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Ahikal ☆ Egypt, 2022-02-11 19:34 (965 d 01:34 ago) Posting: # 22773 Views: 3,857 |
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Dear all, I did a bioequivalence project using William's design (3 treatment, 3 period, 6 sequence), 2 test products against one reference. I analyzed the data as 3-way, and also separated the test products, each with a reference, and analyzed them. My question: should I get the same result? Best Regards Ahmed Edit: Category changed; see also this post #1. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2022-02-11 20:07 (965 d 01:01 ago) @ Ahikal Posting: # 22774 Views: 3,359 |
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Hi Ahmed, ❝ […] William's design (3 treatment, 3 period, 6 sequence), 2 test products against one reference. I analyzed the data as 3-way, and also separated the test products, each with a reference, and analyzed them. My question: should I get the same result? Extremely unlikely. In the separate evaluations (as Incomplete Block Designs) you get two estimates of the within-subject variances (one in the comparison of T1 vs R and the other in the comparison of T2 vs R). Even if they would be identical, you have different degrees of freedom in the analyses. In each of the IBDs you have \(\small{df=n-2}\) and in the pooled ANOVA \(\small{df=2\times n-4}\), where \(\small{n}\) is the total number of subjects. Although the point estimates might be the same, the confidence intervals will not. — 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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Ahikal ☆ Egypt, 2022-02-11 20:43 (965 d 00:25 ago) @ Helmut Posting: # 22775 Views: 3,283 |
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Thank you much, Helmut, for clarifying the issue. Sincerely Ahmed |
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Ahikal ☆ Egypt, 2022-02-12 15:58 (964 d 05:09 ago) @ Helmut Posting: # 22776 Views: 3,340 |
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Now a question arises, which way should be submitted to regulatory authorities? |
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Helmut ★★★ Vienna, Austria, 2022-02-12 16:02 (964 d 05:06 ago) @ Ahikal Posting: # 22777 Views: 3,288 |
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Hi Ahmed, ❝ Now a question arises, which way should be submitted to regulatory authorities? Simple: The one you stated in the protocol. — 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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Ahikal ☆ Egypt, 2022-02-12 16:41 (964 d 04:26 ago) @ Helmut Posting: # 22778 Views: 3,278 |
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Thanks again Ahmed |
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Ahikal ☆ Egypt, 2022-02-17 23:16 (958 d 21:51 ago) @ Helmut Posting: # 22792 Views: 3,177 |
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Hi Helmut, One last question, if you separate the two test products, do you maintain three periods or make it as two period? Best Regards Ahmed |
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Helmut ★★★ Vienna, Austria, 2022-02-17 23:33 (958 d 21:35 ago) @ Ahikal Posting: # 22794 Views: 3,157 |
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Hi Ahmed, ❝ One last question, if you separate the two test products, do you maintain three periods or make it as two period? You have to keep the codes (sequence, period). See here (scroll down to David Brown’s slides) and there. — 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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Ahikal ☆ Egypt, 2022-02-18 00:45 (958 d 20:22 ago) @ Helmut Posting: # 22796 Views: 3,163 |
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Hi Helmut, Thanks a million Best Regards Ahmed |
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dshah ★★ India, 2022-02-18 11:26 (958 d 09:41 ago) (edited by dshah on 2022-02-18 16:27) @ Ahikal Posting: # 22797 Views: 3,108 |
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Dear Ahmed! Particularly for EMA as per the guideline: - "In studies with more than two treatment arms (e.g. a three period study including two references, one from EU and another from USA, or a four period study including test and reference in fed and fasted states), the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question." So you will need to show the calculations separately. Regards, Dshah |
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Ahikal ☆ Egypt, 2022-02-25 14:42 (951 d 06:25 ago) @ dshah Posting: # 22805 Views: 3,000 |
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Dear Dshah: Thank you, this is how our regulatory committee wanted me to do it, and I was fighting them Best Regards Ahmed |
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Ahikal ☆ Egypt, 2022-02-25 15:22 (951 d 05:46 ago) @ dshah Posting: # 22806 Views: 3,014 |
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Dear Dshah; ❝ Particularly for EMA as per the guideline" Would you please provide me with a reference to this Best Regards Ahmed |
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Helmut ★★★ Vienna, Austria, 2022-02-25 15:37 (951 d 05:30 ago) @ Ahikal Posting: # 22807 Views: 2,965 |
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— 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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Ahikal ☆ Egypt, 2022-02-26 10:54 (950 d 10:13 ago) @ Helmut Posting: # 22808 Views: 2,990 |
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Dear Helmut: Got it, my apology Sincerely Ahmed |
Ing. Helmut Schütz