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scorp2011 ☆ India, 2015-04-01 08:12 (4098 d 17:34 ago) Posting: # 14644 Views: 9,118 |
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Dear Members, I have the below listed query: Whether it is possible to calculate BE parameters for a 2-group 2-Period Crossover BE study in Phoenix Winnonlin 6.3. If yes, kindly share the step by step procedure. Thanks in advance. Regards Sonu Edit: Category changed. [Helmut] |
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mittyri ★★ Russia, 2015-04-01 09:06 (4098 d 16:39 ago) @ scorp2011 Posting: # 14645 Views: 7,841 |
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Dear Sonu, I'm little bit bewildered: did you read the user's guide for Phoenix? It's included to the main program. Also you can find there some examples. By the way you can find one great template on this forum. Very detailed instruction is also presented. — Kind regards, Mittyri |
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scorp2011 ☆ India, 2015-04-01 10:28 (4098 d 15:17 ago) @ mittyri Posting: # 14648 Views: 7,737 |
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Dear Sir, Thanks for the prompt response. I am a bit confused now and I am now trying to be little clear with query. A crossover BE study conducted in two groups due to logistical reasons. In group I, 18 subjects were dosed. In group II, another 18 subjects dosed. My question is whether there is a provision in Phoenix Winnonlin 6.3 to analyze the group effect. If group effect is found significant, can we calculate bioequivalence parameters after including this group effect in Winnonlin 6.3 after including group effect in fixed variance or any other effects, Regards Sonu |
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mittyri ★★ Russia, 2015-04-01 10:48 (4098 d 14:57 ago) @ scorp2011 Posting: # 14650 Views: 7,648 |
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Dear Sonu, You can modify the model before executing the BEQ module by including the group effect. The information about the group belonging for each subject should be added accordingly. The ANOVA results will show the significance of all effects. — Kind regards, Mittyri |
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scorp2011 ☆ India, 2015-04-01 11:37 (4098 d 14:08 ago) @ mittyri Posting: # 14652 Views: 7,632 |
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Dear Sir, I am unable to find the procedure. Request you to please see if you can kindly share the procedure to include the group effect. Regards Sonu |
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Helmut ★★★   Vienna, Austria, 2015-04-01 15:34 (4098 d 10:11 ago) @ scorp2011 Posting: # 14653 Views: 7,715 |
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Hi Sonu, ❝ A crossover BE study conducted in two groups due to logistical reasons. ❝ In group I, 18 subjects were dosed. ❝ In group II, another 18 subjects dosed. You used the past tense. For the future it might be a good idea not to perform a study if you don’t know how to analyze it. The model(s) and procedures should be stated in the clinical protocol and/or SAP. ❝ My question is whether there is a provision in Phoenix Winnonlin 6.3 to analyze the group effect. Sure – RTFM: Section ‘Bioequivalence’ and details about specifying effects in section ‘Linear Mixed Effects Modeling’. ❝ If group effect is found significant, can we calculate bioequivalence parameters after including this group effect in Winnonlin 6.3 after including group effect in fixed variance or any other effects, Whether you include a group-term or not does not affect the residual error. Therefore, the PE and CI will be identical in both cases. For a discussion see this thread. If you are unsure about the setup, register at Certara’s Forum where you could upload your project-file. PS: I suggest to update to Phoenix/WinNonlin 6.4 (released last November). — 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 |
Ing. Helmut Schütz