Mikalai ★ Belarus, 2019-12-14 16:39 (1789 d 08:44 ago) Posting: # 20975 Views: 3,849 |
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Dear all. What would be a sample size for a BE study when the CV of the drug is 30% but bioequivalence should be in range 90_110%? Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative Best regards. |
Helmut ★★★ Vienna, Austria, 2019-12-14 17:11 (1789 d 08:11 ago) @ Mikalai Posting: # 20976 Views: 2,946 |
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Hi Mikalai, ❝ What would be a sample size for a BE study when the CV of the drug is 30% but bioequivalence should be in range 90_110%? Unless the drug belongs to the last generation anticoagulants (dabigatran, rivaroxaban) that's a contradiction. NTIDs show low variability. Otherwise, there would have been serious problems in phase III: toxicity, lacking efficacy – no approval – end of story. BTW, the acceptance limits for NTIDs in the EEA are 90.00–111.11%. ❝ Our assumption is around 400 subject if the design is standard, and 200 if the design is replicative library(PowerTOST) — 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 |