Bioequivalence and Bioavailability Forum

Canadian variation [NCA / SHAM]

posted by d_labes  – Berlin, Germany, 2010-08-27 16:06 (5764 d 16:42 ago) – Posting: # 5855
Views: 9,972

Dear Helmut, dear Nees!

❝ 1. Calculate the median of t_max values observed in all

❝   subjects under the reference treatment.

❝ 2. Calculate partial AUCs from t=0 to this time point for all subjects

❝   under all treatments. ...

------ [nitpicking] ------ .
If you calculate partial AUC for a Canadian submission change the algo to:

1. Read off the time of max. concentration from the concentration-time course of Reference for each subject.
   
2. Calculate partial AUC's from t=0 to these time points for each subject under both treatments.

------ [/nitpicking] ------

See the guidance section of this great forum:
Notice to Industry
Bioequivalence Requirements for Drugs for Which an Early Time of Onset or Rapid Rate of Absorption Is Important (rapid onset drugs)

Complete thread:

• AUCreftmax neethu 2010-08-27 08:59 [NCA / SHAM] 
  • US, Canada only Helmut 2010-08-27 13:32
    • Canadian variationd_labes 2010-08-27 14:06
      • Canadian variation Helmut 2010-08-27 14:19
        • Canadian variation neethu 2010-08-30 06:09
          • Canadian variation Parveen Arora 2012-05-22 08:35
  • AUCreftmax SDavis 2012-06-28 22:29