Helmut
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2021-02-02 17:26
(1117 d 22:10 ago)

(edited by Helmut on 2021-12-03 16:00)
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 5th GBHI Conference [Conferences / Workshops]

Dear all,

the 5th conference of

The Global Harmonisation Initiative

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

Sessions:
  1. Statistical considerations for BE assessment in specific situations
    • 2-stage, adaptive and replicate design: a regulatory update after the discussions at GBHI 2
    • Modeling & Simulation
  2. Fed vs fasting conditions in BE trials: current status and new insights
  3. Equivalence assessment of topical products: product-dependent approaches
  4. Bioequivalence evaluation of narrow therapeutic index (NTI) Drugs

Update: Postponed; new dates September 28 – 29, 2022. Website, Programme.
The early-bird registration ends on July 10, 2022.

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Helmut
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2023-08-20 10:23
(189 d 06:13 ago)

@ Helmut
Posting: # 23703
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 Conference report

Dear all,

The pre-print was recently published.1

Quote from Section 2.1.1.3:

A vast majority2 of the attendees preferred applying scaling procedures also to AUC, obviously supporting the concept that HVDs need to have a broad therapeutic range. Application of widening to AUC would be a major step towards increasing the concordance rate among US-FDA, HC and EMA. The majority of meeting participants think that the regulatory agencies should give a clear recommendation on the method to be used for BE evaluation of HVD products. Some participants suggested that recommendations on the scaling method and the PK parameters for which scaling should be allowed may be included in product-specific guidances (PSGs). This proposal would allow for a scientifically based BE approach considering the pharmacological aspects of a certain drug or drug class and the clinical relevance of the endpoint.



  1. Mehta M, Schug B, Blume HH, Beuerle G, Jiang W, Koenig J, Paixão P, Tampal N, Tsang Y-C, Walstab J, Wedemeyer R, Welink J. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference. Europ. J. Pharm. Sci. 15 August 2023. doi:10.1016/j.ejps.2023.106566. [image] Open access PDF.
  2. According to the supplementary material 84%.

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Achievwin
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2023-09-26 16:02
(152 d 00:34 ago)

@ Helmut
Posting: # 23724
Views: 1,392
 

 Presentations

is there a place where all these presentations of 2022 conference can be downloaded? conference report?


Edit: Subject line changed; see also this post #2. [Helmut]
Helmut
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2023-09-26 16:11
(152 d 00:25 ago)

@ Achievwin
Posting: # 23725
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 Presentations

Hi Achievwin,

❝ is there a place where all these presentations of 2022 conference can be downloaded?


No. Was accessible only for a limited time (don’t remember – two weeks?) for attendees. Contact me by email.

❝ conference report?


See above.

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