Bioequivalence and Bioavailability Forum 11:06 CET

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Nice numbers [Regulatives / Guidelines]

posted by Beholder - Russia, 2018-06-22 10:33  - Posting: # 18946
Views: 2,082

Hi, Helmut!

» We find nice numbers which are “easy to remember” everywhere.

Thx a lot for clarification.

Im just comparing the EU legislation and EEU legislation because it is very similar. May be you or other members of the forum know how can one understand whether we need to perform BEQ study in case of changes in amount of tablets in production batch or not? I refer to the table B.II.b.4 Change in the batch size (including batch size ranges) of the finished product which says (point c):
c) The change requires assessment of the comparability of a biological/immunological medicinal product or the change in batch size requires a new bioequivalence study
(my emphasis)

Best regards
Beholder

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