Regarding Statistical criteria for BE study of anticoagulant molecule [Regulatives / Guidelines]

posted by suchit_bhavsar – India, 2017-04-24 09:29 (2847 d 20:43 ago) – Posting: # 17255
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Dear All,

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:

Tnx & Regards,
Nirav

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