Document Detail

An international appraisal of the minimum duration of chronic animal toxicity studies.
MedLine Citation:
PMID:  1352109     Owner:  NLM     Status:  MEDLINE    
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.
C E Lumley; C Parkinson; S R Walker
Related Documents :
18024669 - Are there circumstances in which phase 2 study results should be practice-changing?
12628259 - Laparoscopic colposuspension: a systematic review.
19628879 - Short versus long duration of antibiotic therapy for bacterial meningitis: a meta-analy...
18708279 - Auspen clinical practice guideline for home parenteral nutrition patients in australia ...
11294919 - Phase iii randomized trial of gabapentin in patients with amyotrophic lateral sclerosis.
12559639 - Monitoring mortality at interim analyses while testing a composite endpoint at the fina...
20616549 - Long-term follow-up of the first patients to undergo transcatheter alcohol septal ablat...
16594289 - Mental adjustment after surgery for non-small cell lung cancer.
1558339 - A comparison of a new two-layer anatomic repair to the traditional shouldice herniorrha...
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    
Centre for Medicines Research, Carshalton, Surrey, UK.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Databases, Factual
Drug Evaluation, Preclinical / methods*
Drug Toxicity*
International Cooperation*
Research Design
Time Factors

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

Previous Document:  The INVITTOX Data Bank of in-vitro techniques in toxicology.
Next Document:  Differences in the radiotoxicity of two plutonium isotopes in cells in vitro: can they be ascribed t...