Russian Guidance – PK Data assay [NCA / SHAM]

posted by Karthikeyan – India, 2013-08-27 15:54 (3865 d 22:46 ago) – Posting: # 11355
Views: 9,329

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]

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