Subject-by-Formulation interaction? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2020-07-22 12:03 (189 d 10:30 ago) – Posting: # 21775
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Hi Loky do,

» Now another case for a non highly variable drug, […]

What you confirmed already:What is still possible:
» Is it applicable to consider these subjects as outliers, is there any way to conclude this?

That’s similar to the cases we discussed before. Even if you would perform a statistical test (which is not acceptable acc. to current regulatory practice), you would get a p-value of 0.2453 which would speak against excluding them. Even for Health Canada (where an outlier assessment of studentized model residuals can be done if pre-specified in the protocol) you could exclude only one subject (≤5% if the sample size is ≥20).

» or could we re-dose them again to be confirmed?

Re-dosing is discouraged and likely not accepted.

» or simply the product fails :-|?

I’m afraid, yes.

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