The enhanced pre- and postnatal study for nonhuman primates: Update and perspectives

The enhanced pre‐ and postnatal (ePPND) study design has been developed in response to new scientific knowledge and subsequent guideline changes, that is, ICH M3(R2) and ICH S6(R1). The design changes were basically driven by the experiences obtained during preclinical development of biopharmaceutic...

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Published in:Birth defects research. Part C. Embryo today 2011-12, Vol.93 (4), p.324-333
Main Authors: Weinbauer, Gerhard F., Fuchs, Antje, Niehaus, Michael, Luetjens, Craig M.
Format: Article
Language:English
Subjects:
Animal Use Alternatives
Animals
Animals, Newborn
Antibodies, Monoclonal - toxicity
cynomolgus monkeys
Disease Models, Animal
enhanced pre-and postnatal study
Guidelines as Topic
Humans
Infant
Infant, Newborn
Macaca fascicularis
nonhuman primates
Primates
Research Design - trends
Toxicity Tests
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Summary:The enhanced pre‐ and postnatal (ePPND) study design has been developed in response to new scientific knowledge and subsequent guideline changes, that is, ICH M3(R2) and ICH S6(R1). The design changes were basically driven by the experiences obtained during preclinical development of biopharmaceuticals. The ePPND concept typically does not apply to pharmaceuticals. In essence, the ePPND design is a PPND study in which key elements of an embryofetal development (EFD) study are being investigated in newborns and infants rather than in the fetus. The current relevant nonhuman primate model is the cynomolgus monkey. The ICH S6(R1) has reached step 4 during June 2011 and provides detailed recommendations on various parameters and the conduct of an ePPND study. By the time this article is written, it appears that for monoclonal antibodies, the ePPND study is the preferred approach although ICH S6(R1) also leaves options for modified EFD and PPND study concepts. Our data also demonstrate that social housing is feasible for developmental toxicity studies in the cynomolgus monkey model. Birth Defects Research (Part C) 93:324–333, 2011. © 2012 Wiley Periodicals, Inc.
ISSN:1542-975X
1542-9768
DOI:10.1002/bdrc.20220