Document Detail

Animal toxicology studies on new medicines and their relationship to clinical exposure: a review of international recommendations.
MedLine Citation:
PMID:  1747442     Owner:  NLM     Status:  MEDLINE    
Written guidance on the toxicology studies which should be completed to support an application to market a new medicinal product in the EEC, Japan, and the USA is readily available, although the recommendations can vary significantly between the three markets. Less clear are the regulatory authorities' expectations concerning the timing of these studies relative to the clinical development programme. All available guidelines for premarketing toxicology requirements, and the portions thereof needed to support various stages of the clinical trials programme will be reviewed. Significant differences among the three markets and between written guidance and customary practice will be highlighted. The practical implications for the clinical development programme will be identified.
M D Scales; K Mahoney
Publication Detail:
Type:  Guideline; Journal Article; Review    
Journal Detail:
Title:  Adverse drug reactions and toxicological reviews     Volume:  10     ISSN:  0964-198X     ISO Abbreviation:  Adverse Drug React Toxicol Rev     Publication Date:  1991  
Date Detail:
Created Date:  1992-01-23     Completed Date:  1992-01-23     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  9109474     Medline TA:  Adverse Drug React Toxicol Rev     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  155-68     Citation Subset:  IM    
Glaxo Group Research Limited, Ware, Hertfordshire, UK.
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MeSH Terms
Drug Toxicity*
European Union
Legislation, Drug*
Research Design / standards*
Toxicology / standards*
United States

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