Fundamentals of drug development / Jeffrey S. Barrett.

Includes bibliographical references and index.

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.

Available to OhioLINK libraries.

"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.

About the Author
Jeffrey S. Barrett, PhD is the Chief Science Officer at Aridhia Digital Research Environment promoting life science partners to collaborate, access and share secure data to deliver better patient outcomes. He has over 30 years’ experience in pharmaceutical research and development, 13 of which were spent in the industry (1990 –2003) followed by over 10 years (2001 –13) at the University of Pennsylvania and The Children’s Hospital of Philadelphia and then back to industry at Sanofi Pharmaceuticals (2013 –17) while still serving as an adjunct faculty member at University of Pennsylvania.