Bioequivalence and Statistics in Clinical Pharmacology By Scott Patterson, Byron Jones

Description

Establishing techniques used in the assessment of bioequivalence, this work 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 from bioequivalence and clinical pharmacology studies. They feature a wide range of datasets, as well as SAS and SPLUS code (available for download) and examine regulatory considerations regarding the application of statistics in drug development. This work, as stated in a recent issue of Biometrics, "provides a springboard for all scientists from academia who are looking to do research in this area of medical applications."

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