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Article

Embryo‐fetal 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 International Conference on Harmonization (ICH) S5(R2) document (available at http://www.ich.org). The studies that assess developmental hazard are generally conducted in rodents and rabbits. Based on the authors' collective experience, adequate designs (including range-finding studies) and the...

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PMID: 20025038
DOI: 10.1002/bdrb.20214

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