Tricky TAB ☆ Bangladesh, 2022-07-04 13:33 (822 d 22:09 ago) Posting: # 23103 Views: 3,060 |
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Hello! The Design for Rivaroxaban 20 mg BE Study stated by US-FDA is as follows: Single-dose, two-treatment, two-sequence, four-period, fully replicate crossover Is it possible to go with Single-dose, two-treatment, two-sequence, two-period crossover study design? Thank You! Edit: Category changed; see also this post #1. Guidance linked. [Helmut] |
Helmut ★★★ Vienna, Austria, 2022-07-04 15:19 (822 d 20:23 ago) @ Tricky TAB Posting: # 23104 Views: 2,522 |
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Hi Tricky, ❝ Is it possible to go with Single-dose, two-treatment, two-sequence, two-period crossover study design? It depends on the ‘target’ agency. For the FDA and China’s CDE no way because you have to compare the within-subject variability of test and reference. That requires a full replicate design. For details see the warfarin-guidance (ignore the part about reference-scaling; for rivaroxaban the conventional limits of 80.00–125.00% are applicable). For all other agencies a 2×2×2 likely would do. In the EMA’s product-specific guidance no design is mentioned. However, rivaroxaban may show high variability, esp. in fed state. Be prepared for large sample sizes. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Tricky TAB ☆ Bangladesh, 2022-07-05 08:42 (822 d 03:00 ago) @ Helmut Posting: # 23105 Views: 2,476 |
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❝ It depends on the ‘target’ agency. Thanks a lot, Helmut! For taking the time to help me out! Wanted to perform BE for ASEAN Regions! 2x2x2 would matter anyway for those countries with same sample size as suggested in FDA guideline? 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] |
Helmut ★★★ Vienna, Austria, 2022-07-05 11:49 (821 d 23:53 ago) @ Tricky TAB Posting: # 23106 Views: 2,492 |
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Hi Tricky, ❝ Wanted to perform BE for ASEAN Regions! ❝ 2x2x2 would matter anyway for those countries with same sample size as suggested in FDA guideline? The FDA’s (and the EMA’s) guideline don’t give a sample size. Search the literature or – much better – perform a pilot study with your formulation. PS: Did you also register with the user name ‘Tajbiul Alam’ (same IP like yours, registration seven minutes apart)? If yes, I will delete the other account. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Tricky TAB ☆ Bangladesh, 2022-07-06 08:52 (821 d 02:49 ago) @ Helmut Posting: # 23107 Views: 2,565 |
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❝ PS: Did you also register with the user name ‘Tajbiul Alam’ (same IP like yours, registration seven minutes apart)? If yes, I will delete the other account. Yes Sir, Please delete the earlier one. 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! [Ohlbe] |