Bioequivalence and Bioavailability Forum • Multiple methods within a single trial

Multiple methods within a single trial [Regulatives / Guidelines]

posted by Ohlbe – France, 2019-03-13 20:10 (1864 d 00:53 ago) – Posting: # 20029
Views: 4,635

Dear Osama,

❝ 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.

BE trials in patients are indeed usually multi-centre trials. But multiple clinical sites does not mean there has to be multiple bioanalytical labs (unless the analyte is so unstable the samples cannot even afford to be shipped to a central lab ? I don't have any practical example in mind).

The one difficulty could be if due to the study duration the lab closes down half-way through the study and a new lab has to be used.

—
Regards
Ohlbe

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 trial wienui 2019-03-13 18:44
      - Multiple methods within a single trialOhlbe 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