Achievwin
★    

US,
2021-08-18 00:30
(922 d 20:10 ago)

Posting: # 22526
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 Bootstrapping methodology in Bioequivalence [Regulatives / Guidelines]

Anyone have knowledge on whether any regulatory agency accepts bootstrapping methodology (other than for sparse sampling) for establishing bioequivalence in PK/CE studies?

Thanks a lot for your feed back
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[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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