ICH M10 draft [Regulatives / Guidelines]

posted by wienui – Germany, Oman, 2019-03-13 17:06  – Posting: # 20023
Views: 244

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).:confused::confused:
Why ??

Best regards,
Osama


Edit: Post moved. [Helmut]

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