5th GBHI Conference [Conferences / Workshops]

posted by Helmut Homepage – Vienna, Austria, 2021-02-02 16:26 (512 d 18:42 ago) – Posting: # 22202
Views: 2,061

(edited by Helmut on 2021-12-03 16:00)

Dear all,

the 5th conference of

The Global Harmonisation Initiative

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

  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

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

Dif-tor heh smusma 🖖 [image]
Helmut Schütz

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