Bioequivalence and Bioavailability Forum

Dear NK!

❝ How to handle this subject’s data? Outlier? Can the regulatory accept the based on C_max and AUC_0-t results?

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

The CRO have SOP for handling such observation. Kindly follow the SOP and treat accordingly.

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The SOP I am talking of CRO are mainly w.r.t. repeat analysis.

Kindly ask for Investigation for failed analytical runs or abnormal/unexpected results or Anomalous Value repeats.

1. An investigation must be conducted to determine the cause whenever analytical run failure or abnormal / unexpected results are observed.

b. A detailed investigation is required in case, low or below LLOQ concentration obtained in an entire period, re-analysis of a particular set of samples, poor chromatography obtained in a particular period and others, but not limited to above list.


Regards,
Divyen

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Edit: Second part merged with a later (now deleted post). You can edit your original post for 24 h. [Helmut]