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Volumn 39, Issue 1, 1999, Pages 1-4

On the determination of bioequivalence

Author keywords

Area under the curve; Bioequivalence; Extent of absorption; Maximum concentration; Rate of absorption

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DRUG ABSORPTION; PRIORITY JOURNAL;

EID: 0033059952     PISSN: 10436618     EISSN: None     Source Type: Journal    
DOI: 10.1006/phrs.1998.0405     Document Type: Article
Times cited : (26)

References (10)
  • 1
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    • Bioavailability and bioequivalence requirements
    • Title 21; Chapter I; Part 320 January 7
    • US Food and Drug Administration. Bioavailability and bioequivalence requirements (Title 21; Chapter I; Part 320). Federal Register January 7, 1977; 42 (5): 1624-53.
    • (1977) Federal Register , vol.42 , Issue.5 , pp. 1624-1653
  • 2
    • 0031987387 scopus 로고    scopus 로고
    • AUC and Cmax are not sufficient to prove bioequivalence
    • Rescigno A, Powers JD. AUC and Cmax are not sufficient to prove bioequivalence. Pharmacol Res 1998; 37: 93-5.
    • (1998) Pharmacol Res , vol.37 , pp. 93-95
    • Rescigno, A.1    Powers, J.D.2
  • 4
    • 0001893703 scopus 로고
    • On the estimation of the discrepancy between empirical curves of distribution for two independent samples
    • Smirnov NV. On the estimation of the discrepancy between empirical curves of distribution for two independent samples (in Russian). Bull Moscow Univ 1939; 2: 3-16.
    • (1939) Bull Moscow Univ , vol.2 , pp. 3-16
    • Smirnov, N.V.1
  • 5
    • 0026772726 scopus 로고
    • Bioequivalence
    • Rescigno A. Bioequivalence. Pharm Res 1992; 9: 925-8.
    • (1992) Pharm Res , vol.9 , pp. 925-928
    • Rescigno, A.1
  • 6
    • 0013606446 scopus 로고
    • Bioequivalence of two recombinant human growth hormones in healthy male volunteers after subcutaneous administration
    • Chen SA, Izu AE, Mordenti J, Rescigno A. Bioequivalence of two recombinant human growth hormones in healthy male volunteers after subcutaneous administration. Am J Ther 1995; 2: 190-5.
    • (1995) Am J Ther , vol.2 , pp. 190-195
    • Chen, S.A.1    Izu, A.E.2    Mordenti, J.3    Rescigno, A.4
  • 7
    • 0030240329 scopus 로고    scopus 로고
    • Mefenamic acid bioequivalence assessment with a new statistical procedure
    • Rescigno A, Marzo A, Thyroff-Friesinger U. Mefenamic acid bioequivalence assessment with a new statistical procedure. Pharmacol Res 1996; 34: 149-52.
    • (1996) Pharmacol Res , vol.34 , pp. 149-152
    • Rescigno, A.1    Marzo, A.2    Thyroff-Friesinger, U.3
  • 9
    • 0015092649 scopus 로고
    • Monoexponential extrapolation of tracer clearance curves in kinetic analysis
    • Lassen NA, Sejrsen P. Monoexponential extrapolation of tracer clearance curves in kinetic analysis. Circ Res 1971; 29: 76.
    • (1971) Circ Res , vol.29 , pp. 76
    • Lassen, N.A.1    Sejrsen, P.2
  • 10
    • 0021711824 scopus 로고
    • Asymptotic form of tracer clearance curves: Theory and applications of improved extrapolations
    • Bass L, Aisbett J, Bracken AJ. Asymptotic form of tracer clearance curves: Theory and applications of improved extrapolations. J Theor Biol 1984; 111: 755-85.
    • (1984) J Theor Biol , vol.111 , pp. 755-785
    • Bass, L.1    Aisbett, J.2    Bracken, A.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.