Under-representation of older adults in pharmacokinetic and pharmacodynamic studies: a solvable problem?

ABSTRACT

The impact of advancing age, with or without the presence of structural and/or functional organ impairment, on the disposition and effects of drugs, demands adequate representation of older adults in pharmacokinetic and pharmacodynamic studies. Currently, however, this group remains poorly represented both in pre- and post-marketing studies. This review discusses recent data on the participation of older adults in pharmacokinetic/pharmacodynamic studies using established databases, the potential barriers to study recruitment and retention and possible strategies to enhance participation in this group. The article also provides a critical appraisal of current regulatory documents on the conduct of such studies.