The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
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Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs

고변동성 제제의 생물학적 동등성 평가에서 3×3 교차설계법 연구

  • Park, Ji-Ae (Department of Applied Statistics, Chung-Ang University) ;
  • Park, Sang-Gue (Department of Applied Statistics, Chung-Ang University)
  • 박지애 (중앙대학교 응용통계학과) ;
  • 박상규 (중앙대학교 응용통계학과)
  • Received : 2015.10.01
  • Accepted : 2016.01.15
  • Published : 2016.02.29
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Abstract

Bioequivalence trials based on higher order crossover designs have recently been conducted for highly variable drugs since the Ministry of Korea Food and Drug Safety (MFDS) added new regulations in 2013 to widen bioequivalence limits for highly variable drugs. However, a statistical discussion of higher order crossover designs have not been discussed yet. This research proposes the statistical inference of bioequivalence based on $3{\times}3$ crossover design and discusses it with the MFDS regulations. An illustrated example is also given.

최근 식품의약품안전처는 의약품동등성시험기준에 고변동성 제제의 생물학적 동등성(생동성) 평가 기준을 넓혀주는 새로운 규정을 추가하면서 고차 교차설계법을 활용하여 생동성 평가를 하는 논의가 확대되고 있다. 확장된 생동성 기준을 적용하기 위해서는 3기간 이상의 교차설계법이 적용되어야 하지만 아직 관련된 논의가 많이 이루어지지 않고 있다. 본 연구에서는 $3{\times}3$ 교차설계법에 기초한 생동성 평가의 통계적 추론과정을 제시하고 논의한다. 또한 사례를 통해 $3{\times}3$ 교차설계법을 활용한 생동성 평가를 식품의약품안전처 의약품동등성시험기준에 따라 진행하고 그 의미를 논의한다.

Keywords

References

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