Bioequivalence and Bioavailability Forum

Missing samples [Study As­sess­ment]

posted by Amira Gouda – Egypt, 2020-05-01 23:50 (139 d 16:03 ago) – Posting: # 21383
Views: 1,999

Hi ElMaestro,

thanks for your reply

» This guy is clearly not participating PP, his AUC is not outright a meaningful indicator of product performance, so out he goes, I think.

Yes, he actually missed the terminal phase, his AUC0-t is about 17% of his AUC0-inf, also check his figure



What we could do?

1- Extrapolate to 72 h
2- Use AUC common (0-12)
3- or based on the results of the current study could we make another stage on 12 subjects (knowing that the first one was performed on 24)?
4- Exclude the subject from stat evaluation of AUC(0-t) and include in all other parameters (as long as it does not jeopardize the acceptance of the study)

looking forward to your opinion
thanks

Complete thread:

• Outlier in BE study Amira 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 samplesAmira Gouda 2020-05-01 23:50
              • Options Helmut 2020-05-02 11:35
                • Options Amira Gouda 2020-05-03 21:15