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 20:35 (2194 d 11:54 ago) – Posting: # 20030
Views: 5,773

Dear Ohlbe,

❝ 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.

Such multiple clinical trial centers ( for one drug product), you might find them in different cities, ( you could find them even in different countries depending on the presence of the patients for a certain disease, therefore we will not be able to talk about a central lab, which uses the same technology.

I have already dealt with such study conducted for an anti-cancer drug in different CRO's in different cities.

Best regards,
Osama

—
Cheers,
Osama

Complete thread:

Draft ICH M10 published Ohlbe 2019-03-03 23:18 [Regulatives / Guidelines]
- 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 trialwienui 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