Document Detail


International Conference on Harmonisation: guidance on testing for carcinogenicity of pharmaceuticals. Notice. Food and Drug Administration, HHS.
MedLine Citation:
PMID:  12269370     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is publishing a guidance entitled "S1B Testing for Carcinogenicity of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance outlines experimental approaches to evaluating the carcinogenic potential of pharmaceuticals to humans that may obviate the necessity for the routine conduct of two long-term rodent carcinogenicity studies
Authors:
-
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  63     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  1998 Feb 
Date Detail:
Created Date:  2002-09-23     Completed Date:  2002-10-11     Revised Date:  2009-11-03    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  8983-6     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Animals
Carcinogenicity Tests / standards*
Congresses as Topic
Drug Approval
Drug Evaluation, Preclinical / standards*
Drug Toxicity*
European Union
Guidelines as Topic*
Humans
International Cooperation*
Japan
Mice
Rats
United States
United States Food and Drug Administration*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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