| Safety pharmacology in the nonclinical assessment of new medicinal products: definition, place, interest and difficulties. | |
| | |
MedLine Citation:
|
PMID: 12031059 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
Jean-Roger Claude |
Related Documents
:
|
18258099 - Emerging angiostrongyliasis in mainland china. 19833039 - Application of quantitative microbial risk assessments for estimation of risk managemen... 19719129 - Food chemistry and u.s. food regulations. 15787769 - Trust in risk regulation: cause or consequence of the acceptability of gm food? 18159469 - Food safety and foodborne disease in 21st century homes. 17386689 - Why consumers behave as they do with respect to food safety and risk information. 6306619 - Relationship between plasma concentrations of immunoreactive beta-endorphin and food in... 21613299 - Spatial heterogeneity in the effects of climate and density-dependence on dispersal in ... 17395459 - Batch and fed batch production of pectin lyase and pectate lyase by novel strain debary... |
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 |
Affiliation:
|
Faculty of Pharmacy, Department of Toxicology, 4 avenue de l'Observatoire, 75 006 Paris -France. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Drug Evaluation, Preclinical*
/
methods Drug Toxicity* Drugs, Investigational / adverse effects Laboratories / standards Pharmacology, Clinical / methods* Risk Assessment Terminology as Topic* Toxicity Tests / methods |
| Chemical | |
Reg. No./Substance:
|
0/Drugs, Investigational |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Harnessing expertise: involving peer interviewers in qualitative research with hard-to-reach populat...
Next Document: Quality management of pharmacology and safety pharmacology studies.