Intelligent drug development : trials and errors in clinical research

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

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 stringe...

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Bibliographic Details
Main Author: Tansey, Michael (Author)
Format: eBook
Language:English
Published: New York, NY : Oxford University Press, 2020.
Subjects:
Drug approval.
Clinical trials.
Drug development.
Medical protocols.
Clinical trials
Drug approval
Drug development
Medical protocols
Online Access:Click for online access
Table of 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

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