Population variability in animal health: Influence on dose‐exposure‐response relationships: Part II: Modelling and simulation |
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| Authors: | Marilyn N Martinez Ronette Gehring Jonathan P Mochel Devendra Pade Ludovic Pelligand |
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| Institution: | 1. Center for Veterinary Medicine, US Food and Drug Administration, Rockville, MarylandCommunicating authorThis article reflects the views of the author and should not be construed to represent FDA’s views or policies.;2. Utrecht Institute for Risk Assessment Sciences, Utrecht University, Utrecht, The Netherlands;3. Department of Biomedical Sciences, College of Veterinary Medicine, Iowa State University, Ames, Iowa;4. Simcyp Limited (a Certara Company), Sheffield, UK;5. Department of Clinical Services and Sciences and Department of Comparative Biomedical Sciences, The Royal Veterinary College, Hatfield, UK |
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| Abstract: | During the 2017 Biennial meeting, the American Academy of Veterinary Pharmacology and Therapeutics hosted a 1‐day session on the influence of population variability on dose‐exposure‐response relationships. In Part I, we highlighted some of the sources of population variability. Part II provides a summary of discussions on modelling and simulation tools that utilize existing pharmacokinetic data, can integrate drug physicochemical characteristics with species physiological characteristics and dosing information or that combine observed with predicted and in vitro information to explore and describe sources of variability that may influence the safe and effective use of veterinary pharmaceuticals. |
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| Keywords: | exposure response modeling and simulation population variability |
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