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ceylan ☆ Turkey, 2021-11-19 16:46 (1151 d 08:11 ago) Posting: # 22676 Views: 2,764 |
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Hi, For PK bioequivalence, 90% confidence interval is ok both for US and EMA. For PD bioequivalence, I want to ask about the confidence interval for US and EMA? Is it 90% CI for US and 95% CI for EMA? And in what circumstances, 90 % CI and / or 95 % CI are being used? Thank you, Best Regards, Ceylan |
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ElMaestro ★★★ Denmark, 2021-11-19 17:22 (1151 d 07:35 ago) @ ceylan Posting: # 22677 Views: 2,280 |
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Hi ceylan, ❝ For PK bioequivalence, 90% confidence interval is ok both for US and EMA. ❝ ❝ For PD bioequivalence, I want to ask about the confidence interval for US and EMA? ❝ Is it 90% CI for US and 95% CI for EMA? ❝ ❝ And in what circumstances, 90 % CI and / or 95 % CI are being used? I think the question is a little too general. Sometimes regulators want a 95% CI other times they want a 90% CI. Here's a case of a 95% CI being used. Here's a case of 90% CI being used. Whatever you do, if you need PD I recommend to go for a scientific advice. Ask about 90% vs 95% if there is nothing written in a guideline. Don't make assumptions and don't take chances. — Pass or fail! ElMaestro |
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ceylan ☆ Turkey, 2021-11-21 00:14 (1150 d 00:43 ago) @ ElMaestro Posting: # 22678 Views: 2,229 |
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Hi ElMaestro, Thank you for your help. |
Ing. Helmut Schütz