What ’bout science? [NCA / SHAM]
Hi Compliance,
Impossible without a crystal ball. You should know the PK/PD of the API and the properties of the formulation.
The GL states:
❝ Please teach me how to decide/ fix partial AUC regimen.
![[image]](img/uploaded/image77.jpg)
❝ Europe guidance for modified release formulation ask for the partial AUC but i don't have knowledge how to select regimen for partial AUC.
The GL states:
An early partialAUC(0 – cut-off t) and a terminal partialAUC(cut-off t - tlast), separated by a predefined cut-off time point, e.g. the half of the dosage interval are recommended, unless otherwise scientifically justified.
In other words, if you have no clue you could always use τ/2. For some formulations (e.g., biphasic release) such a cut-off is meaningless and IMHO, for the others of doubtful value. I cannot imagine a situation where I would ever use it myself. That’s why the second option was added in the final version. Up to you.—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- How to decide partial AUC Compliance 2016-02-11 09:02 [NCA / SHAM]
- What ’bout science?Helmut 2016-02-11 17:43
- What ’bout science? Jay 2016-02-16 08:21
- What ’bout science? Helmut 2016-02-16 13:12
- What ’bout science? Jay 2016-02-16 08:21
- What ’bout science?Helmut 2016-02-11 17:43