WELAB BARCELONA

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
– Biomarkers/Pharmacodynamics
– 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

Welab Barcelona is a Spanish leading platform for Drug Discovery and Development. Our goal is to be your partner in creating the next generation of tomorrow’s medicines

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  • Parc Científic de Barcelona, Edifici Clúster II, Planta 4, Baldiri Reixac, 4-8. 08028 Barcelona Spain
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