The Johns Hopkins Bloomberg School of Public Health
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Welcome Medical product development, from initial animal and clinical studies through post-marketing surveillance, involves statistical thinking. The specific applications of experimental design and biostatistical methods are addressed in this course, with emphasis on regulatory requirements. Guidance from various international regulatory sources will be reviewed, with example of recent experience with new medical products. Students interested in, and pharmaceutical industry personnel focused on, the development of new medical products will benefit from this perspective. Important Information • Username and password: If you have forgotten your personalized username and password, use the DED Password Retrieval. • Technical support: DEhelp • Help: Computing requirements and tutorials for technologies used in online courses. • Fair use: The material at this Web site is subject to the copyright of the owners of the material and is being provided under rules of fair use for registered students in this course only. No additional copies of the copyrighted work may be made or distributed. • Privacy policy: Your access to certain portions of this Web site is tracked for educational purposes—much like taking "class attendance" at an on-site course. This information is accessible only by course faculty and the Distance Education Division. |
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