AME SERVICES

New drug discovery is depending more heavily on absorption, metabolism, and excretion analyses (AME) and toxicology testing than ever before. In the past, cost and time were key reasons for positioning this work later in clinical development. Financial efficiencies and market success depend on complete and accurate data about human toxicity. But also, newer, more complex molecules with novel actions have prompted earlier acquisition of the requisite information. The strategic question is: How much knowledge about human AME is needed or valuable at different stages of clinical development? Worldwide provides quantitative predictions and translational science acumen to help you make better decisions earlier and select drug candidates with the best chance of success.

Key Human AME Tests

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

Our Laboratory Capabilities

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 via ground courier to our lab in Austin, Texas, for analysis, allowing study volunteers to leave the research center after adequate radioactive recovery has been confirmed.

Our AME laboratory equipment includes:

• 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

Specialized Research Personnel

We offer industry-leading 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

Research Subjects — Healthy Volunteers

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 for availability and flexible schedules. They are regularly instructed throughout the study on the importance of following protocol (eg, collecting samples).