Bioequivalence and Bioavailability Forum

Dear Ohlbe,

❝ I found one from January 2023. Refers to RSABE in the text, to the EMA guideline in the bibliography.

THX for this goody!
Following the bullet points of Section 4), RSABE in this context is a misnomer. It should be SABE. RSABE* (preferred by the US FDA and China’s CDE) is one approach and ABEL another. See also this article.

@John: Since the references of the guideline are the EMA’s (in the previous post #2 and #4), an ANOVA (Proc GML). Scaling only for C_max if \(\small{CV_\text{wR}>30\%}\), upper cap of scaling at \(\small{CV_\text{wR}=50\%}\) (maximum expansion 69.84 – 143.19%), point estimate constraint 80.00 – 125.00%. Likely an ANOVA also for ABE.

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• Why the FDA recommends Proc Mixed for partial replicate designs and Proc GLM for full replicate designs is beyond me. For ABE Proc Mixed is recommended for any design.