dedicated to the research and development of Nitric oxide
CAPABILITIES AND EXPERTISE
- Device validation using ICH 10 compliant assays for both topical and in vivo nitric oxide analysis
- New Drug and Supplement validations using ICH 10 guidance assays for topical and in vivo nitric oxide analysis
- Patent and trademark searches as well as novelty and obviousness patentability landscape analysis
- Expertise in wound healing studies with IACUC approvals
- Clinical trial design using American College of Sports Medicine (ACSM) guidelines for sports medicine/exercise science wearable devices to assess nitric oxide
- Evaluation of nitric oxide based coatings for orthopedic implant protection
- Bioanalytical detection of NO, NO2, nitrate/nitrite/nitrosothiols, NO-heme, and other NO-metals in biological fluids such as blood, urine, cerebrospinal fluid, and bronchial-alveolar lavage, as well as cell culture media and tissue homogenates
- Cell viability and cytotoxicity studies including dose and time-response, and determination of ID50 assessing gaseous NO/NO-donors in mammalian and prokaryotic cells
- Custom synthesis and purification of NO-donor compounds from milligram (GLP) to kilogram (cGMP) scale
- Characterization of NO-donors and kinetic NO-release profiles using multiple analytic platforms such as HPLC, UV/Vis, FTIR, and head-space chemiluminescence analysis
- Design of custom projects tailored for NO delivery in a variety of R&D healthcare applications
- Design and execution of pharmacokinetic and pharmacodynamic studies of NO donors undertaken with full IACUC approvals
- Validation and analysis to support research & development, clinical and commercial needs
- Gold standard analytical instrumentation and testing methods