ICH M13A (IR BE) [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-12-23 10:05 (46 d 15:29 ago) – Posting: # 23409
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Dear all,

the ICH Draft Guideline Bioequivalence for Immediate-Release Solid Oral Dosage Forms (M13A Step 2) was published yesterday.

Note the new terminology: A – C instead of Tier 1 – 3 mentioned in the Concept Paper.

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