Course Description
Biostatistical issues regarding the introduction and regulatory agency (FDA) approval of new drugs, biologics, medical devices, and combination products, and their postmarket surveillance are considered. Data quality assurance, experimental design, clinical trials, power and sample size determination, uncertainty assessment, regression, survival analysis, and variable and model selection are considered.
Athena Title
APP PHARM BIOTECH
Equivalent Courses
Not open to students with credit in BIOS 7100
Non-Traditional Format
Three hours per week for fifteen weeks online study, including teaching, assignments, discussion, problem-based learning, and case-based learning. Weekend seminar(s) totaling eight contact hours (multi-point video conference) utilizing case-based and problem-based learning methods.
Prerequisite
BIOS 7010 or permission of department
Grading System
A - F (Traditional)
Course Objectives
At the end of the course, the successful student should be able to: 1. Analyze and interpret statistical issues related to government approval of new pharmaceuticals, biologicals, or medical devices; 2. Analyze and interpret statistical issues regarding postmarket surveillance for adverse effects; 3. Evaluate and report on the statistical content of biomedical literature; 4. Interact with statisticians regarding the design, data analysis plan, and implementation of preclinical and clinical studies for drugs, biologics, medical devices and combination products.
Topical Outline
Data quality assurance; experimental design; clinical trials; power and sample size determination; uncertainty assessment; multiple regression; logistic regression; survival analysis; variable and model selection; meta analysis.
Syllabus