Description |
1 online resource (241 pages) |
Physical Medium |
polychrome |
Description |
text file |
Contents |
Cover; Intelligent Drug Development; Copyright; CONTENTS; Acknowledgments; Intelligent Drug Development; PART ONESetting the Scene; Introduction; Chapter 1 Aiming for Excellence; PART twoPlanning: From Chaos to Cosmos; Chapter 2 The Target Product Profile and Its Uses; Chapter 3 Planning the Individual Clinical Trial; PART ThreeThe Practicable Protocol; Chapter 4 Distilling the Essence of the Protocol: The Protocol Synopsis; Chapter 5 Redistillation: Eliminating Impurities by Carrying out Protocol Feasibility; Chapter 6 The Optimal Blend: The Approved Synopsis and the Final Protocol. |
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PART FOURThe Sponsor, The Physician, and The Patient: The Eternal Clinical Trial TriangleChapter 7 Of Chickens and Eggs: The Sponsor's Dilemma; Chapter 8 Clinician or Clinical Trialist: The Physician's Dilemma; Chapter 9 What about the Customer? The Patient's Dilemma; PART FIVEAnd Another Thing ... ; Chapter 10 About Time: Making Meetings Matter; Chapter 11 The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor Laser Show; References; Index. |
Summary |
Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the proces. |
Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
Subject |
Clinical trials -- Ethics.
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Clinical trials. |
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Ethics. |
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Clinical trials -- Methods.
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Drug approval -- Methods.
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Drug approval. |
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Medical protocols.
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Medical protocols. |
Genre/Form |
Electronic books.
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Other Form: |
Print version: Tansey, Michael. Intelligent Drug Development. Oxford : Oxford University Press, 2014 9780199974580 |
ISBN |
9780190200657 (electronic book) |
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0190200650 (electronic book) |
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