Acceptance Criteria for Sample Reanalysis in BA/BE Studies: Regulatory Expectations and Best Practices
Acceptance Criteria for Sample Reanalysis in BA/BE Studies: Regulatory Expectations and Best Practices Regulatory Guide to Sample Reanalysis in BA/BE Studies Introduction: Why Sample Reanalysis Is a Critical Topic Sample reanalysis is an essential component of bioanalytical integrity in bioavailability and bioequivalence (BA/BE) studies. It ensures the accuracy and reproducibility of drug concentration measurements in…