ABSTRACT
This chapter deals with pharmacodynamic assessments in early development, highlighting their value in making decisions about compounds at this stage of development, but at the same time adding a word of caution that the assessments have to be performed correctly to obtain reliable evidence. Important in any study involving man, and in particular when assessing pharmacodynamic responses to new compounds, is the problem of variability within human subjects. Methods used to measure the pharmacodynamic effects of compounds need to relate to the assessments and be reliable and reproducible. Pharmacodynamic assessments in early studies of a compound in man can provide vital evidence to aid future investigations in patients. The method should be tested with established drugs to prove that it is measuring the assessment it should be measuring and to estimate its sensitivity to any changes induced by these drugs, so that the kind of change looked for from a new compound can be expected to be seen.
