Bioanalysis

Quantitative bioanalysis is an important part of the drug development process for the determination of systemic exposure. Concentration-time data of the test item (and its metabolites) provide valuable information on the pharmacokinetic/toxicokinetic behaviour of the investigated compounds in toxicological/comparative bioavailability/ clinical studies etc.

We can offer our services to support your needs in:

Bioanalytical method development/adaptation

  • Bioanalytical method validation according to the ICH M10 guideline
  • Study sample bioanalysis with incurred sample reanalysis (ISR) according to the ICH M10 guideline
  • Pharmacokinetic/toxicokinetic (PK/TK) analysis by the industrial gold standard Phoenix WinNonlin software

–        instrument platforms available: LC-MS/MS (SCIEX 5500 Qtrap, Shimadzu LCMS-8060), Shimadzu HPLC/UHPLC equipped with UV, DAD, fluorescence, RI, ELSD detectors

–        typical sample matrices: plasma, serum, whole blood, urine, tissue (e.g. brain, liver, etc.)

Guidelines and literature:
The International Council for Harmonisation (ICH) Link: https://www.ich.org/

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