Choose Worldwide as Your Highly Experienced Mass Balance Research Unit

Worldwide Clinical Trials is licensed to handle compounds labeled with carbon-14 (14C) and tritium (3H) for traditional AME studies (50–100 microcurie [μCi] range). In addition, we accommodate performance of nanotracer/microdose studies (<1 μCi). Procedural, sample processing, and drug-storage areas are available and monitored to support these studies.

Samples collected and prepared for assay (whole blood, plasma, urine, and fecal) can be conveniently and quickly transported within one hour via a ground courier to our lab in Austin, TX, for analysis, allowing study volunteers to leave the research center after adequate radioactive recovery has been confirmed.

We offer the highest quality AME laboratory equipment, including:

  • Packard Oxidizer analyzer for sample homogenization and extraction
  • Beckmann Liquid Scintillation Counter for high-sensitivity quantitation in mass balance studies
  • Waters Acquity UPLC for high resolution separations in metabolite profiling and identification
  • Sciex API 4000 and API 5000 for NL and standard reference material (SRM) profiling
  • LEAP Fraction Collector and Top Count for high sensitivity radiochemical profiling and preparative isolation
  • Thermo-Finnigan LXQ mass spectrometer for parent-product relationships (MSn fragmentation maps) and high-resolution mass spectrometry

Key Human AME Tests: Experience You Can Trust

  • Blood-plasma partitioning
  • Bioavailability
  • Conventional and nanotracer dosing
  • Mass balance
  • Metabolite identification
  • Metabolite profiling
  • Pharmacokinetics

Highly Specialized Research Personnel Experienced in Handling Radioactive Materials for Clinical Trials

We offer industry-leading mass balance study conduct expertise. Our highly trained scientists, research staff, and physician investigators ensure collection of high-quality data.

We also provide the following specialist services for radiolabeled AME studies:

  • Health physicist
  • Radiation safety officer
  • Radiologist/sub-investigator
  • Pharmacists
  • Ethics review board
  • Pharmacokineticists

Specialized Techniques for Recruitment of Healthy Volunteers for Radiolabeling Studies

Recruitment can be challenging for AME studies because multiple biological samples must be collected and the length of confinement in the research facility may be extended. Subjects are carefully chosen to ensure availability and flexible schedules. They are regularly instructed throughout the study on the importance of following protocol (e.g., collecting samples), and our highly trained staff is often praised for their ability to recruit and retain these subjects.