Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. The studies conducted to comply with these recommendations are often referred to as metabolites in safety testing or MIST.

This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies to address the regulatory expectations.

Frontage Laboratories has developed an approach that integrates a series of in-vitro and in-vivo assays that in combination demonstrate due diligence in meeting MIST regulatory expectations. This approach includes several inter-related experiments and the bulk of the presentation with involve a detailed discussion of the scientific basis for the approach Frontage utilizes in conducting a MIST study.

Featured Speakers

Dr. Philip R. Tiller

Senior Director 
Frontage Laboratories, Inc.

Dr. Tiller obtained his Ph.D. from the Imperial College of Science, Technology and Medicine, London. He has more than 25 years’ experience working in the Pharmaceutical industry at Glaxo in England, at Merck in the US, at RMI Laboratories, and now at Frontage. His focus has been the application of high-resolution mass spectrometry (HRMS) to metabolite Identification.

Date:  Wednesday, July 29, 2020
Time:  1pm ET / 10am PT
Duration:  1 Hour

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