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A brief review of Phase 1 and Clinical Pharmacology statistics in clinical drug development
Author(s) -
Patterson Scott D.,
Jones Byron
Publication year - 2007
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.280
Subject(s) - clinical pharmacology , drug development , drug , pharmacology , statistical analysis , medicine , statistics , mathematics
Abstract Following a brief description of historical Phase 1 research, Clinical Pharmacology studies, and the role of statistics in this setting, Phase 1 study design and statistical analysis are reviewed. A description of design and analysis for Clinical Pharmacology studies is also provided, and the role of statistics in this area of drug development in the future is discussed. While challenging, this area of statistics in drug development is likely to have an active and engaging future. Copyright © 2007 John Wiley & Sons, Ltd.