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Improvement in Dose Selection: FDA Perspective

Improvement in Dose Selection: FDA Perspective. IDSA/ISAP/FDA Workshop April 16, 2004 Jenny J Zheng, Ph.D. Pharmacometrician DPEIII/OCPB/CDER/FDA. Objectives. To discuss the studies to support dose selection To discuss a model based quantitative approach to guide dose selection

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Improvement in Dose Selection: FDA Perspective