3×2 교차설계법에서 생물학적 동등성 시험의 통계분석Statistical Analysis of Bioequivalence Study in 3X2 Crossover Design
- Authors
- 박상규; 김정일; 채성산; 고승곤; 오현숙; 양완연; 김동섭; 최영욱
- Issue Date
- Jan-1999
- Publisher
- 한국약제학회
- Citation
- 약제학회지, v.28, no.4, pp 231 - 239
- Pages
- 9
- Journal Title
- 약제학회지
- Volume
- 28
- Number
- 4
- Start Page
- 231
- End Page
- 239
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/39756
- ISSN
- 2093-5552
2093-6214
- Abstract
- A 3×2 crossover design is considered for the bioequivalence of two test formulations with a control. It could be considered as a better choice over 3×3 crossover design because of the cost and experimental duration. Oh et al.(1998) derived 3×2 crossover design and discussed its benefits over the typical crossover designs. We consider here the statistical models for 3×2 crossover design and show its statistical properties. The statistical procedures for the bioequivalence in 3×2 crossover design are shown through an example and the results are summarized by satisfying the 3 standards that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence.
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Collections - College of Business & Economics > Department of Applied Statistics > 1. Journal Articles
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