Document Detail

Safety pharmacology in the nonclinical assessment of new medicinal products: definition, place, interest and difficulties.
MedLine Citation:
PMID:  12031059     Owner:  NLM     Status:  MEDLINE    
Until the year 2000 there was no internationally-accepted definition for the terms used in nonclinical pharmacology (primary, secondary pharmacodynamics, discovery, safety pharmacology, etc). Now, after ICH5 (San Diego, November 2000), a harmonisation of the nomenclature is adopted: safety pharmacology is defined as the studies that investigate the potential undesirable pharmacodynamic effects of a medicinal product on physiological functions in relationship to exposure. Consequently, safety pharmacology studies are a part of the safety assessment for a new product, in the same way than toxicological studies, and a basic battery of tests (core battery) has to be conducted prior to the first administration to humans. Safety pharmacology studies are of peculiar interest: they show a good predictive potential for humans, they do not require a large number of laboratory animals, long-term studies, large amount of products and they are more dynamic and more flexible than toxicological studies. Nevertheless, many difficulties occur for the implementation in industry, related to practical and/or scientific problems: location of the studies, routine activity for the pharmacologists, sometimes difficulties in the relationship between toxicologists and pharmacologists, adaptation to the GLP requirements, elaboration of an early relevant scientific programme, necessity to go to contract-labs or to academic research for unusual or for up to date methods, etc. To conclude, a retrospective timetable of the regulatory evolution for the last 10 years will be provided, as an illustration of the worldwide progress in the concept of 'harmonisation' for the assessment of new medicinal products.
Jean-Roger Claude
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Fundamental & clinical pharmacology     Volume:  16     ISSN:  0767-3981     ISO Abbreviation:  Fundam Clin Pharmacol     Publication Date:  2002 Apr 
Date Detail:
Created Date:  2002-05-28     Completed Date:  2002-12-12     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8710411     Medline TA:  Fundam Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  75-8     Citation Subset:  IM    
Faculty of Pharmacy, Department of Toxicology, 4 avenue de l'Observatoire, 75 006 Paris -France.
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MeSH Terms
Drug Evaluation, Preclinical* / methods
Drug Toxicity*
Drugs, Investigational / adverse effects
Laboratories / standards
Pharmacology, Clinical / methods*
Risk Assessment
Terminology as Topic*
Toxicity Tests / methods
Reg. No./Substance:
0/Drugs, Investigational

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