Weiner, Ph.D. Weiner has extensive drug development experience and has served as an expert consultant to the U.S.

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Food and Drug Administration (FDA) on pharmacokinetic modeling and bioequivalence assessment. Weiner is the co-author of Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications’ 5th ed.

He is a co-developer of PCNonlin, NONLIN84, and WinNonlin and a co-designer of Phoenix NLME and has presented numerous workshops on the statistical evaluation of PKPD and bioavailability data. Weiner is currently an industry consultant and a member of the Simulations Plus Board of Directors. He has held previous management positions including Chief Scientific Officer and Senior Vice President at Certara/Pharsight Corporation. Weiner is an Adjunct Associate Professor with the Division of Pharmacotherapy and Experimental Therapeutics in the School of Pharmacy, University of North Carolina and is an Affiliate Professor of Pharmacometrics, Center for Translational Medicine in the School of Pharmacy at the University of Maryland. During his career he has provided PKPD training to over 3,000 students. Thursday, May 16, 2019 8:00 to 17:00, followed by a group dinner at 18:00 Friday, May 17, 2019 8:00 to 17:00, evening on own Saturday, May 18, 2019 8:00 to 15:00, course adjourns Examples will include structural population model building for: • Simultaneous modeling of plasma and urine data • Simultaneous modeling of data from different routes (e.g. Iv and oral) • Metabolite modeling – single vs multiple metabolites, formation in plasma and/or tissue, reversible and irreversible metabolite formation, metabolites measured in plasma and/or urine • Modeling dual absorption such as from a controlled release formulation (containing IR and ER formulations) • Modeling endogenous drugs • TMDD modeling approaches • Modeling data from crossover designs.

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