Virtual Bioequivalence: an update from PAGE (+TSD!) [Dissolution / BCS / IVIVC]

posted by mittyri – Russia, 2019-06-21 13:50  – Posting: # 20356
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Dear All!

here's the update from the latest PAGE meeting:
  1. Model-based approach for group sequential and adaptive designs in parallel and cross-over bioequivalence studies
    AFAIK this one is the most interesting. Authors are INSERM and FDA people. But it looks like their adaptive design cannot control TIE. How come?
  2. Selection of optimal study design based on the bioequivalence simulation study in highly variable drugs
  3. An In Vitro – In Vivo Simulation Methodology for Predicting the Outcome of Bioequivalence Studies
  4. Investigation of the impact of population parameters describing gastric emptying on bioequivalence metrics

Kind regards,
Mittyri

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