reason to exclude volunteer [Study As­sess­ment]

posted by Loky do – Egypt, 2024-11-10 12:52 (92 d 14:47 ago) – Posting: # 24267
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Dears

I am working on fed and fasted studies for a bilayer drug containing empagliflozin/metformin XR. In the fed study, one volunteer showed no measurable concentration of empagliflozin for the test product, although a measurable concentration of metformin was observed in the same individual. The sponsor asserts that empagliflozin does not require a reliable concentration in the fed state since it is intended to be taken in the fasted state and is immediate-release, which would, in their view, negate the need for fed-state evaluation.

We attempted to include this subject in the statistical calculations; however, SAS and WinNonLin automatically excluded the subject due to the missing concentration for empagliflozin, resulting in a passed study.

As the CRO, we have raised concerns, viewing the lack of measurable concentration for empagliflozin in the fed state as a potential issue regarding product conformity. How can we configure the statistical software to include this subject in the analysis, potentially yielding a failed study outcome? Alternatively, what rationale could we provide in the study documentation to ensure regulatory acceptance of our approach and prevent potential questions for the CRO?.
Thanks in advance


Edit: Category changed; see also this post #1[Helmut]

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