title: Rational use of medicines in older adults: Can we do better during clinical development?
abstract: There is an evidence gap to ensuring safe/effective use of medicines in older adults. Generating clinical data in these patients poses ethical and operational challenges, yielding results that may not be generalizable to the overall population. Modeling and simulation (M&S) is proposed as a basis for assessing the impact of age-related changes and their clinical implications. M&S can be used in conjunction with bridging and extrapolation to ensure the selection of appropriate dose(s)/regimen(s) in this population.
authors: Kellogg College, University of Oxford, UK; Global Regulatory Affairs, GlaxoSmithKline, Uxbridge, UK.
authors: M A
authors: MA
authors: Saeed
authors: G
authors: G
authors: Vlasakakis
authors: O
authors: O
authors: Della Pasqua
mesh_terms: D000367:Age Factors; D000375:Aging; D003198:Computer Simulation; D003661:Decision Support Techniques; D003663:Decision Trees; D004305:Dose-Response Relationship, Drug; D054796:Drug Dosage Calculations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology* / Q000517:prevention & control; D019317:Evidence-Based Medicine; D006801:Humans; D008954:Models, Biological; D018579:Patient Selection; D018570:Risk Assessment; D012307:Risk Factors