As one of the two Co-Chairs of the 5th Global Bioequivalence Harmonisation Conference, I am pleased to announce that the program for 6-7 April, 2022 is almost final. Through fruitful and exciting discussions among EMA and US regulatory representatives, industry and academia, we have developed a program that we are confident will advance the harmonization of regulatory requirements.
This time our topics are:
– . : relevance of excipients, disintegration/dissolution specificities, drug substance properties and physiological GI conditions – new findings shall help achieve harmonization.
– Statistical considerations for BE assessment: replicate design for , two-stage design and PK modelling as supportive tools for BE assessment
– : Scientifically-based approaches for a waiver of clinical endpoint trials
– : study design and acceptance criteria
The program website will be released very soon. Please visit also EUFEPS announcement