Drug Discovery
New findings from Center for Drug Evaluation and Research in the area of drug discovery described
Published in Medical Letter on the CDC and FDA, March 4th, 2007
Research findings, "Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006," are discussed in a new report. "Exploratory analyses of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression are often referred to as the pharmacometrics (PM) analyses. The objective of the current report is to assess the role of PM, at the Food and Drug Administration (FDA), in drug approval and labeling decisions," investigators in the United States report.
"We surveyed the impact of PM analyses on New Drug Applications (NDAs) reviewed over 15 months in 2005-2006. The survey...
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