{"product_id":"fundamentals-of-drug-development-isbn-9781119691693","title":"Fundamentals of Drug Development","description":"\u003cp\u003eFundamentals of \u003cb\u003eDRUG DEVELOPMENT\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eEnables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThis 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.\u003c\/p\u003e \u003cp\u003eTo 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. Sample topics covered in the book include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eDrug development and its phases\u003c\/li\u003e \u003cli\u003eDecision-making processes, drug development milestones, and compound progression metrics\u003c\/li\u003e \u003cli\u003eThe various disciplines involved along with an assessment of the complexity and risks associated across the stages of development\u003c\/li\u003e \u003cli\u003eDifferences in the nature and scope of development programs due to the therapeutic area of interest\u003c\/li\u003e \u003cli\u003eAssociated costs and resources required\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eGraduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.\u003c\/p\u003e \u003cp\u003ePreface and Introduction\u003c\/p\u003e \u003cp\u003eChapter 1: The History of Drug Development\u003c\/p\u003e \u003cp\u003eChapter 2: The Modern Pharmaceutical Industry: Big and Small Pharma, Biotechnology Companies, and Generic Drug Makers\u003c\/p\u003e \u003cp\u003eChapter 3: Legal Considerations, Intellectual Property, Patents and Patent Protection\u003c\/p\u003e \u003cp\u003eChapter 4: The Global Regulatory Landscape\u003c\/p\u003e \u003cp\u003eChapter 5: Phases of Drug Development: Old and New Paradigms\u003c\/p\u003e \u003cp\u003eChapter 6: Discovery \/ Preclinical\u003c\/p\u003e \u003cp\u003eChapter 7: Phase I\u003c\/p\u003e \u003cp\u003eChapter 8: Phase II\u003c\/p\u003e \u003cp\u003eChapter 9: Phase III\u003c\/p\u003e \u003cp\u003eChapter 10: Phase IV, Special Populations and Post Marketing Commitments\u003c\/p\u003e \u003cp\u003eChapter 11: Role and Function of Project Teams\u003c\/p\u003e \u003cp\u003eChapter 12: Compound Progression and Go \/ No Go Criteria\u003c\/p\u003e \u003cp\u003eChapter 13: Regulatory Milestones and the Submission Process\u003c\/p\u003e \u003cp\u003eChapter 14: Life Cycle Management\u003c\/p\u003e \u003cp\u003eChapter 15: Formulation Development\u003c\/p\u003e \u003cp\u003eChapter 16: Chemistry and Manufacturing (CMC)\u003c\/p\u003e \u003cp\u003eChapter 17: Health Economics and the Healthcare Industry\u003c\/p\u003e \u003cp\u003eChapter 18: Current State of Affairs: Attrition Rates and Evolving Corporate Strategies\u003c\/p\u003e \u003cp\u003eChapter 19: Medical Devices\u003c\/p\u003e \u003cp\u003eChapter 20: Distribution and the Supply Chain\u003c\/p\u003e \u003cp\u003eChapter 21: Sales, Marketing and Advertising\u003c\/p\u003e \u003cp\u003eChapter 22: Generic Drugs and the Generic Industry\u003c\/p\u003e \u003cp\u003eChapter 23: The Generic Approval Process\u003c\/p\u003e \u003cp\u003eChapter 24: Data Sharing and Collaboration\u003c\/p\u003e \u003cp\u003eChapter 25: The Future of the Pharmaceutical Industry\u003c\/p\u003e \u003cp\u003eGlossary\u003c\/p\u003e \u003cp\u003eChapter Self-Assessments and Quiz\u003c\/p\u003e \u003cp\u003e\u003cb\u003eJeffrey S. Barrett\u003c\/b\u003e, 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eEnables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThis 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. \u003c\/p\u003e\u003cp\u003eTo 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. Sample topics covered in the book include: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eDrug development and its phases\u003c\/li\u003e \u003cli\u003eDecision-making processes, drug development milestones, and compound progression metrics\u003c\/li\u003e \u003cli\u003eThe various disciplines involved along with an assessment of the complexity and risks associated across the stages of development\u003c\/li\u003e \u003cli\u003eDifferences in the nature and scope of development programs due to the therapeutic area of interest\u003c\/li\u003e \u003cli\u003eAssociated costs and resources required\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eGraduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989258420453,"sku":"NP9781119691693","price":115.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119691693.jpg?v=1761783410","url":"https:\/\/k12savings.com\/products\/fundamentals-of-drug-development-isbn-9781119691693","provider":"K12savings","version":"1.0","type":"link"}