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Director of Pharmacy and Respiratory Services, McLaren Regional Medical Center, Flint, MI; Adjunct Assistant Professor, Department of Psychiatry, College of Human Medicine, Michigan State University, Lansing, MI
Published Online, November 6, 2007. www.theannals.com, DOI 10.1345/aph.1K378
Format: The book is organized into 8 primary sections of 3–10 well-referenced chapters each, for a total of 55 chapters. There is also an appendix containing Internet links as well as a comprehensive index.
Audience: While the intended audience is listed as "all those working in pharmaceutical medicine regardless of their degrees, titles, or affiliations," this text would also be a useful reference in the academic and administrative fields.
Purpose: The purpose of this book is to offer a comprehensive and updated reference for the practice developments in the international field of pharmaceutical medicine. In the authors' words, "pharmaceutical medicine involves the combination of the following: first, the medical sciences to evaluate the diseases; second, the economic sciences to evaluate the value with respect to costs; and third, the ethical and social sciences to evaluate the utility of any new drug to patients and to society as a whole." Given the expansive details contained within this publication, it easily meets these functions and could also serve as a primary text in required and elective academic courses, in addition to being a useful reference for established practitioners in the field.
Content: The first 3 sections (Overview of Pharmaceutical Medicine, Drug Discovery and Development, Special Populations and Required Special Studies) outline the basics of drug research and development, from drug discovery and testing to recently required testing for special patient populations and conditions. The fourth section (Applied Aspects of Drug Development) delves into more contemporary topics such as biotechnology, pharmacoepidemiology, pharmacoeconomics, and complementary medicine, as well as the more standard topics of statistics and data management. This section is an interesting mixture of definitions, assessment tools, paradigms, and case study references. The fifth section (Drug Regulation) details regulatory principles from major global participants, allowing the reader to compare and contrast the various practices. The next section (Medical Services) compares and contrasts global requirements for labeling, surveillance, and reporting, describing the complexities of the separate requirements along with the potential for harmonization. The seventh section (Legal and Ethical Aspects) provides a primer on legal issues in pharmaceutical medicine, ranging from bioethics for professionals and fraud or misconduct in clinical research to product liability and patent law. The eighth and final section addresses business aspects, highlighting the collaborative efforts, international differences, and cultural issues that contribute to the financial structure and support of the pharmaceutical industry as a whole, as well as pharmaceutical medicine specialties.
Usability: This book is written in a logical, organized fashion that allows the reader to discover the breadth of pharmaceutical medicine, both historically and in today's changing global climate. The sections and chapters are well organized and have a similar format throughout, making the book flow well from section to section. Chapters on individual topics can be used as stand-alone references. Despite the sheer volume of information contained in this publication, the organization allows for easy navigation through many topics to find specific information and references. References are appropriate and abundant.
Highlights: Principles and Practice of Pharmaceutical Medicine provides a unique perspective on the global developments and rapid changes taking place in the relatively young field of organized pharmaceutical medicine. From basic definitions to the escalation through regulatory agencies, the authors have organized information into a comprehensive single resource to provide the reader with a better understanding of pharmaceutical medicine and the practical application of knowledge.
Limitations: The primary strength of this book is also its primary limitation: this publication is clearly intended to be a comprehensive textbook and reference source and, as such, is not an effective quick-reference guide. It is also unlikely to be the most well-worn text in direct patient-care practice settings.
Comparison with Previous Editions: The second edition is clearly expanded, with updated chapters on basic topics of pharmaceutical medicine. New chapters on risk management and various international regulations and developments, specifically in Europe, the Middle East, and Asia, are included as well.
Comparison with Other Related Books or Products: There are few books that address the ever-developing world of pharmaceutical medicine. This text stands alone as a definitive reference for all involved in the field, as it takes an all-encompassing journey from the simple basics to the complex international regulatory systems.
Reviewer's Summary: Principles and Practice of Pharmaceutical Medicine is a comprehensive, well-written, updated text that outlines equally well both basic concepts and critical developments. It can serve as a definitive reference source for everyone in the pharmaceutical medicine field, including those involved directly in research and development and those involved indirectly in clinical or administrative areas. While it may be priced on the high end of the spectrum for ready addition to personal libraries, this textbook should be on the quick-access shelf of every academic and research institution.
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