Statistics In the Pharmaceutical Industry

The pharmaceutical industry has grown significantly over the past decade, but the impact of this growth on statistics is confusing. This Third Edition of Statistics in the Pharmaceutical Industry provides updated and expanded information to reflect the latest trends and developments in the field, including experimental design, post-marketing studies, global harmonization of regulatory standards, and anti-cancer studies. It combines regulatory and industrial points of view to demystify the approval process and is a must-read for anyone performing statistical analysis at any point in the drug approval process.

Format: Paperback / softback
Length: 496 pages
Publication date: 21 January 2023
Publisher: Taylor & Francis Ltd

The pharmaceutical industry has experienced remarkable growth over the past decade, but the impact of this growth on statistics remains somewhat perplexing. While software has undoubtedly streamlined and enhanced the analysis process, regulatory bodies now require deeper and more intricate analyses, necessitating the use of pharmacogenetic/genomic studies. For over two decades, Statistics in the Pharmaceutical Industry has served as the authoritative approach to navigating the complexities within the industry, and this Third Edition continues that legacy.

In an effort to reflect the most recent trends and advancements in the field, this Third Edition has been extensively updated and expanded. Chapters authored by experts from both regulatory agencies and pharmaceutical companies cover a wide range of topics, including experimental design, post-marketing studies, and more. This comprehensive approach sheds light on the methodologies that regulators deem acceptable and the strategies that have proven successful for industrial statisticians.

Recognizing the increasingly global nature of the industry, authors from Japan and Europe have contributed to this edition, along with authors from other regions. The book also delves into the growing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. Furthermore, the book examines the latest considerations in anti-cancer studies.

By presenting a balanced perspective that combines regulatory and industrial viewpoints, Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process. It serves as a vital resource for anyone involved in statistical analysis at any stage of the drug approval process, providing valuable insights and guidance.

Weight: 920g
Dimension: 229 x 152 (mm)
ISBN-13: 9781032477879
Edition number: 3 ed