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ICH M13B: Step 2b (draft for consultation) [BE/BA News]

posted by Nirali – India, 2026-03-04 19:59 (91 d 03:20 ago) – Posting: # 24583
Views: 1,001

Still curious about this — is there any statistical logic behind this “lucky number” 46? Looks like high-variability drugs might get a bit of an advantage with this relaxed similarity criterion.

-Nirali

Complete thread:

ICH M13B: Step 2b (draft for consultation) Helmut 2025-03-15 10:31 [BE/BA News]
- ICH M13B: EMA Helmut 2025-04-09 09:10
- ICH M13B: Step 2b (draft for consultation)Nirali 2026-03-04 18:59

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