Bioequivalence and Bioavailability Forum

Hi Achievwin,

❝ Can you also please share RSABE example for US FDA.

Regrettably the FDA didn’t publish reference data sets…

Four data sets (calculations in full precision, results with five significant digits):$$\small{\begin{array}{ccccccccc}
\hline
\mathsf{Ref.} & \mathsf{Design} & s_\text{wR} & \geq0.294 & \mathsf{critbound} & \leq0 & PE & \in \left\{ 0.8000-1.2500 \right\} & \mathsf{aggregate / mixed}\\
\hline
1 & \text{TRRT|RTTR} & 0.38604 & \text{yes} & +0.076541 & \text{no} & 0.73339 & \text{no} & \text{fails RSABE}\\
2 & \text{TRRT|RTTR} & 0.39453 & \text{yes} & -0.087152 & \text{yes} & 1.0360\;\; & \text{yes} & \text{passes RSABE}\\
3 & \text{TRTR|TRTR} & 0.44645 & \text{yes} & -0.092076 & \text{yes} & 1.1546\;\; & \text{yes} & \text{passes RSABE}\\
4 & \text{TRTR|TRTR} & 0.34358 & \text{yes} & -0.051725 & \text{yes} & 1.1102\;\; & \text{yes} & \text{passes RSABE}\\\hline
\end{array}}$$ Enjoy, if you can.

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1. U.S. Food and Drug Administration, CDER. Bioequivalence Studies. Bioequivalence study files. Rock­ville. 1997.  webarchive 2017 (C_max data of Drug 14a).
   
2. Hauschke D, Steinijans VW, Pigeot I. Bioequivalence studies in drug development. Chichester: John Wiley; 2007. p. 216 (C_max data).
   
3. European Medicines Agency. EMA/582648/2016. Annex II. 21 September 2016.
   
4. Patterson SD, Jones B. Bioequivalence and statistics in clinical pharmacology. Boca Raton: CRC Press; 2^nd edition 2016. p. 105–6 (AUC data).