From the Back Cover
Setting the standard for modern biopharmaceutical education, the new Fourth Edition is a completely revised text to reflect the rapid growth in the importance of biopharmaceuticals and the techniques of biotechnologies to modern medicine and the life sciences. The editors have provided a well-balanced framework for introductory as well as more detailed education in various aspects of pharmaceutical biotechnology and the production, biopharmaceutics, and clinical pharmacology of biotechnology-produced drugs. The new edition improves upon the strong chapters of previous editions, adding emergent trends and cutting-edge advances as well as new graphic illustrations and new authors. The textbook includes key concepts at the foundation of the technology relevant for protein therapeutics including molecular biology, production and analysis procedures, formulation development, pharmacokinetics and pharmacodynamics, and immunogenicity, as well as chapters dealing with regulatory, economic, and pharmacy practice considerations.
The Fourth Edition brings an exciting and fundamental reorganization of the text, now structured into two sections: 1) an initial basic science and general features section; and 2) a section profiling the various therapeutic classes of biologics, including gene therapy. Additionally, reorganization of the chapters examining the properties and applications of monoclonal antibodies, and oligonucleotides and siRNA has enhanced these important concepts in the text. A completely new chapter has been added on cell-based technologies.
The Fourth Edition continues the popular self-assessment questions after each chapter to reinforce understanding of practical pharmaceutical applications, making this an indispensable text for self-study, the biopharmaceutical classroom, as well as for professional reference in practice or industry.
About the Author
DAAN J.A. CROMMELIN is Professor at the Department of Pharmaceutics at Utrecht University. Until December 2011 he was scientific director of the Dutch Top Institute Pharma in Leiden. He is adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Dr. Crommelin is co-founder of OctoPlus, a Leiden based company specialized in the development of pharmaceutical product formulations and advanced drug delivery systems. He published over 335 articles and has held leadership positions at the International Pharmaceutical Federation (FIP) and the European Federation for Pharmaceutical Sciences (EUFEPS).
ROBERT D. SINDELAR is currently President, The Providence Health Care Research Institute, Vice President Research and Academic, Providence Health Care (part of the British Columbia public health care system), Professor Faculty of Pharmaceutical Sciences and Associate Dean Research Faculty of Medicine The University of British Columbia (UBC). He served for 11 years as Dean and Professor, The UBC Faculty of Pharmaceutical Sciences following 19 years at the University of Mississippi where he held the positions of Professor and Chair of Medicinal Chemistry, School of Pharmacy and served as Interim Dean. Dr. Sindelar’s expertise lies in medicinal chemistry, computer-aided drug discovery and design, pharmaceutical biotechnology, and creating opportunities to integrate innovation into the health care system. His research work resulted in significant extramural funding and 70 refereed journal articles, six U.S. patents, and over 100 scientific and professional presentations. He has been active in promoting the profession of pharmacy and the biotechnology community. Dean Sindelar has helped build a unified vision for the future of pharmacy and pharmaceutical sciences education in BC and beyond and has been inducted as a fellow in the Canadian Academy of Health Sciences.
BERND MEIBOHM is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee College of Pharmacy in Memphis. His area of expertise lies in clinical pharmacology and pharmacokinetic/pharmacodynamics correlations. Dr. Meibohm obtained his doctoral degree in Pharmaceutics from the Technical University Carolo-Wilhelmina, Braunschweig, Germany and received postdoctoral training at the University of Florida, Gainesville. Dr. Meibohm is a fellow of the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology, and has published three textbooks, more than 90 peer-reviewed research articles and book chapters, 130 abstracts, and over 100 invited scientific presentations to national and international audiences.