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Volumn 49, Issue 3, 2004, Pages 283-286

The degree of predictivity in pilot studies on six subjects in bioequivalence trials

Author keywords

Bioequivalence; Pilot trials; Pivotal trials; Predictivity index

Indexed keywords

ALPRAZOLAM; AMLODIPINE; BUTAMIRATE; CEFALEXIN; CHLORTALIDONE; FLUTAMIDE; ISOSORBIDE 5 NITRATE; NAPROXEN; NORTAMOXIFEN; TAMOXIFEN;

EID: 0346690093     PISSN: 10436618     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.phrs.2003.09.007     Document Type: Article
Times cited : (6)

References (9)
  • 2
    • 0000562299 scopus 로고    scopus 로고
    • In vivo bioequivalence guidances. General information
    • Food and Drug Administration (FDA). In vivo bioequivalence guidances. General information. United States Pharmacopoeia 1998;XXIII(Suppl. 8):4382-426.
    • (1998) United States Pharmacopoeia , vol.23 , Issue.8 SUPPL. , pp. 4382-4426
  • 3
    • 0029151246 scopus 로고
    • Bioequivalence: An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products
    • Marzo A., Balant L.P. Bioequivalence: an updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products. Arzneim. Forsch. 45:1995;109-115.
    • (1995) Arzneim. Forsch. , vol.45 , pp. 109-115
    • Marzo, A.1    Balant, L.P.2
  • 6
    • 0032825293 scopus 로고    scopus 로고
    • Open questions on bioequivalence: Some problems and some solutions
    • Marzo A. Open questions on bioequivalence: some problems and some solutions. Pharmacol. Res. 40:1999;357-368.
    • (1999) Pharmacol. Res. , vol.40 , pp. 357-368
    • Marzo, A.1
  • 7
    • 0033694137 scopus 로고    scopus 로고
    • Bioequivalence of endogenous substances facing homeostatic equilibria: An example with potassium
    • Marzo A., Vuksic D., Crivelli F. Bioequivalence of endogenous substances facing homeostatic equilibria: an example with potassium. Pharmacol. Res. 42:2000;523-525.
    • (2000) Pharmacol. Res. , vol.42 , pp. 523-525
    • Marzo, A.1    Vuksic, D.2    Crivelli, F.3
  • 9
    • 0026451765 scopus 로고
    • Sample size determination for bioequivalence assessment by means of confidence intervals
    • Diletti E., Hauschke D., Steinijans V.W. Sample size determination for bioequivalence assessment by means of confidence intervals. Int. J. Clin. Pharmacol. Ther. Toxicol. 30(Suppl. 1):1992;S51-S58.
    • (1992) Int. J. Clin. Pharmacol. Ther. Toxicol. , vol.30 , Issue.SUPPL. 1
    • Diletti, E.1    Hauschke, D.2    Steinijans, V.W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.