Identification of populations at risk in drug testing and therapy: application to elderly patients.

Risks associated with drug therapy are more prevalent with advancing age. In drug evaluation it is imperative to identify risk groups. Six strategies are discussed to identify risk groups: (a) from physico-chemical, preclinical drug data, and expected physiologic changes; (b) from animal and human phase I PK data and expected physiologic changes; (c) from epidemiologic data and expected physiological changes; (d) from animal/human toxicokinetic data and expected physiologic changes; (e) from retrospective patient monitoring; (f) from population kinetics using NONMEM; and (g) from pharmacokinetic screen approach.