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Challenge with New FDA Requirement for Partial AUCs for Bioequivalence Assessment of Modified-Release Products

PRESENTED TO: BioPharma Services Inc., Toronto, ON, Canada
PRESENTED BY: Juan He, Priscila Pequeno, Yu Ding, Rabiya Chandani, Negar Gharavi, and Fethi Trabelsi


Single dose studies under both fasting and fed state are generally required by FDA to demonstrate Bioequivalence (BE) for modified-release (MR) formulations on AUCt , AUCinf, and Cmax. The 90% confidence interval (CI) of the geometric mean ratios (T/R) of AUCt , AUCinf, and Cmax must be within the acceptable range of 80.00% to 125.00% to prove the same rate and extend of absorption of the active moiety of the two products.

FDA recently requested BE demonstration on additional partial AUC (pAUC) for certain products including an immediate-release (IR) and modified-release component such as Dexmethylphenidate extended-release (ER) capsules, Mesalamine delayed-release (DR) capsules, Methylphenidate ER tablets, Naltrexone (ER suspension, Intramuscular), and Zolpidem ER tablets which IR component is necessary for rapid onset of the pharmacological effect while the DR component is destined to sustain it.

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