Bioequivalence and Bioavailability Forum • Plateau-time etc.

Plateau-time etc. [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2013-08-27 16:44 (4681 d 23:29 ago) – Posting: # 11356
Views: 12,526

Hi K@K,

❝ 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.

What do you not understand? The PK metrics as such, or why they are mentioned in the guideline, or what?

t_75% is the “Plateau time” – sometimes also called “POT-75” (Peak Occupancy Time 75%). The other metric is somewhat unusual. First calculate C_av = AUC_τ/τ and then the time interval where C ≥C_av.

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Complete thread:

Russian Guidance – PK Data assay Karthikeyan 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