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hiren379 ★ India, 2012-07-28 14:56 (4620 d 09:54 ago) Posting: # 8986 Views: 6,562 |
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Hello friends, Is it possible that my T/R is 85 and there was a significant formulation effect in ANOVA but variability was so low in BE, that 90%CI came to 81-90 (BE established). Is this possible???  |
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Helmut ★★★   Vienna, Austria, 2012-07-28 15:42 (4620 d 09:08 ago) @ hiren379 Posting: # 8987 Views: 5,645 |
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Dear Hiren! ❝ Is it possible that my T/R is 85 and significant formulation effect but variability in my study was so low that 90%CI came to 81-90. Yes it is, though a significant formulation effect is irrelevant in BE (except in Denmark). If the CI does not include 100% one will always get a significant formulation effect. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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hiren379 ★ India, 2012-07-28 15:49 (4620 d 09:01 ago) @ Helmut Posting: # 8988 Views: 5,580 |
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❝ If the CI does not include 100% one will always get a significant formulation effect. Thanks HS... But I am not geting how can we claim two formulation bioequivalent if there is significant formulation effect???? Just on the basis that the variability of such difference will be less (narrow CI) how can we claim BE??? If someone can throw some light |
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Helmut ★★★ Vienna, Austria, 2012-07-28 18:23 (4620 d 06:27 ago) @ hiren379 Posting: # 8989 Views: 6,220 |
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Dear Hiren! ❝ But I am not geting how can we claim two formulation bioequivalent if there is significant formulation effect???? Statistically significant does not imply clinically relevant. In BE any [≥-20.00% & ≤+25.00%] difference (log-scale ±0.2231) generally* is considered irrelevant. ❝ Just on the basis that the variability of such difference will be less (narrow CI) how can we claim BE??? ![[image]](img/uploaded/image116.png) Since the CI is within the acceptance range. BE is defined as ARlo ≤CLlo and CLhi ≤ARhi; nothing else. If we increase the sample size (keeping the CV constant) sooner or later any (!) formulation will show a statistically significant difference – if the PE ≠ 100%. Have a look at this slide: The minimum sample size according to many guidelines is 12. With T/R 0.95 and a CV of 15% we expect already a power of 83% (the CI will be 85.07 – 106.09%). With 48 subjects the upper CL drops below 100% and we will get a statistical significant difference (CI 90.27 – 99.98%).Or, if we keep the sample size at 12 and our CV is even lower, the power will increase – and therefore, also the chance to get a significant difference (exemplified by the light blue curve in the linked presentation). With a CV% of 10% power will be 98.8% and with 5% 99.99999995%.  May I ask you for the sample size in your study?
— 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 |
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hiren379 ★ India, 2012-08-14 16:51 (4603 d 07:59 ago) @ Helmut Posting: # 9062 Views: 5,250 |
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Thank You HS... Very nicely explained sir ❝ May I ask you for the sample size in your study? Actually this was just a question arised in my mind. There is no practical case faced. But really good explanation...  |
Ing. Helmut Schütz