Pharmacokinetic Studies
ADME & Safety

In Vivo PK/PD Studies

Reaction Biology supports clients with pharmacokinetic (PK) and pharmacodynamic (PD) studies to understand the interaction of the drug and body. In the early preclinical research phase of a new drug, PK studies provide data necessary for determining a dosing schedule and route of administration for in vivo efficacy testing. PD studies give an insight into whether the drug actually does act on its target in the mouse body.

Pharmacokinetic Studies

Pharmacokinetics (PK) is a fundamental aspect of drug discovery for the characterization of drug candidates in hit-to-lead and lead optimization programs in regards to adsorption, distribution, metabolism, and excretion after administration to mice.

Setups:

  • Single-dose and multiple-dose studies for up to 3 weeks.
  • Anti-cancer therapeutics testing can be performed on tumor-bearing mice.

Routes of administration:

  • Intravenous, intraperitoneal, oral, subcutaneous, intratumoral, AlzetTM pump, and others upon request.

Samples:

  • Whole blood, plasma (EDTA, heparin), serum, tissues/organs, excreta (urine, feces)

Bioanalysis of the samples is performed by our collaborator Pharmacelsus GmbH

Sample Preparation:

  • Protein Precipitation and Liquid-Liquid Extraction
  • Hybrid protein precipitation / solid phase extraction (PPT/SPE)

Substance Identification:

  • Immunoassay
  • TSQ Quantum LC-MS/MS Systems
  • Orbitrap Q-ExactiveLC-MS System
  • LC-Q-TOF (X500B)

Deliverable:

  • Detailed report including animal weight and behavior
  • Graphical presentation of a time course of substance quantity
  • Calculation of common PK parameters

Options:

  • Dose proportionality
  • Organ distribution, excretion, mass balance
  • First pass effect

We can conduct pharmacokinetic (PK) studies on animal models:

  • Mice at our facilities in Hershey, Pennsylvania, USA and Freiburg, Germany
  • Rats at our facilities in Hershey, Pennsylvania, USA and Heidelberg, Germany

Please contact us for additional information.

Pharmacodynamic Studies

Pharmacodynamic (PD) is the area in pharmacology to determine how the drug acts on the body. At the endpoint of a mouse study, organs or tumor tissue is isolated and subjected for testing of biomarkers, functional readouts and efficacy on the target molecule.

Tumor tissue or other tissue can be subject to a variety of readouts:

  • Flow cytometry
  • Western-Blotting
  • Multiplex-ELISA (MSD)
  • qPCR
  • Immunohistochemistry
  • Histology
  • ELISA
  • PD markers that can be quantified via MesoScale or Mass Spectrometry
  • Blood cell counts