Biostats ☆ India, 20180329 12:39 (1345 d 04:55 ago) Posting: # 18613 Views: 5,527 

Dear All, As per Draft Guidance on Warfarin Sodium bioequivalence criteria for NTID as
Thanks in advanced. 
Helmut ★★★ Vienna, Austria, 20180329 14:27 (1345 d 03:07 ago) @ Biostats Posting: # 18615 Views: 4,377 

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? — Diftor heh smusma 🖖 Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
Biostats ☆ India, 20180330 06:25 (1344 d 11:09 ago) @ Helmut Posting: # 18623 Views: 4,254 

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, 20180330 11:19 (1344 d 06:15 ago) @ Biostats Posting: # 18624 Views: 4,423 

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. — Diftor heh smusma 🖖 Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
arl_stat ★ India, 20201015 16:12 (414 d 01:22 ago) @ Helmut Posting: # 22010 Views: 1,050 

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, 20180329 17:20 (1345 d 00:14 ago) @ Biostats Posting: # 18618 Views: 4,309 

» Please guide me to understand the bioequivalence criteria of NTI drugs. This might help. A nice article from my professor... Endrenyi  NTI John 