Clinical Absorption-Metabolism-Excretion (AME) studies

To obtain in vivo human AME data, XenoBiotic Laboratories (XBL) assists sponsors in conducting clinical studies using radiolabeled drugs. Typically, 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.

XBL provides comprehensive AME study services

• Evaluation of the pre-clinical ADME package
• Dosimetry calculations
• Clinical study protocol design
• Radiolabel drug synthesis through preferred partners
• Radiolabeled drug purity, radiopurity, and specific activity determination
• Labeled API purification or re-purification
• Isotopic dilution, dosing formulation and stability evaluation
• Sample collection (blood, plasma, urine, and feces), processing and shipping
• Sample analysis for mass balance
• Metabolite radioprofiling in plasma, urine and feces
• Radiokinetics on blood and pharmacokinetics on plasma
• Metabolite identification
• Training for clinical sites handling radioactive samples

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.