Nonprametric Inference of Shelf-life in Drug's Stability Study

안정성 연구에서의 사용기간에 관한 비모수적 추론

  • 김태규 (한남대학교 비즈니스통계학과) ;
  • 박상규 (중앙대학교 수학통계학부) ;
  • 하명호 (중앙대학교 수학통계학부)
  • Received : 2010.01.26
  • Accepted : 2010.03.05
  • Published : 2010.03.31

Abstract

The shelf-life of pharmaceutical products is the time that the average product characteristic remains within an approved specification after manufacture. Since the true shelf-life of a drug product is typically unknown, it has to be estimated based on assay results of the drug characteristic from a stability study usually conducted during the process of drug development. The nonparametric statistical methods of assessing the shelf-life of drug are considered with the current FDA regulations. Some simulation studies of nonparametric methods are also presented with the discussion.

Keywords

References

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