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Panelists: subject-period reanalysis is evaluated and its SOP identification can affect BE outcomes
Summary
Dr. Wren said the agency carefully evaluates subject-period reanalysis (ISPR), whether it is identified in SOPs, and whether the analysis could affect bioequivalence outcomes.
An online attendee asked whether the agency includes subject-period reanalysis (ISPR) in its evaluations.
Dr. Wren said the agency does "definitely" consider subject-period reanalysis in its evaluation, and that reviewers assess whether the type of reanalysis is identified in the sponsor's SOP and whether the analysis criteria are appropriate and could impact a BE outcome.
The panel's remarks were advisory and procedural; they did not change policy but clarified that sponsors should document their reanalysis procedures and evaluation criteria in their SOPs and submissions.
