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Survey: Value of collecting PK data in late phase clinical trials

From: Mehrotra, Nitin <Nitin.Mehrotra>
Date: Wed, 31 Mar 2010 08:13:12 -0400

Dear All:
While sparse PK sampling in late phase trials (so-called phases 2, 3) is
becoming a norm these days, the value-based proposition of sparse
sampling is not well documented. Each of us might have been asked to
justify the need for such sampling time and again. We are in the process
of evaluating the value of sparse PK sampling in late phase trials
across NDA/BLAs, and we need your blinded input via a 5 minute survey!
Please click on the Google link provided above to access the survey.
Click "Submit" at the bottom of the page when you are done. Your time
and input is highly appreciated.
This survey is a follow up of the poster presentation at the American
Conference on Pharmacometrics (ACoP 2009) highlighting the value of
collecting PK data in late phase clinical trials specifically from a
regulatory perspective
PS: The results from the current survey will be made publicly available
via a publication of the above poster and can be used by all of us.

Nitin Mehrotra
Office of Clinical Pharmacology
US Food and Drug Administration

"The contents of this message are mine personally and do not necessarily
reflect any position of the Government or the Food and Drug

Received on Wed Mar 31 2010 - 08:13:12 EDT

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