Multiple methods within a single trial [Regulatives / Guidelines]
Dear Ohlbe,
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
❝ 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
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Cheers,
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 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
- Multiple methods within a single trial wienui 2019-03-13 19:35
- Multiple methods within a single trial Ohlbe 2019-03-13 19:10
- Multiple methods within a single trialwienui 2019-03-13 18:44
- one study, one method Helmut 2019-03-13 18:23
- Multiple methods within a single trial Ohlbe 2019-03-13 18:21
- Consultation period? Helmut 2019-03-04 01:08