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Registerimportance of bioanalytical validation [Bioanalytics]
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.
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.
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.
Complete thread:
- importance of bioanalytical validation averroes1304 2019-03-27 11:55 [Bioanalytics]
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- 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 Helmut 2019-03-27 19:16
- 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
- OT: Nerds chatting Ohlbe 2019-03-28 10:28
- OT: Nerds chatting nobody 2019-03-27 19:01
- OT: Nerds chatting Helmut 2019-03-27 18:48
- OT: Correct as often ElMaestro 2019-03-27 15:35
- OT: Your signature Helmut 2019-03-27 14:41
- importance of bioanalytical validationElMaestro 2019-03-27 12:08
Ing. Helmut Schütz