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Doody's Review ServiceReviewer: Rahmat M. Talukder, PhD, RPh (West Coast University School of Pharmacy)
Description: This two-volume compendium focuses on the application of statistical principles to clinical research and design and development of biopharmaceutical products. This edition is considerably revised and updated in the area of regulatory requirements pertaining to the drug approval process. The 230 self-contained chapters, with more than 600 tables and figures, are arranged alphabetically to provide ready access to the respective topics.
Purpose: The essential objectives are to elucidate recent developments in statistical analysis and show how statistical designs and methodologies can be applied in demonstrating safety, efficacy, and quality of drug products. Development of a new drug product and optimization of its processing, manufacturing, quality control, and therapeutic efficacy is often a challenging and complex task. Undoubtedly the use of a suitable statistical design and methodology, at least in part, can help reduce the overall time and cost of the drug development process. In that respect, this is an excellent resource for anyone interested in learning the application of statistical concepts, tests, and analytical methods to pharmaceutical research projects. The second edition was well received by pharmaceutical scientists, and this updated edition will be as well.
Audience: This is an excellent reference for researchers and scientists working in the pharmaceutical industry, clinical sciences, and academia. Members of regulatory agencies who are actively involved in the drug review and approval process also will find this an extremely helpful resource. The editor is well known for his expertise in pharmaceutical statistics, and over 280 scholars, scientists, and statisticians from academia, industry, and regulatory agencies, some of whom are internationally recognized experts in their fields, have contributed to this compendium.
Features: This edition adds many new chapters to reflect current regulatory requirements in the drug approval process and the development of new statistical methods and their applications in pharmaceutical sciences. Chapters of particular interest to pharmaceutical scientists cover topics such as adaptive design methods in clinical trials, adaptive survival tests, stability analysis for frozen drug products, equivalence trials, statistical genetics, targeted clinical trials, and USP tests. Moreover, applications of statistical principles to pharmaceutical product development are illustrated with examples that readers with a moderate statistical background should have no difficulty comprehending.
Assessment: This is a comprehensive reference source of statistical principles, design, and methodology applicable to translational medicine, clinical research, and pharmaceutical research. This is an important resource for pharmaceutical product development scientists and members of regulatory agencies who apply statistical principles in their work. There are other references on statistical sciences in the marketplace, but none provides relevant information, especially on the application of statistical principles to the pharmaceutical sciences, as concisely as this one does.