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Study Phase
Definitions
Phase
I Trials - Safety. The first time an experimental drug will be
used in humans. The purpose of a Phase I trial is to assess the initial
safety of the drug, as well as the metabolism, absorption, elimination and
other drug activities, the preferred mode of drug administration (topical,
IV, oral, etc.) and safe drug range. Usually trials are conducted on
healthy volunteers.
Phase
II Trials - Dosage. The purpose is to explore the effectiveness
of different dosage schedules for a research treatment following safety
evaluation in a Phase I trial. Trials are usually conducted on
patients.
Phase
III Trials - Efficacy. The purpose of a Phase III trial is to
assess a drug's effectiveness (efficacy) and safety compared against a
suitable placebo or best current treatment or to determine the optimum
dosage level for the treatment of a specific condition in a specific group
of patients. These studies are randomized, intervention allocation and
measurement is usually masked form study participants and
investigators.
Other
Trials - Any prospective comparative study involving human
participants and the administration of a treatment or type of management,
including diagnosis or the provision of lifestyle (e.g. dietary) advice.
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