ABSTRACT

The assessment of drugs designed to affect the central nervous system will of course include detailed studies of pharmacology and effects on psychomotor performance. The use of females taking oral contraceptives is open to criticism and should be avoided until proper interaction studies have been conducted, since oestrogen and progestogens can interfere with the absorption of some drugs. Tolerance studies in non-patient volunteers help to bridge the gap between animal and patient studies and reduce exposure to ineffective therapy during the early evaluation of a new drug in man. The management of patients is improved by the information gained on the nature of side- and toxic effects and the dose level at which they occur. Quantitative assessments of side-effects and other adverse reactions based on tolerance studies in non-patient volunteers are best avoided, in view of the frequently observed differences between healthy adults and patients.