The industry view on long-term toxicology testing in drug development of human pharmaceuticals

Citation
H. Van Cauteren et al., The industry view on long-term toxicology testing in drug development of human pharmaceuticals, PHARM TOX, 86, 2000, pp. 1-5
Citations number
26
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology & Toxicology
Journal title
PHARMACOLOGY & TOXICOLOGY
ISSN journal
0901-9928 → ACNP
Volume
86
Year of publication
2000
Supplement
1
Pages
1 - 5
Database
ISI
SICI code
0901-9928(2000)86:<1:TIVOLT>2.0.ZU;2-#
Abstract
The approach to chronic toxicity testing over the past decade is reviewed a nd assessed in the light of developing ICH guidelines. The 1990's have seen a general acceptance that studies with a maximal duration of 6 months in r odents are all that is required for adequate safety assessment of developme ntal pharmaceutical agents. However, controversy has arisen concerning the most appropriate duration for chronic toxicity testing in non-rodents. Init ial suggestions that 6 months duration was sufficient have been countered b y findings noted in 12-month studies that were not seen in shorter-term stu dies. Retrospective analysis of available data eventually lead to a subsequ ent ICH recommendation that studies of 9 months duration would be now accep table. However, until recently the FDA position on this recommendation was unclear and an analysis of industry practices since the ICH recommendation was made in 1997 has shown that the 9-month guideline is not widely applied . Recent clarification by the FDA will probably result in a continued but l imited use of this alternative. An industry view on the future of chronic t oxicology testing in rodents and non-rodents is presented.