Simultaneous analytical method [Bioanalytics]
Dear Giang
I don't think you need to revalidate as long as the 2/3 APIs were among the 5 APIs that were validated.
But if I may ask, did you include all the CCs and QCs for the entire 5 APIs in the same analytical run?
❝ It's a bioanalytical method for determination of 5 anti-TB drugs by LC-MS/MS. One just raise the question: Can we apply this method for just 2/3 APIs? Is there any infuence or differences? Do we need to revalidate the method, partial or full, and which criteria? Many thanks!
I don't think you need to revalidate as long as the 2/3 APIs were among the 5 APIs that were validated.
But if I may ask, did you include all the CCs and QCs for the entire 5 APIs in the same analytical run?
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Scopy
Scopy
Complete thread:
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- Simultaneous analytical method giang nidqc 2018-09-13 03:50
- Simultaneous analytical method Helmut 2018-09-13 11:25
- Simultaneous analytical method Ohlbe 2018-09-13 14:06
- Simultaneous analytical method giang nidqc 2018-09-13 03:50
- Simultaneous analytical methodObinoscopy 2018-09-12 09:35
- Simultaneous analytical method giang nidqc 2018-09-12 03:37
- Simultaneous analytical method Obinoscopy 2018-09-11 21:22