Bioequivalence and Bioavailability Forum

Dear all,

I have reviewed the RSABE design possibilities according new draft FDA guideline Bioequivalence Studies With Pharmacokinetic End­points for Drugs Submitted Under an ANDA and in accordance with FDA Draft Guidance on Progesterone; regarding RSABE. And it is set out as follow:

- Full replicate: 4-ways, 2-sequences: TRTR/RTRT
- Partial replicate: 3-ways, 3-sequences: TRR / RTR / RRT

But nothing is said about the option full-replicate 3-ways, 2-sequences: TRT / RTR, which does seem to be included in the guideline Statistical Approaches to Establishing Bioequivalence. Does this mean that this design can no longer be used?

Thank you so much

Best regards,

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Edit: Guidances linked. [Helmut]