Bioequivalence and Bioavailability Forum

Dear all,

we are planning validation of a bioanalytical method for the determination of a drug candidate in plasma. This method should be used for the analysis of samples from various species (rat, mouse, dog, etc.). The European Guideline states that full validation should be performed for each species and matrix concerned, while the FDA guideline states that partial validation is required for the change of species within matrix.

What is your experience with this topic? Is the approach really different in Europe and US?

With best regards,

Jan