Generic drugs: The Canadian perspective

Transplantation Proceedings

Volumn 31, Issue 3 SUPPL. 1, 1999, Pages

  McGilveray, I J ^a   Gallicano, K ^b,c  

^a McGilveray Pharmacon Inc   (Canada)

^b UNIVERSITY OF OTTAWA   (Canada)

^c UNIVERSITY OF OTTAWA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN A;

BIOEQUIVALENCE; CANADA; CONFERENCE PAPER; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG MONITORING; DRUG QUALITY; IMMUNOSUPPRESSIVE TREATMENT; PRIORITY JOURNAL; TABLET FORMULATION;

CANADA; DRUGS, GENERIC; HEALTH POLICY; HUMANS; LEGISLATION, DRUG; PATENTS; THERAPEUTIC EQUIVALENCY;

EID: 0032964138     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0041-1345(99)00096-2     Document Type: Conference Paper

References (15)

1. Loo J.C.K., Gallicano K.D., McGilveray I.J., et al. Clin Biochem. 24:1991;49.
2. Shaw L.M., Yatscoff R.W., Bowers L.D., et al. Clin Chem. 36:1990;1841.
3. Oellerich M., Armstrong V.W., Kahan B., et al. Ther Drug Monit. 17:1995;642.
4. Cook D. Bioavailability of Drugs. 1972;190 S. Karger, Basel.
5. McGilveray I.J. Pharmaceutical Bioequivalence. 1991;381 Marcel Dekker, New York.
6. Ruedy J., Davies R.O., Brodeur J., et al. Can Med Assoc J. 109:1973;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. 260:1988;2259.
14. N Engl J Med. 325:1991;293.
15. Health Protection Board, Therapeutic Products Programme, Minutes of Expert Advisory Committee on New Active Substances, May 1997.