survey, 1984

    Energy Technology Data Exchange (ETDEWEB)

    1984-01-01

    This is the seventh edition of the statistical survey commissioned by the Australian Mining Industry Council. It represents the most comprehensive review of the financial position of the Australian minerals industry and provides timely financial data on the minerals industry. The tables of this survey have been prepared for AMIC by Coopers and Lybrand, Chartered Accountants, based on information supplied to them in confidence by the respondent companies. For the purpose of the survey, the minerals industry has been defined as including exploration for, and extraction and primary processing of, minerals in Australia. The oil and gas industry is not included.

  6. Minerals industry survey 1987

    Energy Technology Data Exchange (ETDEWEB)

    1987-01-01

    This is the eleventh Minerals Industry Survey produced by the Australian Mining Industry Council. It represents an invaluable time series on the minerals industry's financial performance, as well as an up to date description of the industry for the latest financial year. The survey has been conceived as a supplement to and expansion of the various Australian Bureau of Statistics and Bureau of Mineral Resources, Geology and Geophysics publications which describe the exploration, mining and smelting and refining industries in Australia. The tables in this survey have been prepared by Coopers and Lybrand, Chartered Accountants, based on information supplied to them in confidence by the respondent companies.

  7. Historicism and Industry Emergence

    DEFF Research Database (Denmark)

    Kirsch, David; Moeen, Mahka; Wadhwani, Dan

    2014-01-01

    Management and organization scholars have increasingly turned to historical sources to examine the emergence and evolution of industries over time. This scholarship has typically used historical evidence as observations for testing theoretically relevant processes of industry emergence....... In this chapter, an alternative approach is explored that focuses on reconstructing causes and processes that time and theory have erased. The emergence of three industries—plant biotechnology, savings banking, and the automobile—shows how time, along with prevailing functional models of industry evolution, leads...... excluded phenomena and explanations, reconstructing uncertainty and alternative paths of industry emergence, and studying the processes of information elision and exclusion in the formation of industry knowledge....

  8. Industrial statistics with Minitab

    CERN Document Server

    Cintas, Pere Grima; Llabres, Xavier Tort-Martorell

    2012-01-01

    Industrial Statistics with MINITAB demonstrates the use of MINITAB as a tool for performing statistical analysis in an industrial context. This book covers introductory industrial statistics, exploring the most commonly used techniques alongside those that serve to give an overview of more complex issues. A plethora of examples in MINITAB are featured along with case studies for each of the statistical techniques presented. Industrial Statistics with MINITAB: Provides comprehensive coverage of user-friendly practical guidance to the essential statistical methods applied in industry.Explores

  9. Advanced Industrial Materials Program

    Science.gov (United States)

    Stooksbury, F.

    1994-06-01

    The mission of the Advanced Industrial Materials (AIM) program is to commercialize new/improved materials and materials processing methods that will improve energy efficiency, productivity, and competitiveness. Program investigators in the DOE national laboratories are working with about 100 companies, including 15 partners in CRDA's. Work is being done on intermetallic alloys, ceramic composites, metal composites, polymers, engineered porous materials, and surface modification. The program supports other efforts in the Office of Industrial Technologies to assist the energy-consuming process industries. The aim of the AIM program is to bring materials from basic research to industrial application to strengthen the competitive position of US industry and save energy.

  10. Metalcasting Industry Technology Roadmap

    Energy Technology Data Exchange (ETDEWEB)

    none,

    1998-01-01

    The Roadmap sets out the strategy for pursuing near-, mid-, and long-term goals set out by industry and for carrying out the cooperative agreement between the U.S. Department of Energy and industry. The Roadmap outlines key goals for products and markets, materials technology, manufacturing technology, environmental technology, human resources, and industry health programs. The Roadmap sets out the strategy for pursuing near-, mid-, and long-term goals set out by industry and for carrying out the cooperative agreement between the U.S. Department of Energy and industry. The Roadmap sets out the strategy for pursuing near-, mid-, and long-term goals set out by industry and for carrying out the cooperative agreement between the U.S. Department of Energy and industry.

  11. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Science.gov (United States)

    2013-11-20

    ...] Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and... entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' When... promotional labeling and advertising for prescription human drugs, including biological drug products, and...

  12. Protein Crystallography: A 'Must' Technology for Drug Design

    International Nuclear Information System (INIS)

    Matsuzaki, Takao

    2004-01-01

    The history of drug-related protein crystallography and drug design is reviewed to show that 'Lead Generation' is high-lighted in the pharmaceutical industry nowadays. A new drug design method has been developed. The method gave very high success rate; 10-60 % gave < 100 μM, 90 % gave < 10 mM. The crystal structures of drug-protein complexes have become even more important to give solid experimental bases for e.g. 1,000 designed structures and to find the new mechanisms of drug action

  13. Finnish industry's energy requirement

    International Nuclear Information System (INIS)

    Punnonen, J.

    2000-01-01

    Industry uses around half of the electricity consumed in Finland. In 1999, this amounted to 42.3 TWh and 420 PJ of fuel. Despite the continual improvements that have been made in energy efficiency, energy needs look set to continue growing at nearly 2% a year. Finnish industrial output rose by some 5.5% in 1999. In energy-intensive sectors such as pulp and paper, output rose by 3.4%, in the metal industry by 4%, and in the chemical industry by 3.1%. Growth across Finnish industry is largely focused on the electrical and electronics industries, however, where growth last year was 24.3% The Finnish forest products industry used a total of 26.1 TWh of electricity last year, up 1% on 1998. This small increase was the result of the industry's lower-than-average operating rate in the early part of the year The metal industry used 7.2 TWh of electricity, an increase of 5.8% on 1998. Usage in the chemical industry rose by 2% to 5.2 TWh. Usage by the rest of industry totalled 3.8 TWh, up 2.3% on 1998. All in all, industry's use of electricity rose by 2% in 1999 to 42,3 TWh. Increased demand on industry's main markets in Europe will serve to boost industrial output and export growth this year. This increased demand will be particularly felt in energy-intensive industries in the shape of an increased demand for electricity. Overall, electricity demand is expected to grow by 3% this year, 1% more than industry's longterm projected electricity usage growth figure of 2%. The structure of industry's fuel use in Finland has changed significantly over the last 25 years. Oil, for example, now accounts for only some 10% of fuel use compared to the 40% typical around the time of the first oil crisis. Oil has been replaced by biofuels, peat, and natural gas. The pulp and paper industry is the largest industrial user of renewable energy sources in Finland, and uses wood-related fuels to cover nearly 70% of its fuel needs

  14. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Directory of Open Access Journals (Sweden)

    M Venkatesh

    2011-01-01

    Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

  15. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Science.gov (United States)

    Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

    2011-01-01

    Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

  16. Drugs Cheaper Than Threepenny: The Market of Extremely Low-Priced Drugs within the National Health Insurance in Taiwan

    Science.gov (United States)

    Chou, Li-Fang

    2014-01-01

    While most drug policy researches paid attention to the financial impact of expensive drugs, the market situation of low-priced drugs in a country was seldom analyzed. We used the nationally representative claims datasets to explore the status within the National Health Insurance (NHI) in Taiwan. In 2007, a total of 12,443 distinct drug items had been prescribed 853,250,147 times with total expenditure of 105,216,950,198 new Taiwan dollars (NTD). Among them, 7,366 oral drug items accounted for 701,353,383 prescribed items and 68,133,988,960 NTD. Besides, 2,887 items (39.2% of oral drug items) belonged to cheap drugs with the unit price ≤1 NTD (about 0.03 of US dollar). While the top one item among all oral drugs had already a market share of 5.0%, 30 items 30.3% and 107 items 50.0%, the cheap drugs with aggregate 332,893,462 prescribed items (47.5% of all prescribed oral drug items) only accounted for 2,750,725,433 NTD (4.0% of expenditure for oral drugs and 2.6% of total drug expenditure). The drug market of Taiwan's NHI was abundant in cheap drugs. The unreasonably low prices of drugs might not guarantee the quality of pharmaceutical care and the sustainability of a healthy pharmaceutical industry in the long run. PMID:24719568

  17. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Science.gov (United States)

    2013-02-25

    ...; formerly 2005D-0183] Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... 20852. FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug Evaluation and Research, Food...

  18. The use of drugs in food animals: benefits and risks

    National Research Council Canada - National Science Library

    ...; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industries--poultry, dairy, beef, swine, and aquaculture...

  19. Rescuing drug discovery: In vivo systems pathology and systems pharmacology

    NARCIS (Netherlands)

    Greef, J. van der; McBurney, R.N.

    2005-01-01

    The pharmaceutical industry is currently beleaguered by close scrutiny from the financial community, regulators and the general public. Productivity, in terms of new drug approvals, has generally been falling for almost a decade and the safety of a number of highly successful drugs has recently been

  20. Nonclinical statistics for pharmaceutical and biotechnology industries

    CERN Document Server

    2016-01-01

    This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The cha...

  1. Prediction of potential drug targets based on simple sequence properties

    Directory of Open Access Journals (Sweden)

    Lai Luhua

    2007-09-01

    Full Text Available Abstract Background During the past decades, research and development in drug discovery have attracted much attention and efforts. However, only 324 drug targets are known for clinical drugs up to now. Identifying potential drug targets is the first step in the process of modern drug discovery for developing novel therapeutic agents. Therefore, the identification and validation of new and effective drug targets are of great value for drug discovery in both academia and pharmaceutical industry. If a protein can be predicted in advance for its potential application as a drug target, the drug discovery process targeting this protein will be greatly speeded up. In the current study, based on the properties of known drug targets, we have developed a sequence-based drug target prediction method for fast identification of novel drug targets. Results Based on simple physicochemical properties extracted from protein sequences of known drug targets, several support vector machine models have been constructed in this study. The best model can distinguish currently known drug targets from non drug targets at an accuracy of 84%. Using this model, potential protein drug targets of human origin from Swiss-Prot were predicted, some of which have already attracted much attention as potential drug targets in pharmaceutical research. Conclusion We have developed a drug target prediction method based solely on protein sequence information without the knowledge of family/domain annotation, or the protein 3D structure. This method can be applied in novel drug target identification and validation, as well as genome scale drug target predictions.

  2. 76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

    Science.gov (United States)

    2011-03-14

    ...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...

  3. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  4. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Science.gov (United States)

    2013-04-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  5. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Science.gov (United States)

    2012-10-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

  6. Landscape of Industry: Transformation of (Eco Industrial Park through history

    Directory of Open Access Journals (Sweden)

    Archana Sharma

    2013-11-01

    Full Text Available The landscape of industry has been changing over time. Industry has transformed and many tangents have emerged from the sporadic home-based cottage industries to geographically scattered large manufacturing industries to co-located industrial parks to environment friendly eco-industrial parks. Curiosity about the catalysts that bring about the transformation of industrial landscape is the motivation of this article. Through the narrative on Industrial Park and the gradual shift towards Eco-Industrial Park, this article aims to shed light on the context and conditions that act as catalysts for industrial transformations, so as to serve as a reference for predicting future changes in industrial landscape.

  7. Results of workplace drug testing in Norway

    Directory of Open Access Journals (Sweden)

    Hilde Marie Erøy Lund

    2011-12-01

    Full Text Available Workplace drug testing is less common in Norway than in many other countries. During the period from 2000-2006, 13469 urine or blood samples from employees in the offshore industry, shipping companies and aviation industry were submitted to the Norwegian Institute of Public Health for drug testing. The samples were analysed for benzodiazepines, illicit drugs, muscle relaxants with sedating properties, opioids and z-hypnotics. In total, 2.9% of the samples were positive for one or more substances. During the study period the prevalence decreased for morphine (from 1.9% to 1.1% and increased for amphetamine (from 0.04% to 0.6%, clonazepam (from 0% to 0.1%, methamphetamine (from 0.04% to 0.6%, nitrazepam (from 0% to 0.4% and oxazepam (from 0.5% to 1.3% (p<0.05. There was no significant change in prevalence for the other substances included in the analytical programme. Illicit drugs were significantly associated with lower age (OR: 0.93, p<0.05. This study found low prevalence of drugs among employees in companies with workplace drug testing programmes in Norway.

  8. Target Essentiality and Centrality Characterize Drug Side Effects

    OpenAIRE

    Wang, Xiujuan; Thijssen, Bram; Yu, Haiyuan

    2013-01-01

    Author Summary The ultimate goal of medical research is to develop effective treatments for disease with minimal side effects. Currently, about 20% of drug candidates failed at clinical trial phases II and III due to safety issues. Therefore, understanding the determining factors of drug side effects is of paramount importance to human health and the pharmaceutical industry. Here, we present the first systematic study to uncover key factors leading to drug side effects within the framework of...

  9. Effects of Drugs

    Science.gov (United States)

    ... Used Drugs in the Past Drug Use Prevention Phone Numbers and Websites Search ... who aren't yet born. Drug use can hurt the body and the brain, sometimes forever. Drug use can also lead to addiction, a long-lasting brain disease in which people ...

  10. Drugs and Young People

    Science.gov (United States)

    Drug abuse is a serious public health problem. It affects almost every community and family in some way. Drug abuse in children and teenagers may pose a ... of young people may be more susceptible to drug abuse and addiction than adult brains. Abused drugs ...

  11. Industry and energy; Industrie et energie

    Energy Technology Data Exchange (ETDEWEB)

    Birules y Bertran, A.M. [Ministere des Sciences et de la Technologie (Spain); Folgado Blanco, J. [Secretariat d' Etat a l' Economie, a l' Energie et aux PME du Royaume d' Espagne (Spain)

    2002-07-01

    This document is the provisional version of the summary of the debates of the 2433. session of the European Union Council about various topics relative to the industry and the energy. The energy-related topics that have been debated concern: the government helps in coal industry, the internal electricity and gas market, the trans-European energy networks, the bio-fuels in transportation systems, the energy charter, the pluri-annual energy program, and the green book on the security of energy supplies. (J.S.)

  12. Industry Study, Environment Industry, Spring 2009

    Science.gov (United States)

    2009-01-01

    practices. For example, the cruising sector of the tourism industry has widely- acknowledged negative environmental impacts (carbon emissions and ocean...Services: An Industry Analysis ,” (2009): 4. http://www.berr.gov.uk/files/file50253.pdf 18 Ibid., 5. 19 EBI, 21 20 Department for Business...Ibid., 26. 50 DataMonitor Country Analysis Report, “Korea: In-Depth PESTLE Insights,” (June 2008): 4. 51 EBI, “3000,” 1-22. 52 Ibid., 5-130, 5

  13. Industry X.0 : Reimaging industrial development

    CSIR Research Space (South Africa)

    Zachar, H

    2017-10-01

    Full Text Available Quantum Mainframe Client-server & PCs Web 1.0 ecommerce Web 2.0, cloud, mobile Big data, analytics, visualization IoT & smart machines Artificial intelligence Quantum computing 6 T o d a y 1950 1960 1970 1980 1990 2000 2010 2020... NEW SET OF CORE CAPABILITIES TO SUCCEED INDUSTRY X.0 INDUSTRY 4.0 EFFICIENCIES HYPER-PERSONALIZED EXPERIENCES & NEW SOURCES OF GROWTH SOCIAL MEDIA CLOUD ANALYTICS MOBILITY WEB 1.0/E-COMMERCE PCS, SERVERS AND DEDICATED HARDWARE PCS...

  14. Industry X.0 : Reimaging industrial development.

    CSIR Research Space (South Africa)

    Zachar, H

    2017-10-01

    Full Text Available Quantum Mainframe Client-server & PCs Web 1.0 ecommerce Web 2.0, cloud, mobile Big data, analytics, visualization IoT & smart machines Artificial intelligence Quantum computing 6 T o d a y 1950 1960 1970 1980 1990 2000 2010 2020... NEW SET OF CORE CAPABILITIES TO SUCCEED INDUSTRY X.0 INDUSTRY 4.0 EFFICIENCIES HYPER-PERSONALIZED EXPERIENCES & NEW SOURCES OF GROWTH SOCIAL MEDIA CLOUD ANALYTICS MOBILITY WEB 1.0/E-COMMERCE PCS, SERVERS AND DEDICATED HARDWARE PCS...

  15. Open source drug discovery--a new paradigm of collaborative research in tuberculosis drug development.

    Science.gov (United States)

    Bhardwaj, Anshu; Scaria, Vinod; Raghava, Gajendra Pal Singh; Lynn, Andrew Michael; Chandra, Nagasuma; Banerjee, Sulagna; Raghunandanan, Muthukurussi V; Pandey, Vikas; Taneja, Bhupesh; Yadav, Jyoti; Dash, Debasis; Bhattacharya, Jaijit; Misra, Amit; Kumar, Anil; Ramachandran, Srinivasan; Thomas, Zakir; Brahmachari, Samir K

    2011-09-01

    It is being realized that the traditional closed-door and market driven approaches for drug discovery may not be the best suited model for the diseases of the developing world such as tuberculosis and malaria, because most patients suffering from these diseases have poor paying capacity. To ensure that new drugs are created for patients suffering from these diseases, it is necessary to formulate an alternate paradigm of drug discovery process. The current model constrained by limitations for collaboration and for sharing of resources with confidentiality hampers the opportunities for bringing expertise from diverse fields. These limitations hinder the possibilities of lowering the cost of drug discovery. The Open Source Drug Discovery project initiated by Council of Scientific and Industrial Research, India has adopted an open source model to power wide participation across geographical borders. Open Source Drug Discovery emphasizes integrative science through collaboration, open-sharing, taking up multi-faceted approaches and accruing benefits from advances on different fronts of new drug discovery. Because the open source model is based on community participation, it has the potential to self-sustain continuous development by generating a storehouse of alternatives towards continued pursuit for new drug discovery. Since the inventions are community generated, the new chemical entities developed by Open Source Drug Discovery will be taken up for clinical trial in a non-exclusive manner by participation of multiple companies with majority funding from Open Source Drug Discovery. This will ensure availability of drugs through a lower cost community driven drug discovery process for diseases afflicting people with poor paying capacity. Hopefully what LINUX the World Wide Web have done for the information technology, Open Source Drug Discovery will do for drug discovery. Copyright © 2011 Elsevier Ltd. All rights reserved.

  16. Introduction to fragment-based drug discovery.

    Science.gov (United States)

    Erlanson, Daniel A

    2012-01-01

    Fragment-based drug discovery (FBDD) has emerged in the past decade as a powerful tool for discovering drug leads. The approach first identifies starting points: very small molecules (fragments) that are about half the size of typical drugs. These fragments are then expanded or linked together to generate drug leads. Although the origins of the technique date back some 30 years, it was only in the mid-1990s that experimental techniques became sufficiently sensitive and rapid for the concept to be become practical. Since that time, the field has exploded: FBDD has played a role in discovery of at least 18 drugs that have entered the clinic, and practitioners of FBDD can be found throughout the world in both academia and industry. Literally dozens of reviews have been published on various aspects of FBDD or on the field as a whole, as have three books (Jahnke and Erlanson, Fragment-based approaches in drug discovery, 2006; Zartler and Shapiro, Fragment-based drug discovery: a practical approach, 2008; Kuo, Fragment based drug design: tools, practical approaches, and examples, 2011). However, this chapter will assume that the reader is approaching the field with little prior knowledge. It will introduce some of the key concepts, set the stage for the chapters to follow, and demonstrate how X-ray crystallography plays a central role in fragment identification and advancement.

  17. Paving roads for new drugs in oncology.

    Science.gov (United States)

    Zaenker, Kurt S; Entschladen, Frank

    2009-06-01

    Low productivity and the escalating costs of drug development have been well documented over the past years. A fraction of new pre-clinical compounds successfully pass experimental test batteries, and less than 10% of these compounds that enter clinical trials ultimately make it to the market. These challenges in the "critical path" of drug development will be discussed for drugs in the field of oncology, regarding the i) the impact of FDA and EMEA guidelines, and ii) microdosing studies/phase 0 trials before a drug enters phase I to III, to inform drug development, compressing drug development timelines and decision-making for continuation into clinical trials. Moreover, this review should embark on i) how to find new key molecules involved in life-and-death decision of a cell, how ii) old drugs will have a revival for new indications, because of novel information for their mode of action, and iii) how the revolutionary advances - high-throughput technologies, gene therapy and the deciphering of the human genome - do have their potential to develop personalized therapy. Therapy has progressed from an age of administering herbal remedies and organ extracts to an era of meticulously planned drug discovery, when pharmaceutical industry was born in a Western understanding. The relevant patents are discussed.

  18. Nanocomposite thin films for triggerable drug delivery.

    Science.gov (United States)

    Vannozzi, Lorenzo; Iacovacci, Veronica; Menciassi, Arianna; Ricotti, Leonardo

    2018-05-01

    Traditional drug release systems normally rely on a passive delivery of therapeutic compounds, which can be partially programmed, prior to injection or implantation, through variations in the material composition. With this strategy, the drug release kinetics cannot be remotely modified and thus adapted to changing therapeutic needs. To overcome this issue, drug delivery systems able to respond to external stimuli are highly desirable, as they allow a high level of temporal and spatial control over drug release kinetics, in an operator-dependent fashion. Areas covered: On-demand drug delivery systems actually represent a frontier in this field and are attracting an increasing interest at both research and industrial level. Stimuli-responsive thin films, enabled by nanofillers, hold a tremendous potential in the field of triggerable drug delivery systems. The inclusion of responsive elements in homogeneous or heterogeneous thin film-shaped polymeric matrices strengthens and/or adds intriguing properties to conventional (bare) materials in film shape. Expert opinion: This Expert Opinion review aims to discuss the approaches currently pursued to achieve an effective on-demand drug delivery, through nanocomposite thin films. Different triggering mechanisms allowing a fine control on drug delivery are described, together with current challenges and possible future applications in therapy and surgery.

  19. Nuclear industry technology boomerang

    International Nuclear Information System (INIS)

    Scholler, R.W.

    1987-01-01

    The benefits to the medical, pharmaceutical, semiconductor, computer, video, bioscience, laser, defense, and numerous high-tech industries from nuclear technology development fallout are indeed numerous and increase every day. Now those industries have made further progress and improvements that, in return, benefit the nuclear industry. The clean-air and particle-free devices and enclosures needed for protection and decontamination are excellent examples

  20. VE of construction industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1987-10-15

    This book gives descriptions of basic of VE of construction industry including doing away with mannerism, necessity of cost reduction, management method of cost reduction, thinking of idea, target of VE, starting VE activity, technical method of VE of construction industry such as thinking of idea with brainstorming, function trade method, new brainstorming, MM method, morphology analysis and lateral thinking, cases of VE of construction industry.

  1. Modern electrochemistry and industry

    International Nuclear Information System (INIS)

    Kim, Sun Yong

    1985-04-01

    This book is divided into fifteen chapters on modern electrochemistry and industry. The contents of this book are electrochemistry and industry, electrochemistry for electrolyte like ionic mobility quantity of activity of electrolyte, potential balance system like cell potential, concentration cell and membrane potential, electrochemical kinetics, electrochemistry for surfactant, electrochemistry for electrolysis test such as polarography, chronopotentiometry and Cyclic voltametry, electrolysis reactor NaOH electrolysis industry, H 2 O electrolysis, molten metal electrolysis, copper electrolysis, battery and electro-organic chemistry.

  2. VE of construction industry

    International Nuclear Information System (INIS)

    1987-10-01

    This book gives descriptions of basic of VE of construction industry including doing away with mannerism, necessity of cost reduction, management method of cost reduction, thinking of idea, target of VE, starting VE activity, technical method of VE of construction industry such as thinking of idea with brainstorming, function trade method, new brainstorming, MM method, morphology analysis and lateral thinking, cases of VE of construction industry.

  3. A Study on How Industrial Pharmacists Rank Competences for Pharmacy Practice: A Case for Industrial Pharmacy Specialization

    Directory of Open Access Journals (Sweden)

    Jeffrey Atkinson

    2016-02-01

    Full Text Available This paper looks at the way in which industrial pharmacists rank the fundamental competences for pharmacy practice. European industrial pharmacists (n = 135 ranked 68 competences for practice, arranged into 13 clusters of two types (personal and patient care. Results show that, compared to community pharmacists (n = 258, industrial pharmacists rank competences centering on research, development and production of drugs higher, and those centering on patient care lower. Competences centering on values, communication skills, etc. were ranked similarly by the two groups of pharmacists. These results are discussed in the light of the existence or not of an “industrial pharmacy” specialization.

  4. DRUG POLICY AND DRUG ADDICTION IN TURKEY

    OpenAIRE

    İLHAN, Mustafa Necmi

    2018-01-01

    The NationalStrategy Document on Drugs and Emergency Action Plan started with thecontributions of all the relevant institutions within the year of 2014 wasprepared and after that in accordance with the Prime Ministry Notice entitledFight Against Drugs published within this scope, the committees for FightAgainst Drugs were established (under the presidency of Deputy Prime Ministerand with the help of Ministry of Health, Ministry of Justice, Ministry of Laborand Social Security, Ministry of Fam...

  5. Drug interactions with oral sulphonylurea hypoglycaemic drugs.

    Science.gov (United States)

    Hansen, J M; Christensen, L K

    1977-01-01

    The effect of the oral sulphonylurea hypoglycaemic drugs may be influenced by a large number of other drugs. Some of these combinations (e.g. phenylbutazone, sulphaphenazole) may result in cases of severe hypoglycaemic collapse. Tolbutamide and chlorpropamide should never be given to a patient without a prior careful check of which medicaments are already being given. Similarly, no drug should be given to a diabetic treated with tolbutamide and chlorpropamide without consideration of the possibility of interaction phenomena.

  6. Uranium industry annual, 1986

    International Nuclear Information System (INIS)

    1987-01-01

    Uranium industry data collected in the EIA-858 survey provide a comprehensive statistical characterization of annual activities of the industry and include some information about industry plans over the next several years. This report consists of two major sections. The first addresses uranium raw materials activities and covers the following topics: exploration activities and expenditures, resources and reserves, mine production of uranium, production of uranium concentrate, and industry employment. The second major section is concerned with the following uranium marketing activities: uranium purchase commitments, uranium prices, procurement arrangements, uranium imports and exports, enrichment services, inventories, secondary market activities utility market requirements and related topics

  7. Miscellaneous Industrial Mineral Operations

    Data.gov (United States)

    Department of Homeland Security — This map layer includes miscellaneous industrial minerals operations in the United States. The data represent commodities covered by the Minerals Information Team...

  8. Industrial Economics in Scandinavia

    DEFF Research Database (Denmark)

    Foss, Nicolai Juul; Møllgaard, Peter

    2004-01-01

    Based on diverse research methods, we trace and map industrial economics research in Denmark, Norway and Sweden in the periode of 1880 to 1908. After describing this research in terms of key contributors, we argue that industrial economics developed rather unevenly in the Scandinavian countries....... Danish research was mainly theoretical and strongly oriented towards the international context, whereas Norwegian research was largely industry analysis with a strong leaning towards managerial economics. Swedish research in industrial economics is very scant until the end of the 1960s.JEL Code: B1, B2...

  9. Process and petroleum industry

    International Nuclear Information System (INIS)

    1998-01-01

    In comparison with many industries, the oil and gas industry is somewhat unique in that it has been operating in a global environment for many decades. The North Sea exploration and production industry is now entering a challenging era for business growth which is a mature region with smaller and smaller fields, more difficult to find and which require innovative development schemes. This presentation relates to information technology offering the exploration and production industry a unique set of business tools to improve performance and enable growth while reducing risk

  10. Process and petroleum industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    In comparison with many industries, the oil and gas industry is somewhat unique in that it has been operating in a global environment for many decades. The North Sea exploration and production industry is now entering a challenging era for business growth which is a mature region with smaller and smaller fields, more difficult to find and which require innovative development schemes. This presentation relates to information technology offering the exploration and production industry a unique set of business tools to improve performance and enable growth while reducing risk

  11. Standard Industry Fare Level

    Data.gov (United States)

    Department of Transportation — Standard Industry Fare Level was establish after airline deregulation to serve as the standard against which a statutory zone of operating expense reasonableness was...

  12. Forest industries energy research

    Energy Technology Data Exchange (ETDEWEB)

    Scott, G. C.

    1977-10-15

    Data on energy use in the manufacturing process of the wood products industry in 1974 are tabulated. The forest industries contributed 10% of New Zealand's factory production and consumed 25% of all industrial energy (including that produced from self-generated sources such as waste heat liquors and wood wastes) in that year. An evaluation of the potential for savings in process heat systems in existing production levels is shown to be 3% in the short, medium, and long-term time periods. The industry has a high potential for fuel substitution in all sectors. The payback periods for the implementation of the conservation measures are indicated.

  13. Wastewater Industrial Contributors

    Data.gov (United States)

    Iowa State University GIS Support and Research Facility — Industrial contributors to municipal wastewater treatment facilities in Iowa for the National Pollutant Discharge Elimination System (NPDES) program.

  14. Automotive Industry in Malaysia

    DEFF Research Database (Denmark)

    Wad, Peter; Govindaraju, V.G.R. Chandran

    2011-01-01

    ) limited participation in the global value chain. Although the Malaysian infant industry protection policy comprised many promising initiatives, the national and the overall domestic automobile industry ended up as a captive of the regionalised Japanese keiretsu system in automobile manufacturing. A new...... expanded in terms of sales, production, employment and local content, but failed in industrial upgrading and international competitiveness. The failures can be attributed to (a) lack of political promotion for high challenge-high support environment, (b) low technological and marketing capabilities and (c...... transformation is required to push the industry beyond its current performance through a more strategic productive coalition with multiple stakeholders including trade unions....

  15. Transportation Industry 2004

    National Research Council Canada - National Science Library

    Miller, Evan; Kathir, Nathan; Brogan, Dennis M

    2004-01-01

    .... Because the defense sector relies on commercial transportation for both peacetime activities and for power projection, senior military leaders must understand the global transportation industry...

  16. Mapping of wine industry

    OpenAIRE

    Віліна Пересадько; Надія Максименко; Катерина Біла

    2016-01-01

    Having reviewed a variety of approaches to understanding the essence of wine industry, having studied the modern ideas about the future of wine industry, having analyzed more than 50 maps from the Internet we have set the trends and special features of wine industry mapping in the world, such as: - the vast majority of maps displays the development of the industry at regional or national level, whereas there are practically no world maps; - wine-growing regions are represented on maps very un...

  17. International Drug Control Policy

    Science.gov (United States)

    2009-08-24

    Common illegal drugs include cannabis, cocaine, opiates, and synthetic drugs. International trade in these drugs represents a lucrative and what...into effect, decriminalizing “personal use” amounts of marijuana , heroin, cocaine, methamphetamine, and other internationally sanctioned drugs.15 While...President Calls for Legalizing Marijuana ,”CNN.com, May 13, 2009. 15 “Mexico Legalizes Drug Possession,” Associated Press, August 21, 2009. 16 In support

  18. 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...

  19. Drug-Target Kinetics in Drug Discovery.

    Science.gov (United States)

    Tonge, Peter J

    2018-01-17

    The development of therapies for the treatment of neurological cancer faces a number of major challenges including the synthesis of small molecule agents that can penetrate the blood-brain barrier (BBB). Given the likelihood that in many cases drug exposure will be lower in the CNS than in systemic circulation, it follows that strategies should be employed that can sustain target engagement at low drug concentration. Time dependent target occupancy is a function of both the drug and target concentration as well as the thermodynamic and kinetic parameters that describe the binding reaction coordinate, and sustained target occupancy can be achieved through structural modifications that increase target (re)binding and/or that decrease the rate of drug dissociation. The discovery and deployment of compounds with optimized kinetic effects requires information on the structure-kinetic relationships that modulate the kinetics of binding, and the molecular factors that control the translation of drug-target kinetics to time-dependent drug activity in the disease state. This Review first introduces the potential benefits of drug-target kinetics, such as the ability to delineate both thermodynamic and kinetic selectivity, and then describes factors, such as target vulnerability, that impact the utility of kinetic selectivity. The Review concludes with a description of a mechanistic PK/PD model that integrates drug-target kinetics into predictions of drug activity.

  20. Spring 2007. Industry Study. Manufacturing Industry

    Science.gov (United States)

    2007-01-01

    their success. Each company advertised the world-class capabilities of their product, not its price. By contrast, a struggling company we visited in...business disruptions lurking within the Trojan Horse we have nestled in the US industrial base. It is important to note that a catastrophic disaster from

  1. Industry Study, Weapons Industry, Spring 2009

    Science.gov (United States)

    2009-01-01

    Agencies Sdn. Bhd.; Malaysia Aircraft Inspection, Repair, and Overhaul Depot; Malaysia American Malaysian Chamber of Commerce; Malaysia Samsung Techwin...Ministry of Defense: Defense Science and Technology Agency; Singapore Ministry of Defense: Industrial Affairs Office; Malaysia Boustead Shipping...Singapore, Malaysia , and Korea). Recommended policy changes included in the conclusion will strengthen these conditions, given that government goals and

  2. Industry Study, Electronics Industry, Spring 2009

    Science.gov (United States)

    2009-01-01

    not have the flexibility in their processes to quickly produce custom system-on-chips because they are optimized for high-end production. Dell ...building its semiconductor industry, Malaysia has moved in the same overall directions but has lagged a few years. Malaysia has succeeded in the backend

  3. Polish food industry 2008-2013

    OpenAIRE

    Mroczek, Robert; Drożdż, Jadwiga; Tereszczuk, Mirosława; Urban, Roman

    2014-01-01

    The aim of the study is to evaluate the functioning of the food industry and its various sectors in 2008-2013. Meat and poultry industry. Dairy industry. Fishing industry. Milling industry. Sugar industry. Oil-mill industry. Processing of fruit, vegetables and potatoes. Bakery industry. Confectionery industry. Feed industry. Production of other food products. Production of alcoholic beverages.Tobacco industry. Food industry.

  4. [Designer drugs in Jutland].

    Science.gov (United States)

    Simonsen, K W; Kaa, E

    2001-04-16

    The aim of this investigation was to examine illegal tablets and capsules seized in Jutland, the western part of Denmark, during the period 1995-1999. The drugs are described according to technical appearance (colour, logo, score, diameter) and content of synthetic drugs. All illegal tablets and capsules received during the period 1995-1999 (109 cases containing 192 different samples) were examined. MDMA was the most common drug and was seen during the entire period. Amphetamine was the second most common drug and has been frequently detected during the the last two years. Drugs like MDE, MBDB, BDB, and 2-CB were rarely seen and they disappeared quickly from the illegal market. MDA appeared on the market at the end of 1999. Only 53% of the tablets contained MDMA as the sole drug. Eighty-one percent of the tablets/capsules contained only one synthetic drug, whereas 13% contained a mixture of two or more synthetic drugs. Six per cent of the samples did not contain a euphoric drug/designer drug. The content of MDMA, MDE, and amphetamine in the tablets varied greatly. MDMA is apparently the drug preferred by the users, but still only half of the tablets contained MDMA as the only drug. The rest of the tablets contained either another synthetic drug or a mixture of drugs. In conclusion, the increasing supply of various drugs with different and unpredictable effects and of miscellaneous quality brings about the risk of serious and complicated intoxications.

  5. Drug interactions evaluation: An integrated part of risk assessment of therapeutics

    International Nuclear Information System (INIS)

    Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping; Huang, Shiew-Mei

    2010-01-01

    Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industry and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.

  6. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  7. Archaeal Enzymes and Applications in Industrial Biocatalysts.

    Science.gov (United States)

    Littlechild, Jennifer A

    2015-01-01

    Archaeal enzymes are playing an important role in industrial biotechnology. Many representatives of organisms living in "extreme" conditions, the so-called Extremophiles, belong to the archaeal kingdom of life. This paper will review studies carried by the Exeter group and others regarding archaeal enzymes that have important applications in commercial biocatalysis. Some of these biocatalysts are already being used in large scale industrial processes for the production of optically pure drug intermediates and amino acids and their analogues. Other enzymes have been characterised at laboratory scale regarding their substrate specificity and properties for potential industrial application. The increasing availability of DNA sequences from new archaeal species and metagenomes will provide a continuing resource to identify new enzymes of commercial interest using both bioinformatics and screening approaches.

  8. Drug and alcohol task force

    Energy Technology Data Exchange (ETDEWEB)

    Gordey, T [ConocoPhillips Canada Resources Corp., Calgary, AB (Canada); Sunstrum, M [Enform, Calgary, AB (Canada)

    2006-07-01

    Worker absenteeism due to substance abuse costs the Alberta economy approximately $720 million a year. It is estimated that 20 per cent of all drivers in fatal crashes were using alcohol, and the use of cannabis and cocaine in Alberta has more than doubled over the last 15 years. In addition, 1 in 10 Alberta workers have reported using alcohol while at work and 4 per cent have reported using alcohol 4 hours prior to coming to work during the previous 12 months. In an effort to ensure appropriate health and safety for workers in the Canadian petroleum industry, 6 trade associations in the sector have joined together as the Enform Alcohol and Drug Initiative and are now working to develop a common approach to drug and alcohol guidelines and workplace rules. The task group will determine if existing policies and guidelines are sufficient to ensure a safe workplace and will consider standardizing the testing, application and rehabilitation of workers with respect to the use of drugs and alcohol. In the past, disciplinary actions have often been reversed because employers have not been consistent or did not follow established alcohol and drug policies or test to specific standards. Various work rules for inappropriate alcohol and drug use were reviewed, as well as education and communication strategies regarding policy content. Standards for testing criteria were discussed, as well as issues concerning duty-to-accommodate circumstances. An excerpt of concentration standards was presented. It was concluded that a matrix for companies to assess and determine safety sensitive positions is needed. refs., tabs., figs.

  9. Drug and alcohol task force

    International Nuclear Information System (INIS)

    Gordey, T.; Sunstrum, M.

    2006-01-01

    Worker absenteeism due to substance abuse costs the Alberta economy approximately $720 million a year. It is estimated that 20 per cent of all drivers in fatal crashes were using alcohol, and the use of cannabis and cocaine in Alberta has more than doubled over the last 15 years. In addition, 1 in 10 Alberta workers have reported using alcohol while at work and 4 per cent have reported using alcohol 4 hours prior to coming to work during the previous 12 months. In an effort to ensure appropriate health and safety for workers in the Canadian petroleum industry, 6 trade associations in the sector have joined together as the Enform Alcohol and Drug Initiative and are now working to develop a common approach to drug and alcohol guidelines and workplace rules. The task group will determine if existing policies and guidelines are sufficient to ensure a safe workplace and will consider standardizing the testing, application and rehabilitation of workers with respect to the use of drugs and alcohol. In the past, disciplinary actions have often been reversed because employers have not been consistent or did not follow established alcohol and drug policies or test to specific standards. Various work rules for inappropriate alcohol and drug use were reviewed, as well as education and communication strategies regarding policy content. Standards for testing criteria were discussed, as well as issues concerning duty-to-accommodate circumstances. An excerpt of concentration standards was presented. It was concluded that a matrix for companies to assess and determine safety sensitive positions is needed. refs., tabs., figs

  10. Experiences in fragment-based drug discovery.

    Science.gov (United States)

    Murray, Christopher W; Verdonk, Marcel L; Rees, David C

    2012-05-01

    Fragment-based drug discovery (FBDD) has become established in both industry and academia as an alternative approach to high-throughput screening for the generation of chemical leads for drug targets. In FBDD, specialised detection methods are used to identify small chemical compounds (fragments) that bind to the drug target, and structural biology is usually employed to establish their binding mode and to facilitate their optimisation. In this article, we present three recent and successful case histories in FBDD. We then re-examine the key concepts and challenges of FBDD with particular emphasis on recent literature and our own experience from a substantial number of FBDD applications. Our opinion is that careful application of FBDD is living up to its promise of delivering high quality leads with good physical properties and that in future many drug molecules will be derived from fragment-based approaches. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. New Antimicrobial Approaches: Reuse of Old Drugs.

    Science.gov (United States)

    Savoia, Dianella

    2016-01-01

    The global situation of antibiotic resistance and the reduction of investments in antibiotics research by the pharmaceutical industry suggest the need for specific cost-effective approaches in order to identify drugs for the therapy of many microbial infections. Among the viable alternative anti-infective compounds, drug repurposing, i.e. to find new uses for previously approved medicines, revealed some encouraging in vitro and in vivo results. In this article the reader has a panoramic view of the updated references on the strategies encountered during the repositioning process. New findings are reported about the anti-microbial efficacy of antipsychotic, cardiovascular, anti-inflammatory and anti-neoplastic drugs. This approach may enhance the portfolio of pharmaceutical companies reducing the need for pharmacokinetic and toxicity studies; the development of new uses of old drugs for different infectious diseases, leading to better health for patients, also in poor, tropical countries, appears to be having better results.

  12. Updates on drug-target network; facilitating polypharmacology and data integration by growth of DrugBank database.

    Science.gov (United States)

    Barneh, Farnaz; Jafari, Mohieddin; Mirzaie, Mehdi

    2016-11-01

    Network pharmacology elucidates the relationship between drugs and targets. As the identified targets for each drug increases, the corresponding drug-target network (DTN) evolves from solely reflection of the pharmaceutical industry trend to a portrait of polypharmacology. The aim of this study was to evaluate the potentials of DrugBank database in advancing systems pharmacology. We constructed and analyzed DTN from drugs and targets associations in the DrugBank 4.0 database. Our results showed that in bipartite DTN, increased ratio of identified targets for drugs augmented density and connectivity of drugs and targets and decreased modular structure. To clear up the details in the network structure, the DTNs were projected into two networks namely, drug similarity network (DSN) and target similarity network (TSN). In DSN, various classes of Food and Drug Administration-approved drugs with distinct therapeutic categories were linked together based on shared targets. Projected TSN also showed complexity because of promiscuity of the drugs. By including investigational drugs that are currently being tested in clinical trials, the networks manifested more connectivity and pictured the upcoming pharmacological space in the future years. Diverse biological processes and protein-protein interactions were manipulated by new drugs, which can extend possible target combinations. We conclude that network-based organization of DrugBank 4.0 data not only reveals the potential for repurposing of existing drugs, also allows generating novel predictions about drugs off-targets, drug-drug interactions and their side effects. Our results also encourage further effort for high-throughput identification of targets to build networks that can be integrated into disease networks. © The Author 2015. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  13. Factors influencing GPs’ choice between drugs in a therapeutic drug group. A qualitative study

    DEFF Research Database (Denmark)

    Buusman, Allan; Andersen, Morten; Merrild, Camilla Hoffmann

    2007-01-01

    (GPs) were selected with reference to variation in organizational structure, age, and gender. Main outcome measures. GPs' description of drug choice in relation to specific patient encounters involving a prescription. Results. All informants appeared to consider drug price important...... as it was a recurring theme during all interviews. External factors outside the GP's control such as governmental regulation on prescribing and the pharmaceutical industry influenced most GPs. Internal factors related to the actual consultation included characteristics of the GP and the patient, drug characteristics......, and repeat prescriptions. These factors interact in a non-linear and unpredictable way similar to complex adaptive systems. Conclusion. GPs balance both internal and external factors when choosing between analogues. Drug choice is a regulated process in the realm of complex prescribing behaviour with drug...

  14. Numerate Intends to Join ATOM Consortium to Rapidly Accelerate Preclinical Drug Development | Frederick National Laboratory for Cancer Research

    Science.gov (United States)

    SAN FRANCISCO – Computational drug design company Numerate has signed a letter of intent to join an open consortium of scientists staffed from two U.S. national laboratories, industry, and academia working to transform drug discovery and developmen

  15. Medicaid Drug Rebate Program Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — Product Data for Drugs in the Medicaid Drug Rebate Program. The rebate drug product data file contains the active drugs that have been reported by participating drug...

  16. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Cigs Other Drugs Related Topics Addiction Science Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the Brain Genetics Global Health Health Consequences of Drug Misuse ...

  17. Food-drug interactions

    DEFF Research Database (Denmark)

    Schmidt, Lars E; Dalhoff, Kim

    2002-01-01

    Interactions between food and drugs may inadvertently reduce or increase the drug effect. The majority of clinically relevant food-drug interactions are caused by food-induced changes in the bioavailability of the drug. Since the bioavailability and clinical effect of most drugs are correlated......, the bioavailability is an important pharmacokinetic effect parameter. However, in order to evaluate the clinical relevance of a food-drug interaction, the impact of food intake on the clinical effect of the drug has to be quantified as well. As a result of quality review in healthcare systems, healthcare providers...... are increasingly required to develop methods for identifying and preventing adverse food-drug interactions. In this review of original literature, we have tried to provide both pharmacokinetic and clinical effect parameters of clinically relevant food-drug interactions. The most important interactions are those...

  18. Geothermal industry assessment

    Energy Technology Data Exchange (ETDEWEB)

    1980-07-01

    An assessment of the geothermal industry is presented, focusing on industry structure, corporate activities and strategies, and detailed analysis of the technological, economic, financial, and institutional issues important to government policy formulation. The study is based principally on confidential interviews with executives of 75 companies active in the field. (MHR)

  19. Aluminum Industry Technology Roadmap

    Energy Technology Data Exchange (ETDEWEB)

    none,

    2003-02-01

    This roadmap describes the industry's R&D strategy, priorities, milestones, and performance targets for achieving its long-term goals. It accounts for changes in the industry and the global marketplace since the first roadmap was published in 1997. An updated roadmap was published November 2001. (PDF 1.1 MB).

  20. Industry and Happiness

    DEFF Research Database (Denmark)

    Olsén, Peter; Nielsen, Birger Steen; Nielsen, Kurt Aagaard

    1996-01-01

    A wage earner utopia on a democratic innovation of society. A hermeneutic reconstruction from an action research project with a group of workers from the danish fishing industry.......A wage earner utopia on a democratic innovation of society. A hermeneutic reconstruction from an action research project with a group of workers from the danish fishing industry....

  1. Uranium industry annual 1998

    International Nuclear Information System (INIS)

    1999-01-01

    The Uranium Industry Annual 1998 (UIA 1998) provides current statistical data on the US uranium industry's activities relating to uranium raw materials and uranium marketing. It contains data for the period 1989 through 2008 as collected on the Form EIA-858, ''Uranium Industry Annual Survey.'' Data provides a comprehensive statistical characterization of the industry's activities for the survey year and also include some information about industry's plans and commitments for the near-term future. Data on uranium raw materials activities for 1989 through 1998, including exploration activities and expenditures, EIA-estimated reserves, mine production of uranium, production of uranium concentrate, and industry employment, are presented in Chapter 1. Data on uranium marketing activities for 1994 through 2008, including purchases of uranium and enrichment services, enrichment feed deliveries, uranium fuel assemblies, filled and unfilled market requirements, and uranium inventories, are shown in Chapter 2. The methodology used in the 1998 survey, including data edit and analysis, is described in Appendix A. The methodologies for estimation of resources and reserves are described in Appendix B. A list of respondents to the ''Uranium Industry Annual Survey'' is provided in Appendix C. The Form EIA-858 ''Uranium Industry Annual Survey'' is shown in Appendix D. For the readers convenience, metric versions of selected tables from Chapters 1 and 2 are presented in Appendix E along with the standard conversion factors used. A glossary of technical terms is at the end of the report. 24 figs., 56 tabs

  2. EU Industrial Policy

    DEFF Research Database (Denmark)

    Pellegrin, Julie; Giorgetti, Maria Letizia; Jensen, Camilla

    Following disregard in the 1980s, industrial policy has recently attracted policy attention at EU level. The objective of this study provided by Policy Department A at the request of the ITRE Committee, is to establish the state of the art of a coordinated and integrated EU industrial policy...

  3. Industrial applications and metallurgy

    International Nuclear Information System (INIS)

    Torres M, N.; Melendrez C, G.; Morales, F.L.

    1989-01-01

    From 1961 the use of nuclear energy in the industrial field in Colombia has a big advance. Today nuclear isotopes are used by private companies in this kind of application the Area of Industrial Applications and Metallurgy was the institution section that has trained and has transferred the technology needed for this purpose

  4. Manual on industrial radiography

    International Nuclear Information System (INIS)

    1981-08-01

    This manual is intended as a source of educational material to personnel seeking certification as industrial radiographers, and as a guide and reference text for educational organizations that are providng courses in industrial radiography. It covers the basic principles of x-ray and gamma radiation, radiation safety, films and film processing, welding, casting and forging, aircraft structures and components, radiographic techniques, and records

  5. Innovations in Hospitality Industry

    Science.gov (United States)

    Dzhandzhugazova, Elena A.; Blinova, Ekaterina A.; Orlova, Liubov N.; Romanova, Marianna M.

    2016-01-01

    The article focuses on the study of the role and importance of innovation, its classification, the problems of its application in the hotel industry with emphasis on the application of sensory marketing tools in the development of the innovative marketing mix within the hospitality industry. The article provides an analysis of the "seven…

  6. Uranium industry annual 1994

    International Nuclear Information System (INIS)

    1995-01-01

    The Uranium Industry Annual 1994 (UIA 1994) provides current statistical data on the US uranium industry's activities relating to uranium raw materials and uranium marketing during that survey year. The UIA 1994 is prepared for use by the Congress, Federal and State agencies, the uranium and nuclear electric utility industries, and the public. It contains data for the 10-year period 1985 through 1994 as collected on the Form EIA-858, ''Uranium Industry Annual Survey.'' Data collected on the ''Uranium Industry Annual Survey'' (UIAS) provide a comprehensive statistical characterization of the industry's activities for the survey year and also include some information about industry's plans and commitments for the near-term future. Where aggregate data are presented in the UIA 1994, care has been taken to protect the confidentiality of company-specific information while still conveying accurate and complete statistical data. A feature article, ''Comparison of Uranium Mill Tailings Reclamation in the United States and Canada,'' is included in the UIA 1994. Data on uranium raw materials activities including exploration activities and expenditures, EIA-estimated resources and reserves, mine production of uranium, production of uranium concentrate, and industry employment are presented in Chapter 1. Data on uranium marketing activities, including purchases of uranium and enrichment services, and uranium inventories, enrichment feed deliveries (actual and projected), and unfilled market requirements are shown in Chapter 2

  7. RESTRUCTURING OF INDUSTRIAL ENTERPRISE

    Directory of Open Access Journals (Sweden)

    L. I. Podderegina

    2009-01-01

    Full Text Available The paper presents main principles for execution of current and strategic restructuring of national enterprises while using experience of countries with developed market economy. The principles contribute to higher efficiency in internal industrial relations at national industrial enterprises.

  8. Australian uranium industry

    Energy Technology Data Exchange (ETDEWEB)

    Warner, R K

    1976-04-01

    Various aspects of the Australian uranium industry are discussed including the prospecting, exploration and mining of uranium ores, world supply and demand, the price of uranium and the nuclear fuel cycle. The market for uranium and the future development of the industry are described.

  9. Commercial Banking Industry Survey.

    Science.gov (United States)

    Bright Horizons Children's Centers, Cambridge, MA.

    Work and family programs are becoming increasingly important in the commercial banking industry. The objective of this survey was to collect information and prepare a commercial banking industry profile on work and family programs. Fifty-nine top American commercial banks from the Fortune 500 list were invited to participate. Twenty-two…

  10. Nuclear industry chart

    International Nuclear Information System (INIS)

    Anon.

    1975-01-01

    As part of a survey on Switzerland a pull-out organisation chart is presented of the nuclear industry showing Swiss government bodies and industrial concerns. Their interests, connections with each other and their associations with international and other national organizations and firms are indicated. (U.K.)

  11. The Danish Industrial Foundations

    DEFF Research Database (Denmark)

    Thomsen, Steen

    and governed, what role it plays in the Danish economy, and how industrial foundation-owned companies perform. The book is the result of a large collaborative research project, led by the author, on industrial foundations. Some global companies such as IKEA, Robert Bosch or the Tata Group are foundation...

  12. Insurance industry guide

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    This is an insurance industry guide for the independent power industry. The directory includes the insurance company's name, address, telephone and FAX numbers and a description of the company's area of expertise, products and services, and limitations. The directory is international in scope. Some of the companies specialize in independent power projects

  13. Sustainable Industrial Production

    DEFF Research Database (Denmark)

    Christensen, Irene

    2015-01-01

    The purpose of this case is to create awareness about a somewhat unfamiliar industry that accounts for over €3 billion in Scandinavia and £5,6 billion in the UK, the Metals recycling industry. The case features a Scandinavian Company and includes several perspectives from managerial disciplines...

  14. Sustainable Industrial Production

    DEFF Research Database (Denmark)

    Brattebö, Helge; Jørgensen, Michael Søgaard; Lorentzen, Børge

    The book discusses the concepts of waste minimization, cleaner technology and industrial ecology, including the experiences with employee participation in preventive environmental activities in companies.......The book discusses the concepts of waste minimization, cleaner technology and industrial ecology, including the experiences with employee participation in preventive environmental activities in companies....

  15. Wanted! Industrial Hygienists.

    Science.gov (United States)

    Stilkind, Jerry

    1979-01-01

    Due to increased pressure (for example, from the Occupational Safety and Health Act) to create healthier/safer worker environments, the number of industrial hygienist positions has increased. Compares the need to the demand. Examines industrial hygienist salary ranges, expected educational background, job opportunities, and training program…

  16. Greening of Danish Industry

    DEFF Research Database (Denmark)

    Remmen, Arne

    2002-01-01

    The article outlines the major changes in the discourse on cleaner technology and on pollution prevention, together with policy instuments applied in the Danish industry.......The article outlines the major changes in the discourse on cleaner technology and on pollution prevention, together with policy instuments applied in the Danish industry....

  17. Nuclear industry takes off

    International Nuclear Information System (INIS)

    Du Plessis, A.; Stevens, R.C.B.

    1982-01-01

    For more than a decade irradiation sterilisation of medical and pharmaceutical products proved a highly successful semi-commercial operation at Pelindaba, until it made way recently for the first full-scale radiation processing industry in SA - a classic case of science transferring technology to industry

  18. ATLAS rewards industry

    CERN Document Server

    Maximilien Brice

    2006-01-01

    For contributing vital pieces to the ATLAS puzzle, three industries were recognized on Friday 5 May during a supplier awards ceremony. After a welcome and overview of the ATLAS experiment by spokesperson Peter Jenni, CERN Secretary-General Maximilian Metzger stressed the importance of industry to CERN's scientific goals. Picture 30 : representatives of the three award-wining companies after the ceremony

  19. Reconsidering Japan's underperformance in pharmaceuticals: evidence from Japan's anticancer drug sector.

    Science.gov (United States)

    Umemura, Maki

    2010-01-01

    Unlike its automobile or electronics industries, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and has introduced few global blockbuster drugs. Alfred Chandler argued that Japan's pharmaceutical firms remained relatively weak because Western firms enjoyed an insurmountable first first-mover advantage. However, this case study of the anticancer drug sector illustrates that Chandler's explanation is incomplete. Japanese medical culture, government policy, and research environment also played a substantial role in shaping the industry. In the 1970s and 1980s, these factors encouraged firms to develop little few effective drugs with low side effects, and profit from Japan's domestic market. But, these drugs were unsuitable to foreign markets with more demanding efficacy standards. As a result, Japan not only lost more than a decade in developing ineffective drugs, but also neglected to create the infrastructure necessary to develop innovative drugs and build a stronger pharmaceutical industry.

  20. Uranium industry annual 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-04-01

    The Uranium Industry Annual 1996 (UIA 1996) provides current statistical data on the US uranium industry`s activities relating to uranium raw materials and uranium marketing. The UIA 1996 is prepared for use by the Congress, Federal and State agencies, the uranium and nuclear electric utility industries, and the public. Data on uranium raw materials activities for 1987 through 1996 including exploration activities and expenditures, EIA-estimated reserves, mine production of uranium, production of uranium concentrate, and industry employment are presented in Chapter 1. Data on uranium marketing activities for 1994 through 2006, including purchases of uranium and enrichment services, enrichment feed deliveries, uranium fuel assemblies, filled and unfilled market requirements, uranium imports and exports, and uranium inventories are shown in Chapter 2. A feature article, The Role of Thorium in Nuclear Energy, is included. 24 figs., 56 tabs.