Review of embryo-fetal developmental toxicity studies performed for recent FDA-approved pharmaceuticals

Author:

Ishihara-Hattori Kana,Barrow Paul

Funder

Roche, Switzerland

Chugai Pharmaceutical Co., Ltd.

Publisher

Elsevier BV

Subject

Toxicology

Reference27 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 04.01.16).

2. ICH Final Concept Paper S5(R3) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5/S5_R3__Final_Concept_Paper_27Mar2015.pdf (accessed 01.07.16).

3. Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use;FDA,1966

4. ICH Harmonised tripartite guideline preclinical safety evaluation of biotechnology-derived pharmaceuticals. S6(R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S6_R1/Step4/S6_R1_Guideline.pdf (accessed 02.17.16).

5. ICH Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals. http://www.fda.gov/downloads/Drugs/…/Guidances/ucm085389.pdf (accessed 02.17.16).

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