Current Industry Practices in the in vivo Assessment of Human Drug Metabolism Webinar

October 25, 2013

Webinar

Location: Webinar

We are pleased to invite you to the October 25 Webinar “Current Industry Practices in the in vivo Assessment of Human Drug Metabolism”,  sponsored by the IQ Consortium Drug Metabolism and Clinical Pharmacology Leadership Groups.   The webinar will present results from the 2013 IQ Consortium survey of the same name.  Survey results are available only to members from IQ Consortium member companies and can be accessed here by logging into the Member Portal on the IQ website https://iqconsortium.org/initiatives/working-groups/human-in-vivo-metabolism/.  Information on the survey is provided below.

Human radiochemical excretion and metabolism studies are a standard aspect of most small molecule drug development programs. The 2008 Safety Testing of Drug Metabolites, ICH M3(R2), M3(R2) Q&A, ICH S9 regulatory guidances (hereafter referred to as “MIST guidances” (metabolites in safety testing guidances)), and new technologies such as accelerator mass spectrometry (AMS) and high resolution LCMS/ MS may be changing industry perceptions of how, when and why these studies are run. Likewise, new study designs, made possible by these technologies, and sometimes involving the administration of much lower doses of radioactivity, or no radioactive tracer at all, have resulted in divergent industry approaches to the in vivo assessment of human drug metabolism.

The Working Group was chartered in 1H2012 to conduct a survey of current industry practices in the assessment of in vivo human drug metabolism.  The scope of the survey encompassed human clinical studies that have some determination of drug metabolism, including both radiolabel ADME studies on small molecule (<1500 Da) investigational drugs and non radioactive drug administrations with some assessment of candidate drug metabolism are in scope. Clinical metabolism studies conducted in the 5 year period 2008-2012 are in scope. Some aspects of foundational in vivo preclinical ADME studies are in scope. Some questions may refer to the present, meaning current practice in the year 2012.  Targeted respondents included experts in drug metabolism, bioanalysis, human ADME studies, preclinical safety, and clinical development, all of whose responses were blinded prior to analysis.