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Volumn 39, Issue 4, 2001, Pages 162-166

Evaluation of some properties of individual bioequivalence (IBE) from replicate-design studies

Author keywords

Aggregate model; Individual bioequivalence; Regulatory decisions; Within subject variations

Indexed keywords

DRUG;

EID: 0035057397     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP39162     Document Type: Article
Times cited : (8)

References (22)
  • 2
    • 85037440454 scopus 로고    scopus 로고
    • Individual bioequivalence: An overview. AAPS International Workshop on Individual Bioequivalence, Montreal, Quebec. Distributed handout
    • (1999)
    • Benet, L.1
  • 7
    • 85037442401 scopus 로고    scopus 로고
    • FDA Average, Population, and Individual Approaches to Establishing Bioequivalence - Draft Guidance for Industry. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD.
    • (1999)
  • 8
    • 0034735587 scopus 로고    scopus 로고
    • A practical approach for evaluating population and individual bioequivalence
    • (2000) Stat Med , vol.19 , pp. 2721-2740
    • Gould, L.1
  • 9
  • 11
    • 0034735555 scopus 로고    scopus 로고
    • The US draft guidance regarding population and individual bioequivalence approaches: Comments by a research-based pharmaceutical company
    • (2000) Stat Med , vol.19 , pp. 2769-2774
    • Hauschke, D.1    Steinijans, W.W.2
  • 15
    • 85037433018 scopus 로고    scopus 로고
    • Aggregate versus disaggregate criterion. AAPS International Workshop on Individual Bioequivalence, Montreal, Quebec. Distributed handout
    • (1999)
    • Schall, R.1
  • 19
    • 0030461283 scopus 로고    scopus 로고
    • A three-step procedure for assessing bioequivalence in the general mixed model framework
    • (1996) Stat Med , vol.15 , pp. 2635-2655
    • Vuorinen, J.1    Turunen, J.2
  • 21
    • 0034735534 scopus 로고    scopus 로고
    • On a reasonable disaggregate criterion of population bioequivalence admitting of resampling-free testing procedures
    • (2000) Stat Med , vol.19 , pp. 2755-2767
    • Wellek, S.1
  • 22
    • 85037437341 scopus 로고    scopus 로고
    • S x F interaction replicate study design studies and other studies. AAPS International Workshop on Individual Bioequivalence. Distributed handout. Montreal, Quebec.
    • (1999)
    • Williams, R.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.