Bioequivalence and Bioavailability Forum

Dear all,

As mentioned in the final guidelines, for prolonged release products, the partial AUC is required for those products with no risk of accumulation.

As in draft GL, it was required by default for prolonged release products. So what would be the rational behind not determining pAUC for PR drugs products with accumulation.

Also, to determine accumulation before study one either need to literature search or there would be compulsory requirement of pilot study.

Suppose, the study designed who is designed on the basis of accumulation i.e. without pAUC and the results does show accumulation. Would it be acceptable?

Also regarding the truncation point for pAUC, in 6.1.1.2, "the half of the dosage interval are recommended" so can this be considered thumb rule for truncation of pAUC of PR Products.?

Regards,
Jay