Comparative PK? [Study Per­for­mance]

posted by PVRC – India, 2021-05-12 17:48 (569 d 07:33 ago) – Posting: # 22346
Views: 1,266

Hi Helmut,

Thank you for the reply..,

❝ ❝ […] the agency …


❝ May I ask: Which agency?


The FDA

❝ … recommend to demonstrate comparative PK in the absence of bioequivalence.


❝ Do I get you right: The study was planned to demonstrate BE, failed, and now you were asked about ‘comparative PK’? I never came across such a term.


The following is the guidance....

To use pharmacokinetics (PK) bridging only, you should establish bioequivalence between test drug the listed drug under both fasting and fed conditions.

If the bioequivalence cannot be established due to different food effect or other reasons, you should demonstrate comparable PK and pharmacodynamics (PD) between Test and reference.

To establish "comparable PK" between test and reference, the active drug exposure (AUC, Cmax and Ctrough) of test at the proposed dosing regimen should be comparable with the listed drug.

Thanks

Complete thread:

UA Flag
Activity
 Admin contact
22,426 posts in 4,694 threads, 1,600 registered users;
23 visitors (0 registered, 23 guests [including 9 identified bots]).
Forum time: 00:22 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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