Clinical Trial Simulations for Earlier Development Phases

Author(s):  
Mark Chang
Author(s):  
Philip Wiffen ◽  
Marc Mitchell ◽  
Melanie Snelling ◽  
Nicola Stoner

Clinical trial regulations 108Licensing of a clinical trial 109Clinical trial development phases 110Trial design, randomization, and blinding 111European Clinical Trials Directive 112Clinical trials: hospital pharmacy guidance 114Ethical committees 116Clinical trials form a fundamental part in the research, development, and licensing of new medicines. Research of how the drug interacts in humans is essential to ensure safe and effective medicines are licensed as new treatments. It is an exciting and varied role at the cutting edge of modern research with trials ranging across all therapeutic specialities. Clinical Trial pharmacists are therefore required to have a broad clinical knowledge and a specialist knowledge of the regulations that clinical trials have to follow....


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