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BRI Biopharmaceutical Research Inc.
101 - 8898 Heather Street
Vancouver, BC V6P 3S8 CA
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