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Nonparametric procedure for identifying effective and safe doses with ordinal response data
Journal of the Korean Data & Information Science Society 2018;29:1575-84
Published online November 30, 2018
© 2018 Korean Data and Information Science Society.

Seonhui Kim1 · Dongjae Kim2

12Department of Biomedicine · Health Science, The Catholic University of Korea
Correspondence to: Professor, Department of Biomedicine · Health Science, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul 137-701, Korea. E-mail: djkim@catholic.ac.kr
Received September 13, 2018; Revised November 2, 2018; Accepted November 7, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
The primary interest drug development studies is to find therapeutic window that satisfying both efficacy and safety by identifying minimum effective dose (MED) and maximum safe dose (MSD). Previously, the range of effective and safe drug treatment for continuous response variables was studied, In this paper, we propose a nonparametric procedure which can identify the minimum effective dose (MED) and the maximum safe dose (MSD) in many cases measured by ordinal response variables. The performance of the proposed method is verified through family-wise error rate (FWE) and power by Monte Carlo simulation.
Keywords : Maximum safe dose (MSD), minimum effective dose (MED), ordinal reponse variables, therapeutic window.