The performance of human clinical and preclinical animal research to test the efficacy of ingredients or products aimed at improving various aspects of human health is greatly needed. This includes the testing of dietary ingredients and finished products marketed as nutraceuticals or dietary supplements. In this modern era of the educated consumer, it is in the company's best interest to perform such investigations (preferably, independent third party) in an attempt to address questions raised in relation to product claims.
The research team within The School of Health Studies at The University of Memphis offers the research and supporting services to companies who market and sell dietary ingredients, nutraceuticals, dietary supplements, and related items aimed at enhancing health and/or performance (e.g., physical, cognitive).
Bioanalytical, pharmacokinetics, and pharmacodynamics (B/PK/PD) Services
Through collaboration with the University of Tennessee Health Science Center (UTHSC) College of Pharmacy, the CNDSR offers essential product support services for work with nutraceuticals. A key component of our B/PK/PD service core is The Shared Analytical Facility at the UTHSC College of Pharmacy, which is a state of the art facility outfitted with all the equipment necessary to provide extensive analytical and bioanalytical characterization of nutraceuticals. Examples include characterization of cGMP-grade nutraceuticals to ensure purity and identity of the product, bioanalytical method development, qualification, and validation using accepted best practices as outlined by the Food and Drug Administration, and characterization of pharmacokinetics in animals and humans. Sponsor's will receive a complete analysis of samples including the development of (bio)analytical methods, sample preparation, and data analysis for clinical and non-clinical studies. Support for experimental design along with interpretation of PK/PD modeling data by leading experts in the field is also available.
Cell Culture Experiments
In vivo cell culture testing can be used as a powerful tool to elucidate the safety of a compound or its tissue specific effects. Our labs have the ability to use both immortalized cell lines that can be cultured repeatedly, and primary cells isolated from an animal. Early stage investigations may use cell culture models to determine compound cytotoxicity. We are able to perform several assays in a cell culture model that can determine the effects of a compound on cell proliferation, differentiation, growth, and viability. In addition, later stage compounds can be used in this model to elucidate cell specific mechanisms of action that may alter cell metabolism, cell signaling, gene expression, growth and viability. Our team has the experience in helping clients with the selection of appropriate models and assays to meet the specific needs of a particular compound.
Pre-Clinical Animal Studies
Animal models are essential for translating theoretical and cell-based data into living systems, and are critical for testing the efficacy and safety of ingredients, compounds, and multiple component systems before advancing to clinical studies. Our research team includes basic scientists, DACLAM boarded veterinary support, and exceptional animal technicians with demonstrated experience in identifying and using the most appropriate animal models to answer specific questions. A key strength is our documented success in developing new animal models for evaluating responses throughout the life history, in health and disease, and in combination with diet and pharmacologic interventions. We have expertise with a diversity of animal species ranging from traditional and non-tradition rodent species, such as mice (wild type and genetically modified), rats, hamsters, voles, mole rats, rabbits, and also pigs as a translational species. The animal facilities have advanced diagnostics, including blood and urine chemistries, hematology, blood gases, and digital radiography. Our relationship with the Memphis biomedical research community provides additional expertise and facilities. Importantly, our team excels in collaborating with industry partners in the design, performance, and interpretation of studies.
Human Studies and Clinical Trials
We are fully equipped to provide a wide variety of human studies of varying design, including single laboratory assessments, placebo-controlled and cross-over designs, randomized and placebo-controlled clinical trials, as well as pharmacokinetic studies. We have expertise in IRB document writing and application approval, protocol development, subject recruitment and retention, data collection and analysis, peer-reviewed manuscript preparation, and professional scientific presentations. The University of Memphis is home to nearly 25,000 students, faculty, and staff of varying age, ethnicity and background, making our campus community an excellent source for the recruiting of human subjects. For examples of evaluations that can be performed using your product, please click here.