Bioequivalence and Bioavailability Forum

❝ Dear Divyen!

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❝ It will be good to evaluate it based on dissolution and not just PK linearity/dose proportionality for lower strength Biowaiver.

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We have evaluated the dissolution profiles for all strengths of the product. The lower and middle strengths demonstrated in vitro dissolution profiles comparable to that of the highest strength. In summary, the following conditions are fulfilled:
• Proportional Formulation: The lower and middle strengths are proportionally similar in composition to the highest strength, maintaining the same ratio of active and inactive ingredients.
• Consistent Manufacturing Process: All strengths are manufactured using the same process and equipment.
• Linear Pharmacokinetics: According to literature, the drug exhibits linear pharmacokinetics across the dosage range, with AUC and Cmax increasing proportionally with dose.
• Dissolution Profile Similarity: The lower strengths exhibit similar in vitro dissolution behavior to the highest strength across multiple pH conditions.

In light of the above, would appreciate your guidance on whether it would be acceptable to waive the in vivo bioequivalence studies for the 60 mg and 80 mg strengths. Alternatively, please advise if individual BE studies are still required for each strength