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Course Catalog

140.633.11 BIOSTATISTICS IN MEDICAL PRODUCT REGULATION

Cancelled

Department:
Biostatistics
Term:
Summer Inst. term
Credits:
2 credits
Academic Year:
2012 - 2013
Location:
East Baltimore
Class Times:
  • M Tu W Th F,  8:30 - 11:50am
Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Ayesha Khan
Course Instructor:

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Prerequisite:

Basic epidemiology and biostatistics

Description:

Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.

Methods of Assessment:

Class exercises

Instructor Consent:

No consent required