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
Intelligent drug development: trials and errors in clinical research
โ Scribed by Tansey, Michael
- Publisher
- Oxford University Press
- Year
- 2014
- Tongue
- English
- Leaves
- 241
- Category
- Library
No coin nor oath required. For personal study only.
โฆ Synopsis
Aiming for excellence -- The target product profile and its uses -- Planning the individual clinical trial -- Distilling the essence of the protocol: the protocol synopsis -- Redistillation: eliminating impurities by carrying out protocol feasibility -- The optimal blend: the approved synopsis and the final protocol -- Of chickens and eggs: the sponsors' dilemma -- Clinician or clinical trialist: the physicians' dilemma -- What about the customer? the patients' dilemma -- About time: making meetings matter -- The brain-scrambling, fit-inducing, mind-numbing technicolor laser show.
โฆ Table of Contents
Aiming for excellence --
The target product profile and its uses --
Planning the individual clinical trial --
Distilling the essence of the protocol: the protocol synopsis --
Redistillation: eliminating impurities by carrying out protocol feasibility --
The optimal blend: the approved synopsis and the final protocol --
Of chickens and eggs: the sponsors' dilemma --
Clinician or clinical trialist: the physicians' dilemma --
What about the customer? the patients' dilemma --
About time: making meetings matter --
The brain-scrambling, fit-inducing, mind-numbing technicolor laser show.
โฆ Subjects
Clinical Protocols;Clinical Trials as Topic--ethics;Clinical Trials as Topic--methods;Drug Approval--methods;Medical protocols;Clinical trials;Drug approval;Drug development;Drug Approval -- methods;Clinical Trials as Topic -- methods;Clinical Trials as Topic -- ethics
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