Outlier [Study As­sess­ment]

posted by NK – India, 2023-06-27 05:57 (161 d 04:09 ago) – Posting: # 23616
Views: 864

Dear All,

Please give your valuable inputs.

We have performed 2x2 fasting BE pivotal study for USFDA after seeing pilot study results.

We've noted following from pivotal study data,How to handle this subject’s data? Outlier? Can the regulatory accept the based on Cmax and AUC0-t results?

Can we select the time point manually for Kel calculation instead of best fit method by the tool?

Thanks & Regards

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

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