응용통계연구 (The Korean Journal of Applied Statistics)

  • 제25권1호
  • /
  • Pages.125-138
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  • 2012
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  • 1225-066X(pISSN)
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  • 2383-5818(eISSN)
한국통계학회 (The Korean Statistical Society)
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바이오시밀러 개발에 필요한 통계방법들에 대한 고찰

Statistical Consideration of the Development of Biosimilar Products

  • 강승호 (연세대학교 응용통계학과) ;
  • 남주선 (이화여자대학교 통계학과, 식품의약품안전청 바이오생약국 바이오의약품정책과)
  • Kang, Seung-Ho (Department of Applied Statistics, Yonsei University) ;
  • Nam, Ju-Sun (Department of Statistics, Ewha Womans University, Biopharmaceutical Policy Division, KFDA)
  • 투고 : 20111200
  • 심사 : 20120100
  • 발행 : 2012.02.29
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초록

최근 들어 바이오시밀러에 대한 국내외 관심이 매우 증가하고 있다. 바이오시밀러가 오리지널 생물의약품과 효능과 안전성이 유사함을 보이기 위해서는 최종적으로 임상시험을 수행하여야 한다. 본 논문에서는 이러한 임상시험의 수행과 통계적 분석에 필요한 여러 방법들과 외국의 사례 그리고 관련된 가이드라인들을 살펴볼 것이다.

Recent assessments of the biosimilarity of biologic products have received considerable global attention. A clinical trial should be conducted to assess the biosimilarity of a biosimilar product and a innovator biological product. In this paper we will describe several methods for the implementation of clinical trials and statistical analysis, a real international case and related international guidelines.

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참고문헌

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