[논문]동물 및 임상 시험의 시계열 프로파일 데이터 비교를 위한 유사성 지수 개발

이예경; 이현정; 장현애; 신상문

doi:10.7469/jksqm.2021.49.2.145

동물 및 임상 시험의 시계열 프로파일 데이터 비교를 위한 유사성 지수 개발
Development of a New Similarity Index to Compare Time-series Profile Data for Animal and Human Experiments 원문보기

品質經營學會誌 = Journal of Korean society for quality management, v.49 no.2, 2021년, pp.145 - 159

이예경 (동아대학교 산업경영공학과) , 이현정 (동아대학교 산업경영공학과) , 장현애 (전주대학교 미래기술융합공학과) , 신상문 (동아대학교 산업경영공학과)

Abstract ▼ AI-Helper

Purpose: A statistical similarity evaluation to compare pharmacokinetics(PK) profile data between nonclinical and clinical experiments has become a significant issue on many drug development processes. This study proposes a new similarity index by considering important parameters, such as the area under the curve(AUC) and the time-series profile of various PK data. Methods: In this study, a new profile similarity index(PSI) by using the concept of a process capability index(Cp) is proposed in order to investigate the most similar animal PK profile compared to the target(i.e., Human PK profile). The proposed PSI can be calculated geometric and arithmetic means of all short term similarity indices at all time points on time-series both animal and human PK data. Designed simulation approaches are demonstrated for a verification purpose. Results: Two different simulation studies are conducted by considering three variances(i.e., small, medium, and large variances) as well as three different characteristic types(smaller the better, larger the better, nominal the best). By using the proposed PSI, the most similar animal PK profile compare to the target human PK profile can be obtained in the simulation studies. In addition, a case study represents differentiated results compare to existing simple statistical analysis methods(i.e., root mean squared error and quality loss). Conclusion: The proposed PSI can effectively estimate the level of similarity between animal, human PK profiles. By using these PSI results, we can reduce the number of animal experiments because we only focus on the significant animal representing a high PSI value.

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표/그림 (13)

그림 Figure 1. PK profile Over Time
표 Table 1. Terminologies and Their Associated Explanations for Pharmaceutical Processes
그림 Figure 2. Mahalanobis Distance and Euclidean Distance
그림 Figure 3. Profile Similarity Index(PSI) Considering the Importance of Each Time Zone
그림 Figure 4. Statistical Simulation Overview
표 Table 2. True PK Concentration Data by Target and Bias
표 Table 3. Standard Deviation and Specification of Target PK Concentration Data
표 Table 4. Summary of similarity evaluation results of Simulation I
그림 Figure 5. Human and Animal PK profile
표 Table 5. Summary of similarity evaluation results of Simulation II
그림 Figure 6. Human and Animal PK profile using DS
표 Table 6. Average PK profile of Human, Animal A, Animal B, and Animal C using DS
표 Table 7. Summary of Similarity Evaluation Results for PK profile of Animal A, Animal B, and Animal C versus Human PK profile

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