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2. ICH S5 (R2): guidance on reproductive toxicology and male fertility: detection of toxicity to reproduction for medicinal products,2005
3. ICH M3 (R2): guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization of pharmaceuticals,2009
4. Developmental toxicity testing of monoclonal antibodies: an enhanced pre- and postnatal study design option;Stewart;Reprod Toxicol,2009
5. The enhanced pre- and postnatal study for nonhuman primates: update and perspectives;Weinbauer;Birth Defects Res (Part C),2011