Current challenges in bioequivalence, quality, and novel assessment technologies for topical products.

摘要: This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry regulatory agencies to discuss current issues practices for establishing therapeutic bioequivalence (BE) dermatologic topical products. The methods currently available assessment BE were reviewed as well alternatives advantages disadvantages each method considered. Guidance on quality performance products was framework categorise existing alternative evaluation discussed. outcome emphasized both need greater attention quality, possibly, via Quality-By-Design (QBD) approach develop "whole toolkit" towards problem determination rate extent in bioavailability. discussion clinical equivalence revealed considerable concerns about variability present methodologies utilized by agencies. It proposed that academicians, researchers, regulators work evaluate validate are based underlying science adapted drug product itself instead single "universal" method.