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Record Nr. |
UNINA9910677344203321 |
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Autore |
Barrett Jeffrey S. |
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Titolo |
Fundamentals of drug development / / Jeffrey S. Barrett |
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Pubbl/distr/stampa |
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Hoboken, New Jersey : , : Wiley, , [2022] |
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©2022 |
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ISBN |
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1-119-91327-6 |
1-119-69173-7 |
1-119-69170-2 |
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Descrizione fisica |
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1 online resource (512 pages) |
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Disciplina |
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Soggetti |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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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Sommario/riassunto |
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"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, |
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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"-- |
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