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NEBA SERVICES
NorthEast Bioanalytical Laboratories
offers a comprehensive suite of services to support research and
development, preclinical (Phase 0), early clinical (PK/PD) and
late-stage studies (Phase I-IV).
Bioanalytical and Pharmacokinetic Analyses
• Analytical method development and validation of a diverse array of therapeutic compounds; click here for a listing of our analytical methods.
• Rapid qualitative or quantitative analysis of drugs and their
metabolites in a wide variety of biological matrices (whole blood,
plasma, serum, urine, feces, tissue, etc.)
• Preclinical studies
• Bioavailability and drug-metabolism studies
• Bioequivalence studies
• Protein binding determinations
• Chiral separations
• Elisa-based assays
• Cell-based assays
• Pharmacokinetic analysis using WinNonlin
Drug Discovery and Research
• Development of target-specific biochemical and cellular assays
• Development of assays for "mechanism of action" and "lead optimization" studies
• Metabolite isolation and identification
• Translational medicine assays
• Mutational analysis
• Protein expression and purification
• Stable cell line production
• Recombinant DNA cloning
Clinical Sample Management and Storage
• Long-term sample storage
• Clinical trial sample collection kits for clinical sites
• Management and support of pharmacokinetic and biomarker sample collection
Protocol and Systems Development
• Support for the design, development and management of preclinical and clinical pharmacokinetic studies
• Training in HPLC and LC/MS/MS
• Validation and calibration of laboratory equipment (IQ, OQ and PQ)
• Auditing of GLP studies
• Electronic Monitoring (freezers, refrigerators, stability chambers, laboratory environments)
• Customized databases and information solutions
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