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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Bibliographic Details
Main Author Barrett, Jeffrey S. (Author)
Format Electronic eBook
LanguageEnglish
Published Hoboken, NJ : John Wiley & Sons, Inc., 2022.
Subjects
Drug development > Methodology.
Pharmaceutical technology > Methodology.
Drugs > Research > Methodology.
elektronické knihy
electronic books
Online AccessFull text
ISBN9781119913276
1119913276
1119691737
9781119691709
1119691702
9781119691730
9781119691693
Physical Description1 online resource (xxi, 489 pages) : illustrations (some color)

Cover

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.

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