BRI Biopharmaceutical Research Inc. Test or Service List : Bioanalytical Assays for Clinical Trials LC/MS/MS assays of drug candidates, metabolites and small molecule biomarkers in various biological matrices supporting clinical Phase I to IV studies Existing small molecule assays for quantiation of biomarkers in biological fluids Existing drug assays supporting clinical DDI and BA/BE studies Established protocols for validation of proprietary or commercial ELISA or cell-based assays supporting GLP and cGMP studies Assay systems include LC/MS/MS, LC/MS, GC/MS, HPLC/UV, GC/FID and ELISA PK Sample Collection Kit and Equipment Rental Customize chemical stabilization kit for blood and plasma clinical PK sample collection Venous / capillary blood / 24-Hr urine / saliva / nail clipping collection kits & handling protocol customized to clinical design Clinical trial equipment rental of portable refrigerated centrifuges and -70°C freezers PK sample storage & stability assessment Cross-Border custom / TDG shipment documentation support & clinic Webinar training Vast Experience in Bioanalytical Assays for Clinical Trials Drug metabolite assay in conformance with US FDA MIST guidance Personalized medicine based on translational study & therapeutic drug monitoring Botanical drug candidate IND and NDA enabling development Assay of uncommon PK sample matrices: neonatal dried-blood spot, CSF and others Automated Barcode Sample Inventory & Data Handling Thermo-WatsonT LIMS barcode sample and data handling of clinical PK samples WinNonlinT non-compartmental model PK parameter determination