Bioequivalence and Bioavailability Forum • Simultaneous analytical method

Simultaneous analytical method [Bioanalytics]

posted by Obinoscopy – USA, 2018-09-12 11:35 (2832 d 07:19 ago) – Posting: # 19268
Views: 6,170

Dear Giang

❝ 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?

—
Scopy

Complete thread:

Simultaneous analytical method giang nidqc 2018-09-10 09:39
- Simultaneous analytical method Obinoscopy 2018-09-11 21:22
  - Simultaneous analytical method giang nidqc 2018-09-12 03:37
    - Simultaneous analytical methodObinoscopy 2018-09-12 09:35
      - 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