Bioequivalence and Bioavailability Forum

Puzzle: Estimation of half life [Surveys]

posted by d_labes  – Berlin, Germany, 2011-07-28 10:44 (4649 d 05:47 ago) – Posting: # 7230
Views: 9,518

Dear Helmut!

❝ What do you think?

The more interesting question is: What do regulators think?
I never have seen deficiency questions concerning the fit of the terminal phase of concentration time courses in my ~30 years career. Even if the 'fit' was done with only 2 points .

Although I find the fit a little bit strange, I have the opinion it doesn't matter much in the case shown.

• Half live is only a secondary/additional metric analysed by summary statistics only.
  "... The mean half life was found for Test as 5.018 hours and for Reference as 5.021 hours with a standard deviation of ..."
  
• Extrapolations to infinity for AUC will obviously affected only to a minor extent. And this is the main reason to calculate the half life within a BE study.

OK, OK not so very scientific, if one has that pretension.

BTW: What is Your eyeball solution for this curve?

Complete thread:

• Puzzle: Estimation of half life Helmut 2011-07-26 16:03 
  • Puzzle: Estimation of half life ElMaestro 2011-07-27 10:58
    • Puzzle: Estimation of half life Helmut 2011-07-27 15:10
  • Puzzle: Estimation of half lifed_labes 2011-07-28 08:44
    • Puzzle: Estimation of half life Helmut 2011-07-28 11:38
  • Puzzle: Estimation of half life ElMaestro 2011-07-28 10:24
    • Puzzle: Estimation of half life Helmut 2011-07-28 11:53
      • 100% QC? ElMaestro 2011-07-28 16:38
        • No idea Helmut 2011-07-28 17:03