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Wednesday, November 22, 2017

Webinar: Advanced Analytical Approaches to Regulatory "MIST" Requirements

Presented by Dr Ron White, Senior VP for DMPK Science and Technology at XenoBiotic Laboratories
Original Air Date: 09/22/2011

"MIST" (Metabolites In Safety Testing) refers to guidances issued by the U.S. Food and Drug Administration and the European Medicines Agency that outline the requirements for assessing the safety of circulating human metabolites of new drug candidates.

A consequence of MIST is that analytical chemists have been challenged to find and quantitate human metabolites in plasma during early clinical trials without using radiolabeled drug. This challenge has now been largely accomplished by applying modern, start-of-the-art mass spectrometers which have the ability to accurately determine molecular weights of ions to three decimal places.

When combined with sophisticated data processing algorithms such as mass defect filtering, isotope pattern filtering and background subtraction, these methods allow us to reliably discern drug-related compounds among the many background compounds present in typical biofluids.

This webinar described how these currently available techniques may be integrated to reliably find, structurally identify and semi-quantitate metabolites from the plasma and urine samples that you typically already collect in your Phase I clinical trials.

This will allow you to comply with regulatory expectations for metabolite safety assessment without the need to wait for the conventional 14C-ADME studies that are usually conducted in Phases II or III.

Who Will Benefit?
Many industrial, academic and regulatory scientists, whether you are just getting started or a seasoned veteran, will gain a practical understanding of why and how to accomplish MIST objectives in Phase I clinical studies, including:

  • Pharmacokineticists
  • Quality Assurance specialists
  • Drug metabolism scientists
  • Regulatory submissions personnel
  • Bioanalytical chemists
  • Clinical pharmacologists
  • Toxicologists

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