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RegisterICH M10 draft [Regulatives / Guidelines]
Dear all,
"New or Alternative Technologies" an interesting part in the newly issued draft of BIOANALYTICAL METHOD VALIDATION, ICH M10 which Endorsed on 26 February 2019.
- When a new or alternative technology is used as the sole bioanalytical technology from the onset of drug development, cross-validation with an existing technology is not required.
Cross-validation but required when using two different bioanalytical technologies for the development of a drug.
on the other hand, The use of two methods or technologies within a
comparative BA/BE study is strongly discouraged:. (i.e not applicable at all also with cross-validation).
Why ??
Best regards,
Osama
Edit: Post moved. [Helmut]
"New or Alternative Technologies" an interesting part in the newly issued draft of BIOANALYTICAL METHOD VALIDATION, ICH M10 which Endorsed on 26 February 2019.
- When a new or alternative technology is used as the sole bioanalytical technology from the onset of drug development, cross-validation with an existing technology is not required.
Cross-validation but required when using two different bioanalytical technologies for the development of a drug.
on the other hand, The use of two methods or technologies within a
comparative BA/BE study is strongly discouraged:. (i.e not applicable at all also with cross-validation).
Why ??
Best regards,
Osama
Edit: Post moved. [Helmut]
—
Cheers,
Osama
Cheers,
Osama
Complete thread:
- Draft ICH M10 published Ohlbe 2019-03-03 23:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Consultation period? Helmut 2019-03-04 01:08
- EU/EEA Ohlbe 2019-03-14 23:16
- ICH M10 draftwienui 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
- 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 trial wienui 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
Ing. Helmut Schütz