QUALITY OF PHARMACOKINETIC RESEARCH IN ONCOLOGY

These usefulness of pharmacokinetically guided individualisation of dr ug therapy will depend, among other things, on the quality of the anal ytical and pharmacokinetic methods used. We surveyed the quality of an alytical and pharmacokinetics methodology and reporting in a literatur e search of the oncology literature from 1987 to 1992, using the Medli ne database. Thirty articles that examined relationships between norma l tissue toxicity and area under the plasma concentration-time curve ( AUG) formed the study sample. Analytical procedures were adequately de scribed in 77% of the articles, but details of validation of the assay were seriously deficient in the great majority of articles. Methods f or calculation of AUC were also deficient in over half of the articles . The findings suggest that greater attention needs to be paid to the quality of pharmacokinetic investigation in oncology, otherwise progre ss in the use of pharmacokinetically guided individualisation of dosag e may be hindered.