연구동향 분석
박사

생물학적 동등성 평가에서의 고차원 교차시험 설계법에 대한 통계적 연구

오정현 2020년

논문상세정보
인용/피인용
' 생물학적 동등성 평가에서의 고차원 교차시험 설계법에 대한 통계적 연구' 의 주제별 논문영향력
논문영향력 선정 방법
논문영향력 요약
주제
  • bioequivalence, generic drug
  • higher-order crossover design
  • highly variable drug
  • within-subject variability
  • 고변동성 의약품
  • 고차원 교차시험
  • 생물학적동등성
  • 제네릭 의약품
  • 피험자 내 변동
동일주제 총논문수 논문피인용 총횟수 주제별 논문영향력의 평균
24 0

0.0%

' 생물학적 동등성 평가에서의 고차원 교차시험 설계법에 대한 통계적 연구' 의 참고문헌

  • [25] EMEA (2010). European Medicines Agency, Committee for Medicinal Products for Human Use. Draft guideline on the investigation of bioequivalence, London.
  • Why Highly Variable Drugs are Safer . Meeting of FDA Committee for Pharmaceutical Science
    http : //www.fda.gov/ohrms/ dockets/ac/06/slides/2006-4241s2_2.ppt [2006]
  • Statistical tests for population bioequivalence
    13 , 539-554 . [2003]
  • Statistical Methods for Bioequivalence Trials
    [2014]
  • Some Remarks onConsistency Test of Add-on Test in Bioequivalence Trials
    19 , 47-55 [2012]
  • Sample size determination for the two one-sided tests procedure in bioequivalence
    20 ( 1 ) , 101-104 . [1992]
  • Policy Issues on Bio-Equivalence Assurance of Generic Drugs .
    88 , 67-79 [2004]
  • Pharmaceutical Bioequivalence Studies : Ensuring Safety , Effectiveness and High Quality
    [2015]
  • On sample size determination of Bioequivalence Trials
    18 , 365 ? 373 [2007]
  • On assessment of bioequivalence in variability of bioavailability studies .
    21 , 2591-2607 . [1992]
  • On Sample Size Calculation in Bioequivalence Trials
    28 ( 2 ) , 155-169 [2001]
  • On Evaluaion of Bioequivalence for Highly Variable Drugs
    26 ( 4 ) , 1055-1076 [2011]
  • Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence
    48 ( 11 ) , 725-743 . [2009]
  • Design and Analysis of Bioavailability and Bioequivalence Studies
    [2009]
  • Carryover negligibility and relevance in bioequivalence studies
    14 ( 5 ) , 400-8. doi : 10.1002/pst.1699 .
  • Bioequivalence approaches for highly variable drugs : Issue and solution
    19 , 50 ? 60 [2009]
  • An Approach for Widening the Bioequivalence Acceptance Limits in the Case of Highly Variable Drugs
    12 , 1865-1868 [1995]
  • A comparison of two one-sided tests procedures and the power approach for assessing the bioequivalence trials
    15 , 657- 680 [1987]