importance of bioanalytical validation [Bioanalytics]
Dear all,
could you explain to me the importance of bioanalytical validation in bioequivalence studies? is it really critical and important to perform the bioanalytical validation exercise? knowing that the purpose of bioequivalence studies is only to highlight differences in bioavailability between the test and reference drug and that this difference will be highlighted in all cases even with an invalidated analytical method and that chance cannot be the only factor in case of bioequivalence between two drugs with an invalidated analytical method..... is it scientifically acceptable to use analytical methods published in the literature?
Best regards,
Edit: Category changed; see also this post #1. [Mittyri]
could you explain to me the importance of bioanalytical validation in bioequivalence studies? is it really critical and important to perform the bioanalytical validation exercise? knowing that the purpose of bioequivalence studies is only to highlight differences in bioavailability between the test and reference drug and that this difference will be highlighted in all cases even with an invalidated analytical method and that chance cannot be the only factor in case of bioequivalence between two drugs with an invalidated analytical method..... is it scientifically acceptable to use analytical methods published in the literature?
Best regards,
Edit: Category changed; see also this post #1. [Mittyri]
Complete thread:
- importance of bioanalytical validationaverroes1304 2019-03-27 11:55 [Bioanalytics]
- importance of bioanalytical validation ElMaestro 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 validation ElMaestro 2019-03-27 12:08