Phase IConducted in healthy
volunteers to provide evidence of safety. The trial also examines
the pharmacokinetic profile of the drugthe absorption,
distribution, metabolism and excretion of the drug by the human
body and its biological effects on humans.
Phase IIRequires detailed
submission to the MCA on quality and safety of test medicines
before commencement and approval to proceed from the MCA. Conducted
in limited number of patients to assess short-term safety and
preliminary efficacy. Appropriate dose ranges and regimens for
Phase III trials are also determined.
Phase IIIRequires more detailed
submissions on quality, safety and efficacy to the MCA. Comprehensive
evaluation of safety and efficacy in large numbers of patients.