Bioequivalence and Bioavailability Forum

Dear all,

the 5^th conference of

The Global Harmonisation Initiative

is planned for April 6–7, 2022 in Amsterdam, The Netherlands.

Sessions:

1. Fed vs fasted studies for immediate release dosage forms: Relevance of excipients, disintegration/dissolution speci­fi­ci­ties, drug substance properties and physiological GI conditions – new findings shall help achieve harmonisation
   
2. Statistical considerations for BE assessment: Replicate design for BE of Highly Variable Drugs, two-stage design and PK modelling as supportive tools for BE assessment
   
3. Topical products: Scientifically-based approaches for a waiver of clinical endpoint trials
   
4. Narrow therapeutic index drugs: Study design and acceptance criteria
   

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Update: Postponed; new dates September 28 – 29, 2022. Website, Programme.
The early-bird registration ends on June 15, 2022.