Bioanalytical Services

  • Leading LC-MS/MS-laboratory in Europe with more than
  • 100 validated LC-MS/MS-assays
  • Largest worldwide experience in LC-MS/MS of antiinfectives including modern antiretroviral compounds
  • LC-UV/fluorescence assays:
  • More than 300 validated assays
     

Bioavailability and Pharmacokinetic Studies

  • Bioequivalence
  • Drug-drug interaction,
  • Food-drug interaction
  • Dose-proportionality studies
     

Quality Service

  • Pharmacodynamic studies
  • Studies in Eastern Europe
  • Full study service (consulting, report writing), publications
  • Pharmacokinetic modeling using Kinetica™, SIPHAR, P-Pharm, NONLIN, TOPFIT, NONMEM
  • Statistical services using SAS
  • PK-PD modeling
  • Bioequivalence services
  • In vitro - in vivo correlation (Level A-C acc. to USP XVIII)
  • In vivo dissolution studies
  • Special studies
  • Drug penetration into uninflamed or inflamed CSF (new drug entities) in man (only therapeutically relevant agents in these patients).
  • Phototoxicity studies in man.
  • Model of drug distribution by analysis of body fluids such as saliva, sweat, tears, nasal secretion, prostatic fluid.
  • In vitro - in vivo protein and cell binding studies.
  • Liver: microsomal perfusion, hepatocyte work.
  • Studies on gastrointestinal site of absorption by local application of drug solutions and/or tablets with predependent dissolving coatings.
  • Probe-studies using newly developed drug cocktails to assess drug absorption, metabolism and elimination simultaneously
     

Tissue Penetration Studies:

  • Microdialysis
  • Blister fluid
  • Sputum
  • Body fluids: salvia, sweat, tears; nasal secretions, prostatic fluid (integrated body fluid model)
  • Single cell concentration measurement
  • Prostatic fluid and sperm
  • CSF
  • Peritoneal fluid, bronchial lavage
  • Feces
  • Saliva
  • Tissues: prostatic, lung, bronchial, bone, muscle, fat and virtually any other tissue in humans.
  • Special populations:
    • obese subjects
    • breast-feeding mothers
    • post-menopausal women
    • women on oral contraceptives
    • hepatic insufficiency patients
    • poor metabolizer studies
    • intestinal elimination
    • studies with charcoal model + feces in humans
    • cystic fibrosis patients
    • middle aged subjects
    • HIV-positive patients