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Register5th GBHI Conference [Conferences / Workshops]
posted by Helmut 
– Vienna, Austria, 2021-02-02 16:26 (77 d 04:01 ago) – Posting: # 22202
Views: 909
Dear all,
the 5th conference of
Topics:
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.
—
Dif-tor heh smusma 🖖
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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- 5th GBHI ConferenceHelmut 2021-02-02 16:26 [Conferences / Workshops]
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Ing. Helmut Schütz