What You Should Know About Bioanalytical Method Validation
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What You Should Know About Bioanalytical Method Validation

Stacey Smith, Pharma Tech Outlook | Monday, August 23, 2021

Bioanalytical technique validation is an essential part of any bioanalytical program. It ensures that quantitative results are accurate, precise, selective, and stable, allowing the correctness of sample analysis results to be justified.

FREMONT, CA: For assessing the concentration of medicines and their metabolites and numerous pharmacodynamic indicators in biological fluids, bioanalytics is an important technique in drug discovery and development. Scientists employ developed and established methods to identify analytes and metabolites in biological matrices such as serum, plasma, urine, and Cerebrospinal Fluid (CSF) in these studies. Bioanalytical technique validation is an essential part of any bioanalytical program. It ensures that quantitative results are accurate, precise, selective, and stable, allowing the correctness of sample analysis results to be justified.

Bioanalytical Method Validation

Full Validation

The FDA, ICH, and other regulatory bodies provide bioanalytical method development and validation guidelines and outline the needed criteria for appropriate bioanalytical development, validation, and analysis. Any custom assay method that is novel or has been created based on the literature should undergo a comprehensive validation investigation. A completely validated method demonstrates that it can be used to consistently determine the amounts of analytes like a 

medication and its metabolite(s) in a biological sample matrix from a certain species.

Sensitivity selectivity, reproducibility, intra, and inter-day accuracy and precision, dilutional integrity, matrix effects, and analyte stability under all storage and sample handling and preparation conditions are the key characteristics that must be determined for a method's performance to be considered acceptable.

Partial Validation

There are situations when a complete method validation is not required. For instance, if a technique is based on a previously verified technique with only minor modifications. When an analysis is done in a separate laboratory or with different equipment, partial validation is required when the sample origin or storage conditions have changed. A partial validation could be as simple as determining the improved method's accuracy and precision.

Cross-Validation

If data in a study was pieced together using different methodologies or data was obtained in separate laboratories, a cross-validation study was required. Essentially, cross-validation research allows data from different sources to be accurately compared.

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