Helmut ★★★ Vienna, Austria, 2021-02-02 17:26 (1407 d 20:23 ago) (edited on 2021-12-03 16:00) Posting: # 22202 Views: 6,398 |
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Dear all, the 5th conference of The Global Harmonisation Initiative is planned forSessions:
Update: Postponed; new dates September 28 – 29, 2022. Website, Programme. The early-bird registration ends on July 10, 2022. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Helmut ★★★ Vienna, Austria, 2023-08-20 10:23 (479 d 04:26 ago) @ Helmut Posting: # 23703 Views: 3,301 |
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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.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Achievwin ★★ US, 2023-09-26 16:02 (441 d 22:47 ago) @ Helmut Posting: # 23724 Views: 2,742 |
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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 ★★★ Vienna, Austria, 2023-09-26 16:11 (441 d 22:38 ago) @ Achievwin Posting: # 23725 Views: 2,714 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |