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Drug Metabolism Related Safety Considerations in Drug Development

  • Published on December 5, 2019
  • Drug Drug Interactions (DDI)
  • Drug Metabolism
  • Regulatory Guidance
  • Webinars

Presenter: Larry Wienkers, Ph.D., Sekisui XenoTech Consultant

With the close of our 2019 Drug Metabolism Updates Seminar Series, Dr. Wienkers presented his primary keynote topic as a webinar for all of those who could not attend one of our seminar events.


Approximately 30 years ago, sub-optimal DMPK properties were recognized as the primary contributor to the failure (~40%) of potential new therapies in early clinical trials. This observation precipitated a renaissance period across the discipline which served to align DMPK efforts within discovery to assist in selecting optimal drug candidates to advance to clinical testing. As a consequence, the failure rate for NCEs due to poor DMPK attributes is currently below 5%. While the success of DMPK groups to resolve issues is impressive, there is still a critical need to understand the activity and safety implications of key drug metabolites as part of the overall evaluation of the NCE.

This overview touches upon strategies for building phase appropriate packages for metabolites to account for pharmacological activity, potential drug interaction and associated metabolism-dependent drug safety concerns.

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