Generic substitution: Issues for problematic drugs

Southern Medical Journal

Volumn 94, Issue 1, 2001, Pages 16-21

  Henderson, James D ^a   Esham, Richard H ^b  

^a UNIVERSITY OF SOUTH ALABAMA   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; BRONCHODILATING AGENT; CARDIOTONIC AGENT; DIGOXIN; GENERIC DRUG; SALBUTAMOL; THYROXINE; WARFARIN;

DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; METHODOLOGY; PHARMACOKINETICS; REPRODUCIBILITY; REVIEW; STANDARD; UNITED STATES;

ALBUTEROL; ANTICOAGULANTS; BRONCHODILATOR AGENTS; CARDIOTONIC AGENTS; DIGOXIN; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; REPRODUCIBILITY OF RESULTS; THERAPEUTIC EQUIVALENCY; THYROXINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WARFARIN;

EID: 0035220110     PISSN: 00384348     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007611-200194010-00003     Document Type: Article

References (32)

1. Pub L No. 98-417, 98 Stat 1585-1605; 21 USC 355
2. US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Management: Approved Drug Products With Therapeutic Equivalence Evaluations. Washington, DC, US Government Printing Office, 19th Ed, 1999
3. Henderson JD: Bioequivalence and bioavailability. Regul Affairs 1993; 5:367-374
4. Henderson JD: Current issues in bioequivalence determination. Appl Clin Trials 1992; 1:44-49
5. Henderson JD: Current issues in bioequivalence determination: Part II. Appl Clin Trials 1992; 1:58-61
6. Henderson JD, White GL Jr: A generic drug primer: regulatory aspects and scientific concepts. Mil Med 1998; 163:193-197
7. Lewis BP Jr, Castle RV Jr: Grandfathered drugs of 1938. Am Pharm 1978; 18:36-39
8. Kradjan WA: Congestive heart failure. Applied Therapeutics: The Clinical Use of Drugs. Young LY, Koda-Kimble MA (eds). Vancouver, Wash, Applied Therapeutics Inc, 6th Ed, 1995, pp 15-17
9. Drug Topics Red Book. Montvale, NJ, Medical Economics Co Inc, 1998, pp 275-276,383-385,548
10. 62 Federal Register 157 (1997)
11. Dong BJ: Thyroid disorders. Applied Therapeutics: The Clinical Use of Drugs. Young LY, Koda-Kimble MA (eds). Vancouver, Wash, Applied Therapeutics Inc, 6th Ed, 1995, pp 47-49
12. Dong BJ, Hauck WW, Gambertoglio JG, et al: Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 1997; 277:1205-1213
13. Pharmacists Letter 1997; 13:25
14. 65 Federal Register 24488-24489 (2000)
15. Rx Ipsa Loquitor 1997 (September); 24:1
16. ASHP Newsletter 1998 (March); 31:1
17. FDA position on product selection for "narrow therapeutic index" drugs. Am J Health Syst Pharm 1997; 54:1630-1632
18. Benet LZ: Narrow therapeutic index drugs. International Open Conference on Dissolution, Bioavailability, and Bioequivalence. Toronto, Canada, June 15-18, 1992, pp 35-39
19. Benet LZ, Goyan JE: Bioequivalence and narrow therapeutic index drugs. Pharmacotherapy 1995; 15:433-440
20. Benson SR, Vance-Bryan K: In favor of Coumadin over generic warfarin. Am J Health Syst Pharm 1998; 55:727-729
21. Haines ST: Reflections on generic warfarin. Am J Health Syst Pharm 1998; 55:729-733
22. Hopefl A: Differences in warfarin products are not the issue. Am J Health Syst Pharm 1998; 55:1935
23. Noviasky JA: Evidence-based pharmacy versus opinion on generic product selection of warfarin. Am J Health Syst Pharm 1999; 56:2246-2247
24. Malik AK, Taylor AJ: Can warfarin randomized trials be reproduced in 'real life'?: adherence to warfarin guidelines for intensity of anticoagulation in a university-based warfarin clinic. South Med J 2000:93:58-61
25. Hylek EM, Helman H, Skates SJ, et al: Acetaminophen and other risk factors for excessive warfarin anticoagulation. JAMA 1998; 279:657-662
26. Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration: Guidance on Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design. Rockville, Md, Office of Training and Communications, Division of Communications Management, Drug Information Branch, 1992
27. Banahan BF III, Bonnarens JK, Bentley JP: Generic substitution of NTI drugs: issues for formulary committee consideration. Formulary 1998; 33:1082-1096
28. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Guidance for Industry. Average, Population, and Individual Approaches to Establishing Bioequivalence (Draft Guidance). Rockville, Md, Office of Training and Communications, Division of Communications Management, Drug Information Branch, 1999
29. Swenson CN, Fundak G: Observational cohort study of switching warfarin sodium products in a managed care organization. Am J Health Syst Pharm 2000; 57:452-455
30. Schuirmann DJ: A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15:657-680
31. Banahan BF III, Kolassa EM: A physician survey on generic drugs and substitution of critical dose medications. Arch Intern Med 1997; 157:2080-2088
32. Nightingale SL, Morrison JC: Generic drugs and the prescribing physician. JAMA 1987; 258:1200-1204