AUC passes, Cmax fails: biopharmaceutical difference [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2021-03-23 12:03 (686 d 04:17 ago) – Posting: # 22292
Views: 1,065

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

Complete thread:

UA Flag
Activity
 Admin contact
22,485 posts in 4,710 threads, 1,603 registered users;
28 visitors (0 registered, 28 guests [including 9 identified bots]).
Forum time: 16:21 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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