Safety and efficacy of generic drugs with respect to brand formulation

被引：31

作者：

Gallelli, Luca ^{[1
,2
]}

Palleria, Caterina ^{[1
,2
]}

De Vuono, Antonio ^{[3
]}

Mumoli, Laura ^{[1
,2
]}

Vasapollo, Piero ^{[3
]}

Piro, Brunella ^{[4
]}

Russo, Emilio ^{[1
,2
]}

机构：

[1] Mater Domini Univ Hosp, Reg Ctr Drug Informat, Dept Sci Hlth, Catanzaro, Italy

[2] Univ Catanzaro, Sch Med, Pharmacol, Catanzaro, Italy

[3] ASP Cosenza, Dept Gen Med, Cosenza, Italy

[4] ASP Cosenza, Dept Pharmacovigilance, Cosenza, Italy

来源：

JOURNAL OF PHARMACOLOGY & PHARMACOTHERAPEUTICS | 2013年 / 4卷 / 05期

关键词：

Antibiotics; bioequivalence; brand; clinical efficacy; generic; safety;

D O I：

10.4103/0976-500X.120972

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

引用

页码：S110 / S114

页数：5

共 40 条

[1] Efficacy of substituting innovator propafenone for its generic formulation in patients with atrial fibrillation [J].

Amit, G ;

Rosen, A ;

Wagshal, AB ;

Bonneh, DY ;

Liss, T ;

Grosbard, A ;

Ilia, R ;

Katz, A .

AMERICAN JOURNAL OF CARDIOLOGY, 2004, 93 (12) :1558-1560

[2]

[Anonymous], 2003, BLACK BOOK LONG VIEW

[3]

Araszkiewicz A Aleksander, 2008, Expert Rev Pharmacoecon Outcomes Res, V8, P549, DOI 10.1586/14737167.8.6.549

[4] The use of Nolvadex in the treatment of generic Tamoxifen-associated small joint arthralgia [J].

Blencowe, N. S. ;

Reichl, C. ;

Gahir, J. ;

Paterson, I. .

BREAST, 2010, 19 (03) :243-245

[5] Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration [J].

Davit, Barbara M. ;

Nwakama, Patrick E. ;

Buehler, Gary J. ;

Conner, Dale P. ;

Haidar, Sam H. ;

Patel, Devvrat T. ;

Yang, Yongsheng ;

Yu, Lawrence X. ;

Woodcock, Janet .

ANNALS OF PHARMACOTHERAPY, 2009, 43 (10) :1583-1597

[6] Role of CYP3AS in abnormal clearance of methadone [J].

De Fazio, Salvatore ;

Gallelli, Luca ;

De Siena, Antonella ;

De Sarro, Giovambattista ;

Scordo, Maria Gabriella .

ANNALS OF PHARMACOTHERAPY, 2008, 42 (06) :893-897

[7] Lack of efficacy during the switch from brand to generic allopurinol [J].

De Vuono, Antonio ;

Scicchitano, Francesca ;

Palleria, Caterina ;

Russo, Emilio ;

De Sarro, Giovambattista ;

Gallelli, Luca .

JOURNAL OF FORENSIC AND LEGAL MEDICINE, 2013, 20 (05) :540-542

[8] Treatment failure in osteoporosis [J].

Diez-Perez, A. ;

Adachi, J. D. ;

Agnusdei, D. ;

Bilezikian, J. P. ;

Compston, J. E. ;

Cummings, S. R. ;

Eastell, R. ;

Eriksen, E. F. ;

Gonzalez-Macias, J. ;

Liberman, U. A. ;

Wahl, D. A. ;

Seeman, E. ;

Kanis, J. A. ;

Cooper, C. .

OSTEOPOROSIS INTERNATIONAL, 2012, 23 (12) :2769-2774

[9] Generalised urticaria in a young woman treated with clomipramine and after ingestion of codfish - A case report [J].

Gallelli, L. ;

De Fazio, S. ;

Corace, E. ;

De Sarro, G. ;

Garcia, C. S. ;

De Fazio, P. .

PHARMACOPSYCHIATRY, 2006, 39 (04) :154-156

[10] Levofloxacin-induced taste perversion/ blurred vision and dyspnoea in a young woman [J].

Gallelli, L ;

Del Negro, S ;

Naty, S ;

Colosimo, M ;

Maselli, R ;

De Sarro, G .

CLINICAL DRUG INVESTIGATION, 2004, 24 (08) :487-489

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