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Volumn 25, Issue 6, 1997, Pages 743-752

Bioequivalence: Issues and options

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG;

EID: 0031397620     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (2)

References (15)
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    • Bioequivalence and narrow therapeutic index drugs
    • L. Z. Benet and J. E. Goyan. Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 15:433-40 (1995).
    • (1995) Pharmacotherapy , vol.15 , pp. 433-440
    • Benet, L.Z.1    Goyan, J.E.2
  • 3
    • 0023639698 scopus 로고
    • Bias in pharmacokinetics and clinical pharmacology
    • E. Ariens and E. Wuis. Bias in pharmacokinetics and clinical pharmacology. Clin. Pharmacol. Ther. 42:361-363 (1987).
    • (1987) Clin. Pharmacol. Ther. , vol.42 , pp. 361-363
    • Ariens, E.1    Wuis, E.2
  • 4
    • 0027141414 scopus 로고
    • Bio International '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies
    • H. H. Blume and K. K. Midha. Bio International '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. J. Pharm. Sci. 82:1186-1189 (1993).
    • (1993) J. Pharm. Sci. , vol.82 , pp. 1186-1189
    • Blume, H.H.1    Midha, K.K.2
  • 5
    • 0027987424 scopus 로고
    • Pharmacokinetics of two enteric-coated ketoprofen products in humans with or without coadministration of omeprazole and comparison with solution finding
    • S. Qureshi, G. Caille, Y. Lacasse, and I. McGilveray. Pharmacokinetics of two enteric-coated ketoprofen products in humans with or without coadministration of omeprazole and comparison with solution finding. Pharm. Res. 11:1669-1672 (1994).
    • (1994) Pharm. Res. , vol.11 , pp. 1669-1672
    • Qureshi, S.1    Caille, G.2    Lacasse, Y.3    McGilveray, I.4
  • 6
    • 0031461087 scopus 로고    scopus 로고
    • Stereoselective in vivo and in vitro studies on the metabolism of doxepin and n-desmethyldoxepin
    • in press
    • Y.-H. Yan, J. Hubbard, G. McKay, and K. Midha. Stereoselective in vivo and in vitro studies on the metabolism of doxepin and n-desmethyldoxepin. Xenobiotica (in press) (1997).
    • (1997) Xenobiotica
    • Yan, Y.-H.1    Hubbard, J.2    McKay, G.3    Midha, K.4
  • 7
    • 0030012868 scopus 로고    scopus 로고
    • The impact of stereoisomerism in a bioequivalence study on two formulations of doxepin
    • K. K. Midha, J. W. Hubbard, M. Rawson, and R. Schwede. The impact of stereoisomerism in a bioequivalence study on two formulations of doxepin. Eur. J. Pharm. Sci. 4:133-138 (1996).
    • (1996) Eur. J. Pharm. Sci. , vol.4 , pp. 133-138
    • Midha, K.K.1    Hubbard, J.W.2    Rawson, M.3    Schwede, R.4
  • 9
    • 0028915498 scopus 로고
    • Bio International '94, Conference on bioavailability, bioequivalence and pharmacokinetics studies - Pre-conference satellite on in vivo/in vitro correlation
    • H. H. Blume, I. J. McGilveray, and K. K. Midha. Bio International '94, Conference on bioavailability, bioequivalence and pharmacokinetics studies - pre-conference satellite on in vivo/in vitro correlation. Eur. J. Pharm. Sci. 3:113-124 (1995).
    • (1995) Eur. J. Pharm. Sci. , vol.3 , pp. 113-124
    • Blume, H.H.1    McGilveray, I.J.2    Midha, K.K.3
  • 12
    • 0029962695 scopus 로고    scopus 로고
    • The role of stereochemistry and partial areas in a parallel design study to assess the bioequivalence of two formulations of hydroxychloroquine: A drug with a very long half life
    • K. Midha, J. Hubbard, M. Rawson, G. McKay, and R. Schwede. The role of stereochemistry and partial areas in a parallel design study to assess the bioequivalence of two formulations of hydroxychloroquine: A drug with a very long half life. Eur. J. Pharm. Sci. 4:283-292 (1996).
    • (1996) Eur. J. Pharm. Sci. , vol.4 , pp. 283-292
    • Midha, K.1    Hubbard, J.2    Rawson, M.3    McKay, G.4    Schwede, R.5
  • 13
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    • The application of partial areas in assessment of rate and extent of absorption in bioequivalence studies of conventional release products: Experimental evidence
    • K. K. Midha, J. W. Hubbard, M. J. Rawson, and L. Gavalas. The application of partial areas in assessment of rate and extent of absorption in bioequivalence studies of conventional release products: Experimental evidence. Eur. J. Pharm. Sci. 2:351-363 (1994).
    • (1994) Eur. J. Pharm. Sci. , vol.2 , pp. 351-363
    • Midha, K.K.1    Hubbard, J.W.2    Rawson, M.J.3    Gavalas, L.4
  • 14
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    • Bioequivalence of two tablet formulations of nadolol using single and multiple dose data: Assessment using stereospecific and non-stereospecific assays
    • N. R. Srinivas, W. H. Barr, W. C. Shyu, E. Mohandoss, S. Chow, J. Staggers, G. Balan, F. J. Belas, I. A. Blair, and R. H. Barbhaiya. Bioequivalence of two tablet formulations of nadolol using single and multiple dose data: Assessment using stereospecific and non-stereospecific assays. J. Pharm. Sci. 85:299-303 (1996).
    • (1996) J. Pharm. Sci. , vol.85 , pp. 299-303
    • Srinivas, N.R.1    Barr, W.H.2    Shyu, W.C.3    Mohandoss, E.4    Chow, S.5    Staggers, J.6    Balan, G.7    Belas, F.J.8    Blair, I.A.9    Barbhaiya, R.H.10
  • 15
    • 0030018387 scopus 로고    scopus 로고
    • Enantioselective assays in comparative bioavailability studies of racemic drug formulations: Nice to know or need to know?
    • A. Karim. Enantioselective assays in comparative bioavailability studies of racemic drug formulations: Nice to know or need to know? J. Clin. Pharmacol. 36:490-499 (1996).
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    • Karim, A.1


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