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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.
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:
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.
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.
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.