Human Radiolabeled Mass Balance (hAME) Studies for Regulatory Submission
Sponsored by: QPS
- Human Mass Balance
Date: 20 May
Time: 9am EDT – 15:00 CEST
Part I: A comprehensive overview and practical guide
In this webinar, QPS will provide a comprehensive overview and practical guide to get the most out of your hAME study, covering the many nuanced steps and considerations.
Through this discussion, Wim Tamminga will walk through main objectives of an hAME study and the ethical and regulatory considerations for hAME studies. In addition, he will cover formulation of mock batches, releasing of a subject based on radioactivity, an overview of the timelines, data analysis and reporting.
QPS can offer all services required for traditional hAME studies, including studies with radiolabeled compounds (approx. 100 µCi and therapeutic dose of IMP) and micro-tracer studies. To better describe the various study types and components, Wim will present three Case Studies, based on recent experiences in our QPS Netherlands facility.
Vice President and Global Head of Early Phase Clinical at QPS
Wim Tamminga joined QPS in 2010 and is currently serving as Global Head of Early Phase Clinical, based in Groningen, The Netherlands. In this position, Wim oversees QPS’ fast growing Early Phase Clinical business (Phase 0, I and IIa) in the US, Europe and Asia. In this role, Wim leads a large team of cross functional clinical development personnel, ensuring seamless implementation of Early Phase Clinical studies in over 500 beds at 6 sites around the world. Under his leadership more than 100 hAME studies have been performed. Wim received his PhD in Pharmacology/Pharmacogenetics from the University of Groningen in The Netherlands.
Key Learning Objectives
- A practical explanation on how to conduct an hAME study.
- How to decide to conduct an hAME or Microdose study.
- When to choose Healthy Volunteers or Patients in an hAME study.
- Should you measure PK in an hAME study?
- DMPK Researchers
- VPs and Directors of Clinical Research
- Drug Development Scientists
- Clinical Trials Managers
- Clinical Research Services Team Members
- Clinical Operations Team Members
- Head of Research & Development