Intelligent Drug Development: Trials and Errors in Clinical Research

Hardcover | May 28, 2014

byMichael Tansey

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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 sostringent 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 theprocess at all stages.With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conductingclinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can beimplemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinicalresearch have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

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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 sostringent that researchers often approach tri...

Michael Tansey is former Vice President of La Jolla Pharmaceutical Company. He is currently an RandD consultant to pharmaceutical and biotechnology companies.

other books by Michael Tansey

Format:HardcoverDimensions:240 pages, 9.25 × 6.12 × 0.98 inPublished:May 28, 2014Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199974586

ISBN - 13:9780199974580

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Table of Contents

PART 1: SETTING THE SCENEIntroduction: Cutting the Gordian Knot1. Aiming for ExcellencePART 2: PLANNING: FROM CHAOS TO COSMOS2. The Target Product Profile and Its Uses3. Planning the Individual Clinical TrialPART 3: THE PRACTICABLE PROTOCOL4. Distilling the Essence of the Protocol: The Protocol Synopsis5. Redistillation: Eliminating Impurities By Carrying Out Protocol6. The Optimal Blend: The approved Synopsis and the Final ProtocolPART 4: THE SPONSOR, THE PHYSICIAN AND THE PATIENT; THE ETERNAL CLINICAL TRIAL TRIANGL7. Of Chickens and Eggs: The Sponsors' Dilemma8. Clinician or Clinical Trialist: the Physicians' Dilemma9. What About the Customer? the Patients' DilemmaPART 5: AND ANOTHER THING...10. About Time: Making Meetings Matter11. The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor