Generics: world and domestic practice
- Авторлар: Plotnikova E.Y.1, Sukhikh A.S1, Gracheva T.Y.1
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Мекемелер:
- Kemerovo State Medical University
- Шығарылым: Том 26, № 9 (2019)
- Беттер: 87-94
- Бөлім: Articles
- URL: https://journals.eco-vector.com/2073-4034/article/view/312324
- DOI: https://doi.org/10.18565/pharmateca.2019.9.87-94
- ID: 312324
Дәйексөз келтіру
Аннотация
The article provides historical data on the world drug legislation, primarily regarding generics. The types of generics, their differences and methods of production are described. Katherine Katherine Eban’s journalistic investigation on the issue of quality of generics is also being discussed. Two branded Russian generics, Kalmirex and Flamadex, are presented; research on their pharmaceutical equivalence is considered.
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Авторлар туралы
E. Plotnikova
Kemerovo State Medical University
Email: eka-pl@rambler.ru
MD, Professor, Head of the Course of Clinical Gastroenterology
A. Sukhikh
Kemerovo State Medical University
T. Gracheva
Kemerovo State Medical University
Әдебиет тізімі
- Henry D., Lexchin J. The pharmaceutical industry as a medicines provider. Lancet. 2002;360:1590;1-1595. doi: 10.1016/S0140-6736(02) 11527-3.
- Kirking D.M., Ascione F.J., Gaither C.A., Welage L.S. Economics and structure of the generic pharmaceutical industry. J Am Pharm Assoc (Wash). 2001;41:578-84.
- Kelly C. The balance between innovation and competition: The Hatch-Waxman act, the 2003 amendments, and beyond. Food Drug Law J. 2011;66:417-78.
- Swain S., Dey A., Patra C.N., Bhanoji Rao M.E. Pharmaregulations for generic drug products in India and US: Case studies and future prospectives. Pharmaceut Reg Affairs. 2014;3:2.
- Frank R.G. The ongoing regulation of generic drugs. N Engl J Med. 2007;357:1993-96.
- Sheela D., Tharani C.B. A comparative study on pharmaceutical equivalence of generic and branded carbamazepine tablet. international J. Pharm and Bio Sci. -015;6(1):P589-P597.
- Gota V., Patial P. Toward better quality of anticancer generics in India. Indian J. Cancer. -014;51:366.
- Joshi S.S., Shetty Y.C., Karande S. Generic drugs - The Indian scenario. J. Postgrad Med. 2019;65(2):67-69. doi: 10.4103/jpgm.
- Blossom D.B., Kallen A.J., Patel PR., et al. Outbreak of adverse reactions associated with contaminated heparin. N. Engl J. Med. 2008;359:2674-84. doi: 10.1056/NEJMoa0806450.
- Feldschreiber P. Public health issues with counterfeit medicines. Clin Med. 2009;9:63-64.
- Mastoraki E., Michalopoulos A., Kriaras I., et al. Incidence of postoperative infections in patients undergoing coronary artery bypass grafting surgery receiving antimicrobial prophylaxis with original and generic cefuroxime. J. infect. 2008;56:35-39. doi: 10.1016/j.jinf.2007.09.011.
- Katzung B.G. Basic & clinical pharmacology New York: McGraw-Hill Medical; London: McGraw-Hill [distributor]. 2012.
- Henderson J.D., Esham R.H. Generic substitution: issues for problematic drugs. South Med J. 2001;94:16-21.
- Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther. 2003;25:2875-90. doi: 10.1016/s0149-2918(03)80340-5.
- Nation R.L., Sansom L.N. Bioequivalence requirements for generic products. Pharmacol Ther. 1994;52:41-55.
- Strom B.L. Generic drug substitution revisited. N. Engl J. Med. 1987;316:1456-62.
- Apte S.P., Ugwu S.O. A Review and Classification of Emerging Excipients in Parental Medications. Pharm Tech Eur. 2003;15:45-55.
- Dodd S., Besag F.M. lessons from contaminated heparin. Curr Drug Saf. 2009;4:1. doi: 10.2174/157488609787354431.
- Roy J. Pharmaceutical impurities - a mini-review. AAPS Pharm Sci Tech. 2002;3:E6. Doi: https://doi. org/10.1-08/pt030-06.
- Welage L.S., Kirking D.M., Ascione F.J., Gaither C.A. Understanding the scientific issues embedded in the generic drug approval process. J. Am Pharm Assoc (Wash). 2001;41:856-67.
- US Food and Drug Administration. Generic drugs: questions & answers. https://www.fda. gov/Drugs/ResourcesForYou/Consumers/ QuestionsAnswers/ucm100100.htm Accessed August 10, 2017.
- Andrade C. Bioequivalence of generic drugs: a simple explanation for a US Food and Drug Administration requirement. J Clin Psychiatry. -015;76:e74--e744. Doi: 10.4088/ JCP15f10094
- Evers P Global Markets for Generic Drugs | BCC Research [Internet]. Bccresearch.com. 2019 [cited 11 July -019 Available from: https:// www.bccresearch.com/market-retearch/
- Отчет индийской фармацевтической промышленности за 2018 год. URL: https://www.ibef. ocg/industcy/ph/cm/seutis/l-ind/./spx
- Eban К. Bottle of Lies: The Inside Story of the Genenc Drug Boom. Ecco Hardcover -019;512 pages
- Духанин А.С., Шимановский Н.Л. Оригинальные и воспроизведенные лекарственные препараты: мифы и реальность. Международный медицинский журнал. 2014;1:81-88
- Сайты-реестры клинических исследований России: https://slinline.cu; http:// clinicaltrialsregister.ru/index.php [Clinical trial registry sites in Russia. [(In Russ.)]
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