Bioequivalence and Bioavailability Forum

❝ the section continues with:

❝

If data are obtained from different fully validated methods, and these data are not to be combined across studies, cross validation is not generally required.

❝ In the area of BE, I was never asked for a cross-validation, since each study stands on each own.

Dear Helmut,

Thank you so much for your response.

I was referring for a new molecule (full dossier), in which you have several phase I from different CROs. Despite you used same method in all CRO (method transfer and full validation), since all studies will support the efficacy/safety of the dossier, would it be necessary a cross-validation?

Or in the case of multiple BE study (for example prolonged realease: Fast, Fed, steady-state), if you use two different bioanalytical sites, do you need a cross-reference since "Data are obtained from different fully validated methods across studies that are going to be combined or compared to support..."? Or the word "combined" and "compared" is only applicabe if they are pooled?

Best regards,