The Importance of Bioanalytical Method Validation

The purpose of method validation is to determine an assay's prime characteristics, like sample volume, linearity, the limit of quantification, precision, accuracy, and selectivity, and to address potential issues such as sample storage analyte stability.

FREMONT, CA: Scientists require analytical methods to measure elements, low molecular weight compounds, and macromolecules in several matrices to support pharmaceuticals, biological, environmental, medical, or food sciences.

Therefore, quantitative methods are developed and characterized, representing that the analytical procedure employed for a particular test is appropriate for its intended use. This process is often denoted as the method validation. The purpose of method validation is to determine an assay's prime characteristics, like sample volume, linearity, the limit of quantification, precision, accuracy, and selectivity, and to address potential issues such as sample storage analyte stability.

Essentially, the degree of validation and the formalism are desired based on the fit for the evaluation. Method validation can be considered a time-consuming process, but not doing it accurately will waste resources, money, and wrong scientific knowledge. In bioanalysis, several players are involved, including universities, Contract Research Organization (CRO), governmental agencies, and hospitals; assessment methods are developed to quantify pharmaceutical and their metabolites, peptides, endogenous compounds, and proteins various biological matrices.

In an academic environment, new analytical approaches and workflows are examined to improve sensitivity, decrease cost, and enhance the throughput of analysis or analytical procedures developed to provision research programs. Pharmaceutical industries and CRO authenticate assays for their use in the drug discovery and development process, while in hospital, analytical techniques are applied to optimize drug treatment.

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Governmental agencies require assay methods to control drugs' quality and administer abuse of drugs or exposure in the environment. The need of the Food and Drug Administration (FDA) guidance is to certify sound scientific principles and with strict attention to quality assurance and control and to help sponsors of Investigational New Drug Applications (INDs) or candidates of New Drug Applications (NDAs) to authorize bioanalytical methods employed in human or animal studies, or biomarker concentration evaluation.

Method validation is a central topic in analytical sciences for quantitative analysis and is controversial, particularly for publications. Validation data are essential to the readers and reviewers to build an idea about a new assay's applicability, performance, or innovative analytical methodology. The degree of validation relies on the fit of purpose and must be clearly defined and discussed.