The enhanced pre- and postnatal study for nonhuman primates: update and perspectives.
作者： Gerhard F. Weinbauer , Antje Fuchs , Michael Niehaus , Craig M. Luetjens
DOI: 10.1002/BDRC.20220
关键词:
摘要: The enhanced pre- and postnatal (ePPND) study design has been developed in response to new scientific knowledge subsequent guideline changes, that is, ICH M3(R2) S6(R1). changes were basically driven by the experiences obtained during preclinical development of biopharmaceuticals. ePPND concept typically does not apply pharmaceuticals. In essence, is a PPND which key elements an embryofetal (EFD) are being investigated newborns infants rather than fetus. current relevant nonhuman primate model cynomolgus monkey. S6(R1) reached step 4 June 2011 provides detailed recommendations on various parameters conduct study. By time this article written, it appears for monoclonal antibodies, preferred approach although also leaves options modified EFD concepts. Our data demonstrate social housing feasible developmental toxicity studies monkey model.
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