Russian Guidance – PK Data assay [NCA / SHAM]
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).
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.
Please help me out in understanding this.
Thanks,
K@K
Edit: Category changed. [Helmut]
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).
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.
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
- 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
- t75% mittyri 2013-08-28 09:51
- t75% Helmut 2013-08-27 17:37
- t75% Dr_Dan 2013-08-27 16:56
- 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
- Partial AUC? Dr_Dan 2013-08-28 21:08
- Russian Guidance – PK Data assay Helmut 2013-08-27 16:31