devishabana
●    

2005-09-24 16:38
(6760 d 01:41 ago)

Posting: # 34
Views: 19,318
 

 what is the major role of PK in BE [Off Topic]

I have doubt ie what is the major role of pharmacokinetics in BE studies.
Is it his role is starts from the designing of the BE study and till the report. Kindly clarify my doubt. If you dont mind.

what is the eligibility to become the pharmacokinetist for BE studies.

thanks in advance.

devi.
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2005-09-24 20:12
(6759 d 22:08 ago)

@ devishabana
Posting: # 35
Views: 14,044
 

 what is the major role of PK in BE

Dear devi!

❝ … what is the major role of pharmacokinetics in BE studies.

❝ Is it his role is starts from the designing of the BE study and till the report. Kindly clarify my doubt. If you dont mind.


Knowledge of the PK of your drug helps a lot in the planning stage.

But since according to the guidelines BE studies must be evaluated by noncompartmental methods,* actual PK experience in the evaluation stage generally is restricted to the ability to choose which data points are on a straight line in lin/log-plots ;-)

❝ what is the eligibility to become the pharmacokinetist for BE studies.


To my knowledge PK experts are very rarely involved in the evaluation of BE studies (mainly people are statisticians, chemists, physicians, etc.)
If you are a pharmacokinetist, your skills probably will ‘overpower’ the study ;-)


  • OK, there are exceptions, like studies performed in children, where the only ethical approach would be a population PK study (even for BE).

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
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
75 visitors (0 registered, 75 guests [including 10 identified bots]).
Forum time: 17:20 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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