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Dear members
Happy new year.i would like to know about how to go about for the
above mentioned study.plz let me know some tips regarding protocol
design.
Regards
Ramu
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The following message was posted to: PharmPK
I assume you refer to single vs multi-dose PK studies?
Would need to know more about what you are trying to achieve and what
the dose interval is expected to be to think about designing a study.
In the simplest case, you would dose QD and take standard PK time-points
to 24 hr. Couple of things to consider
- On the night before the study, be sure that both groups are
handled the same - IE: fasted or fed. Is this an animal study?
- While Cmax and Tmax may vary, the AUC over the dosing interval
should be the same for both groups. If the AUC's are significantly
different, you should worry about induction/inhibition.
Hope that helps,
Joyce
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The following message was posted to: PharmPK
You can refer to USNF, latest edition. There is a chapter on designing
of bioavailability / bioequivalence study. Also there is book available
titled - Design and analysis of Bioavailability and bioequivalence
study.
This will help you in understanding the basic concepts.
Regards
Mitesh Gandhi
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