390.631.01 | AY 2013-2014 - 1st Term | 2 Credit(s)
W 1:30:00 PM
  • Contact Information
    Charles Flexner
  • Course Learning Objectives

    Upon successfully completing this course, students will be able to:

    • Describe how new drugs and devices are taken from the laboratory to the marketplace in the United States
    • Distinguish Phase I, II, III, and IV studies
    • Evaluate the balance between medical benefit, medical risk, economic reward, and economic risk in the decision making process as it relates to drugs and devices in development
  • Course Description
    Presents principles underlying preclinical and clinical development of new therapeutic drugs, devices, and diagnostic tests. Describes and evaluates specific examples, and discusses legal and ethical regulations that apply to drug development. Uses a case-based class format.
  • Intended Audience
    GTPCI students
  • Methods of Assessment
    Student evaluation based on an exam.
  • Course Schedule

    Please see the course Session for a full list of dates and items for this course.

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    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

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