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Volumn 5, Issue 3, 2006, Pages 201-211

Comparison of models for average bioequivalence in replicated crossover designs

Author keywords

Average bioequivalence; Random slopes and intercepts model; Replicated crossover design; Subject formulation interaction; Variance components

Indexed keywords

DRUG;

EID: 33748751289     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.212     Document Type: Article
Times cited : (10)

References (8)
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    • Food and Drug Administration. FDA: Rockville, MD
    • Food and Drug Administration. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - General considerations. FDA: Rockville, MD, 2003. http://www.fda.gov/cder/ guidance/index.htm
    • (2003)
  • 2
    • 0003478656 scopus 로고    scopus 로고
    • Note for guidance on the investigation of bioavailability and bioequivalence
    • The European Agency for the Evaluation of Medicinal Products. EMEA/EUDRA London, UK
    • The European Agency for the Evaluation of Medicinal Products. Note for guidance on the investigation of bioavailability and bioequivalence. EMEA/EUDRA London, UK, 2001. http://www.emea.eu.int/pdfs/human/ewp/ 140198en.pdf
    • (2001)
  • 3
    • 10644254023 scopus 로고    scopus 로고
    • Bioequivalence and the pharmaceutical industry
    • (DOI:10.1002/pst.015)
    • Patterson SD, Jones B. Bioequivalence and the pharmaceutical industry. Pharmaceutical Statistics 2002; 1:83-95. (DOI:10.1002/pst.015).
    • (2002) Pharmaceutical Statistics , vol.1 , pp. 83-95
    • Patterson, S.D.1    Jones, B.2
  • 4
    • 0003922013 scopus 로고    scopus 로고
    • Guidance for industry: Statistical approaches to establishing bioequivalence
    • Food and Drug Administration. FDA: Rockville, MD
    • Food and Drug Administration. Guidance for industry: statistical approaches to establishing bioequivalence. FDA: Rockville, MD, 2001. http://www.fda.gov/cder/guidance/index.htm
    • (2001)
  • 5
    • 0024947084 scopus 로고
    • The subject-by-formulation interaction as a criterion of interchangeability of drugs
    • Ekbohm G, Melander H. The subject-by-formulation interaction as a criterion of interchangeability of drugs. Biometrics 1989; 45:1249-1254.
    • (1989) Biometrics , vol.45 , pp. 1249-1254
    • Ekbohm, G.1    Melander, H.2
  • 6
    • 10644255729 scopus 로고    scopus 로고
    • Simulation assessments of statistical aspects of bioequivalence in the pharmaceutical industry
    • (DOI:10.1002/pst.088)
    • Patterson SD, Jones B. Simulation assessments of statistical aspects of bioequivalence in the pharmaceutical industry. Pharmaceutical Statistics 2004; 3:13-23. (DOI:10.1002/pst.088).
    • (2004) Pharmaceutical Statistics , vol.3 , pp. 13-23
    • Patterson, S.D.1    Jones, B.2
  • 7
    • 0027244039 scopus 로고
    • On population and individual bioequivalence
    • Schall R, Luus HG. On population and individual bioequivalence. Statistics in Medicine 1993; 12:1109-1124.
    • (1993) Statistics in Medicine , vol.12 , pp. 1109-1124
    • Schall, R.1    Luus, H.G.2
  • 8
    • 0026481178 scopus 로고
    • Bioequivalence revisited
    • Sheiner LB. Bioequivalence revisited. Statistics in Medicine 1992; 11:1777-1788.
    • (1992) Statistics in Medicine , vol.11 , pp. 1777-1788
    • Sheiner, L.B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.