![]() ![]() LASA, Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals.Birth Defects Res B Dev Reprod Toxicol 86(6):429–436 Lerman SA, Hew KW, Stewart J, Stump DG, Wise LD (2009) The nonclinical fertility study design for pharmaceuticals.Detection of toxicity to reproduction for medicinal products and toxicity to male fertility, S5(R2), 24 June 1993 Environmental methylmercury: health criteria 101. World Health Organization International (1990) Program on chemical safety.Hong Y-S, Kim Y-M, Lee K-E (2012) Methyl mercury exposure and health effects.Faqi AS (2012) A critical evaluation of developmental and reproductive toxicology in nonhuman primates.Section 4.1.3, Study for effects on embryo-fetal development. International Conference on Harmonisation (ICH) Guideline for detection of toxicity to reproduction for medicinal products Availability Notice. Food and Drug Administration (FDA) (1994).Organization for Economic Cooperation and Development (OECD) (1981) Guideline for testing of chemicals: teratogenicity.Department of Health and Social Security, London United Kingdom, Committee on Safety of Medicines (1974) Notes for guidance on reproduction studies.Canada Ministry of Health and Welfare, Health Protection Branch (1973) The testing of chemicals for carcinogenicity, mutagenicity and teratogenicity.Studies of the Effects of Drugs on Reproduction. Pharmaceutical Affairs Bureau, Ministry of Health and Welfare (1984) Japanese guidelines of toxicity studies, notification no.Guidance for industry considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.Tyl RW (December 4, 2006) Toxicology 707: advanced toxicology regulatory aspects of developmental and reproductive toxicology.In: Hood RD (ed) Handbook of developmental toxicology. Developmental toxicity testing-methodology. Drug Review Branch, Division of Toxicological Evaluation, Bureau of Science, Food and Drug Administration, Washington, DC Goldenthal EJ (1966) Guidelines for reproduction studies for safety evaluation of drugs for human use.50 Years: The Kefauver-Harris Amendments.Kelsey, presented at the Medicine and Health Since World War II, National Library of Medicine, Bethesda, MD, Dec. From a speech “Denial of Approval for Thalidomide in the United States”, by Frances O.Herbert Burkholz (September-October 1997).McFadyen RE (1976) Thalidomide in America: a brush with tragedy. Madison Area Technical College, Madison, WI. Seidman LA, Warren N (June, 2001) Pharmaceutical regulation in the United States: history and a case study.Reversal of fortune: how a vilified drug became a life-saving agent in the “War” against cancer - Onco’Zine - The International Cancer Network (November 30, 2013).Answers begin to emerge on how thalidomide caused defects. Lenz W (1988) A short history of thalidomide embryopathy.Alternative methods for in vitro evaluations of reproductive and developmental toxicology are also reviewed in this chapter. With the increase in biopharmaceutical development, the chapter also includes consideration for evaluating Reproductive and Developmental Toxicity in nontraditional animal models. The chapter incorporates reviews of the basic requirements for Conducting Fertility, Embryo–Fetal Development, and Prenatal and Postnatal Developmental Toxicology Studies as core components of pharmaceutical drug development programs. The initial FDA guidelines and the subsequent International Conference on Harmonisation (ICH) S5(R2) currently used for the assessment of potential developmental and reproductive toxicity for safety evaluations of medicinal products are in some measure a testament of the endeavor of government authorities to prevent future tragedies, such as that of Thalidomide. A brief history of the regulatory perspective of drugs which provides background to the current study designs presented in the chapter is discussed. ![]() This chapter reviews the current regulatory considerations for reproductive and developmental toxicology testing specifically relating to pharmaceuticals and biopharmaceuticals.
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