Fundamentals of drug development /
"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...
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| Main Author: | |
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| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, NJ :
John Wiley & Sons, Inc.,
2022.
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| Subjects: | |
| Online Access: | CONNECT |
Table of Contents:
- The history of drug development
- The modern pharmaceutical industry : big and small pharma, biotechnology companies, and generic drug makers
- Legal considerations, intellectual property, patents and patent protection
- The global regulatory landscape
- Phases of drug development : old and new paradigms
- Discovery / preclinical
- Phase I
- Phase II
- Phase III
- Phase IV, special populations and post marketing commitments
- Role and function of project teams
- Compound progression and go / no go criteria
- Regulatory milestones and the submission process
- Life cycle management
- Formulation development
- Chemistry and manufacturing (CMC)
- Health economics and the healthcare industry
- Current state of affairs : attrition rates and evolving corporate strategies
- Medical devices
- Distribution and the supply chain
- Sales, marketing and advertising
- Generic drugs and the generic industry
- The generic approval process
- Data sharing and collaboration
- The future of the pharmaceutical industry.
