LITMIR.BIZ

      1 The emergence of legislative regulatory controls over pharmaceutical drug development and clinical trials was often prompted by:Protests from university medical students ______________Tragic outcomes from administration of unsafe and/or ineffective drug products_____________Promises made to voters by candidates for political office:______

      2 Failure of medical researchers to apply ethical principles has never been a problem that needed solving? True ____ False ______

      3 The Belmont Report was authorized by the National Research Act of 1974. True ____ False _______

      4 The ICH Efficacy Guideline – GCP – is considered the industry standard for the conduct of human biomedical clinical trials with drug products. It was developed because:Of continuing abuses against study subjects by drug researchers _________The United States, Japan, and the European Union wanted manufacturers in their countries to have a monopoly on drug marketing _____________Manufactures and regulatory authorities wanted to establish harmonized standards to facilitate the mutual acceptance of clinical data supporting drug approval________

      5 The ICH headquarters are located in the United States and the organization is under the US FDA. True __________ False ________

      1 1 NIH1908. A short History of the National Institutes of Health, p. 3 http://history.nih.gov/exhibits/history/docs/page_03.html (accessed 11 November 2019)

      2 2 Janssen, W.F. (1981). Story of the laws lehind the labels, Part 1. The 1906 Food and Drugs Act. https://wayback.archive‐it.org/7993/20170111191530/http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm (accessed 27 November 2019)

      3 3 FDA (2012). History of drug regulation in the United States, 1906–2006, p6, wayback.archive‐it.org/7993/20170114041745/http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/UCM114468.pdf (accessed 27 November 2019)

      4 4 United States Holocaust Memorial Museum. United States Holocaust Memorial Museum Note https://www.ushmm.org/information/exhibitions/online‐exhibitions/special‐focus/doctors‐trial/nuremberg‐code (assessed 27 November 2019)

      5 5 FDA (2012). Consumer updates, Kefauver‐Harris Amendments Revolutionized Drug Development http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm322856.htm (accessed 27 November 2019)

      6 6 World Medical Association (2018). WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. https://www.wma.net/policies‐post/wma‐declaration‐of‐helsinki‐ethical‐principles‐for‐medical‐research‐involving‐human‐subjects/ (accessed 27 November 2019)

      7 7 Grady, C. Institutional review boards, purpose and challenges, commentary, chest, November 2015 (1148–1155) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631034/pdf/chest_148_5_1148.pdf (accessed 28 May 2020)

      8 8 Centers for Disease Control and Prevention. U.S. Public Health Service Syphilis Study at Tuskegee. http://www.cdc.gov/tuskegee/timeline.htm (accessed 27 November 2019)

      9 9 NIH (1908). National Research Act – Office of NIH History. https://history.nih.gov/research/downloads/PL93‐348.pdf (accessed 27 November 2019)

      10 10 US Government Accountability Office. Federal control of new drug testing is not adequately protecting human test subjects and the public HRD‐76–96: published: Jul 15, 1976. publicly released: July 15, 1976. http://www.gao.gov/products/HRD‐76‐96. (accessed 27 November 2019)

      11 11 US Department of Health and Human Services. Office of human research protections, the belmont report. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html (accessed 27 November 2019)

      12 12 ICH. The international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH), http://www.ich.org/ (accessed 27 November 2019)

      13 13 ICH E6 (R2). ICH E6 (R2) (2016) INTEGRATED ADDENDUM TO ICH E6(R1):GUIDELINE FOR GOOD CLINICAL PRACTICE: International Council on Harmonization https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf (accessed 27 November 2019)

      14 14 European Commission European commission directive 2001/20/EC, clinical trials. https://ec.europa.eu/health/human‐use/clinical‐trials/directive_en (accessed 27 November 2019)

      15 15 ANSI WEBSTORE. Clinical Investigation of Medical Devices for Human Subjects ‐ Good Clinical Practice. International Standards Organization http://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2014155:2011&source=google&adgroup=iso11&gclid=CO6fhuXkx70CFU5rfgodQGwA9Q (accessed 27 November 27, 2019).ISO 14155:2011

      16 16 GPO. Federal register, 32467, Vol. 69, No. 112, Thursday, June 10, 2004 human subject protection; foreign clinical studies not conducted under an investigational new drug application – proposed rule http://www.gpo.gov/fdsys/pkg/FR‐2004‐06‐10/pdf/04‐13063.pdf (accessed 27 November 2019)

      17 17 Authenticated U.S. Government Information. Federal register/Vol. 73, No. 82/Monday, April 28, 2008/Rules and regulations, human subject protection; foreign clinical studies not conducted under an investigational new drug application, final rule https://www.govinfo.gov/content/pkg/FR‐2008‐04‐28/pdf/E8‐9200.pdf (accessed 27

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