Identification of Out-of-Trend Stability Results

April 2, 2003
Mary Ann Gorko

Mary Ann Gorko is principal statistician at AstraZeneca.

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2003, Volume 27, Issue 4

Representatives from PhRMA member companies discuss the growing concern about out-of-trend stability data, including possible statistical approaches and the implementation challenges to identifying OOT results.