The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs

Clinical Therapeutics

Volumn 25, Issue 6, 2003, Pages 1578-1592

  Borgherini, Giuseppe ^a,b  

^a UNIVERSITY OF PADOVA   (Italy)

^b Casa di Cura Parco dei Tigli   (Italy)

Author keywords

Bioavailability; Bioequivalence; Brand name drug; Excipients; Generic drug; Psychoactive drugs; Safety; Toxicity

Indexed keywords

ANTICONVULSIVE AGENT; BRAND NAME DRUG; CARBAMAZEPINE; CLOZAPINE; DIAZEPAM; DRUG; EXCIPIENT; GENERIC DRUG; NORCLOZAPINE; NORDAZEPAM; PAROXETINE; PHENYTOIN; PSYCHOTROPIC AGENT; UNCLASSIFIED DRUG; VALPROIC ACID;

ADULT; ANGER; ANXIETY DISORDER; BIOEQUIVALENCE; CASE REPORT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; COST EFFECTIVENESS ANALYSIS; DATA BASE; DEPRESSION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; EPILEPSY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; HUMAN; INSOMNIA; MALE; MOOD DISORDER; PRACTICE GUIDELINE; PRURITUS; PUBLICATION; RECURRENT DISEASE; RELAPSE; REVIEW; SCHIZOPHRENIA; SEIZURE; SIDE EFFECT; STATISTICAL ANALYSIS; TREATMENT INDICATION; TREATMENT OUTCOME;

EID: 0038721595     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(03)80157-1     Document Type: Review

References (43)

1. Centro Degli Studi Investimenti Sociali (CENSIS). Farmaci generici: Quale risparmio? Available at: http://www.censis.it/censis/ricerche/2000/farmaci/#_Toc496010262. Accessed November 11, 2002.
2. Cantor LB. Generics: Not all drugs are created equal. Rev Ophthalmol [serial online]. 2002;9:72-74. Available at: http://www.revophth.com/publish/content/1_10.htm. Accessed December 17, 2002.
3. Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration. Guidance for industry. ANDAs: Impurities in drug substances. Int J Generic Drugs. Available at: http://www.locumusa.com. Accessed October 27, 2002.
4. Davies G. Changing the salt, changing the drug. Pharm J. 2001;266:322-323.
5. Salt Selection - Reducing Time to Market. SSCI Application Note 4. Available at: http://www.ssci-inc.com/tab6Info/app_note_4.pdf. Accessed December 22, 2002.
6. Cutler NR. Pharmacokinetic studies of antipsychotics in healthy volunteers versus patients. J Clin Psychiatry. 2001;62(Suppl 5): 10-13.
7. Besag FM. Is generic prescribing acceptable in epilepsy? Drug Saf. 2000;23;173-182.
8. Meyer MC. United States Food and Drug Administration requirements for approval of generic drug products. J Clin Psychiatry. 2001;62(Suppl 5):4-9.
9. Approved Drug Products with Therapeutic Equivalence Evaluations. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm. Accessed November 11, 2002.
10. Ansbacher R. Low-dose oral contraceptives: Health consequences of discontinuation. Contraception. 2000;62:285-288.
11. Kluznik JC, Walbek NH, Farnsworth MG, Melstrom K. Clinical effects of a randomized switch of patients from clozaril to generic clozapine. J Clin Psychiatry. 2001;62(Suppl 5): 14-17.
12. Hope KA, Havrda DE. Subtherapeutic INR values associated with a switch to generic warfarin. Ann Pharmacother. 2001;35:183-187.
13. Richens A. Impact of generic substitution of anticonvulsants on the treatment of epilepsy. CNS Drugs. 1997;8:123-133.
14. Richton-Hewett S, Foster E, Apstein CS. Medical and economic consequences of a blinded oral anticoagulant brand change at a municipal hospital. Arch Intern Med. 1988;148:806-808.
15. Nuwer MR, Browne TR, Dodson WE, et al. Generic substitutions for antiepileptic drugs. Neurology. 1990;40:1647-1651.
16. Sabatini S, Ferguson RM, Helderman JH, et al. Drug substitution in transplantation: A National Kidney Foundation White Paper. Am J Kidney Dis. 1999;33:389-397.
17. Grubb BP. Recurrence of ventricular tachycardia after conversion from proprietary to generic procainamide. Am J Cardiol. 1989;63:1532-1533.
18. Kowey PR. Pharmacological effects of antiarrhythmic drugs: Review and update. Arch Intern Med. 1998;158:325-332.
19. Ozahowski TP, Greenberg ML, Mock PP. Clinical inequivalence of generic and brand name type IA antiarrhythmic drugs. Pacing Clin Electrophysiol. 1998;21:809. Abstract.
20. Chereson R. Bioavailability, bioequivalence, and drug selection. In: Makoid MC, Vuchetich P. Banakar U, eds. Basic Pharmacohinetics. Available at: http://pharmacy.creighton.edu/pha443/pdf/pkin08.pdf. Accessed September 17, 2002.
21. Meyer MC, Straughn AB. Biopharmaceutical factors in seizure control and drug toxicity. Am J Hosp Pharm. 1993;50(Suppl 5):S17-S22.
22. Crawford P, Hall WW, Chappell B, et al. Generic prescribing for epilepsy: Is it safe? Seizure. 1996;5:1-5.
23. Rosenbaum DH, Rowan AJ, Tuchman L, French JA. Comparative bioavailability of a generic phenytoin and Dilantin. Epilepsia. 1994;35:656-660.
24. Chen SS, Allen J, Oxley J, Richens A. Comparative bioavailability of phenytoin from generic formulations in the United Kingdom. Epilepsia. 1982;23:149-152.
25. Hodges S, Forsythe WI, Gillies D, et al. Bio-availability and dissolution of three phenytoin preparations for children. Dev Med Child Neurol. 1986;28:708-712.
26. Mikati M, Bassett N, Schachter S. Double-blind randomized study comparing brand-name and generic phenytoin monotherapy. Epilepsia. 1992;33:359-365.
27. Hartley R, Aleksandrowicz J, Bowmer CJ, et al. Dissolution and relative bioavailability of two carbamazepine preparations for children with epilepsy. J Pharm Pharmacol. 1991;43:117-119.
28. Pedersen SA, Dam M. Carbamazepine: Are synonymous preparations identical [in Danish]? Ugeskr Laeger. 1985;147:2676-2677.
29. Welty TE, Pickering PR, Hale BC, Arazi R. Loss of seizure control associated with generic substitution of carbamazepine. Ann Pharmacother. 1992;26:775-777.
30. Meyer MC, Straughn AB, Jarvi EJ, et al. The bioinequivalence of carbamazepine tablets with a history of clinical failures. Pharm Res. 1992;9:1612-1616.
31. Oles KS, Penry JK, Smith LD, et al. Therapeutic bioequivalency study of brand name versus generic carbamazepine. Neurology. 1992;42:1147-1153.
32. Silpakit O, Amornpichetkoon M, Kaojarem S. Comparative study of bioavailability and clinical efficacy of carbamazepine in epileptic patients. Ann Pharmacother. 1997;31:548-552.
33. Vadney VJ, Kraushaar KW. Effects of switching from Depakene to generic valproic acid on individuals with mental retardation. Ment Retard. 1997;35:468-472.
34. Sherwood Brown E, Shellhorn E, Suppes T. Gastrointestinal side-effects after switch to generic valproic acid. Pharmacopsychiatry. 1998;31:114.
35. MacDonald JT. Breakthrough seizure following substitution of Depakene capsule (Abbott) with a generic product. Neurology. 1987;37:1885.
36. Locniskar A, Greenblatt DJ, Harmatz JS, Shader RI. Bioinequivalence of a generic brand of diazepam. Biopharm Drug Dispos. 1989;10:597-605.
37. Vergouwen AC, Bakker A. Adverse effects after switching to a different generic form of paroxetine: Paroxetine mesylate instead of paroxetine HCl hemihydrate [in Dutch]. Ned Tijdschr Geneeskd. 2002;146:811-812.
38. Ereshefsky L, Lam YW, Toney GB, et al. Clozapine bioequivalence in patients. In: Program and abstracts of the 153rd Annual Meeting of the American Psychiatric Association; May 18, 2000; Chicago, Ill. Abstract 710.
39. Toney GB, Ereshefsky L, Lam YW, et al. Interchangeability of clozapine formulations in stabilized patients. In: Program and abstracts of the 153rd Annual Meeting of the American Psychiatric Association; May 18, 2000; Chicago, Ill. Abstract 711.
40. VanderZwaag C, McGee M, McEvoy JP, et al. Response of patients with treatment-refractory schizophrenia to clozapine within three serum level ranges. Am J Psychiatry. 1996;153:1579-1584.
41. Kronig MH, Munne RA, Szymanski S, et al. Plasma clozapine levels and clinical response for treatment-refractory schizophrenic patients. Am J Psychiatry. 1995;152:179-182.
42. Bellnier TJ, Singh RP Karki S, et al. Evaluation of the interchangeability of generic clozapine with brand name Clozaril. In: Program and abstracts of the 152nd Annual Meeting of the American Psychiatric Association; May 15-20, 1999; Washington, DC. Abstract 673.
43. Ereshefsky L, Glazer WM. Comparison of the bioequivalence of generic versus branded clozapine. J Clin Psychiatry. 2001;62(Suppl 5):25-27.