Solving Statistical Mysteries - What Does FDA Want?

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Deadline: July 10, 2020 | Date: July 20, 2020

Venue/Country: U.S.A

Updated: 2020-06-24 19:39:40 (GMT+9)

Call For Papers - CFP

"What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.