Replicate analysis is the standard practice of ligand binding analysis(LBA) in bioanalysis, which is to reduce the variability of the analysis. With the progress of analytical instrument technology and the improvement of reagent quality, especially the automation application, the precision of LBA has been significantly improved, the bioanalysis industry is asking whether LBA could also be single-pore assayed as LC-MS. In recent years, ICH M10 (Draft for comment) has accepted the singlicate analysis, and several industry organizations or research institutions have carried out comparative studies of singlicate and replicate analysis. The results show that the use of singlicate analysis did not significantly affect the key parameters of toxicology kinetics(TK) and/or pharmacokinetics(PK), the critical values and sensitivity of anti drug antibody(ADA). This paper summarizes the research progress of existing literature, and propose the technical requirements of singlicate analysis application, in order to provide reference for the application of singlicate analysis in TK/PK and ADA study,and further promote the technical standards of drug registration in line with international standards.
LI Shuai, LI Gang, WU Hao, CHEN Gui-liang
. Progress and technical requirements for ligand binding analysis of singlicate analysis in bioanalysis[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(4)
: 550
-557
.
DOI: 10.16155/j.0254-1793.2023.04.02
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