Bioequivalence and Bioavailability Forum

Hello,

In terms off bioanalytical cross validation expectations. If we have several phase I studies in the dossier with different bioanalytical methods fully validated. And each individual study has single method and/or laboratory. And no pooled studies are performed, but of course all studies are the support of the dossier, should it be performed a cross validation of all studies following ICH M10 below section?

Section 6.2:

• Data are obtained from different fully validated methods across studies that are going to be combined or compared to support special dosing regimens, or regulatory decisions regarding safety, efficacy and labelling.

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Edit: Guideline section linked. [Helmut]