GLP Bioanalytical Assays

By combining 20 years of method development and validation experience and advance instrumentation, BRI supports clinical PK, pre-clinical TK/PK, rapid PK screening and BA/BE studies through automation using Thermo Scientific Watson (LIMS). Every assay is validated based on a protocol-driven process in conformance with regulatory and published industry white paper recommendations.

COMPREHENSIVE EXPERIENCE

Therapeutic Areas

Oncology, Cardiovascular, Neuroleoptic, Respiratory, Anesthetic, Viral Diseases, Anti-parkinsonian, Anti-cholesterol, Anti-obesity and more…

Types of Drugs

– Prodrug
– Small molecule
– Peptides
– Oligonucleotides
– Endogenous biomarkers
– Botanical drugs

Matrices Used

– Blood
– Plasma
– Serum
– Urine
– Feces
– Sputum
– Fingernail
– Neonatal materials
– Other animal organs & tissue

Readily Accessible CITES Materials for Non-Human Primate Studies

– Whole blood
– Plasma
– Urine

BIOANALYTICAL ASSAYS

Bioanalytical & Immunoassays

– Multiple assay systems include LC/MS/MS, LC/MS, HPLC with various detectors, GC/FID , GC/MS, and ELISA platereaders

Pharmacokinetic Data Analysis

– Utilizing Phoenix WinNonLin™ software for non-compartmental PK parameter determinations

PK Sample Collection Kits and Clinical Trial Equipment Rentals

– Customize chemical stabilization kit for blood and plasma PK samples
– Array of venous, capillary blood, 24-hr urine, sputum, nail collection supplies offered
– Support & training worldwide of nurses/health care practitioners for collection and shipment documentation

Drug-Drug Interaction Study

– A large number of validated assays for recommended substrates in support of Phase IV drug-drug and drug-food interaction studies