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This informative book provides a thorough discussion and analysis of the social factors that affect and influence the drug discovery and development processes, including analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development

Table of Contents

SECTION I: PHARMACEUTICAL INDUSTRY, SOCIETY, AND GOVERNANCE1. Pharmaceutical Regulation: The Role of Government2. Trends in Innovation and the Business of Drug Discovery3. Cash Flow Valley of Death: A Pitfall in Drug Discovery

SECTION II: THE DRUG DISCOVERY CYCLE I: DISCOVERY AND PRECLINICAL DRUG DEVELOPMENT4. Prediscovery Research: Challenges and Opportunities5. The Significance of Discovery Screening and Structure Optimization Studies6. Preclinical In Vitro Studies – Development and Applicability7. Animal Utilization in Drug Development – Clinical, Legal, and Ethical Dimensions8. Pharmaceutical Formulation and Manufacturing Development: Strategies and Issues

SECTION III: THE DRUG DISCOVERY CYCLE II: CLINICAL DEVELOPMENT9. Clinical Development: Ethics and Realities 10. Pharmacogenomics in Drug Discovery, Prospects and Clinical Applicability

SECTION IV: THE DRUG DISCOVERY CYCLE III: AUTHORIZATION AND MARKETING11. Patents, Exclusivities, and Evergreening Strategies 12. Drug Pricing and Control for Pharmaceutical DrugsIndex

About the Author

Dr. Odilia Osakwe has published 25 titles, including 1 book (edited), 24 articles in peer reviewed platform including journal articles, scholarly magazines, newsletters and technical notes. And has authored 10 papers/posters and oral presentations in major international professional meetings. Odilia has reviewed numerous manuscripts for different academic journals. Aside from those activities, she served as an editorial board member with Pharmaceutical Science Group of Canada for 3 years reviewing and editing articles with active contribution towards several of the published front cover topics. Odilia received her undergraduate degree from Abia state University and her Masters in Chemistry from Tennessee State University. Within this period, she worked with the Tennessee State Department of Laboratory Services. Following completion of a Master Degree in Chemistry, she took on a two-year post graduate fellowship, which was granted by Vanderbilt University, Nashville, Tennessee; completed in the department of pharmacology of Vanderbilt University Medical Centre. She joined a doctoral program with the department of pharmaceutical Sciences of Mercer University, Atlanta, Georgia and earned a PhD degree. During much of this period, starting from the second year into the doctoral program, she joined the Georgia Perimeter College, Atlanta, Georgia, teaching Chemistry courses for two years till the end of the program. During the all-but-dissertation stage, (ABD), Odilia received a Student Research Fellowship with the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia where she worked as a researcher with the immunology laboratories of National Center for Immunization and Respiratory Diseases (NCIRD) in the Division of Bacterial Diseases (DBD), using the state-of-the-art instrumentation for validation of immunological assays. Further on, Odilia received a competitive National Science and Engineering Research Council of Canada (NSERC) award for Industrial Research and Development Postdoctoral Fellowship (IRDF-NSERC). The two-year training was accomplished at the University of Toronto Hospital Network, Industrial BioDevelopment Laboratory (IBDL) department where she took the lead of the Research and Development activities which include technical oversight and training of the University of Toronto undergraduates on various projects, with published results. Odilia works with Devik Pharma Inc., also a board member of the North American Institute of Pharmaceutical Technology, Scarborough, Ontario, Canada where she undertakes administrative and scholarly duties in the industrial pharmaceutical sector. She is an Adjunct Faculty with Ryerson University, Toronto, Ontario, Canada and Seneca College of Arts and Technology, Toronto, Ontario, Canada, teaching several courses in the Industrial Pharmaceutical Technology program. Dr. Rizvi is currently an Associate Professor of Pharmaceutical Sciences at the College of Pharmacy, Nova Southeastern University in Fort Lauderdale, Florida. Dr. Rizvi earned his Bachelor of Science (B.Sc) and Master of Science (M.Sc) degrees from the University of Karachi, Pakistan, with expertise in Organic and Natural Product Chemistry. Dr. Rizvi then came to the United States and pursued an M.S and Ph.D combined degree program at the Center for Biotechnology and Drug Design, Department of Chemistry, Georgia State University, Atlanta, Georgia, followed by another Ph.D., at the College of Pharmacy and Health Sciences, Department of the Pharmaceutical Sciences, Mercer University, Atlanta, Georgia, in collaboration with Renovo Research, LLC. Furthermore, Dr. Rizvi pursued postdoctoral research in the laboratory of Dr. Fredric M. Menger (Charles Howard Candler Professor) at the Sanford S. Atwood Chemistry Center, Emory University. Dr. Rizvi also conducted research as a visiting scientist in the area of pharmaceutical ionic liquids, in the laboratory of Dr. Robin D. Rogers (Robert Ramsay Chair of Chemistry, Distinguished Research Professor and Director, Center for Green Manufacturing) at the Department of Chemistry, The University of Alabama. Recently, Dr. Rizvi finished course of studies leading to Master of Business Administration (MBA) degree with specialization in Pharmaceutical Marketing and Management from Aspen University and a certificate in Executive Leadership from Johnson Graduate School of Management, eCornell Professional Development Programs, Cornell University.

Dr. Rizvi has published over 100 peer-reviewed articles, including two most highly rated articles, two cover articles and citations in respected textbooks. Dr. Rizvi serves as editor-in-chief, associate editor, executive editor, editorial board member and review manuscripts and books for many well known scientific publishers. Dr. Rizvi’s research interests include micro and nanotechnology for drug delivery, controlled release formulations, solid state chemistry of drugs, surface chemistry and analytical chemistry, material and organic chemistry, natural product chemistry, and immunology. In his free time, Dr. Rizvi enjoys cooking and practicing martial arts.