importance of bioanalytical validation [Bioanalytics]

posted by ElMaestro  – Denmark, 2019-03-27 12:08 (754 d 05:45 ago) – Posting: # 20092
Views: 4,093

Hello Averroes,

if you cannot reliably determine the concentrations in PK samples, then you cannot reliably evaluate bioequivalence. At the end of the day the comparative evaluation of rate and extent of absorption is based on quantification in PK samples.

Thus, in highly regulated markets you will not see products approved unless the reliability of the assay has been confirmed by a validation. Check also ICH E6 e.g. §2.2 and §2.5 or similar entries in WHO's set of practices.

Pass or fail!
ElMaestro

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