메뉴 건너뛰기




Volumn 21, Issue 5, 2004, Pages 781-784

Urinary excretion: Does it accurately reflect relative differences in bioavailability/systemic exposure when renal clearance is nonlinear?

Author keywords

Bioavailability; Nonlinear renal clearance; Systemic exposure; Urinary excretion

Indexed keywords

ACCURACY; ARTICLE; BLOOD LEVEL; COMPARTMENT MODEL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; KIDNEY CLEARANCE; OSTEOPOROSIS; PRIORITY JOURNAL; URINARY EXCRETION;

EID: 3543029269     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:PHAM.0000026428.48103.4f     Document Type: Article
Times cited : (4)

References (29)
  • 1
    • 0001668733 scopus 로고
    • Bioavailability and bioequivalence requirements
    • Food and Drug Administration. Bioavailability and bioequivalence requirements. Fed. Regist. 42:1624-1653 (1977).
    • (1977) Fed. Regist. , vol.42 , pp. 1624-1653
  • 2
    • 0015902704 scopus 로고
    • Use of statistical methods in evaluation of in vivo performance of dosage forms
    • W. J. Westlake. Use of statistical methods in evaluation of in vivo performance of dosage forms. J. Pharm. Sci. 62:1579-1589 (1973).
    • (1973) J. Pharm. Sci. , vol.62 , pp. 1579-1589
    • Westlake, W.J.1
  • 3
    • 0015379868 scopus 로고
    • Use of confidence intervals in analysis of comparative bioavailability trials
    • W. J. Westlake. Use of confidence intervals in analysis of comparative bioavailability trials. J. Pharm. Sci. 61:1340-1341 (1972).
    • (1972) J. Pharm. Sci. , vol.61 , pp. 1340-1341
    • Westlake, W.J.1
  • 4
    • 3543004450 scopus 로고
    • Bioavailability/Bioequivalence Regulations: An FDA Perspective
    • K. S. Albert (ed.), American Pharmaceutical Association Academy of Pharmaceutical Sciences, Washington, DC
    • E. Purich. Bioavailability/Bioequivalence Regulations: An FDA Perspective. In K. S. Albert (ed.), Drug Absorption and Disposition: Statistical Considerations, American Pharmaceutical Association Academy of Pharmaceutical Sciences, Washington, DC, 1980, pp. 115-137.
    • (1980) Drug Absorption and Disposition: Statistical Considerations , pp. 115-137
    • Purich, E.1
  • 5
    • 0026659546 scopus 로고
    • A retrospective assessment of the 75/75 rule in bioequivalence
    • T. W. Dobbins and B. Thiyagarajan. A retrospective assessment of the 75/75 rule in bioequivalence. Stat. Med. 11:1333-1342 (1992).
    • (1992) Stat. Med. , vol.11 , pp. 1333-1342
    • Dobbins, T.W.1    Thiyagarajan, B.2
  • 6
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15:657-680 (1987).
    • (1987) J. Pharmacokinet. Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 8
    • 0026597801 scopus 로고
    • Types of bioequivalence and related statistical considerations
    • W. W. Hauck and S. Anderson. Types of bioequivalence and related statistical considerations. Int. J. Clin. Pharm. Ther. Toxicol. 30:181-187 (1992).
    • (1992) Int. J. Clin. Pharm. Ther. Toxicol. , vol.30 , pp. 181-187
    • Hauck, W.W.1    Anderson, S.2
  • 9
    • 0026481178 scopus 로고
    • Bioequivalence revisited
    • L. B. Sheiner. Bioequivalence revisited. Stat. Med. 11:1777-1788 (1992).
    • (1992) Stat. Med. , vol.11 , pp. 1777-1788
    • Sheiner, L.B.1
  • 10
    • 0024267609 scopus 로고
    • Initial slope technique to estimate first- and zero-order drug absorption rate constants
    • J. G. Zhi. Initial slope technique to estimate first- and zero-order drug absorption rate constants. J. Pharm. Sci. 77:816-817 (1988).
    • (1988) J. Pharm. Sci. , vol.77 , pp. 816-817
    • Zhi, J.G.1
  • 11
    • 0023858202 scopus 로고
    • An area function method for estimating the apparent absorption rate constant
    • H. Cheng, A. E. Staubus, and L. Shum. An area function method for estimating the apparent absorption rate constant. Pharm. Res. 5:57-60 (1988).
    • (1988) Pharm. Res. , vol.5 , pp. 57-60
    • Cheng, H.1    Staubus, A.E.2    Shum, L.3
  • 12
    • 0030060434 scopus 로고    scopus 로고
    • Tmax: An unconfounded metric for rate of absorption in single dose bioequivalence studies
    • R. P. Basson, B. J. Cerimele, K. A. Desante, and D. C. Howey. Tmax: an unconfounded metric for rate of absorption in single dose bioequivalence studies. Pharm. Res. 13:324-328 (1996).
    • (1996) Pharm. Res. , vol.13 , pp. 324-328
    • Basson, R.P.1    Cerimele, B.J.2    Desante, K.A.3    Howey, D.C.4
  • 13
    • 0025918379 scopus 로고
    • Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence
    • L. Endrenyi, S. Fritsch, and W. Yan. Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence. Int. J. Clin. Pharm. Ther. Toxicol. 29:394-399 (1991).
    • (1991) Int. J. Clin. Pharm. Ther. Toxicol. , vol.29 , pp. 394-399
    • Endrenyi, L.1    Fritsch, S.2    Yan, W.3
  • 14
    • 0027987256 scopus 로고
    • Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies - Moving the "goalposts" or changing the "game"
    • A. Rostamihodjegan, P. R. Jackson, and G. T. Tucker. Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies - moving the "goalposts" or changing the "game". J. Pharm. Sci. 83:1554-1557 (1994).
    • (1994) J. Pharm. Sci. , vol.83 , pp. 1554-1557
    • Rostamihodjegan, A.1    Jackson, P.R.2    Tucker, G.T.3
  • 19
    • 0031947633 scopus 로고    scopus 로고
    • Drug interactions at the renal level: Implications for drug development
    • P. L. Bonate, K. Reith, and S. Weir. Drug interactions at the renal level: Implications for drug development. Clin. Pharmacokinet. 34:375-404 (1998).
    • (1998) Clin. Pharmacokinet. , vol.34 , pp. 375-404
    • Bonate, P.L.1    Reith, K.2    Weir, S.3
  • 20
    • 0035693563 scopus 로고    scopus 로고
    • Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making
    • J. V. S. Gobburu and P. J. Marroum. Utilisation of pharmacokinetic- pharmacodynamic modelling and simulation in regulatory decision-making. Clin. Pharmacokinet. 40:883-892 (2001).
    • (2001) Clin. Pharmacokinet. , vol.40 , pp. 883-892
    • Gobburu, J.V.S.1    Marroum, P.J.2
  • 25
    • 3543024236 scopus 로고    scopus 로고
    • Bisphosphonate renal clearance: Assessment of linearity
    • G. A. Thompson, J. H. Powell, and S. Mallikaarjun. Bisphosphonate renal clearance: Assessment of linearity. Pharm. Res. 14:S-510 (1997).
    • (1997) Pharm. Res. , vol.14
    • Thompson, G.A.1    Powell, J.H.2    Mallikaarjun, S.3
  • 26
    • 84939683797 scopus 로고
    • Renal excretion of drugs and other xenobiotics
    • K. Besseghir and F. Roch-Ramel. Renal excretion of drugs and other xenobiotics. Renal Physiol. 10:221-241 (1987).
    • (1987) Renal Physiol. , vol.10 , pp. 221-241
    • Besseghir, K.1    Roch-Ramel, F.2
  • 27
    • 0025221658 scopus 로고
    • Nonlinear kinetics of the thiamine cation in humans: Saturation of nonrenal clearance and tubular reabsorption
    • W. Weber, M. Nitz, and M. Looby. Nonlinear kinetics of the thiamine cation in humans: Saturation of nonrenal clearance and tubular reabsorption. J. Pharmacokinet. Biopharm. 18:501-523 (1990).
    • (1990) J. Pharmacokinet. Biopharm. , vol.18 , pp. 501-523
    • Weber, W.1    Nitz, M.2    Looby, M.3
  • 28
    • 0026338967 scopus 로고
    • System analysis in multiple dose kinetics: Evidence for saturable tubular reabsorption of the organic cation N1-methylnicotinamide in humans
    • W. Weber, S. Toussaint, M. Looby, M. Nitz, and H. Kewitz. System analysis in multiple dose kinetics: Evidence for saturable tubular reabsorption of the organic cation N1-methylnicotinamide in humans. J. Pharmacokinet. Biopharm. 19:553-574 (1990).
    • (1990) J. Pharmacokinet. Biopharm. , vol.19 , pp. 553-574
    • Weber, W.1    Toussaint, S.2    Looby, M.3    Nitz, M.4    Kewitz, H.5
  • 29
    • 0024548255 scopus 로고
    • Saturable pharmacokinetics in the renal excretion of drugs
    • C. A. M. Van Ginneken and F. G. M. Russel. Saturable pharmacokinetics in the renal excretion of drugs. Clin. Pharmacokinet. 16:38-54 (1989).
    • (1989) Clin. Pharmacokinet. , vol.16 , pp. 38-54
    • Van Ginneken, C.A.M.1    Russel, F.G.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.