Vaibhav ☆ India, 2022-06-14 22:57 (974 d 12:32 ago) Posting: # 23057 Views: 2,829 |
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Dear All, This is my first post on this forum. Please ignore any mistake. In 2016, we did BE study of Lenalidomide 25 mg capsule for EMA submission. Enrolled N =54 Completed N =52 Now are planning to conduct another BE study with same Test formulation (used in EMA) for ANVISA. Below are the EMA study results. 1. Cmax T/R 104.13 CI: 97.89-110.77 CV: 18.97 Power: 99.99 2. AUCo-t T/R 102.20 CI: 100.51- 103.92 CV: 5.08 Power:100 My question is can we proceed with sample size i.e. 54 or should re-calculate sample size based on EMA study results? T/R- 105% Power- 90% CV- Approx. 19% What could be the right approach for sample size calculation for ANVISA submission study? Please let us know if you need more information. |
Helmut ★★★ ![]() ![]() Vienna, Austria, 2022-06-15 00:14 (974 d 11:16 ago) @ Vaibhav Posting: # 23058 Views: 2,443 |
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Hi Vaibhav, ❝ Completed N =52 ❝ 1. Cmax ❝ T/R 104.13 ❝ CI: 97.89-110.77 ❝ CV: 18.97 ❝ Power: 99.99 ❝ 2. AUCo-t ❝ T/R 102.20 ❝ CI: 100.51- 103.92 ❝ CV: 5.08 ❝ Power:100 You should base the sample size estimation on Cmax because it was worse than AUC0–t (T/R-ratio more deviating from 100%, larger CV). ❝ Now are planning to conduct another BE study with same Test formulation (used in EMA) for ANVISA. ❝ […] can we proceed with sample size i.e. 54 or should re-calculate sample size based on EMA study results? With 52 subjects power was extremely high. It’s questionable whether the IEC/IRB will accept a study with such a sample size. The same holds for the ANVISA (you have to submit the protocol before initiating the study). Possibly > 90% power will not be accepted (like other agencies ANVISA recommends 80–90%). ❝ T/R- 105% ❝ Power- 90% ❝ CV- Approx. 19% Essentially there are two extreme approaches. One is all too often used – but stupid – and the other conservative. There are others in between. For details see this article. I hope you have PowerTOST . If not, see this article how to download/install them.Start with:
— 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 |
Vaibhav ☆ India, 2022-06-15 23:00 (973 d 12:30 ago) @ Helmut Posting: # 23061 Views: 2,221 |
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Thank you for the guidance and completely agree with you. I think we should proceed for second approach but before that we will confirm the (measured content, dissolution similarity) variability between 02 Reference product. |
dshah ★★ India, 2022-06-16 12:43 (972 d 22:47 ago) @ Vaibhav Posting: # 23063 Views: 2,238 |
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Dear Vaibhav! Kindly do comparison of test Vs Ref (new) rather than Ref (old) vs Ref (new). Regards, Divyen |