Bioanalytical method development and validation are interdependent components crucial for the drug screening strategy. Bioanalytical procedures play a significant role in developing the quantitative data necessary for analyzing compounds during the screening operation. They help establish drug-specific acceptable criteria early during the drug development cycle. Hence, reliable data will be crucial if sponsors desire to identify potential drug compounds from thousands of compounds that enter the early drug screening process.
Bioanalytical assay validation demonstrates that the method is suitable for its intended purpose. The need for assay validation emerged due to stiff competition in the international drug development space and the need for maintaining high standards for ethical and regulatory reasons. Moreover, various regulatory agencies continuously set higher standards for approving new drug products. If sponsors make changes to any standard bioanalytical method, regulatory guidance requires they document and validate the modified assay. However, the extent of assay validation depends on the intended purpose of the assay.
In general, bioanalytical assay validation involves:
- The specification of method requirements
- Determining method characteristics
- Verifying whether the requirements are valid and adequate for conducting the assay Therefore, understanding the importance of method development and validation, we give you three reasons why bioanalytical assay development and validation will be crucial for drug screening in 2022.
Bioanalytical assay development and validation play a crucial role in regulatory submissions.
With an ever-growing demand for new drug products, bioanalytical companies are increasingly applying for investigational new drug applications, new drug applications, and abbreviated new drug applications to the FDA. These applications require several bioanalytical studies, including pharmacology, bioavailability, bioequivalence, and pharmacokinetic studies to be performed in clinical and preclinical trials. And the success of these studies depends on adequate development and assay validation.
The development of robust detection techniques depends on bioanalytical assay validation.
Bioanalytical assay methods involved in drug screening, often analyze complex biological matrices such as blood, plasma, serum, and urine. Analyzing such complex matrices needs robust bioanalytical techniques, including chromatographic and ligand binding assays. These techniques measure biomolecules including proteins, drugs, metabolites, and biomarkers in biological samples. However, these techniques can only deliver reliable results if sponsors adequately validate them.
All regulatory bodies consistently release guidelines for the development of detection techniques. Regulatory bodies understand the importance of efficient validation results. Hence, most guidance is focused on recommendations for developing and validating bioanalytical methods.
The drug screening process depends on adequately developed and validated methods.
Though drug screening is the primary step in the drug discovery process, it is the one that generates critical data for choosing potential drug molecules for subsequent preclinical and clinical studies. Hence, bioanalytical methods providing quantitative data during drug screening are critical ones. A validated bioanalytical method addresses some crucial parameters of accuracy, precision, specificity, sensitivity, and sample storage and handling. Validated bioanalytical methods ensure that the generated safety and efficacy data are reliable.
Assay validation and bioanalytical method development facilitate reliable quantification of analytes and biomarkers in various biological matrices to assess drug safety and efficacy. You need qualified scientists to generate your valuable bioanalytical assay data using fully validated methods and platforms.
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