David Lavrich, Ph.D.,

Senior Principal Scientist, Merck, Inc.

Dr. David Lavrich is a Senior Principal Scientist in Analytical Commercialization and Technology (ACT) at Merck Sharpe and Dohme, West Point, PA.  He received a Bachelor of Science in chemistry from Juniata College in 1989, and a Ph. D. in physical chemistry from Yale University in 1995.  He completed a postdoctoral fellowship in surface chemistry at Princeton University in 1998 and then joined Restek Corp. to develop a commercial silicon chemical vapor deposition process for chromatographic purposes.  He joined Merck Sharpe and Dohme in 2004, supporting the analytical methods development, stability assessment, and filing of small molecule drug NDAs.  His scientific interest has focused on the application of statistical tools to improve analytical methods development, robustness evaluation, and validation, as well as continuous analytical method process verification and improvements through control charting.   Additionally, he has utilized statistical tools to experimentally determine the kinetics of drug product chemical and physical changes to develop accurate predictive models supporting shelf life, specifications, packaging selection, and manufacturing controls.   Stability research has involved a semi-empirical approach utilizing statistical “Design of Experiments” methods with fundamental kinetic theory to expand the classic Arrhenius model beyond temperature dependence to a wide range of other factors including water activity, particle size, excipient interaction, tablet compression forces, and many others.

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