Clinical studies

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):

Method Development
Method Transfer
Method Optimization (sensitivity/specificity)
Full Validation
Biological matrices: blood, plasma, urine, tissues, among others
Quantification of both parent drug and metabolites
Quantification of biomarkers


Clinical studies:

Phase I-IV pharmacokinetics
Drug-drug interaction studies
Bioequivalence studies


Delivered results:

Drug (metabolites) concentrations
Biomarker concentrations
Standard pharmacokinetic parameters determined by non-compartmental analysis

Equipments & facilities:

Mass spectrometry (MS) with both HPLC and ultra-performance liquid chromatography (UPLC), among others.
Spectrometry detectors: Sciex Triple Quad 6500+ System, API 4000, Waters TQ and Waters TQ Micro
Extraction and clean-up methods of the biological matrix based on automated solid phase extraction using Epmotion liquid handling
High capacity to store samples at deep freeze temperatures with a 24/7 temperature monitoring