Bioequivalence and Bioavailability Forum • importance of bioanalytical validation

importance of bioanalytical validation [Bioanalytics]

posted by ElMaestro – Belgium?, 2019-03-27 12:08 – Posting: # 20092
Views: 1,905

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

Complete thread:

importance of bioanalytical validation averroes1304 2019-03-27 11:55 [Bioanalytics]
- importance of bioanalytical validationElMaestro 2019-03-27 12:08
  - OT: Your signature Helmut 2019-03-27 14:41
    - OT: Correct as often ElMaestro 2019-03-27 15:35
      - OT: Nerds chatting Helmut 2019-03-27 18:48
        
        OT: Nerds chatting nobody 2019-03-27 19:01
        
        OT: Nerds chatting Helmut 2019-03-27 19:16
        
        OT: Nerds chatting nobody 2019-03-27 19:38
        OT: Nerds chatting Shuanghe 2019-03-28 13:59
        
        OT: Nerds chatting ElMaestro 2019-03-27 22:07
        
        OT: Nerds chatting Ohlbe 2019-03-28 10:28
        
        OT: Nerds chatting nobody 2019-03-28 11:14