akif
☆    

Turkey,
2021-03-22 21:36
(1899 d 23:06 ago)

Posting: # 22287
Views: 4,967
 

 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
(1899 d 08:39 ago)

@ akif
Posting: # 22292
Views: 3,781
 

 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
(1898 d 02:43 ago)

@ Helmut
Posting: # 22293
Views: 3,783
 

 AUC passes, Cmax fails: biopharmaceutical difference

Merhaba Helmut :)

Thank you
UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
254 visitors (0 registered, 254 guests [including 40 identified bots]).
Forum time: 21:43 CEST (Europe/Vienna)

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

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