Bioequivalence and Bioavailability Forum

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

posted by suchit_bhavsar – India, 2017-04-24 09:29 (3354 d 20:47 ago) – Posting: # 17255
Views: 4,983

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?

Tnx & Regards,
Nirav

Complete thread:

• Regarding Statistical criteria for BE study of anticoagulant moleculesuchit_bhavsar 2017-04-24 07:29 
  • Critical dose drugs d_labes 2017-04-24 11:26
    • Critical dose drugs suchit_bhavsar 2017-04-24 12:04
      • Critical dose drugs - FDA highly variable NTID d_labes 2017-04-25 08:41