Transplantation Proceedings
Volume 31, Issue 3, Supplement 1 , Pages 16S-18S , May 1999

Generic drugs: the Canadian perspective

  • I.J McGilveray

      Affiliations

    • McGilveray Pharmacon Inc (I.J.M.), Nepean, Ontario, Canada
    • Corresponding Author InformationAddress reprint requests to Iain J. McGilveray, McGilveray Pharmacon Inc, 1 Stonehedge Park, Nepean, Ontario K2H 8Z1, Canada
    • ,
  • K Gallicano

      Affiliations

    • Ottawa Hospital (General) (K.G.), Nepean, Ontario, Canada
    • University of Ottawa (K.G.), Faculty of Medicine, Ottawa, Ontario, Canada

References 

  1. Loo JCK, Gallicano KD, McGilveray IJ, et al.  Clin Biochem. 1991;24:49
  2. Shaw LM, Yatscoff RW, Bowers LD, et al.  Clin Chem. 1990;36:1841
  3. Oellerich M, Armstrong VW, Kahan B, et al.  Ther Drug Monit. 1995;17:642
  4. Cook D. In: Bioavailability of Drugs. Basel: S. Karger; 1972;p. 190
  5. McGilveray IJ. In: Pharmaceutical Bioequivalence. New York: Marcel Dekker; 1991;p. 381
  6. Ruedy J, Davies RO, Brodeur J, et al.  Can Med Assoc J. 1973;109:920
  7. Health Protection Branch, Report from Expert Advisory Committee on Bioavailability Guidelines and Standards for Bioavailability Part A. Oral Dosage Forms Used for Systemic Effects. Health Canada, 1990
  8. Health Protection Branch, Report B, for Expert Advisory Committee on Bioavailability Guidelines and Standards for Bioavailability of Oral Modified—Release Dosage Formulations of Drugs Used for Systemic Effects. Health Canada 1990
  9. Health Protection Branch, Expert Advisory Committee on Bioavailability, Report C: on Bioavailability of Oral Dosage Formulations, not in modified-release form, of drugs used for Systemic Effects, having complicated or variable kinetics. Health Canada, 1992
  10. Health Protection Branch Drug Directorate Guideline: Conduct and Analysis of Bioavailability and Bioequivalence Studies—Part A: Oral Dosage Formulations Used for Systemic Effects, 1992
  11. Health Protection Board Drugs Programme Guideline: Conduct and Analysis of Bioavailability and Bioequivalence Studies—Part B Oral Modified Release Formulations, Health Canada, 1995
  12. Draft Policy on Standards for Comparative Bioavailability studies involving drugs with a narrow therapeutic range—oral dosage forms. Therapeutic Products Programme, Health Canada, May 1997
  13. Yusif Y, Wittes J, Friedman L. JAMA. 1988;260:2259
  14. SOLVD Investigators . N Engl J Med. 1991;325:293
  15. Health Protection Board, Therapeutic Products Programme, Minutes of Expert Advisory Committee on New Active Substances, May 1997

PII: S0041-1345(99)00107-4

Transplantation Proceedings
Volume 31, Issue 3, Supplement 1 , Pages 16S-18S , May 1999

Article Tools