Log in
RegisterAdderall XR: pAUCs [NCA / SHAM]
posted by Helmut 
– Vienna, Austria, 2012-10-02 01:50 (4643 d 17:03 ago) – Posting: # 9295
Views: 6,315
Hi all (& especially John),
FDA issued another guidance requiring partial AUCs for biphasic products (mixed salts of amphetamine, RLD Adderall XR). PK metrics are Cmax, AUC0-5, AUC5-t, AUC∞. Clinical justification of the truncation time point is similar to methylphenidate (tmax after IR 3±1h); but identical for fasting and fed studies (MPH: 3h fasting, 4h fed).
FDA issued another guidance requiring partial AUCs for biphasic products (mixed salts of amphetamine, RLD Adderall XR). PK metrics are Cmax, AUC0-5, AUC5-t, AUC∞. Clinical justification of the truncation time point is similar to methylphenidate (tmax after IR 3±1h); but identical for fasting and fed studies (MPH: 3h fasting, 4h fed).
—
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!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Adderall XR: pAUCsHelmut 2012-10-01 23:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Adderall XR: pAUCs jag009 2012-10-02 15:10
- Guidance Sep 2012 Helmut 2012-10-02 15:32
- Guidance Sep 2012 jag009 2012-10-02 16:44
- Guidance Sep 2012 Helmut 2012-10-02 15:32
- Adderall XR: pAUCs jag009 2012-10-02 15:10
Ing. Helmut Schütz