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/