• Bioanalytical Services
• Bioavailability and Pharmacokinetic Studies
• Quality Service

Bioanalytical Services

• Leading LC-MS/MS-laboratory in Europe with more than
  250 validated LC-MS/MS-assays
• Largest worldwide experience in LC-MS/MS of antiinfectives including modern antiretroviral
• Latest additions to our list of difficult and/or most sensitively to measure compounds:
   

Bioavailability and Pharmacokinetic Studies

• Bioequivalence (about 400 completed studies)
• Drug-drug interaction (about 50 studies)
• Food-drug interaction (about 40 studies)
• Dose-proportionality studies (about 20)
   

Investigations on biosimilars: involved in all relevant biosimilars available to date
 

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:

• Tissues: prostatic, lung, bronchial, bone, muscle, fat and virtually any other tissue
  Largest worldwide experiense in tissue concentration measurement of antiinfectives
• 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
• 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