Conference

PBSS Workshop on Radio-labeled Mass Balance and Metabolite Profiling Studies 2021

PBSS Workshop on Radio-labeled Mass Balance and Metabolite Profiling Studies 2021

Julia will be giving a talk at a Boston PBBS workshop being held 14-15 October 2021 on “Synthesis of stable-labeled and radiolabeled metabolites using Hypha’s One-Stop Metabolite Shop.”

The meeting on Radio-labeled Mass Balance and Metabolite Profiling Studies: Fundamentals, Best Practices, Regulatory Requirements, Applications and Case Studies is designed to provide detailed guidance on objectives, study designs, and data analysis of metabolism studies of small molecules, siRNAs, and protein therapeutics. Speakers of this workshop bring a wealth of knowledge from the pharmaceutical industry in drug metabolism sciences. The discussion will be centered around the following topics:

  • Overview of drug metabolism and regulatory requirements for IND and NDA submission
  • Preclinical and human mass balance studies: Design, data analysis, and interpretation
  • New crossover human ADME study design using AMS
  • Approaches for safety assessments of human metabolites
  • Techniques (H/D exchange, derivatization, NMR and stable isotope) beyond mass spectrometry for metabolite identification
  • Human dosimetry calculations
  • Radio-labeled ADME studies of new modalities

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