Bioequivalence and Bioavailability Forum

Dear All

I expect that many of you will have come across regulators who apply current bioanalytical guidelines to studies which were completed prior to 2011, without ISR.

The PKWP Q&A document from 10 DEC 2012 suggests that scientific justification for the lack of ISR might include taking into consideration "the width of the 90% confidence interval and the ratio to possibly justify that a false positive outcome due to ISR problems has a low probability".

Any ideas as to exactly how this might be achieved?

KR

Andrew Leary