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Human ADME Services


Tests to determine the absorption, distribution, metabolism and excretion (ADME) of a compound are among the most vital for a new chemical entity.

Ocean Blue Medical Research Center  as a drug development solutions facility, offers comprehensive ADME services. As indicated in the FDA MIST Guidance (2008): "the identification of differences in drug metabolism between animals used in nonclinical safety assessments and humans as early as possible in the drug development process", is encouraged

When performed in early-phase studies, ADME testing identifies metabolic clearance pathways and defines long-lived, unique or disproportionate human metabolites. ADME studies can also provide insight into pharmacologic activity, metabolism-mediated toxicity and the potential for drug-drug interaction (DDI). This screening process allows researchers to identify and shelve likely-to-fail drug candidates early in the process and improves asset value of promising compounds by enhancing the understanding of clinical pharmacology.

Key ADME tests

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

Facility Capabilities

Our Clinical Research Services team performs ADME testing and analysis from a newly-designed ADME laboratory with state-of-the-art analytical equipment dedicated to metabolism studies. ADME 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 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 MS

Our clinical research facility in Miami Springs, Florida, is licensed to handle carbon-14 (14C) and tritium (3H)-labeled compounds for traditional ADME studies (50-100 microcurie range). In addition, our large capacity facility has space set aside for conduct of nanotracer/microdose studies (<1 ?Ci). Specific procedural, sample processing and pharmacy storage areas have been identified and are appropriately monitored to support these studies.

The comfortable, modern facility is designed for extended in-patient stays with a total of 250 beds. Our experienced clinical research services team has conducted more than 40 studies requiring interval urine and/or fecal collections over extended time periods in the past three years.

Samples collected and prepared for assay (whole blood, plasma, urine and fecal) can be conveniently and rapidly transported via ground courier to Ocean Blue Medical Research Center' state-of-the-art ADME laboratory for analysis, allowing study volunteers to be released from the research center in a timely manner after adequate radioactive recovery has been determined.

Specialized Research Personnel

In addition to our experienced research staff and physician investigators who are key to the successful execution on an ADME clinical trial, we provide services of specialists in the areas of radiolabel research and procedures.

  • Health Physicist. A health physicist consultant is available to review data from preclinical studies and assist in preparation of dosimetry and radiation exposure reports.
  • Radiation Safety Officer (RSO). The RSO is actively involved in staff training and creation and review of standard operating procedures pertaining to all activities involving radioactive materials. The RSO oversees the analysis swipe test samples and bioanalytical samples for radioactivity and reviews dose calculation, preparation and administration procedures throughout the study.
  • Radiologist/Sub-Investigator. In addition to a primary physician investigator, a board-certified radiologist is on site during dose administration.
  • Pharmacists. A pharmacist experienced with handling radioactive materials and radiolabel dosing is highly involved in dose preparation and administration activities and documentation. They are also responsible for accepting radiolabel product, isolation storage, swipe tests in drug storage/preparation area and product accountability.
  • Ethics Review Board. We utilize the services of an independent institutional review board (IRB) for approval of protocol, informed consent and other study-related documents. The IRB that reviews ADME studies has a board membership experienced in ADME study conduct, including a former RSO who serves as board chairperson.
  • Pharmacokineticists and Medical Report Writers. After a thorough quality control (QC) and quality assurance (QA) review, the ADME study data is analyzed by our expert staff and presented in a format to meet your needs and conform to regulatory agency requirements.

Research Subjects

Recruitment of suitable research volunteers to participate in any clinical trial is critical to success. This is especially important when multiple biological samples must be collected and length of confinement in the research facility may be extended. Subjects are carefully chosen for a flexible schedule and availability for a long-term stay. They are clearly instructed throughout the study on the importance of following protocol, including the importance of collecting all urine and fecal matter.

Meals are carefully planned to include adequate fiber content and fluid/water intake is encouraged throughout the study. Subjects are also encouraged to move/walk around and not become sedentary.


The conduct of a human ADME study is recognized as a necessary step whether it falls early or late in the drug development process. Ocean Blue Medical Research Center has been offering contract research services to the pharmaceutical, biotechnology and medical device industries for over 20 years. Our expertise and execution of ADME trials is just one of several flagship services we offer to assist in your drug development plan.

Last update: 07/7/2015 11:24
Content updated on Monday, 10-2-2017 04:35:40 am