Journal article
Model‐Informed Drug Development for Anti‐Infectives: State of the Art and Future
Abstract
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 (PD) measures, patient subpopulations, and drug-drug interactions. Examples are presented for state-of-the-art, empiric, mechanistic, interdisciplinary, and real-world evidence MIDD …
Authors
Rayner CR; Smith PF; Andes D; Andrews K; Derendorf H; Friberg LE; Hanna D; Lepak A; Mills E; Polasek TM
Journal
Clinical Pharmacology & Therapeutics, Vol. 109, No. 4, pp. 867–891
Publisher
Wiley
Publication Date
4 2021
DOI
10.1002/cpt.2198
ISSN
0009-9236
Fields of Research (FoR)
Sustainable Development Goals (SDG)
Medical Subject Headings (MeSH)
Anti-Bacterial AgentsAnti-Infective AgentsAntifungal AgentsAntimalarialsAntitubercular AgentsAntiviral AgentsBody WeightDose-Response Relationship, DrugDrug ApprovalDrug DevelopmentDrug DiscoveryDrug Resistance, MicrobialHumansImmunityIvermectinKidney Function TestsLiver Function TestsMicrobial Sensitivity TestsModels, BiologicalOnchocerciasis, OcularPediatricsResearch DesignUnited StatesUnited States Food and Drug Administration