HC Proposed Policy on Bioequivalence Standards for HVDS [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2015-07-02 11:19 (3517 d 06:01 ago) – Posting: # 15015
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Dear Kotu,

THX for that link.

Interesting! EMA approach but allowed for AUC. Since Cmax doesn't need a CI criterion at all, only a point estimate restriction is imposed.

Regards,

Detlew

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