importance of bioanalytical validation [Bioanalytics]

posted by ElMaestro  – Belgium?, 2019-03-27 12:08 (582 d 03:34 ago) – Posting: # 20092
Views: 3,679

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.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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