Bioequivalence and Bioavailability Forum

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.

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PS: I suggest to update to Phoenix/WinNonlin 6.4 (released last November).