What You Should Know Bioanalytical Method Validation

The aim of method validation is to determine key assay characteristics like sample length, the limit of quantification, linearity, precision, accuracy, and selectivity, and resolve potential issues like analyte stability and sample storage, to name a few.

FREMONT, CA: To support pharmaceuticals, biological, medical, environmental, and food sciences, scientists need analytical methods to measure elements, low molecular weight compounds, and macromolecules in various matrices. Quantitative methods are developed and defined for this purpose, showing that the analytical technique used for a particular test is appropriate for its intended use. Method validation is a term used to describe this method. The aim of method validation is to determine key assay characteristics like sample length, the limit of quantification, linearity, precision, accuracy, and selectivity, and resolve potential issues like analyte stability and sample storage, to name a few.

Fundamentally, the level of validation and formalization required depends on the assay's suitability for its intended intent. Method validation is a time-consuming process, but if done incorrectly, it may result in a waste of money and energy, as well as incorrect scientific knowledge. Assay methods are designed to measure pharmaceuticals and their metabolites,

 endogenous compounds, peptides, and proteins in various biological matrices in bioanalysis, including universities, federal agencies, and Contract Research Organizations (CROs), hospitals, and the pharmaceutical industry.

Novel analytical approaches and workflows are investigated in an academic setting to enhance sensitivity, minimize cost, and increase the throughput of analysis or analytical methods developed to support research programs. Pharmaceutical companies and CROs validate assays for use in drug discovery and development, while in hospitals, analytical techniques are used to improve drug treatment. Government agencies require assay methods to regulate medication quality and track drug misuse or environmental exposure. The FDA guidance's goal is to help sponsors of Investigational New Drug applications (INDs) or applicants of New Drug Applications (NDAs) validate bioanalytical methods used in human or animal research, or biomarker concentration evaluation, by ensuring sound scientific principles and paying close attention to quality assurance and quality control.