Scientific and professional concerns regarding product interchange and subsequent monitoring of cyclosporine and other critical dose drugs

Transplantation Proceedings

Volumn 31, Issue 3, 1999, Pages 1645-1648

  Barr, W H ^a  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN; GENERIC DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CONFERENCE PAPER; DRUG EFFICACY; DRUG LABELING; DRUG MONITORING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MAXIMUM ALLOWABLE CONCENTRATION; PRESCRIPTION; PRIORITY JOURNAL;

CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS; CYCLOSPORINE; DRUG MONITORING; HUMANS; IMMUNOSUPPRESSIVE AGENTS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033135348     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0041-1345(99)00084-6     Document Type: Conference Paper

References (24)

1. Sheiner LB: Stat Med 8:512, 1992
2. Hauck WW, Anderson S: Int J Clin Pharmacol Ther Toxicol 30:181, 1992
3. Wallek S: J Biopharm Stat 7:17, 1997
4. Gleiter CH, Gunder-Remy U: Drug Saf 11:1, 1994
5. Johnston A, Keown PA, Holt DW: Ther Drug Monit 19:375, 1997
6. Wittkowsky AK: Pharmacotherapy 17:640, 1997
7. Pidgen A: J Pharm Pharmacol 48:11, 1996
8. Meredith PA: Drug Saf 15:233, 1996
9. Colaizzi JL, Lowenthal DT: Clin Ther 8:370, 1986
10. Olyaei AJ, deMattos AM, Bennett WM: Drug Saf 16:366, 1997
11. Nightingale SL: JAMA 279:645, 1998
12. Johnston A, Keown PA, Holt DW: Ther Drug Monit 19:375, 1997
13. Gannon PM: Hosp Pharm 26:14, 1991
14. Meyer BM: Am J Health-Syst Pharm 55:686, 1998
15. Patnaik RN, Lesko LJ: Eur J Drug Meta Pharm 212:159, 1996
16. Patnaik RN, Lesko LJ, Chen ML, et al: Clin Pharmacokinet 33:1, 1997
17. Individual Bioequivalence Working Group of the Biopharmaceutics Coordinating Committee: Guidance for industry. In vivo bioequivalence studies based on population and individual bioequivalence approaches [abstract]. Office of the Pharmaceutical Science Center for Drug Evaluation and Research (DER) at the Food and Drug Administration. 1997
18. Nightingale SL: Therapeutic equivalence of generic drugs. Letter to health practitioners, January 28, 1998
19. McGilveray IJ, Gallicano K: Presented at the Transplantation Society Sponsored Symposium, Montreal, Canada, July 12, 1998 (Abstract XX)
20. Yusif, et al. JAMA 260:2259, 1998
21. Carter BL, Noyes MA, Demmler RW: Pharmacotherapy 13:359, 1993
22. Curtis JJ, Van Buren DH, Pirsch J, et al: Presented at American Society of Transplant Physicians Meeting, Chicago, Illinois, May 10, 1998 (Abstract XX)
23. Barr WH: Presented at the Transplantation Society Sponsored Symposium, Montreal, Canada, July 12, 1998 (Abstract XX)
24. Kahan B, Welsh M, Schoenberg L, et al: Transplantation 62:599, 1996