Pharmacokinetics & in vivo Pharmacology

The assessment of preclinical in vivo data of lead compounds is a prerequisite for ensuing regulatory toxicology studies and decisions on a clinical drug candidate in the drug development process. Data generated in relevant species like rat or mouse support the prediction of metabolism or PK in humans and can help to find better formulations or new therapeutic applications for existing drugs.


Pharmacelsus plans and performs state-of-the-art in vivo studies in accordance with and supervised by animal welfare authorities.

 

PK Studies, Pharmacokinetic Service

Exploratory/orientating pharmacokinetic studies

  • Determination of basic PK parameters
  • Dried Blood Spot PK
  • Cassette Dosing
  • Identification of major metabolites

 

Full pharmacokinetic profiling

  • Dose proportionality
  • Organ distribution and excretion, mass balance
  • Metabolism/ First Pass-effect/Elimination
  • Bioequivalence studies (comparison of different formulations)
  • PK/PD relationship based on assessment of biomarkers that can be quantified by ELISA, flow cytometry or LC-MS

 

Pharmacological models

  • Liver fibrosis induced by bile duct ligation in rats
  • Diabetes
  • Aromatase inhibition
  • 5?-reductase (typeII) inhibition