akif
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Turkey,
2021-03-22 20:36
(509 d 04:52 ago)

Posting: # 22287
Views: 1,225
 

 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
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Vienna, Austria,
2021-03-23 11:03
(508 d 14:25 ago)

@ akif
Posting: # 22292
Views: 972
 

 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.

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akif
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Turkey,
2021-03-24 16:59
(507 d 08:29 ago)

@ Helmut
Posting: # 22293
Views: 923
 

 AUC passes, Cmax fails: biopharmaceutical difference

Merhaba Helmut :)

Thank you
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