Model-Informed Drug Development for Anti-Infectives: State of the Art and Future

Authors: Craig R. Rayner, Patrick F. Smith, David Andes, Kayla Andrews, Hartmut Derendorf, Lena E. Friberg, Debra Hanna, Alex Lepak, Edward Mills, Thomas M. Polasek, Jason A. Roberts, Virna Schuck, Mark J. Shelton, David Wesche, Karen Rowland‐Yeo


Model‐informed drug development (MIDD) has a long and rich history in infectious diseases. This review describes foundational principles of translational anti‐infective pharmacology, including choice of appropriate measures of exposure and pharmacodynamic measures, patient subpopulations, and drug‐drug interactions. Examples are presented for state‐of‐the‐art, empiric, mechanistic, interdisciplinary, and real‐world evidence MIDD applications in the development of antibacterials (review of minimum inhibitory concentration (MIC)‐based models, mechanism‐based pharmacokinetic/pharmacodynamic (PK/PD) models, PK/PD models of resistance, and immune response), antifungals, antivirals, drugs for the treatment of global health infectious diseases, and medical countermeasures. The degree of adoption of MIDD practices across the infectious…

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