Helmut ★★★ ![]() ![]() Vienna, Austria, 2025-01-28 11:49 (15 d 23:33 ago) Posting: # 24349 Views: 282 |
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Dear all, as a reminder: The guideline was adopted by the EMA on 23 July 2024 and is effective with 25 January 2025 – superseding applicable parts of the 2010 BE guideline related to design considerations and data analysis for non-replicate studies. See this thread for changes to the draft. Some requirements are beyond my comprehension…
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