5th International Workshop – GBHI 2022 – starting soon

News of August 31st, 2022

We are looking forward to the GBHI conference starting soon, 28 September is fast approaching. The response to registrations is very good and we expect lively and competent interactions from all participants.

Don’t miss out and take the opportunity to discuss the current state of guideline developments with representatives from the authorities. From experience, the discussions are always very informative and also help to anticipate trends for the future.

As a reminder, the topics are as follows:

• 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
• 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
• Topical products: Scientifically based approaches for a waiver of clinical endpoint trials
• Narrow therapeutic index drugs: Study design and acceptance criteria

We look forward to meeting you in Amsterdam!