Sunday, June 15, 2008

Calculation of length of the study drug exposure

We have been using the following formula in calculating the length of the study drug exposure in many studies:

# of days of drug exposure = the last dose date - the first dose date + 1

However, this seems to be correct only if the subject receive daily dose of the study medication. We have many studies where the subject receive weekly infusion or every three weeks infusion of the study medication. In this situation, the above formula will underestimate the length of the study drug exposure.

The correct formula should be tied up with the dose interval.

If a subject receive weekly dose, the formula would be:
# of days of drug exposure = the last infusion date - the first infusion date + 7
or
# of weeks of drug exposure = (the last infusion date - the first infusion date + 7)/7

If a subject receive study drug every three weeks, the formula would be:
# of days of drug exposure = the last infusion date - the first infusion date + 21
or
# of weeks of drug exposure = (the last infusion date - the first infusion date + 21)/7

1 comment:

pawan28887 said...

Thanks for the info.. could u please share your mail id. as i am working on "Drug Exposure and their representation"

Thanks,
Pawan
pawan28887@gmail.com