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Изучение биоэквивалентности трех препаратов на основе ибупрофена у здоровых добровольцев
Изучение биоэквивалентности трех препаратов на основе ибупрофена у здоровых добровольцев
P.Bramlage, A.Goldis. Изучение биоэквивалентности трех препаратов на основе ибупрофена у здоровых добровольцев. Consilium Medicum. Неврология (Прил.). 2009; 1: 65-70.
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Полный текст
Список литературы
1. The story of ibuprofen [http://www.ibuprofen-foundation.com/].
2. Frolich JC, Fricker RM. Pain therapy and analgetics-antipyretics (Nonsteroidal antirheumatic drugs – NSAR). In Praktische Arzneitherapie 4th edition. Eds. by: Fr_lich JC, Kirch W. Heidelberg: Springer; 2006; 675–706.
3. Note for Guidance on the Investigation Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98).
4. GLP: Principles of Good Laboratory Practice as specified by national. German Chemicals Law, Annex 1, 20 June 2002) and international (OECD, Paris, 1998; EC Directive 2004/10/ EC, 11. February 2004.
5. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry Bioanalytical Method Validation [http://www.fda.gov/cder/guidance/index.htm].
6. Sochor J, Klimes J, Sedlacek J, Zahradnicek M. Determination of ibuprofen in erythrocytes and plasma by high performance liquid chromatography. J Pharm Biomed Anal 1995; 13 (7): 899–903.
7. Blume H, Mutschler E. Biooquivalenz, Qualitotsbewertung wirkstoffgleicher Fertigarzneimittel Frankfurt/Main – Eschborn: Govi-Verlag Pharmazeutischer Verlag; 1996.
8. SAS8.2: SAS® software. In Release 8.2 edition Cary NC: SAS Institute Inc; 2001.
9. Furey SA, Waksman JA, Dash BH. Nonprescription ibuprofen: side effect profile. Pharmacotherapy 1992; 12 (5): 403–7.
10. Bienert A, Szkutnik-Fiedler D, Dyderski S et al. Comparative bioavailability study of two ibuprofen preparations after oral administration in healthy volunteers. Arzneimittel-Forschung 2006; 56 (9): 647–51.
11. Laska EM, Sunshine A, Marrero I et al. The correlation between blood levels of ibuprofen and clinical analgesic response. Clin Pharmacol Ther 1986; 40 (1): 1–7.
12. Newa M, Bhandari KH, Kim JO et al. Enhancement of solubility, dissolution and bioavailability of ibuprofen in solid dispersion systems. Chem Pharm Bull (Tokyo) 2008; 56 (4): 569–74.
2. Frolich JC, Fricker RM. Pain therapy and analgetics-antipyretics (Nonsteroidal antirheumatic drugs – NSAR). In Praktische Arzneitherapie 4th edition. Eds. by: Fr_lich JC, Kirch W. Heidelberg: Springer; 2006; 675–706.
3. Note for Guidance on the Investigation Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98).
4. GLP: Principles of Good Laboratory Practice as specified by national. German Chemicals Law, Annex 1, 20 June 2002) and international (OECD, Paris, 1998; EC Directive 2004/10/ EC, 11. February 2004.
5. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry Bioanalytical Method Validation [http://www.fda.gov/cder/guidance/index.htm].
6. Sochor J, Klimes J, Sedlacek J, Zahradnicek M. Determination of ibuprofen in erythrocytes and plasma by high performance liquid chromatography. J Pharm Biomed Anal 1995; 13 (7): 899–903.
7. Blume H, Mutschler E. Biooquivalenz, Qualitotsbewertung wirkstoffgleicher Fertigarzneimittel Frankfurt/Main – Eschborn: Govi-Verlag Pharmazeutischer Verlag; 1996.
8. SAS8.2: SAS® software. In Release 8.2 edition Cary NC: SAS Institute Inc; 2001.
9. Furey SA, Waksman JA, Dash BH. Nonprescription ibuprofen: side effect profile. Pharmacotherapy 1992; 12 (5): 403–7.
10. Bienert A, Szkutnik-Fiedler D, Dyderski S et al. Comparative bioavailability study of two ibuprofen preparations after oral administration in healthy volunteers. Arzneimittel-Forschung 2006; 56 (9): 647–51.
11. Laska EM, Sunshine A, Marrero I et al. The correlation between blood levels of ibuprofen and clinical analgesic response. Clin Pharmacol Ther 1986; 40 (1): 1–7.
12. Newa M, Bhandari KH, Kim JO et al. Enhancement of solubility, dissolution and bioavailability of ibuprofen in solid dispersion systems. Chem Pharm Bull (Tokyo) 2008; 56 (4): 569–74.
Авторы
P.Bramlage1, A.Goldis2
1 Institute for Clinical Pharmacology, Medical Faculty Carl Gustav Carus, Technical University Dresden, Germany;
2 IFE Human Pharmacology SRL, Romania
1 Institute for Clinical Pharmacology, Medical Faculty Carl Gustav Carus, Technical University Dresden, Germany;
2 IFE Human Pharmacology SRL, Romania
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