Document Detail


The developmental toxicity testing of biologics.
MedLine Citation:
PMID:  23138893     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
The characteristics of biologic drugs, as compared with small molecules, confer significant advantages for both the drug developer and the prospective patients. The necessity for, and the timing of, developmental toxicity testing in the preclinical program must be considered. Choice of an appropriate test system is of particular importance, one that shows pharmacodynamic activity comparable to man. Where the conventional rodent/non-rodent species show such functional cross-reactivity, those species can be used in developmental testing, but often the only relevant species will be a nonhuman primate, in which case an extended study design (the ePPND) should be the default. Such an approach provides appropriate toxicity screening while reducing animal usage.
Authors:
Keith P Hazelden
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Methods in molecular biology (Clifton, N.J.)     Volume:  947     ISSN:  1940-6029     ISO Abbreviation:  Methods Mol. Biol.     Publication Date:  2013  
Date Detail:
Created Date:  2012-11-09     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9214969     Medline TA:  Methods Mol Biol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  31-6     Citation Subset:  IM    
Affiliation:
Boehringer-Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, kphazelden@mac.com.
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