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Article

Pre‐ and postnatal developmental toxicity study design for pharmaceuticals

1 Dec 2009

Abstract excerpt

Assessment of potential developmental and reproductive toxicity of human pharmaceuticals is currently guided by the ICH S5(R2) document. The studies that assess the hazard of both pre- and postnatal exposure are predominantly conducted in rodents (rat and mouse). Utilizing the collective experience of the authors, acceptable designs for both the range-finding and definitive studies are presented with detailed...

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PMID: 20025040
DOI: 10.1002/bdrb.20217

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