Bioequivalence and Bioavailability Forum • Multiple methods within a single trial

Multiple methods within a single trial [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2019-03-13 19:44 (1864 d 00:23 ago) – Posting: # 20027
Views: 4,655

Dear Ohlbe,

❝ I would reverse the question: why would you use two different methods, or two different technologies, within a single BE trial, with the risk of increasing variability? We're not talking of 2 different trials here (where one can be done at one CRO and the other at another CRO, with a different method).

Please think about very big clinical trials which required a multi-centers ( e.g for Anti-cancer drugs), you deal here with different CRO's which could have different technologies.

Best regards,
Osama

—
Cheers,
Osama

Complete thread:

Draft ICH M10 published Ohlbe 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 trialwienui 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