akif
☆    

Turkey,
2021-03-22 21:36
(1271 d 23:58 ago)

Posting: # 22287
Views: 2,588
 

 Why is just Cmax out of specification? [PK / PD]

Hi Everyone,

I want to know that why while auc with in spect Cmax out of it? its means that test has higher dissolution rate everytime, or can cause another thing such as CRO, design of study, bioanalytical method?
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2021-03-23 12:03
(1271 d 09:31 ago)

@ akif
Posting: # 22292
Views: 2,034
 

 AUC passes, Cmax fails: biopharmaceutical difference

Merhaba akif,

❝ I want to know that why while auc with in spect Cmax out of it? its means that test has higher dissolution rate everytime, …


Only if your drug is in BCS class I or – under certain conditions – in class III, dissolution plays a major rule. If in class II/IV, dissolution is not predictive. There are a manifold of reasons with the absorption rate differs between products. Even if excipients and their amount are identical, differences in the manufacturing process may explain the different absorption.

❝ … or can cause another thing such as CRO, …


No.

❝ … design of study, …


Only if you have problems with a “first point Cmax”.

❝ … bioanalytical method?


No.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
akif
☆    

Turkey,
2021-03-24 17:59
(1270 d 03:35 ago)

@ Helmut
Posting: # 22293
Views: 2,013
 

 AUC passes, Cmax fails: biopharmaceutical difference

Merhaba Helmut :)

Thank you
UA Flag
Activity
 Admin contact
23,225 posts in 4,879 threads, 1,652 registered users;
44 visitors (0 registered, 44 guests [including 10 identified bots]).
Forum time: 22:35 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5