As the plasma concentration is increased, with larger doses one may begin to see effects in the patients. Hopefully there is an acute surrogate that will predict efficacy. Relate these effects to plasma concentration profiles. Soon you will be ready for multiple doses.

The first multiple-dose patient might be given just a few doses. Shouldn't this be one of the single-dose patients in whom you can predict precisely the plasma concentration profiles after multiple doses from studying the single dose? Later patients might be treated for as long as test animals have indicated repetitive dosing to be safe.

In every patient, dosing should be based on all the knowledge gained from all prior animal and clinical studies, from everything known about that patient, and from the best prediction of what plasma concentrations will be achieved after the dose.

0 0

Post a comment