devishabana
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2005-09-24 14:38

Posting: # 34
Views: 15,484
 

 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
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2005-09-24 18:12

@ devishabana
Posting: # 35
Views: 11,397
 

 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).

Cheers,
Helmut Schütz
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