Bioavailability and bioequivalence requirements in the European community.
An comparative overview is given of the new EC-Note for Guidance on bioavailability and bioequivalence, which now has been sent out for consultation to interested parties. The new version gives more regulatory detail than the version of 1984. It is expected that it will come into force in the course of 1991. Some changes in the final version as compared to the present version, accepted by the CPMP, are possible. The EC-Note for Guidance on modified-release products, which came into force in July 1990, has also been discussed. In comparison with comparable guidance in other areas off the world this guidance gives much thought to the clinical aspects and especially the clinical justification of modified-release products.
Rauws
A G
AG
National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands.
D001682:Biological Availability; D005062:European Union; D007880:Legislation, Drug / Q000639:trends*; D013810:Therapeutic Equivalency