Intelligent drug development : trials and errors in clinical research / Michael Tansey.

Format:

Book

Author/Creator:

Tansey, Michael, author.

Series:

Oxford scholarship online.

Oxford scholarship online

Language:

English

Subjects (All):

Drug approval.

Physical Description:

1 online resource (241 p.)

Edition:

1st ed.

Place of Publication:

New York : Oxford University Press, 2014.

Language Note:

English

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, anobjective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With this book, 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.

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

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

Notes:

Previously issued in print: 2014.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9780197563335

0197563333

9780190200657

0190200650

OCLC:

880827447