Phase I and beyond – the importance of switching to patient’s plasma: considerations and perspectives on bioanalytical procedures

“The challenge may not be in terms of improving sensitivity of the quantitation, but more towards imparting the assay with additional attributes to withstand the evolving needs of drug development.” 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,...