Dalia-Simona Miron

The presentation will focus on the latest revisions, draft versions and finalized guidance documents and compendial chapters addressing the in vitro dissolution and drug release methodologies, bioequivalence / pharmacokinetic studies published since the last edition of the International Conference From Science to Guidance and Practice.

The EMA guideline on quality and equivalence of locally applied, locally acting cutaneous products (EMA/CHMP/QWP/708282/2018 Corr.1*) marks a long pathway in adopting a regulatory framework adapted for the complexity of topical dosage forms. The concept of extended pharmaceutical equivalence was introduced back in 2014 and gradually evolved into an approach which is similar to the one published by US-Food and Drug Administration (FDA). The document marks a clear relation between formulation strategy and the strategy demonstrate the bioequivalence between a generic and the reference product. It also validates an assembly of methodologies alternatives to clinical endpoint studies which includes in vitro release, in vitro permeation, in vivo pharmacokinetic or pharmacodynamic studies. The presentation will focus on the current requirements, similarities with FDA Q1/Q2/Q3 concepts, as well as difficulties or unclarities in definition or application of the stepwise approach.