Abstract
This chapter outlines the different phases of clinical trials, starting with phase I human volunteer studies through to phase III studies using large numbers of patients. The overview includes case histories of a phase I and a phase III trial to illustrate their design and implementation. Also covered are the regulatory applications for the first time in human studies.
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Notes
- 1.
The code can indicate where the compound was originally developed. In this case, SB means SmithKlineBeecham.
- 2.
This is only to make a point. Statistics is actually fundamental to physics.
- 3.
The phase II and III trials are designed and conducted in a very similar way, so there is a significant overlap between them.
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Zanders, E.D. (2011). Clinical Trials. In: The Science and Business of Drug Discovery. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-9902-3_12
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DOI: https://doi.org/10.1007/978-1-4419-9902-3_12
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