Meets primary objective but not secondary objective [Study As­sess­ment]

posted by kratos – India, 2020-03-31 03:17 (210 d 19:18 ago) – Posting: # 21309
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Hi Brus,

Many a times the metabolite has different pharmacokinetics than that of the parent drug.
It is common to design a study only with the parent drug in mind. With timepoints around the Tmax of the parent drug, ignoring the metabolite PK.
In such a case, the design is more in favour of a proper evaluation of the parent drug !
Also sample size calculation is often performed considering the ISCV of the parent drug (in case it is the BE determinant).
The supportive data swings by, not being 'appropriately' evaluated.
It all depends on the regulatory requirement for the application.
FDA verifies point estimate values for supportive data; not the ANOVA, so sample size would not be so significant.
EMA on the other hand, for generics, the preference is always to measure the parent when feasible.
Only in case of a rapid conversion - the major metabolite is considered. . .
It would ultimately depend on the goals of your application.

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