A novel application of t-statistics to objectively assess the quality of IC50 fits for P-glycoprotein and other transporters.

ABSTRACT: Current USFDA and EMA guidance for drug transporter interactions is dependent on IC50 measurements as these are utilized in determining whether a clinical interaction study is warranted. It is therefore important not only to standardize transport inhibition assay systems but also to develop uniform statistical criteria with associated probability statements for generation of robust IC50 values, which can be easily adopted across the industry. The current work provides a quantitative examination of critical factors affecting the quality of IC50 fits for P-gp inhibition through simulations of perfect data with randomly added error as commonly observed in the large data set collected by the P-gp IC50 initiative. The types of errors simulated were (1) variability in replicate measures of trans

SUBMITTER: O'Connor M 

PROVIDER: S-EPMC4317220 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature