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BioPharmaceutical Clinical Trials Regulation

Remember The Basics: Dosing, Placebo Issues Recur In FDA Reviews

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Fundamental trial design issues, from the selection of doses to the use of placebo controls, recur as problems in FDA reviews of new drugs. Post-market studies can remedy missing data, but at a cost.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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