Critical dose drugs [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2017-04-24 13:26 (2845 d 20:58 ago) – Posting: # 17256
Views: 3,386

Dear Nirav,

❝ Can you plz tell me the Statistical criteria to be kept for BE study of Anticoagulant molecule having steep exposure response relationship for both safety and efficacy for canada submission.

❝ Can i follow OGD for BE study conducted for Canada submission?:confused:


If you aimed for a submission in Canada I think the
"Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects"
paragraph 2.1.1.6 Critical dose drugs
applies.

Hope this helps.

Regards,

Detlew

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