| The enhanced pre- and postnatal development study for monoclonal antibodies. | |
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MedLine Citation:
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PMID: 23138905 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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The enhanced pre- and postnatal (ePPND) study design has been developed in response to new scientific knowledge and subsequent guideline changes [ICH M3(R2) and ICH S6(R1)]. The changes in study design were basically driven by the experiences obtained during preclinical development of biopharmaceuticals. The standard ePPND concept does not apply to conventional small molecule pharmaceuticals. In essence, the ePPND design is a pre- and postnatal development (PPND) study in which key elements of an embryo-fetal development study are investigated in newborns and infants rather than in the fetus. The cynomolgus monkey is the current relevant nonhuman primate model. The ICH S6(R1) guideline reached step 5 in June 2011 and provides detailed recommendations on various parameters and the conduct of an ePPND study. This chapter provides working guidance for monitoring menstrual cycles to generate pregnant animals, ultrasound monitoring of pregnancy, morphometric measurements of fetuses and newborns, in vivo skeletal examination, various protocols for evaluation of infants (e.g., neurobehavioral assessment, learning and memory test, grip strength, immune system evaluation) and a comprehensive list of additional infant evaluation parameters for the cynomolgus monkey. |
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Authors:
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Gerhard F Weinbauer; Joerg Luft; Antje Fuchs |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Methods in molecular biology (Clifton, N.J.) Volume: 947 ISSN: 1940-6029 ISO Abbreviation: Methods Mol. Biol. Publication Date: 2013 |
Date Detail:
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Created Date: 2012-11-09 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9214969 Medline TA: Methods Mol Biol Country: United States |
Other Details:
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Languages: eng Pagination: 185-200 Citation Subset: IM |
Affiliation:
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Covance Laboratories GmbH, Muenster, Germany, Gerhard.Weinbauer@covance.com. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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