Bioequivalence and Bioavailability Forum • Draft ICH M10 published

Draft ICH M10 published [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-04 00:18 (1873 d 06:47 ago) – Posting: # 19994
Views: 5,331

Dear all,

The draft ICH M10 guideline on bioanalytical method validation has been published for consultation.

It will be heavily discussed at the next WRIB and EBF meetings.

—
Regards
Ohlbe

Complete thread:

Draft ICH M10 publishedOhlbe 2019-03-03 23:18
- Consultation period? Helmut 2019-03-04 01:08
  - EU/EEA Ohlbe 2019-03-14 23:16
- ICH M10 draft wienui 2019-03-13 18:06
  - Multiple methods within a single trial Ohlbe 2019-03-13 18:21
    - Multiple methods within a single trial wienui 2019-03-13 18:44
      - Multiple methods within a single trial Ohlbe 2019-03-13 19:10
        
        Multiple methods within a single trial wienui 2019-03-13 19:35
        
        Multiple methods within a single trial Ohlbe 2019-03-13 23:01
  - one study, one method Helmut 2019-03-13 18:23