Bioanalytical Chemistry & Drug Metabolism

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Monday, November 10 2008

Quality / Accreditations

By Denis Vignes on Monday, November 10 2008, 18:14

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  • Full GLP compliance
  • Independent QA Unit
  • Review of protocols / raw data / reports
  • Critical phase inspections
  • Process inspections
  • Monitoring and maintenance of archives for materials and study documentation
  • Internal quality assurance program
  • Accreditation to carry out radiolabelled studies (in-life and analytical phases)
  • ISO 14001 Certification (Environment Management System)

Equipment

By Denis Vignes on Monday, November 10 2008, 18:09

  • LC/MS/MS systems (API/Sciex and Waters/MicroMass instruments)

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  • HPLC systems (UV, Fluorescence, DAD)
  • GC - FID, GC - MS (EI, CI) systems
  • Automated liquid / solid-phase extraction systems
  • Equilibrium dialysis (Dianorm)
  • Liquid scintillation counter / oxidizer
  • HPLC systems with on-line radioactivity detection
  • Ultracentrifugation
  • Sample storage at –20°C and –80°C (monitored freezers)

Services

By Denis Vignes on Monday, November 10 2008, 17:54

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Bioanalytical Chemistry

  • Development of analytical methods (plasma, urine, tissues, milk, etc.)
  • Transfer, full or partial validation of methods
  • Analytical assays for pharmacokinetic, metabolism and residue studies (parent compounds and metabolites)

Pharmacokinetics

  • Bioavailability
  • Bioequivalence
  • Single and multiple-dose pharmacokinetics
  • Linearity
  • Dose ranging
  • Toxicokinetics
  • Pharmacokinetic evaluation of data: compartmental and non-compartmental analysis

Metabolism

  • Absorption, Distribution, Metabolism and Elimination (ADME)
  • Mass balance / Excretion (14C, 3H & 35S)
  • Biliary excretion – Enterohepatic recirculation
  • Tissue distribution
  • Metabolite profiling and identification
  • Dose analysis: Radiochemical purity and specific activity
  • In vitro: S9, microsomes, hepatocytes, inductions, inhibition studies, Caco-2 cells)
  • Protein binding (ultrafiltration, equilibrium dialysis)

Residues studies

  • Residue depletion in food-producing species

Ecotoxicity

  • Ecotoxicological studies: Phase I & Phase II
  • Degradation studies (manure, slurry, etc.)
  • Adsorption desorption studies (soils)