Biostats ☆ India, 2018-03-29 14:39 (2414 d 18:43 ago) Posting: # 18613 Views: 7,347 |
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Dear All, As per Draft Guidance on Warfarin Sodium bioequivalence criteria for NTID as
Thanks in advanced. |
Helmut ★★★ Vienna, Austria, 2018-03-29 16:27 (2414 d 16:55 ago) @ Biostats Posting: # 18615 Views: 5,820 |
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Hi Biostats, your understanding of 1 & 2 is correct. Don’t forget #3! ❝ Please guide me to understand the bioequivalence criteria of NTI drugs. Can you be more specific? — 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 |
Biostats ☆ India, 2018-03-30 08:25 (2414 d 00:57 ago) @ Helmut Posting: # 18623 Views: 5,594 |
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Thanks Sir, Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%? 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, 2018-03-30 13:19 (2413 d 20:03 ago) @ Biostats Posting: # 18624 Views: 5,902 |
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Hi Biostats ❝ Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%? See your condition #2 and the guidance Every study should pass the scaled average bioequivalence limits and also regular unscaled bioequivalence limits of 80.00–125.00%. What do you think where the GMR lies if a study passes ABE? It is only nice to know (unless you are concerned about this discussion). If a study fails ABE, the location of the GMR is even less relevant. Hence, the FDA does not ask for it. — 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 |
arl_stat ★ India, 2020-10-15 18:12 (1483 d 15:10 ago) @ Helmut Posting: # 22010 Views: 2,584 |
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Dear All, Greetings !! FDA recommends not to round off the decimal places for confidence intervals. So for NTI drugs, the Swt, Swr and 95% upper bound and point estimate should be presented upto 2 decimal places without rounding off. If for Cmax, the 95% upper bound value is 0.0025 and if presented as 0.00, will the study can be considered as pass? For analysis in SAS, should we present the values in 2 decimals or 4 decimals without rounding off? As in above criteria, if we present the data in 2 decimal places, the study is pass. Please guide. Thanks |
jag009 ★★★ NJ, 2018-03-29 19:20 (2414 d 14:02 ago) @ Biostats Posting: # 18618 Views: 5,705 |
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❝ Please guide me to understand the bioequivalence criteria of NTI drugs. This might help. A nice article from my professor... Endrenyi - NTI John |