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Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development

Metabolites in safety testing (MIST) has become an integrated part of drug metabolism research in drug development, and is a widely discussed topic within the drug development industry.

Recent guidance from the U.S. Food and Drug Administration (FDA) on safety testing of drug metabolites helps drug developers know when and how to identify and characterize drug metabolites. Identifying and characterizing a drug’s metabolic profile is a necessary step in any preclinical program, critical to assessing human risk before moving to clinical trials.

What You’ll Learn

In this webinar, Dr. Peter Wang*, Senior Director of WuXi AppTec’s drug metabolism and biotransformation platform in New Jersey, presents the updated guidance for metabolites in safety testing and discusses the importance of MIST and why, when and how to conduct MIST studies.

Topics include:

o Regulatory Guidance
o Why to Conduct MIST in Drug Development
o When to Conduct MIST in Drug Development
o When and How to Conduct Met ID to Address MIST

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Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development

*Dr. Peter Wang is the Senior Director of Drug Metabolism and Biotransformation at WuXi AppTec, Lab Testing Division. In his current role, he directs operations of the Drug Metabolism department, providing operational, client, and project management support. Dr. Wang has extensive experience in metabolite identification, having worked in in vitro and in vivo DMPK-related fields for more than 15 years. Prior to joining WuXi AppTec in 2008, Peter was a senior scientist at FMC Cooperation, where he served as Study Director for agrochemical metabolism studies in plants and animals.

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient, socially responsible and sustainable solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,200 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”

For more information, please visit: https://labtesting.wuxiapptec.com/

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