Select Committee on Home Affairs Memoranda



    —  Phase I—Conducted in healthy volunteers to provide evidence of safety. The trial also examines the pharmacokinetic profile of the drug—the absorption, distribution, metabolism and excretion of the drug by the human body and its biological effects on humans.

    —  Phase II—Requires 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 III—Requires more detailed submissions on quality, safety and efficacy to the MCA. Comprehensive evaluation of safety and efficacy in large numbers of patients.

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2001
Prepared 20 December 2001