This article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.
Richard Montes
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Richard Montes, rmontes@alnylam.com, director of CMC Statistics, Process, and Analytical Sciences at Alnylam Pharmaceuticals, Cambridge, MA, has more than 20 years of experience in the bio/pharmaceutical industry. He received his PhD in Chemical Engineering (ChE) from the Georgia Institute of Technology, his MSChE from Texas Tech University, and his BSChE from St. Louis University.
Articles by Richard Montes
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