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Vienna, Austria,
2021-02-02 15:26
(30 d 06:22 ago)

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 5th GBHI Conference [Conferences / Workshops]

Dear all,

the 5th conference of

\(\textrm{The}\;\textrm{Global}\;\textrm{Harmoni}\frac{\textrm{z}}{\textrm{s}}\textrm{ation}\;\textrm{Initiative}\)

is planned for December 7–8, 2021 in Amsterdam, The Netherlands.

Topics:
  • 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.
Link

Dif-tor heh smusma 🖖
Helmut Schütz
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