Bioequivalence and Bioavailability Forum

Outlier in BE study [Study As­sess­ment]

posted by Amira Gouda – Egypt, 2020-04-28 17:36 (1689 d 14:27 ago) – Posting: # 21354
Views: 7,885
(edited on 2020-04-29 11:02)

Hi,
a BE study of standard design with truncated AUC 0-72, certain subject in one phase completed the samples up to 72 hours (test product) while in the other phase completed up to 12 hours (Reference product) the difference in AUC is very high (4 times) and the results including this subject dramatically changed to be failed
Now could we

1. Consider this subject as an outlier and represent the data without him?
   
2. Re-dose/Re-test this outlier subject again to test the validity for the outlying value?
   
3. perform another stage for the study (knowing that the study power and CV% were satisfactory)?

Are there any references support this issue?

Thanks
Amira

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

Complete thread:

• Outlier in BE studyAmira Gouda 2020-04-28 15:36 [Study As­sess­ment] 
  • Outlier in BE study mittyri 2020-04-29 11:50
  • Outlier in BE study Ohlbe 2020-04-29 15:19
    • Outlier in BE study Amira Gouda 2020-04-29 16:35
      • Missing samples Ohlbe 2020-04-29 17:02
        • Missing samples Amira Gouda 2020-04-29 17:08
          • Missing samples ElMaestro 2020-04-29 17:21
            • Missing samples Amira Gouda 2020-05-01 23:50
              • Options Helmut 2020-05-02 11:35
                • Options Amira Gouda 2020-05-03 21:15