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Использование генериков в онкологии: есть ли проблемы?
Использование генериков в онкологии: есть ли проблемы?
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Полный текст
Список литературы
1. Вестник российского онкологического научного центра им. Блохина РАМН. 2007; 18 (2, прил. 1).
2. Стенина М. Таксотер (доцетаксел) в адъювантной терапии рака молочной железы. Врач. 2008; 5: 1–4.
3. Семенов Н.Н. Таксотер (доцетаксел): оптимальные режимы применения. Фарматека. 2006; 18: 54–60.
4. Белоусов Ю.Б., Зырянов С.К. Дженерики или бренды: pro et contra. Кач. клин. практ. 2002; 3: 95–101.
5. Newton PN, Green MD, Fernandez FM et al. Counterfeit antiinfective drugs. Lancet Infect Dis 2006; 6: 602–13.
6. Boven K, Stryker S, Knight J et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 2005; 67: 2346–53.
7. Limaye S, Steele RH, Quin J et al. An allergic reaction to erythropoietin secondary to polysorbate hypersensitivity. J Allergy Clin Immunol 2002; 110: 530.
8. Kowey PR. Issues in bioequivalence and generic substitution for antiarrhythmic drugs (editorial). http://www.americanheart.org/presenter.jhtml?identifierј3015266.
9. Reiffel JA. Formulation substitution and other pharmacokinetic variability: underappreciated variables affecting antiarrhythmic efficacy and safety in clinical practice. Am J Cardiol 2000; 85: 46–52.
10. Gross R. New findings in epilepsy from the 60th Annual Meeting of the American Epilepsy Society: an expert interview. Medscape Neurol Neurosurg 2006; 8. http://www.medscape.com/viewarticle/549148
11. Crawford P, Feely M, Guberman A et al. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure 2006; 15: 165–76.
12. Bayer Healthcare Pharmaceuticals. Important Leukine safety information: US market withdrawal and replacement for Liquid Leukine. http://www.fda.gov/CDER/drug/shortages/leukine_DHCP_Instructions_Formulation.pdf
13. Vial J, Cohen M, Sassiat P, Thiebaut D. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Cur Med Res Opin 2008; 24 (7): 2019–33.
14. Massart DL, Vandeginste BGM, Buydens LMC et al. Eds. DL Massart et al. Handbook of chemometrics and qualimetrics: part A. Amsterdam: Elsevier, 1997; 788–90.
15. Bruno R, Vivier N, Veyrat-Follet C et al. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Invest New Drugs 2001; 19: 163–9.
16. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topic Q3B (R2): impurities in new drug products. Geneva, 2006.
17. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topic Q3A (R2): impurities in new drug substances. Geneva, 2006.
18. Kumar D, Tomar RS, Deolia SK et al. Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation. J Pharm Biomed Anal 2007; 43: 1228–35.
19. Gomez Y, Adams E, Hoogmartens J. Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand. J Pharm Biomed Anal 2004; 34: 341–8.
20. Nightingale CH. A survey of the quality of generic clarithromycin products from 18 countries. Clin Drug Investig 2005; 25: 135–52.
21. Nightingale CH. A survey of the quality of generic clarithromycin products from 13 countries. Clin Drug Investig 2000; 19: 293–305.
22. Trefi S, Gilard V, Malet-Martino M et al. Generic ciprofloxacin tablets contain the stated amount of drug and different impurity profiles: a 19F, 1H and DOSY NMR analysis. J Pharm Biomed Anal 2007; 44: 743–54.
2. Стенина М. Таксотер (доцетаксел) в адъювантной терапии рака молочной железы. Врач. 2008; 5: 1–4.
3. Семенов Н.Н. Таксотер (доцетаксел): оптимальные режимы применения. Фарматека. 2006; 18: 54–60.
4. Белоусов Ю.Б., Зырянов С.К. Дженерики или бренды: pro et contra. Кач. клин. практ. 2002; 3: 95–101.
5. Newton PN, Green MD, Fernandez FM et al. Counterfeit antiinfective drugs. Lancet Infect Dis 2006; 6: 602–13.
6. Boven K, Stryker S, Knight J et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 2005; 67: 2346–53.
7. Limaye S, Steele RH, Quin J et al. An allergic reaction to erythropoietin secondary to polysorbate hypersensitivity. J Allergy Clin Immunol 2002; 110: 530.
8. Kowey PR. Issues in bioequivalence and generic substitution for antiarrhythmic drugs (editorial). http://www.americanheart.org/presenter.jhtml?identifierј3015266.
9. Reiffel JA. Formulation substitution and other pharmacokinetic variability: underappreciated variables affecting antiarrhythmic efficacy and safety in clinical practice. Am J Cardiol 2000; 85: 46–52.
10. Gross R. New findings in epilepsy from the 60th Annual Meeting of the American Epilepsy Society: an expert interview. Medscape Neurol Neurosurg 2006; 8. http://www.medscape.com/viewarticle/549148
11. Crawford P, Feely M, Guberman A et al. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure 2006; 15: 165–76.
12. Bayer Healthcare Pharmaceuticals. Important Leukine safety information: US market withdrawal and replacement for Liquid Leukine. http://www.fda.gov/CDER/drug/shortages/leukine_DHCP_Instructions_Formulation.pdf
13. Vial J, Cohen M, Sassiat P, Thiebaut D. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Cur Med Res Opin 2008; 24 (7): 2019–33.
14. Massart DL, Vandeginste BGM, Buydens LMC et al. Eds. DL Massart et al. Handbook of chemometrics and qualimetrics: part A. Amsterdam: Elsevier, 1997; 788–90.
15. Bruno R, Vivier N, Veyrat-Follet C et al. Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Invest New Drugs 2001; 19: 163–9.
16. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topic Q3B (R2): impurities in new drug products. Geneva, 2006.
17. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topic Q3A (R2): impurities in new drug substances. Geneva, 2006.
18. Kumar D, Tomar RS, Deolia SK et al. Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation. J Pharm Biomed Anal 2007; 43: 1228–35.
19. Gomez Y, Adams E, Hoogmartens J. Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand. J Pharm Biomed Anal 2004; 34: 341–8.
20. Nightingale CH. A survey of the quality of generic clarithromycin products from 18 countries. Clin Drug Investig 2005; 25: 135–52.
21. Nightingale CH. A survey of the quality of generic clarithromycin products from 13 countries. Clin Drug Investig 2000; 19: 293–305.
22. Trefi S, Gilard V, Malet-Martino M et al. Generic ciprofloxacin tablets contain the stated amount of drug and different impurity profiles: a 19F, 1H and DOSY NMR analysis. J Pharm Biomed Anal 2007; 44: 743–54.
Авторы
С.К.Зырянов, Ю.Б.Белоусов
Кафедра клинической фармакологии Российского государственного медицинского университета, Москва
Кафедра клинической фармакологии Российского государственного медицинского университета, Москва
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