Phase i and beyond - The importance of switching to patient's plasma: Considerations and perspectives on bioanalytical procedures

摘要

The current drug-development paradigm is in constant flux, with some innovative options always being introduced to solve complex problems or find solutions to critical questions during the long journey of drug discovery to market introduction. It needs to be appreciated that drug-development in itself represents systematic integration and proper channeling of various functional expertise to seamlessly coordinate and execute the 'agreed developmental plan' with efficiency and rigor to predetermined milestones, finally culminating in marketing authorization of the drug in question. In this big picture of drug development, bioanalysis plays a vital role since it helps to provide certain key data reflecting the drug's pharmacokinetics (PK)/disposition in not only preclinical species, but also in human subjects inclusive of both healthy volunteers and targeted patients. Furthermore, bioanalysis is a key surrogate in labeling claims/decisions for not only drug dosing, but also for clinical drug-drug interaction scenarios.