WELAB BARCELONA

Bioanalytical Method Validation

Aim: Validation of analytical method for quantification of drug concentrations in a biological matrix.

 

Background information: For studies submitted for regulatory approval or considered for regulatory decisions, validation of bioanalytical methods is mandatory. The objective of the validation of a bioanalytical method is to demonstrate that it is suitable for its intended purpose, ie to measure concentrations of drug and its metabolites in biological samples. The use of a robust and reliable bioanalytical method is critical for a successful drug development project.

 

Our standard procedure is compliant with GLP/GCP regulations and follow international regulatory standards (ICH) for validation and sample analysis.

Compound requirement: 25 mg

 

Turnaround time: 6 Weeks / one single analyte in plasma

 

Experimental design:

Aliquots of drug-free plasma are spiked with the analyte of interest using solutions of reference standard and internal standard to preparate calibration standards and quality control samples. Sample pre-treatment involved a solid-phase or liquid-liquid extraction for clean-up. The compound is identified and quantified using reverse-phase HPLC with MS/MS detection.

 

Parameters to evaluate:

− Selectivity
− Specificity
− Matrix Effect
− Calibration Curve and Range
− Accuracy and Precision
− Carry-over
− Dilution integrity
− Freeze-thaw of the analyte in matrix
− Bench top stability in matrix
− Long-term stability in matrix
− Stability of the analyte in processed samples
− Stability of the analyte and IS in stock and working solutions
− Reinjection reproducibility

Equipments & facilities:

− Mass spectrometry (MS) with both HPLC and ultra-performance liquid chromatography (UPLC), among others. We have spectrometry detectors such as Sciex Triple Quad 6500+ System, API 4000, Waters TQ and Waters TQ Micro.
− Extraction and clean-up methods of the biological matrix are mainly based on automated solid phase extraction using Epmotion liquid handling, which helps to obtain reproducible and sensitive methods.
− Use of Electronic Notebook avoiding manual data 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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