Journal of Pharmacokinetics and Biopharmaceutics

, Volume 25, Issue 6, pp 743–752 | Cite as

Bioequivalence: Issues and Options

  • Kamal K. Midha
  • Maureen J. Rawson
  • John W. Hubbard


Omeprazole Ketoprofen Doxepin Nadolol Bioequivalence Study 
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  1. 1.
    L. Z. Benet and J. E. Goyan. Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 15:433–40 (1995).PubMedGoogle Scholar
  2. 2.
    V. Shah, A. Yacobi, W. Barr, D. Breimer, M. Dobrinska, E. Endrenyi, W. Fairweather, W. Gillespie, M. Gonzales, J. Hooper, L. Lesko, K. Midha, P. Noonan, R. Patnaik, and R. Williams. Evaluation of orally administered highly variable drugs and drug formulations. Pharm. Res. 13:1590–1594 (1996).PubMedCrossRefGoogle Scholar
  3. 3.
    E. Ariens and E. Wuis. Bias in pharmacokinetics and clinical pharmacology. Clin. Pharmacol. Ther. 42:361–363 (1987).PubMedCrossRefGoogle Scholar
  4. 4.
    H. H. Blume and K. K. Midha. Bio International '92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. J. Pharm. Sci. 82:1186–1189 (1993).PubMedCrossRefGoogle Scholar
  5. 5.
    S. Qureshi, G. Caille, Y. Lacasse, and I. McGilveray. Pharmacokinetics of two entericcoated ketoprofen products in humans with or without coadministration of omeprazole and comparison with solution finding. Pharm. Res. 11:1669–1672 (1994).PubMedCrossRefGoogle Scholar
  6. 6.
    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).Google Scholar
  7. 7.
    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).CrossRefGoogle Scholar
  8. 8.
    K. K. Midha, J. W. Hubbard, G. McKay, M. Rawson, and R. Schwede. Stereoselectivity in bioequivalence studies of nortriptyline. J. Pharma. Sci. 84:1265–1266 (1995).CrossRefGoogle Scholar
  9. 9.
    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).CrossRefGoogle Scholar
  10. 10.
    K. K. Midha, J. W. Hubbard, P. K.-F. Yeung, E. Ormsby, G. McKay, E. M. Hawes, E. D. Korchinski, T. Gurnsey, M. J. Rawson, and R. Schwede. In K. K. Midha and H. H. Blume (eds.), Bio-International: Bioavailability, Bioequivalence and Pharmacokinetics; International Conference of F.I.P. “Bio-International '92” Medpharm Scientific Publishers, Stuttgart, 1993, pp. 53–68.Google Scholar
  11. 11.
    D. R. Brocks, K. J. Skeith, C. Johnston, J. Emamibafrani, P. Davis, A. S. Russell, and F. Jamali. Hematologic disposition of hydroxychloroquine enantiomers. J. Clin. Pharmacol. 34:1088–1097 (1994).PubMedCrossRefGoogle Scholar
  12. 12.
    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).CrossRefGoogle Scholar
  13. 13.
    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).CrossRefGoogle Scholar
  14. 14.
    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 nonstereospecific assays. J. Pharm. Sci. 85:299–303 (1996).PubMedCrossRefGoogle Scholar
  15. 15.
    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).PubMedCrossRefGoogle Scholar

Copyright information

© Plenum Publishing Corporation 1997

Authors and Affiliations

  • Kamal K. Midha
    • 1
  • Maureen J. Rawson
    • 1
  • John W. Hubbard
    • 1
  1. 1.College of Pharmacy and NutritionUniversity of SaskatchewanSaskatoonCanada

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