Auditing drug metabolism protocols, data, and reports.

A critical component of the drug discovery process is to assess the safety and metabolic disposition of a drug. This can be accomplished by evaluating drug concentration levels as part of safety assessment studies (toxicokinetics) and identifying the drug's presence in and throughout the body by conducting ADME (adsorption, distribution, metabolism, and excretion) studies. From a regulatory perspective, the major difference between these two types of evaluations is that toxicokinetic studies are under the purview of the Good Laboratory Practice (GLP) regulations (21 CFR 58) and ADME studies are not. International debate continues to resolve around the need to consider the applicability of the GLPs to ADME studies. While it is recognized that the current regulatory intent between ADME and toxicokinetic studies differs, this inspecting/auditing approach treats them generally the same. It assures management and external reviewers that data integrity measures are in place for all drug metabolism studies conducted by the facility.