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Обзор качества генерических препаратов кларитромицина из 18 стран Реферат
Обзор качества генерических препаратов кларитромицина из 18 стран Реферат
C.H.Nightingale. Обзор качества генерических препаратов кларитромицина из 18 стран. Consilium Medicum. Гастроэнтерология (Прил.). 2010; 1: 71-75.
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Полный текст
Список литературы
1. Langtry HD, Brigadoon RN. Clarithromycin: a review of its efficacy in the treatment of respiratory tract infections in immunocompetent patients. Drugs 1997; 53: 973–1004.
2. Peters DH, Clissold SJ. Clarithromycin: a review of its antimicrobial activity, pharmacokinetic properties and therapeutic potential. Drugs 1992; 44: 117–64.
3. McCarty JM. Clarithromycin in the management of communityacquired pneumonia. Clin Ther 2000; 22 (3): 281–94.
4. Bogossian M. Use of clarithromycin for respiratory infections in general practice. Rev Bras Med 1995; 52: 500–9.
5. Farhat CK. Use of clarithromycin in respiratory infections in pediatrics. Mod Pediatr 1995; 31: 1–8.
6. Endo LH. The use of clarithromycin in respiratory infections in general practice. Otorrinolaringologia 1995; 2: 1–8.
7. Lerner FE, Caliendo G, Santagada V et al. Clarithromycin bioequivalence study of two oral formulations in healthy human volunteers. Int J Clin Pharmacol Ther 2000; 38 (7): 345–54.
8. Lohitnavy M, Lohitnavy O, Wittaya-areekul S et al. Average bioequivalence of clarithromycin immediate released tablet formulations in healthy male volunteers. Drug Dev Ind Pharm 2003; 29 (6): 653–9
9. Lohitnavy O, Lohitnavy M, Sareekan K et al. Average bioequivalence of generic clarithromycin tablets in healthy Thai male volunteers. Biopharm Drug Dispos 2003; 24 (6): 229–31.
10. Nightingale CH. A survey of the quality of generic clarithromycin products from 13 countries. Clin Drug Invest 2000; 19: 293–305.
11. Nightingale CH. A survey of the quality of generic clarithromycin products manufactured in Slovenia and Israel. Adv Ther 2000; 17: 167–78.
12. Morgan DK, Brown DM, Rotsch TD et al. A reversed-phase high-performance liquid chromatographic method for the determination and identification of clarithromycin as the drug substance and in various dosage forms. J Pharm Biomed Anal 1991; 9: 261–9.
13. Morgan DK, Cugier P, Marello B et al. Impurity profiling of clarithromycin using high-performance liquid chromatography with ultraviolet detection. J Chromatogr 1990; 502: 351–8.
14. Davidson AG, McCallum A. A survey of the stability of omeprazole products from 13 countries. Drug Dev Ind Pharm 1996; 22: 1173–85.
15. Ishii K, Katayama Y, Itai S, et al. In vitro dissolution tests corresponding to the in vivo dissolution of clarithromycin tablets in the stomach and intestine. Chem Pharm Bull 1995; 43: 1943–8.
16. Qureshi SA, McGilveray IJ. Assessment of pharmaceutical quality of furosemide tablets from multinational markets. Drug Dev Ind Pharm 1998; 24: 995–1005.
17. CPMP/ICH/282/95 Step 4, Consensus Guideline, 6 November 1996.
18. USP 27, The United States Pharmacopeia, The United States Pharmacopeial Convention Inc., Rockville (MD), 2004.
2. Peters DH, Clissold SJ. Clarithromycin: a review of its antimicrobial activity, pharmacokinetic properties and therapeutic potential. Drugs 1992; 44: 117–64.
3. McCarty JM. Clarithromycin in the management of communityacquired pneumonia. Clin Ther 2000; 22 (3): 281–94.
4. Bogossian M. Use of clarithromycin for respiratory infections in general practice. Rev Bras Med 1995; 52: 500–9.
5. Farhat CK. Use of clarithromycin in respiratory infections in pediatrics. Mod Pediatr 1995; 31: 1–8.
6. Endo LH. The use of clarithromycin in respiratory infections in general practice. Otorrinolaringologia 1995; 2: 1–8.
7. Lerner FE, Caliendo G, Santagada V et al. Clarithromycin bioequivalence study of two oral formulations in healthy human volunteers. Int J Clin Pharmacol Ther 2000; 38 (7): 345–54.
8. Lohitnavy M, Lohitnavy O, Wittaya-areekul S et al. Average bioequivalence of clarithromycin immediate released tablet formulations in healthy male volunteers. Drug Dev Ind Pharm 2003; 29 (6): 653–9
9. Lohitnavy O, Lohitnavy M, Sareekan K et al. Average bioequivalence of generic clarithromycin tablets in healthy Thai male volunteers. Biopharm Drug Dispos 2003; 24 (6): 229–31.
10. Nightingale CH. A survey of the quality of generic clarithromycin products from 13 countries. Clin Drug Invest 2000; 19: 293–305.
11. Nightingale CH. A survey of the quality of generic clarithromycin products manufactured in Slovenia and Israel. Adv Ther 2000; 17: 167–78.
12. Morgan DK, Brown DM, Rotsch TD et al. A reversed-phase high-performance liquid chromatographic method for the determination and identification of clarithromycin as the drug substance and in various dosage forms. J Pharm Biomed Anal 1991; 9: 261–9.
13. Morgan DK, Cugier P, Marello B et al. Impurity profiling of clarithromycin using high-performance liquid chromatography with ultraviolet detection. J Chromatogr 1990; 502: 351–8.
14. Davidson AG, McCallum A. A survey of the stability of omeprazole products from 13 countries. Drug Dev Ind Pharm 1996; 22: 1173–85.
15. Ishii K, Katayama Y, Itai S, et al. In vitro dissolution tests corresponding to the in vivo dissolution of clarithromycin tablets in the stomach and intestine. Chem Pharm Bull 1995; 43: 1943–8.
16. Qureshi SA, McGilveray IJ. Assessment of pharmaceutical quality of furosemide tablets from multinational markets. Drug Dev Ind Pharm 1998; 24: 995–1005.
17. CPMP/ICH/282/95 Step 4, Consensus Guideline, 6 November 1996.
18. USP 27, The United States Pharmacopeia, The United States Pharmacopeial Convention Inc., Rockville (MD), 2004.
Авторы
C.H.Nightingale
Center for Anti-Infective Research and Development, Hartford Hospital and University of Connecticut School of Pharmacy, Hartford, Connecticut, USA
Center for Anti-Infective Research and Development, Hartford Hospital and University of Connecticut School of Pharmacy, Hartford, Connecticut, USA
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