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
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:
Equipments & facilities: