Bioequivalence and Bioavailability Forum • Cmin (story continued)

Cmin (story continued) [NCA / SHAM]

posted by Marcel – 2011-09-16 10:01 (5026 d 09:27 ago) – Posting: # 7355
Views: 8,648

Geia sou, Helmut!

Thanks for the feedback. I think a lot of people are having problem with Cmin because of some of the reasons you mention and because some/most people don't power their studies to Cmin, but to Cmax and occasionally AUC.

At what point do you think the increase in sample size becomes unethical?

Do you have a good reference article that shows that Clast is considered unreliable? By Clast, you mean the sample taken ~5 minutes prior to dosing, right?

Problems will continue to arise with steady state studies until this new draft guideline is released.

Take care,
Marcel

Complete thread:

Cmin (story continued) Helmut 2011-06-22 17:03 [NCA / SHAM]
- Cmin (story continued) Marcel 2011-09-15 10:21
  - Cmin (story continued) Helmut 2011-09-15 14:37
    - Cmin (story continued)Marcel 2011-09-16 08:01
      - Cmin (cave: lengthy post) Helmut 2011-09-16 13:26
        
        Cmin (cave: lengthy post) Marcel 2011-09-20 08:33
        
        Cmin no more? Helmut 2011-09-20 10:08
        
        perspective from the PD world ElMaestro 2011-09-20 10:01
        
        perspective from the PD world Helmut 2011-09-20 10:20