Aim: To quantify therapeutics (drug, metabolites) or biomarkers in samples from clinical trials.
Background information: Drug, metabolite and biomarker analysis in biological samples help to determine the appropiate dose ranges associated to a therapeutic effect.
The validation of bioanalytical methods is expected for studies submitted for regulatory approval or considered for regulatory decisions. The quantification of therapeutics (drug, metabolites) in biological samples from clinical trials is done with bioanalytical methods validated previously working in full compliance with Good Laboratoy Practice (GLP) and international regulatory (ICH) requirements.
Bioanalytical method services (MS):
Equipments & facilities: