Fundamentals of Drug Development

ISBN-13: 9781119691693 / Angielski / Twarda / 2022 / 496 str.

Jeffrey S. (University of Pennsylvania) Barrett

Spis treści

Preface and IntroductionChapter 1: The History of Drug DevelopmentChapter 2: The Modern Pharmaceutical Industry: Big and Small Pharma, Biotechnology Companies, and Generic Drug MakersChapter 3: Legal Considerations, Intellectual Property, Patents and Patent ProtectionChapter 4: The Global Regulatory LandscapeChapter 5: Phases of Drug Development: Old and New ParadigmsChapter 6: Discovery / PreclinicalChapter 7: Phase IChapter 8: Phase IIChapter 9: Phase IIIChapter 10: Phase IV, Special Populations and Post Marketing CommitmentsChapter 11: Role and Function of Project TeamsChapter 12: Compound Progression and Go / No Go CriteriaChapter 13: Regulatory Milestones and the Submission ProcessChapter 14: Life Cycle ManagementChapter 15: Formulation DevelopmentChapter 16: Chemistry and Manufacturing (CMC)Chapter 17: Health Economics and the Healthcare IndustryChapter 18: Current State of Affairs: Attrition Rates and Evolving Corporate StrategiesChapter 19: Medical DevicesChapter 20: Distribution and the Supply ChainChapter 21: Sales, Marketing and AdvertisingChapter 22: Generic Drugs and the Generic IndustryChapter 23: The Generic Approval ProcessChapter 24: Data Sharing and CollaborationChapter 25: The Future of the Pharmaceutical IndustryGlossaryChapter Self-Assessments and Quiz

O autorze

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.