The development of bioanalytical techniques has enabled the pharmaceutical sector to obtain a quantitative measure of the drug and its metabolites.
FREMONT, CA: The advancements in bioanalytical techniques have brought significant changes in the pharmaceutical sector. It has spurred robust developments in drug metabolism, creating new opportunities in the industry. The collection, processing, storage, and analysis of the biological matrix of chemical compounds can be streamlined through the incorporation of bioanalytical techniques.
Pharmaceutical organizations are leveraging bioanalytical method validation (BMV) to decide suitable analytical methods for biochemical applications. Bioanalysis facilitates the quantitative assessment of various features of drugs, including metabolites, biological molecules, and biotics such as macromolecules, proteins, DNA, and large molecule drugs.
Bioanalytics holds great potential in the industry and offers innovative approaches to enhance sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling, processing, analysis cost, and environmental impact. It had made long strides in the field of quantitative measurement, promoting the development of pharmacokinetics, toxicokinetics, bioequivalence, and exposure-response.
Forensic and clinical toxicology requires accurate interpretation of toxicological findings. Bioanalytical techniques can enhance the reliability of analytical findings, thus averting any unjustified legal consequences. By conducting a series of validation experiments and obtaining satisfactory results, the quality and reliability of bioanalytical methods can be ensured.
Bioanalytical assay validation involves the characterization of the biological samples from clinical studies along with the critical assay reagents. BMV comprises the various procedures demonstrating the quantitative measurement of analytes in a biological matrix. The process leverages specific laboratory investigations, using suitable and reliable techniques for analytical applications.
The increase in the use of biological agents for therapeutics has empowered the pharmaceutical sector to incorporate the development and validation of robust bioanalytical methods for quantification in the preclinical and clinical studies. BMV is crucial for the evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic study data.
The accuracy of the studies determines the quality of the bioanalytical data. Hence, the validation of the guiding principles is vital for the pharmaceutical community. The bioanalytical methods, including several physicochemical and biological techniques such as immunoassay, chromatography, and mass spectrometry, have to be validated before the generation of results. The validation parameters include accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery, and stability. The validation requirements for the bioanalytical methods are not only vital for regulatory compliance, but also the generation of high-quality data during drug discovery and development.