FDA RSABE is ISC [🇷 for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 13:11 (937 d 22:59 ago) – Posting: # 21709
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Hi Detlew,

❝ Why not use the ISC estimate of T-R in the ABE decision in case of swR < 0.029356 (CVwR < 30%)?

❝ Politics? Nostalgia (Since years recommended the Proc MIXED code)?


The guidance “Statistical Approaches to Establishing Bioequivalence” of January 2001 (where the same SAS code is given in APPENDIX E) is still in force. Hence, it is only consistent to give it in the progesterone guidance.

❝ I would opt for the full ISC approach because it may be unambiguously implemented in SAS, R, Phoenix and so on for every replicate design, full or partial :cool:.


Cannot agree more. All problems would vanish.

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