Statistical Considerations for Premarketing Risk Assessment

This presentation described important statistical considerations in the premarketing assessment of drug safety, covered the importance of planning for the safety assessment of a drug, and addressed statistical considerations in the analysis of safety data, primarily adverse event data.
Timestamps
00:50 - Appropriate design and Analysis Planning
26:06 - Appropriate Analysis Approaches
01:08:05 - Q&A Discussion Panel
Speakers | Panelists:
Gregory Levin, Ph.D.
Associate Director for Statistical Science and Policy
Office of Biostatistics (OB)
Office of Translational Science (OTS)
Center for Drug Evaluation and Research (CDER) | FDA
Mat Soukup, Ph.D.
Deputy Director
Division of Biometrics VII
OB | OTS | CDER | FDA
Learn more at: www.fda.gov/dr...
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