suchit_bhavsar ★ India, 2017-04-24 09:29 (2530 d 21:50 ago) Posting: # 17255 Views: 3,385 |
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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? Tnx & Regards, Nirav |
d_labes ★★★ Berlin, Germany, 2017-04-24 13:26 (2530 d 17:54 ago) @ suchit_bhavsar Posting: # 17256 Views: 2,910 |
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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? 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 |
suchit_bhavsar ★ India, 2017-04-24 14:04 (2530 d 17:16 ago) @ d_labes Posting: # 17257 Views: 3,022 |
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❝ 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. Thnx a lot for your reply. As per "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs gives criteria of NTI drugs. Actually for molecule like rivaroxaban(Anticoagulant) its OGD says that, Applicants should use the average BE approach with BE limits of 80-125%. The within-subject variability of test (T) and reference (R) products should be compared, and the upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5. So, should i use "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs? Regards, Nirav Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
d_labes ★★★ Berlin, Germany, 2017-04-25 10:41 (2529 d 20:38 ago) @ suchit_bhavsar Posting: # 17260 Views: 3,014 |
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Dear Nirav, again: If you aimed a submission in Canada follow my hint. What you cite as "OGD for rivaroxaban" is FDA recommended evaluation method. Follow it if you aim for an FDA submission. If you aim for an EMA submission follow the EMA recommendations. Other regulatory bodies may have different recommendations. Follow them if you aim for a submission to them. Simple. Isn't it? — Regards, Detlew |