Statistics In the Pharmaceutical Industry

Published in 2005 by CRC Press Inc, the Third Edition of Statistics In the Pharmaceutical Industry, authored by C. Ralph Buncher and Jia-Yeong Tsay, offers a comprehensive look into the evolving role of statistics in modern drug development. The book reflects on how advanced software and increasingly stringent regulatory requirements have reshaped statistical analyses in an industry marked by rapid growth and heightened complexity. This edition brings together contributions from experts entrenched in both regulatory bodies and pharmaceutical companies. By addressing topics ranging from experimental design to post-marketing studies, it offers invaluable insights into accepted methodologies for both statisticians and regulators. The revised chapters not only mirror the global progression of the industry but also delve into innovative approaches such as non-inferiority/equivalence testing, adaptive trial designs, and the harmonization of international regulatory standards. With 504 pages of detailed discussion, Statistics In the Pharmaceutical Industry, Third Edition, demystifies the intricacies of statistical challenges present throughout the drug approval process. Its balanced perspective, merging industrial practices and regulatory insights, makes this volume an essential resource for anyone engaged in pharmaceutical research and development.