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Specific types of Phase I clinical studies First in human studies

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A medicine may look safe and potentially efficacious in the laboratory, but a clinical trial will establish whether this is the case in humans. Studies will start with low, single doses, in just a couple of volunteers. The serious side effects experienced by volunteers taking part in the trial of TGN1412 in March 2006 at Northwick Park Hospital in London are extremely rare but highlights the need for thoroughly testing a treatment before widespread use. First in human studies may also provide evidence for proof of concept, for example a demonstration of inhibition of relevant enzyme systems.

Clinical Pharmacology and Therapeutics

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