Fundamentals of DRUG DEVELOPMENT
Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment
This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration.
To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include:
- Drug development and its phases
- Decision-making processes, drug development milestones, and compound progression metrics
- The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development
- Differences in the nature and scope of development programs due to the therapeutic area of interest
- Associated costs and resources required
Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.
Table of Contents
Preface and Introduction
Chapter 1: The History of Drug Development
Chapter 2: The Modern Pharmaceutical Industry: Big and Small Pharma, Biotechnology Companies, and Generic Drug Makers
Chapter 3: Legal Considerations, Intellectual Property, Patents and Patent Protection
Chapter 4: The Global Regulatory Landscape
Chapter 5: Phases of Drug Development: Old and New Paradigms
Chapter 6: Discovery / Preclinical
Chapter 7: Phase I
Chapter 8: Phase II
Chapter 9: Phase III
Chapter 10: Phase IV, Special Populations and Post Marketing Commitments
Chapter 11: Role and Function of Project Teams
Chapter 12: Compound Progression and Go / No Go Criteria
Chapter 13: Regulatory Milestones and the Submission Process
Chapter 14: Life Cycle Management
Chapter 15: Formulation Development
Chapter 16: Chemistry and Manufacturing (CMC)
Chapter 17: Health Economics and the Healthcare Industry
Chapter 18: Current State of Affairs: Attrition Rates and Evolving Corporate Strategies
Chapter 19: Medical Devices
Chapter 20: Distribution and the Supply Chain
Chapter 21: Sales, Marketing and Advertising
Chapter 22: Generic Drugs and the Generic Industry
Chapter 23: The Generic Approval Process
Chapter 24: Data Sharing and Collaboration
Chapter 25: The Future of the Pharmaceutical Industry
Glossary
Chapter Self-Assessments and Quiz
