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Nonclinical Safety Assessment of Developmental and Reproductive Toxicology: Considerations for Conducting Fertility, Embryo–Fetal Development, and Prenatal and Postnatal Developmental Toxicology Studies

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Developmental and Reproductive Toxicology

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

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Abstract

This chapter reviews the current regulatory considerations for reproductive and developmental toxicology testing specifically relating to pharmaceuticals and biopharmaceuticals. A brief history of the regulatory perspective of drugs which provides background to the current study designs presented in the chapter is discussed. 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. 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. With the increase in biopharmaceutical development, the chapter also includes consideration for evaluating Reproductive and Developmental Toxicity in nontraditional animal models. Alternative methods for in vitro evaluations of reproductive and developmental toxicology are also reviewed in this chapter.

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Authors and Affiliations

  1. Teva Branded Pharmaceutical Products Research and Development, Inc., West Chester, PA, USA

    Kevin H. Denny

  2. MPI Research, Mattawan, MI, USA

    Ali S. Faqi

Authors
  1. Kevin H. Denny
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  2. Ali S. Faqi
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Correspondence to Kevin H. Denny .

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Editors and Affiliations

  1. MPI Research, Mattawan, Michigan, USA

    Ali S. Faqi

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© 2015 Springer Science+Business Media New York

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Denny, K.H., Faqi, A.S. (2015). Nonclinical Safety Assessment of Developmental and Reproductive Toxicology: Considerations for Conducting Fertility, Embryo–Fetal Development, and Prenatal and Postnatal Developmental Toxicology Studies. In: Faqi, A. (eds) Developmental and Reproductive Toxicology. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/7653_2015_53

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  • DOI: https://doi.org/10.1007/7653_2015_53

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-7206-7

  • Online ISBN: 978-1-4939-7208-1

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