The PSRI offers an innovative alternative to traditional contract research organizations by providing timely and highly cost-effective drug discovery-development research services for both non-clinical and clinical development phases.

Pharmaceutical Analysis

The pharmaceutical analysis team specializes in formulation analysis for determination of potency, stability, and compatibility of all forms of drug formulations. We conduct method development/validation as well as method performance evaluation of client transferred methods. Our group utilizes a combination of chromatographic and spectrometric analytical platforms in evaluating formulated drug products for:

  • Potency testing of extemporaneously compounded drug formulations.
  • Stability and Beyond Use Date (BUD) determinations of new and existing formulated products.
  • Y-site and admixture compatibility of multi-API drug formulations.
  • Diversion monitoring and tracking
  • Hazardous exposure wipe testing (USP 800)
  • Chemical and physical drug properties:
    • Log P
    • pH
    • Solubility
    • Turbidity

Small Molecule Bioanalysis

The PSRI specializes in bioanalytical analysis of small molecules using high-performance  liquid chromatography -tandem mass spectrometry  (HPLC-MS/MS) to support research across all areas in drug discovery and development.

  • Method development, transfer, optimization, and validation of chromatographic and mass spectrometric methods
  • Extensive experience in standard and atypical species and biological matrices (tissues and fluids) from non-clinical models
  • Bioanalysis of drugs and metabolites from clinical studies.
    • Pharmacokinetics
    • Toxicokinetics
    • Bioavailability
    • Dose-range finding
    • Biodistribution
    • Metabolism
    • Protein Binding

Metabolism

Comprehensive in vitro metabolism services can be conducted in all commercially available sub-cellular tissue fractions for both phase I and II biotransformations and include:

  • Metabolic stability
  • Metabolite identification
  • CYP450 isozyme phenotyping
  • Metabolic kinetics (Km and IC50)
  • Drug interaction/inhibition

Major Instrumentation/Software

  • AB Sciex 4000, 5000, 5500 QTRAP mass spectrometers
  • Shimadzu Prominence liquid chromatography systems
  • UV-Vis, Diode array and Fluorescence detectors
  • Light Sight 2.1 metabolism software
  • ANALYST 1.6.1, 1.7 and 1.7.2 instrument control and data acquisition and processing software
  • MULTIQUANT 2.0
  • LABSOLUTIONS LC software 5.51