Drug Metabolism Leadership Group

The Drug Metabolism Leadership Group's (DMLG’s) mission is to consider, develop and support best practices and science-based initiatives on issues related to preclinical and clinical drug/biologics metabolism, pharmacokinetics, bioanalysis, and Biopharmaceutics; to advise its member companies on strategic and regulatory issues related to drug/biologics metabolism; and to serve as a resource to other IQ LGs. The DMLG provides a means for member companies to discuss relevant issues across industry, with other trade organizations, and with the FDA and other regulatory agencies.

Active DMLG projects relate to drug-drug interaction modeling and prediction, therapeutic protiens, microsampling, bioanalysis, and radiolabelled materials and ADME Studies. Discussion groups on drug distribution imaging and PK/PD have also been recently formed by the Leadership Group.

The DMLG, along with the CPLG, holds annual roundtables with the Food and Drug Administration’s Office of Clinical Pharmacology. During these roundtables, participants review trends within the field and examine recent and upcoming regulatory guidances.