Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label.

摘要

A critical issue in labeling is to succinctly communicate, in a manner that is readily understandable and actionable, changes in systemic exposure that affect drug dosing. Current practices in labeling make it difficult for prescribers to locate the most important information influencing their dosing decisions. In this report, we propose the use of forest plots for communicating the pharmacokinetic consequences of intrinsic and extrinsic factors in a concise and readily interpretable manner.Safety and effectiveness studies are customarily carried out in patient populations that are heterogeneous to some extent; however, the clinical consequences of possible differences in metabolism and excretion are generally difficult to discern in a conventional analysis of clinical trial data. Also, individuals with marked impairment of excretion and individuals on a full range of concomitant therapy are generally not included in clinical trials. Pharmacokinetics (PK) has therefore served as a surrogate for differences in safety and effectiveness for the purpose of adjusting doses in populations that have not been directly studied in clinical trials or whose numbers are too small to allow subset analyses.