Outlier [Study As­sess­ment]

posted by dshah  – India/United Kingdom, 2023-06-27 10:42 (360 d 08:28 ago) – Posting: # 23617
Views: 1,274

Dear NK!

❝ 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?

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

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.


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

Complete thread:

UA Flag
 Admin contact
23,059 posts in 4,841 threads, 1,665 registered users;
47 visitors (0 registered, 47 guests [including 9 identified bots]).
Forum time: 19:10 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz