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This book covers the applications and basic elements of the theory of statistical methods in clinical pharmacology. It establishes techniques used in the assessment of bioequivalence and describes the use of statistics in clinical pharmacology studies of safety, ECG monitoring, efficacy, and population pharmacokinetics. The authors demonstrate study design, analysis, and interpretation of data using real-data examples. The book features a wide range of datasets as well as SAS and SPLUS code available from the Internet; emphasizes regulatory applications regarding applications of statistics in drug development; and presents the statistical analysis and design of bioequivalence and clinical pharmacology studies.