Bioequivalence and Bioavailability Forum

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RSABE appears in the ANDA draft guidance of December 2013 (footnote 10 on page 4 = page 8 of the PDF).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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• Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, Lionberger RA, Makhlouf FT, Nwa­kama PE, Patel DT, Schuirmann DJ, Yu LX. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration. AAPS J. 2012; 14(4): 915–24. doi:10.1208/s12248-012-9406-x. PMC Free Full text.