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Activity Number: 307 - Clinical Trial Design-3
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #328825 Presentation
Title: Safety Analysis of Clinical Trials in NDA Submissions
Author(s): Linyun Zhou*
Companies: Takeda Global Research & Development
Keywords: clinical trials ; NDA submissions; safety analysis

This topic will focus on how to analyze safety data for some common safety signal evaluations and safety evidences reviewed in many NDA submissions across different therapeutic areas. The widely used statistical methods in safety analysis for NDA submissions will be introduced. Exploratory safety analysis will be discussed. Multiple past NDA submissions will be presented as example applications of these methods.

Authors who are presenting talks have a * after their name.

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