Bioanalytical Method Development, Validation & Transfer
Beyond creating a procedure to identify and quantify your analyte of interest in a matrix, we define the design, operating conditions, limitations and suitability of the method while taking into account numerous scientific and regulatory considerations (1). By utilizing industry leading instrumentation, we deliver rapid LC-MS/MS method development with confidence, currently completing 100-150 method development projects per year.
We also support method development and validation for studies utilizing microsampling, including bridge studies to whole blood analysis. Our method validation is done in compliance with US Food and Drug Administration Guidance for Industry: International Council for Harmonization: Bioanalytical Method Validation M10, and in accordance with Veloxity Labs SOPs. This rigorous process will ensure a robust method that will generate precise and accurate data to give you confidence when making critical decisions for your study.
Veloxity Labs is your go-to bioanalytical contract research organization for bioanalytical method development, validation and transfer.
Reference
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Bioanalytical Method Development and Validation: A Review by Mahesh Mukund Deshpande, Veena Sanjay Kasture, Mahalaxmi Mohan and Macchindra J. Chavan April 10th 2019