TL38: Assessment of the Dose Proportionality of PK Parameters in SRD or MRD Trials and the Evaluation of the Steady State – What is the Common Practice
*Jingtao Wu, TAKEDA Global Developement and Research Center 


“Power” model or ANOVA model has been used commonly to evaluate the dose proportionality of PK parameters, with BE criteria being used. Due to small sample size in each dose group in SRD or MRD trails, the criteria is often missed. What has been done in your work to resolve this? Evaluating steady state of exposure to the a drug is often done using graphs. Are there any inferential statistical methods commonly used? Is a formal assessment needed?