RSABE… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 15:47 (78 d 03:14 ago) – Posting: # 22231
Views: 874

Hi Loky do,

» I didn't find this statement in FDA guidance for bioequivalence studies …

RSABE appears in the ANDA draft guidance of December 2013 (footnote 10 on page 4 = page 8 of the PDF).
Don’t waste your money and get the book mentioned there – the chapter is not helpful. Get the paper by Davit et al.* instead. Free and better.

» … just in progesterone guidance so, is it enough to refer to this guide while submitting the st udy to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way?

Any one would do, IMHO.

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Helmut Schütz

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