Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 166 - Non-Clinical Statistics, Personalized Medicine, and Other Topics
Type: Contributed
Date/Time: Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #318138
Title: Quadratic Slope-Ratio Model for Nonlinear Dose-Response of CBPA Assay
Author(s): Ming Luo*
Companies: AbbVie
Keywords: Slope-ratio Model; Quadratic Dose-response Function; Relative Potency; Similarity of Bioassay; Proportional Drug Effect; CBPA
Abstract:

Commonly used slope-ratio model for bioassay is applicable only in "linear dose range", which usually represents a small part of the dynamic range of the assay responses. Here we propose a non-linear extension of the slope-ratio model based on proportional drug effect assumption. In this approach, the drug dose-response curves are modeled by a pre-selected specific non-linear function that applied on both reference standards and test samples. Relative potency of sample over reference is controlled by a proportion parameter applied on dose levels. The model fitting process is to utilize a modified Gauss-Newton method to iteratively search for such function and the proportion parameter. The fitness of the model and the similarity of the assay is evaluated based on F-test of model comparisons over unrestricted quadratic model and means model. Examples are given for the application of the proposed method. Usually, the specific non-linear function is selected as a quadratic function to ensure the convergence of the model fitting. In this case, we need also to check the monotonicity of the fitted quadratic model over the assay data range.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2021 program