What Are The Fundamental Guidelines For The Validation Of Bioanalytical Methods?
Bioanalytical methods are essential tools in the field of pharmaceutical research and development. These methods are used to quantify the concentration of drug substances and their metabolites in biological matrices such as blood, plasma, and urine. The validation of bioanalytical methods is a critical step in ensuring the
accuracy, precision, and reliability of the data generated from these methods. In this document, we will outline the fundamental guidelines for the validation of bioanalytical methods as practiced by NorthEast BioLab.
Guidelines for Validation of Bioanalytical Methods
Selectivity
Selectivity refers to the ability of the analytical method to distinguish between the analyses of interest and other components present in the sample matrix. The method should not respond to interfering substances that are not part of the analyses of interest. This can be demonstrated by analysing blank matrices and assessing any potential interference.
Sensitivity
Sensitivity refers to the ability of the analytical method to detect and quantify the analyses of interest at low concentrations. The limit of
detection (LOD) and limit of quantification (LOQ) are used to assess the sensitivity of the method. The LOD is the lowest concentration of the analyses that can be reliably detected, and the LOQ is the lowest concentration of the analyses that can be quantified with acceptable accuracy and precision.
Accuracy
Accuracy refers to the closeness of the measured value to the true value. The accuracy of the method can be assessed by analysing spiked samples at different concentrations and comparing the measured values to the expected values. The accuracy should be within an acceptable range, typically defined as 80-120% of the true value.
Precision
Precision refers to the reproducibility of the bioanalysis method validation. The precision can be assessed by analysing replicate samples and calculating the coefficient of variation (CV) or relative standard deviation (RSD). The precision should be within an acceptable range, typically defined as less than 15% CV or RSD.
Linearity
Linearity refers to the relationship between the concentration of the analyses and the response of the analytical method. The linearity can be assessed by analysing spiked samples at different concentrations and plotting the response versus the concentration. The linearity should be within an acceptable range, typically defined as a correlation coefficient (r2) of at least 0.99.
Robustness
Robustness refers to the ability of the analytical method to remain unaffected by small variations in the experimental conditions such as pH, temperature, and sample preparation. The robustness can be
assessed by varying one experimental parameter at a time and assessing the impact on the method performance.
Stability
Stability refers to the ability of the analyses to remain stable in the sample matrix during storage and processing. The stability can be assessed by analysing stability samples at different time points and assessing any degradation or loss of the analyses.
Conclusion
The validation of bioanalytical methods is a critical step in ensuring the accuracy, precision, and reliability of the data generated from these methods. The guidelines outlined above are fundamental principles for the validation of bioanalytical methods and are practiced by NorthEast BioLab. The application of these guidelines ensures that the data generated from bioanalytical methods is robust and reliable, which is essential in the field of pharmaceutical research and development. Contact
Company Name: NorthEast BioLab
Address: 925 Sherman Avenue, Hamden, CT 06514, USA
Contact No: +1 203-407-0703
Website: https://www.nebiolab.com/ Email Id: mailto:info@nebiolab.com