Bioequivalence and Bioavailability Forum • Russian Guidance

Russian Guidance – PK Data assay [NCA / SHAM]

posted by Karthikeyan – India, 2013-08-27 15:54 (4688 d 08:05 ago) – Posting: # 11355
Views: 14,346

Dear all,

i was going through the PK data assay in Russian guidance and i could not understand the following

6.1. Single dosing of pharmaceutical product
Further analysis of pharmacokinetic data assuming calculation of individual; rates AUCt or AUC∞ … for usual forms, and for prolonged-release forms – duration of time when drug substance concentration is 75% higher the Cmax (T>75%Cmax). :confused:

6.2. Repeat dosing of pharmaceutical product
For prolonged-released forms duration of time period is calculated when drug substance concentration is higher than mean steady-state value Css (T>Css), and T>75%Cmax. :confused:

Please help me out in understanding this.
Thanks,

K@K

Edit: Category changed. [Helmut]

Complete thread:

Russian Guidance – PK Data assayKarthikeyan 2013-08-27 13:54 [NCA / SHAM]
- Plateau-time etc. Helmut 2013-08-27 14:44
- Russian Guidance – PK Data assay Dr_Dan 2013-08-27 15:39
  - Russian Guidance – PK Data assay Helmut 2013-08-27 16:31
    - t75% Dr_Dan 2013-08-27 16:56
      - t75% Helmut 2013-08-27 17:37
        
        t75% mittyri 2013-08-28 09:51
        
        t75% (reporting only?) Helmut 2013-08-28 14:32
  - Partial AUC? Helmut 2013-08-28 17:42
    - Partial AUC? Dr_Dan 2013-08-28 21:08
      - Partial AUC? Karthikeyan 2013-08-29 14:04