Bioequivalence and Bioavailability Forum • TSD: BE in stage 1

TSD: BE in stage 1 [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2018-01-19 13:21 (1894 d 18:01 ago) – Posting: # 18224
Views: 3,664

Hi Yura,

❝ If in carrying out a two-stage design in the first stage with N = 20 subjects bioequivalence is shown, what should be done with the second stage?

Open a bottle of champagne, since there is no need for a second stage (see the left branches of the flowcharts in this post). BTW, all of my TSDs passed in the 1^st. :-D

AFAIK, only the Indonesian agency requires a “second stage” in such a case for reasons I fail to comprehend. Think about a fixed-sample study which passed BE: would anybody ask for another one? IIRC, ElMaestro wrote a paper* about it (I’m traveling and can’t check).

Edit:

Fuglsang A. A Sequential Bioequivalence Design with a Potential Ethical Advantage.
AAPS J. 2014;16(4):843–6. doi 10.1208/s12248-014-9622-7

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Complete thread:

CVwithin calculation of biperiden CECIF 2018-01-17 20:44 [Power / Sample Size]
- pooled CV from MR vs. IR Helmut 2018-01-18 16:46
  - pooled CV from MR vs. IR ElMaestro 2018-01-18 17:03
    - pooled CV from MR vs. IR jag009 2018-01-21 03:32
  - pooled CV from MR vs. IR Yura 2018-01-19 10:05
    - TSD: BE in stage 1Helmut 2018-01-19 12:21
      - TSD: BE in stage 1 Yura 2018-01-19 13:21