PHARMACOKINETIC STUDIES IN ELDERLY PEOPLE - ARE THEY NECESSARY

With new compounds the needs of the following groups must all be satisfied, given that the needs of the patient must always remain paramount: (i) the clinical pharmacologist studying the effects of aging on drug metabolism and disposition; (ii) the pharmaceutical company planning clinical trials; (iii) the regulatory authorities wishing to ensure no drug granted a licence will subsequently be found to show unacceptable toxicity that may have been highlighted by closer study of pharmacokinetic parameters at an early stage; and (iv) the physician in hospital or family practice who wants to prescribe safely. Pharmacokinetic studies will generally be required in each case. It seems likely that the present pattern of conducting pharmacokinetic studies in the elderly will continue, but with the possible addition of more population-based studies aimed at minimising the risk of toxicity in individual patients. © 1994, Adis International Limited. All rights reserved.