Document Detail


An international appraisal of the minimum duration of chronic animal toxicity studies.
MedLine Citation:
PMID:  1352109     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
1. There are international differences in regulatory guidelines for the appropriate duration of chronic, two species repeat-dose animal tests for new medicines intended for long-term use in man, ranging from 6 months in Europe to 12 months in Japan and the USA. 2. An adequate data base is necessary to support any challenge to the scientific rationale behind regulatory guidelines with regard to the design, duration and relevance of toxicity tests of new medicines. 3. The Centre for Medicines Research has established an international toxicology data base which has been expanded to enable a comparison of data obtained within 6 months, with information from longer periods, for 154 studies. 4. Although new findings were revealed after 6 months for 9/75 cases for which pathology data are available at 6 and 12 months or longer, and 21/80 with data at 1 or 3 (but not 6 months) and 12 months or longer, in no instance did these influence the decision to drop or further develop the compounds in question. 5. These data suggest that a 6-month period of dosing is all that is routinely required for evaluating the chronic toxic (excluding carcinogenic) potential of a new chemical entity intended for therapeutic use.
Authors:
C E Lumley; C Parkinson; S R Walker
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Publication Detail:
Type:  Comparative Study; Guideline; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Human & experimental toxicology     Volume:  11     ISSN:  0960-3271     ISO Abbreviation:  Hum Exp Toxicol     Publication Date:  1992 May 
Date Detail:
Created Date:  1992-08-04     Completed Date:  1992-08-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9004560     Medline TA:  Hum Exp Toxicol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  155-62     Citation Subset:  IM    
Affiliation:
Centre for Medicines Research, Carshalton, Surrey, UK.
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MeSH Terms
Descriptor/Qualifier:
Animals
Databases, Factual
Dogs
Drug Evaluation, Preclinical / methods*
Drug Toxicity*
Female
Humans
International Cooperation*
Male
Mice
Primates
Rats
Research Design
Time Factors

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


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