Pre-clinical evaluation of contraceptive steroids: regulatory requirements and scientific expectations*
- 1 September 1986
- journal article
- research article
- Published by Oxford University Press (OUP) in Human Reproduction
- Vol. 1 (6) , 401-404
- https://doi.org/10.1093/oxfordjournals.humrep.a136435
Abstract
The development of new contraceptive steroids placed great pressures on regulatory agencies. There was insufficient time to develop a novel pre-clinical safety evaluation, hence their toxicity in animals was assessed as with other drugs. The approach of regulatory agencies to toxicity and carcinogenicity testing of these steroids are discussed and evaluated.This publication has 0 references indexed in Scilit: