Fundamentals of Drug Development PDF 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 find Fundamentals of Drug Development a complete resource for understanding the complexities and nuances involved in drug development.
Table of Contents
The History of Drug Development
The Modern Pharmaceutical Industry
Legal Considerations, Intellectual Property, Patents/Patent Protection, and Data Privacy
Global Regulatory Landscape
Phases of Drug Development and Drug Development Paradigms
Drug Discovery and Preclinical Development
Phase 1
Phase 2
Phase 3
Phase 4, Special Populations, and Post-marketing
Role and Function of Project Teams
Compound Progression and Go/No Go Criteria
Regulatory Milestones and the Submission Process
Life Cycle Management
Pre-formulation and Formulation Development
Chemistry, Manufacturing, and Controls
Health Economics and the Healthcare Industry
Current State of Affairs
Medical Devices
Supply Chain
Sales, Marketing, and Advertising
Generic Drugs and the Generic Industry
The Generic Drug Approval Process
Data Sharing and Collaboration
The Future of the Pharmaceutical Industry
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