Statistics In the Pharmaceutical Industry

Statistics In the Pharmaceutical Industry, 3rd Edition, is a reference work that clarifies the drug approval process by combining perspectives from regulatory agencies and pharmaceutical companies. The volume explains how statistical methodologies guide drug evaluation across the entire development pathway.

Coverage spans experimental design, active-controlled equivalence trials, and post-marketing research. The text also reviews specific methodological considerations in targeted disease areas, such as anti-cancer trials and HIV/AIDS research.

Intended for graduate students in statistics or biostatistics, statisticians, and researchers in health-related disciplines, the book supports professionals seeking a comprehensive understanding of statistical practices throughout pharmaceutical research and development.