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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!
ACCESS SURVEY: https://spreadsheets.google.com/viewform?formkey=dHh3QUc2Yi1ZSmlCMGZ4a21jS0cySVE6MA
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 Pharmacometrics Office of Clinical Pharmacology US Food and Drug Administration
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If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Survey: Value of collecting PK data in late phase clinical trials" as the subject
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