The inspection of drug metabolism and pharmacokinetic studies

Areas in which the regulations apply must be discussed to ensure that an overall standard of "good practice" is applied to Absorption Distribution Metabolism Excretion (ADME) as an integral part of the safety testing program. There are specific problems in adapting the toxicology regulations for drug metabolism and pharmacokinetic studies. In reviewing the laboratories and their experimental procedures, an attempt to identify, through an auditing approach, how a drug metabolism laboratory can comply with regulations is presented. It must be regarded as of paramount importance that all work be carried out to the highest standards to allow the largest margin of safety. With these experiences, ADME Laboratories "new" to Good Laboratory Practice can proceed along the compliance pathway with minimum trauma to man, animal, and machine.