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Overview
The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition.
Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies.
Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.
Synopsis
The pharmaceutical industry has a complex relationship with the study and application of statistics: on the one hand, success in the marketplace and in the development and approval processes depends largely on statistical analysis, and software is making it easier to use statistics in these phases, regulatory requirements have demanded deeper and more complex analyses that even the most up-to-date computing may have trouble attaining exactly to specification. This edition, which has been updated to reflect recent trends and developments, includes chapters written by specialists and covers what regulatory bodies find to be acceptable methodologies. The 24 chapters include such topics as the FDA and the IND/NDA statistical review process, statistics within cancer clinical trials, clinical trials of analgesic drugs, interim analysis and bias, data monitoring, postmarketing studies and the impact of the global economy on tracking and reporting. Annotation © 2006 Book News, Inc., Portland, OR
Journal of the American Statistical Association
The editors should be hailed for their effort to address [a] wide scope of topics... "A unique feature of the book is that many chapters were written by statisticians working for the U.S. Food and Drug Administration (FDA)...[providing] readers with some guidance on what the FDA considers acceptable or questionable. This special feature makes the book a good reference for statisticians (and even nonstatisticians).... "...contains...important information...worthwhile reading.
Editorials
From The Critics
Reviewer: Dan Blaukopf, MS (GlaxoSmithKline)Description: This text describes statistical methods and issues as they related to the pharmaceutical industry.
Purpose: The purpose is to introduce statisticians to the drug development process and describe statistical methods and issues relevant to the pharmaceutical industry. Statisticians interested in working in the pharmaceutical industry will find this book of value.
Audience: This book is one of a series on practical application of statistical theory in a particular field. Graduate students and faculty in statistics, as well as statisticians entering the pharmaceutical industry will find this book of value.
Features: Each chapter addresses a topic related either to the drug development process or the application of statistical methods in the pharmaceutical setting. Special attention is given to clinical trials related to cancer, HIV/AIDS, and hormone replacement therapy research.
Assessment: This is a useful overview of the drug development process and statistical methods for statistician working in the pharmaceutical industry. As with any text, this book will need to be updated to keep up with new developments in the field. This third edition covers special topics not previously covered.