Log in
RegisterThe x unveiled [Regulatives / Guidelines]
Dear Helmut,
Thanks for the reply. As I understood, Cmax(x) denotes for an Immediate release phase of the formulation and Cmax(x+1) denotes for the modified release phase of the formulation. Please correct if I am wrong.
In addition to Cmax(0-2) & Cmax(2-t), shall I consider Cmax(total) [i.e. Cmax(0-t)] to demonstrate BE?
Based on the above discussion shall I keep below PK parameters to demonstrate BE?
AUC0-t, AUC0-∞, partialAUC(0-2), partialAUC(2-t), Cmax(0-2), Cmax(2-t) & Cmax(0-t).
Thanks for the reply. As I understood, Cmax(x) denotes for an Immediate release phase of the formulation and Cmax(x+1) denotes for the modified release phase of the formulation. Please correct if I am wrong.
In addition to Cmax(0-2) & Cmax(2-t), shall I consider Cmax(total) [i.e. Cmax(0-t)] to demonstrate BE?
Based on the above discussion shall I keep below PK parameters to demonstrate BE?
AUC0-t, AUC0-∞, partialAUC(0-2), partialAUC(2-t), Cmax(0-2), Cmax(2-t) & Cmax(0-t).
Complete thread:
- Partial AUC & Cmax in case of multiphasic modified release drug product maulik963 2016-05-31 08:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- The x unveiled Helmut 2016-05-31 13:14
- The x unveiledmaulik963 2016-06-02 13:45
- Biphasic: x=2 Helmut 2016-06-02 14:07
- The x unveiledmaulik963 2016-06-02 13:45
- The x unveiled Helmut 2016-05-31 13:14
Ing. Helmut Schütz