Bioequivalence and Statistics in Clinical Pharmacology

By Scott Patterson

Includes a wide range of examples, derived from drug development and regulatory applications, with datasets, SAS, BUGS, and SPLUS code available on the Internet Features applications of statistics in clinical pharmacology drug development with an emphasis on scientific and regulatory applications Includes discussion of manufacturing, safety, pharmacokinetic, and efficacy assessment in drug development and clinical pharmacology, and where and how statistics fit in Presents the real-world use of statistical analysis and design of bioequivalence and clinical pharmacology studies for use in medical, scientific, and regulatory decision making and drug labeling Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology explores statistics used in day-to-day clinical pharmacology work. The book covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the proposed methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, and dose-proportionality trials. Purposefully designed to be instantly applicable, the book provides examples of SAS code so that the analysis described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS. Each chapter includes a

• Format: Hardcover
• Language: English
• ISBN: 1584885300
• ISBN13: 9781584885306
• Release Date: November 2005
• Publisher: Chapman & Hall/CRC
• Length: 374 Pages
• Weight: 1.55 lbs.
• Dimensions: 1.0" x 6.4" x 9.4"