Fundamentals of Drug Development
About this book
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.
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Information
Table of contents
- Cover
- Title Page
- Copyright Page
- Contents
- Contributors Biographies
- Preface
- About the Companion Website
- Introduction
- Chapter 1 The History of Drug Development
- Chapter 2 The Modern Pharmaceutical Industry: Small, Medium, and Large PhRMA, Biotech, and Generics . . .
- Chapter 3 Legal Considerations, Intellectual Property,Patents/Patent Protection, and Data Privacy
- Chapter 4 Global Regulatory Landscape
- Chapter 5 Phases of Drug Development and Drug Development Paradigms
- Chapter 6 Drug Discovery and Preclinical Development
- Chapter 7 Phase 1
- Chapter 8 Phase 2
- Chapter 9 Phase 3
- Chapter 10 Phase 4, Special Populations and Post-marketing
- 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 Pre-formulation and Formulation Development
- Chapter 16 Chemistry, Manufacturing, and Controls
- 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 Supply Chain
- Chapter 21 Sales, Marketing and Advertising
- Chapter 22 Generic Drugs and the Generic Industry
- Chapter 23 The Generic Drug Approval Process
- Chapter 24 Data Sharing and Collaboration
- Glossary
- Self-Assessment Quiz Answers
- Index
- EULA
