Human Mass Balance Study – How, When, Why: From Practical Issues to Regulatory Guidance | An ISSX 2025 Short Course

Human Mass Balance Study – How, When, Why: From Practical Issues to Regulatory Guidance | An ISSX 2025 Short Course

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Co-Chairs: Lei Zhang, Silver Springs, MD, USA and Dennis Heller, Certara, USA

  • Mass balance study and metabolite profiling: Design, data analysis, and interpretation
    Chandra Prakash, Agios Pharmaceuticals, USA
  • Industry application and case examples
    Ellen Cannady, Eli Lilly, USA
  • FDA guidance on human radiolabeled mass balance studies
    Zhixia Yan Danielsen, US Food and Drug Administration, USA
  • EMA’s perspectives on human mass balance studies
    Karin Fawkner, Medical Products Agency, Sweden

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SC 1.1 Mass balance study and metabolite profiling: Design, data analysis, and interpretation | Chandra Prakash, Agios Pharmaceuticals, USA
Open to view video.
Open to view video. This short course explores the use of clinical probes and biomarkers to evaluate transporter-mediated drug-drug interactions, highlighting their role in drug development, study design, data interpretation, and regulatory guidance.
You must register to access.
SC 1.2 Industry application and case examples | Ellen Cannady, Eli Lilly, USA
Open to view video.
Open to view video. This short course explores the use of clinical probes and biomarkers to evaluate transporter-mediated drug-drug interactions, highlighting their role in drug development, study design, data interpretation, and regulatory guidance.
You must register to access.
SC 1.3 FDA guidance on human radiolabeled mass balance studies | Zhixia Yan Danielsen, US Food and Drug Administration, USA
Open to view video.
Open to view video. This short course explores the use of clinical probes and biomarkers to evaluate transporter-mediated drug-drug interactions, highlighting their role in drug development, study design, data interpretation, and regulatory guidance.
You must register to access.
SC 1.4 EMA’s perspectives on human mass balance studies | Karin Fawkner, Medical Products Agency, Sweden
Open to view video.
Open to view video. This short course explores the use of clinical probes and biomarkers to evaluate transporter-mediated drug-drug interactions, highlighting their role in drug development, study design, data interpretation, and regulatory guidance.
You must register to access.
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