NTIDs [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2022-01-29 12:19 (197 d 20:30 ago) – Posting: # 22760
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Hi Najib,

» […] one PSG asks you to refer to the second, …

The Draft Guidance on Warfarin Sodium of 2012 was the first describing the FDA’s method of reference-scaling for NTIDs. All later ones refer to the first and state

For details about the Method for Statistical Analysis Using the Reference-Scaled Average Bioequivalence Approach for narrow therapeutic index drugs, refer to the Guidance on Warfarin Sodium Tablets.


For the sample size estimation see there (including examples and references).

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