The relevance of experimental reproductive studies in safety assessment

Author:

Stewart Jane

Publisher

Elsevier BV

Subject

Toxicology

Reference89 articles.

1. ICH (International Conference on Harmonisation) Harmonized Tripartite Guideline S5(R2): detection of toxicity to reproduction for medicinal products & toxicity to male fertility. 2005. Available at: http://www.ich.org [Accessed 26 November 2016]

2. The nonclinical fertility study design for pharmaceuticals;Lerman;Birth Defects Res Part B,2009

3. ICH (International Conference on Harmonisation) Final Concept Paper S5(R3): Detection of toxicity to reproduction for medicinal products & toxicity to male fertility dated 9 February 2015 endorsed by the ICH Steering Committee on 27 March 2015 Available at: http://www.ich.org. [Accessed 26 November 2016].

4. OECD guideline for the testing of chemicals number 443 extended one-generation reproductive toxicity study, adopted 2011, available at: http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264185371-en [Accessed 26 November 2016].

5. Detection of effects on male reproduction. A literature survey;Ulbrich;J Am Coll Toxicol,1995

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