XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec
Wednesday, May 23, 2018

Clinical Radiolabel Study Services

To obtain in vivo human Absorption-Metabolism-Excretion(hAME) data, WuXi/XBL offers a comprehensive set of services to assist sponsors in conducting clinical studies using radiolabeled drugs. Typically, WuXi/XBL works with one of our preferred clinical partners or a designated clinical trial unit of sponsor's choice to evaluate a labeled drug in humans.

WuXi/XBL provides comprehensive AME study services

  • Evaluation of the pre-clinical ADME package
  • Dosimetry calculations
  • Clinical study protocol design
  • Radiolabel drug synthesis
  • Radiolabeled drug purity, radiopurity, and specific activity determination
  • Labeled API purification or re-purification
  • Isotopic dilution, dosing formulation and stability evaluation
  • Sample analysis for mass balance
  • Metabolite radioprofiling in plasma, urine and feces
  • Radio-PK on blood and plasma
  • Metabolite identification and structure confirmation
  • Metabolite semi-quantitation and MIST analysis
  • Integration of chromatographic methods with AMS analysis for micro tracer studies
  • Training for clinical sites handling radioactive samples

WuXi/XBL offers fully intergrated services based on years of experience to ensure a successful human radiolabel study including complete mass balance recovery (typically greater than 90%) and high quality metabolite radioprofiling and identification data.