Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis

Author:

Barrow Paul

Publisher

Elsevier BV

Subject

Toxicology

Reference40 articles.

1. ICH Harmonised tripartite guideline: detection of toxicity to reproduction for medicinal products & toxicity to male fertility S5(R2). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5/Step4/S5_R2__Guideline.pdf (accessed 02.17.16).

2. FDA, Guidelines for reproduction studies for safety evaluation of drugs for human use. 1966.

3. Detection of effects on male reproduction—a literature survey;Ulbrich;Int. J. Toxicol.,1995

4. A collaborative study in Japan on optimal treatment period and parameters for detection of male fertility disorders induced by drugs in rats;Takayama;Int. J. Toxicol.,1995

5. Collaborative work to evaluate toxicity on male reproductive organs by repeated dose studies in rats: overview of the studies;Sakai;J. Toxicol. Sci.,2000

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