Fundamentals of drug development / Jeffrey S. Barrett.

Author/creator Barrett, Jeffrey S. author.
Format Electronic
PublicationHoboken, NJ : John Wiley & Sons, Inc., 2022.
Copyright Date©2022
Description1 online resource (xxi, 489 pages) : illustrations (some color)
Supplemental ContentDirect link to eBook
Subjects
Drug development--Methodology.
Pharmaceutical technology--Methodology.
Drugs--Research. --Methodology.
Drug Development--methods.
Technology, Pharmaceutical--methods.
Pharmaceutical Research--methods.

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.
Abstract "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"-- Provided by publisher.
Bibliography noteIncludes bibliographical references and index.
Source of descriptionDescription based on online resource; title from digital title page (viewed on August 23, 2022).
Issued in other formPrint version: Barrett, Jeffrey S. Fundamentals of drug development Hoboken, NJ : Wiley, 2022 9781119691693
LCCN 2022017494
ISBN9781119913276 electronic book
ISBN1119913276 electronic book
ISBN1119691737 electronic book
ISBN9781119691709 electronic book
ISBN1119691702 electronic book
ISBN9781119691730 (electronic bk.)
ISBNhardcover
Stock number9781119691730 Wiley, US