Clinical Trials

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Phase 1


First time meds are administered to humans

Usually in studies of healthy, informed volunteers

Conducted under supervision of a doctor


To determine if new compound is tolerated and if it behaves as predicted


If the drug is seemingly non-hamful then the company can make an application with the data to the medicines and health care products regulatory agency for a certificate to go to phase 2 & 3

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Phase 2


Drug given to patients with the illness

Different dose levels given to different different patient groups

usually 200 - 400 people


To determine if the compound is suitable for further study

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Phase 3


Medicine compared to placebo and medication already used to provide a reference standard

Neither doctor nor patient know which meds they are taking (double blind)

much larger patient group used (3000+)


Positive results mean the company can submit the drug for marketing

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