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:
     

LC-MS/MS

Fluticasone propionate

0.5pg/mL

Fluticasone furoate

0.5pg/mL

Formeterol

0.5pg/mL

Salmeterol

0.5pg/mL

Budesonide

0.5pg/mL

Salbutamol (Albuterol)

12.5pg/mL

Sunitinib and metabolite

60pg/mL for both

Tigecycline

10ng/mL

Cocaine and benzoylecgonine in sewage water

2pg/mL for both

Numerous doping agents

 

ELISA

Interferon alpha 2b

6.25pg/mL


 

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