Comprehensive Review on AQbD-Enabled Latest Advancements of Bioanalysis Using Hyphenated Techniques in Drug Product Development
TL;DR
This review provides a thorough investigation into the design and validation of bioanalytical techniques utilizing the AQbD framework, in accordance with ICH rules that delineate GLP and controlled bioanalysis.
Abstract
Bioanalysis is essential in current drug discovery and development research for the healthcare industry. Bioanalysis involves the assessment of analytes, such as medicines, metabolites, and biomarkers, in biological specimens. This method includes several stages, from sample collection to analysis and subsequent data reporting. The first phase is to gather samples from clinical or preclinical trials, which are then sent to the laboratory for faster analysis. The second step entails sample clean-up, or sample preparation, which is deemed an essential aspect of bioanalysis. Liquid Chromatography-Tandem Mass Spectrometry (LC–MS/MS) is the most favored technique for separation and detection in bioanalytical laboratories. This stems from the enhanced selectivity and sensitivity of other vital techniques, such as LC-NMR, GC-MS, GC-IR, CE-MS, and GC-NMR, which enable precise and rapid analysis of complex sample mixtures, offering improved reproducibility and greater automation. Moreover, comprehending the analyte's chemical structure and characteristics is crucial before initiating bioanalytical procedures. This review provides a thorough investigation into the design and validation of bioanalytical techniques utilizing the AQbD framework, in accordance with ICH rules that delineate GLP and controlled bioanalysis. This review also provides a comprehensive overview of the above-reported hyphenated techniques, employing Statistical Quality Control (SQC) monitoring and regulatory compliance using an advanced AQbD approach, highlighting their current status and future directions.