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Mass balance/ADME studies in oncology patients: Successful answers to the challenge in Central and Eastern Europe

Related topics: Pharmaceutical/Biotech, Europe, Clinical, Central Eastern Europe, Oncology

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Overview
  • Patient pharmacology services: Concept and operational set up.
  • ADME concepts, incl. micro-dose and tracer-dose.
  • Underlying dossier requirements incl. preclinical safety package.
  • General design considerations incl. radiodose and radioburden calculation.
  • Devil is in the details: Operational challenges.
  • Selection of geographic region and patient population.
  • Ethical aspects.
Speaker

Agnes Rethy 
Associate Director of Clinical Operations
EDS Patient Pharmacology Services
PRA Health Services

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