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Volumn 32, Issue 3, 2012, Pages 399-407

Bioequivalence study of montelukast 5 mg chewable tablets;Estudio de bioequivalencia de montelukast en tabletas masticables de 5 mg

Author keywords

Asthma; Generic, drugs; Reference drugs, therapeutic equivalency.

Indexed keywords

ACETIC ACID DERIVATIVE; GENERIC DRUG; MONTELUKAST; QUINOLINE DERIVATIVE;

EID: 84877036347     PISSN: 01204157     EISSN: None     Source Type: Journal    
DOI: 10.7705/biomedica.v32i3.708     Document Type: Article
Times cited : (6)

References (27)
  • 2
    • 0003653029 scopus 로고    scopus 로고
    • Goodman and Gilman. Las bases farmacológicas de la terapéutica
    • México, D.F.: Editorial McGraw-Hill
    • Hardman J, Limbird L. Goodman and Gilman. Las bases farmacológicas de la terapéutica. Novena edición. México, D.F.: Editorial McGraw-Hill; 1996.
    • (1996) Novena edición.
    • Hardman, J.1    Limbird, L.2
  • 4
    • 0003802728 scopus 로고    scopus 로고
    • World Medical Association Declaration of Helsinki 59th WMA General Assembly, Seoul, October 2008. Fecha de consulta: 9 de marzo de Disponible en
    • World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. 59th WMA General Assembly, Seoul, October 2008. Fecha de consulta: 9 de marzo de 2010. Disponible en: http://www.wma.net/en/30publications/10policies/b3/17c.pdf.
    • (2010) Ethical principles for medical research involving human subjects
  • 5
    • 84877031861 scopus 로고
    • Ministerio de Salud. Resolución No. 008430 DE 1993. Por la cual se establecen las normas académicas, técnicas y administrativas para la investigación en salud. BogotÁ D.C.: Ministerio de Salud
    • Ministerio de Salud. Resolución No. 008430 DE 1993. Por la cual se establecen las normas académicas, técnicas y administrativas para la investigación en salud. BogotÁ D.C.: Ministerio de Salud; 1993.
    • (1993)
  • 6
    • 0026711141 scopus 로고
    • Sample size determination for the two one-sided tests procedure in bioequivalence
    • Liu JP, Chow SC. Sample size determination for the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm. 1992;20:101-4. http://dx.doi.org/10.1007/BF01143188
    • (1992) J Pharmacokinet Biopharm , vol.20 , pp. 101-104
    • Liu, J.P.1    Chow, S.C.2
  • 7
    • 33750173601 scopus 로고    scopus 로고
    • New liquid liquid extraction method for determination for montelukast in small volume human plasma samples using HPLC with fluorescence detector
    • Chauhan B, Rani S, Nivsarkar M, Padh H. New liquid liquid extraction method for determination for montelukast in small volume human plasma samples using HPLC with fluorescence detector. Indian J Pharm Sci. 2006;68:517-20. http://dx.doi.org/10.4103/0250-474X.27834
    • (2006) Indian J Pharm Sci , vol.68 , pp. 517-520
    • Chauhan, B.1    Rani, S.2    Nivsarkar, M.3    Padh, H.4
  • 8
    • 77953638428 scopus 로고    scopus 로고
    • Merck Sharp and Dohme de México Fecha de consulta: 13 de mayo de Disponible en
    • Merck Sharp and Dohme de México. Diccionario de especialidades farmacéuticas. Fecha de consulta: 13 de mayo de 2010.Disponible en: http://www.facmed.unam.mx/bmnd/plm_2k8/src/prods/36195.htm.
    • (2010) Diccionario de especialidades farmacéuticas
  • 9
    • 70350025428 scopus 로고    scopus 로고
    • Rapid determination of Montelukast in human plasma by LC-ESI-MS/MS and its application to a bioequivalence study
    • Patel NK, Subbaiah G, Shah H, Kundlik M, Sanyal M, Shrivastav PS. Rapid determination of Montelukast in human plasma by LC-ESI-MS/MS and its application to a bioequivalence study. Anal Lett. 2009;42:2041-59. http://dx.doi.org/10.1080/00032710903082721
    • (2009) Anal Lett , vol.42 , pp. 2041-2059
    • Patel, N.K.1    Subbaiah, G.2    Shah, H.3    Kundlik, M.4    Sanyal, M.5    Shrivastav, P.S.6
  • 10
    • 0037467209 scopus 로고    scopus 로고
    • A semi-automated 96-well protein precipitation method for the determination of Montelukast in human plasma using high performance liquid chromatography/fluorescence detection
    • Kitchen CJ, Wang AQ, Musson DG, Yang AY, Fisher AL. A semi-automated 96-well protein precipitation method for the determination of Montelukast in human plasma using high performance liquid chromatography/fluorescence detection. J Pharm Biomed Anal. 2003;31:647-54. http://dx.doi.org/10.1016/S0731-7085(02)00723-9
    • (2003) J Pharm Biomed Anal , vol.31 , pp. 647-654
    • Kitchen, C.J.1    Wang, A.Q.2    Musson, D.G.3    Yang, A.Y.4    Fisher, A.L.5
  • 12
    • 0030966107 scopus 로고    scopus 로고
    • Determination of Montelukast (MK-0476) and its S-enantiomer in human plasma by stereoselective high-performance liquid chromatography with column-switching
    • Liu L, Cheng H, Zhao Jl, Rogers ID. Determination of Montelukast (MK-0476) and its S-enantiomer in human plasma by stereoselective high-performance liquid chromatography with column-switching. J Pharm Biomed Anal. 1997;15:631-8. http://dx.doi.org/10.1016/S0731-7085(96)01894-8
    • (1997) J Pharm Biomed Anal , vol.15 , pp. 631-638
    • Liu, L.1    Cheng, H.2    Zhao, J.l.3    Rogers, I.D.4
  • 13
    • 0032411218 scopus 로고    scopus 로고
    • Determination of Montelukast sodium in human plasma by column-switching high-performance liquid chromatography with fluorescence detection
    • Ochiai H, Uchiyama N, Takano T, Hara K, Kamei T. Determination of Montelukast sodium in human plasma by column-switching high-performance liquid chromatography with fluorescence detection. J Chromatogr B Biomed Sci Appl. 1998;713:409-14. http://dx.doi.org/10.1016/S0378-4347(98)00179-0
    • (1998) J Chromatogr B Biomed Sci Appl , vol.713 , pp. 409-414
    • Ochiai, H.1    Uchiyama, N.2    Takano, T.3    Hara, K.4    Kamei, T.5
  • 14
    • 0035946723 scopus 로고    scopus 로고
    • Expedient liquid chromatographic method with fluorescence detection for Montelukast sodium in micro-samples of plasma
    • Al-Rawithi S, Al-Gazlan S, Al-Ahmadi W, Alshowaier IA, Yusuf A, Raines DA. Expedient liquid chromatographic method with fluorescence detection for Montelukast sodium in micro-samples of plasma. J Chromatogr B Biomed Sci Appl. 2001;754:527-31. http://dx.doi.org/10.1016/S0378-4347(01)00025-1
    • (2001) J Chromatogr B Biomed Sci Appl , vol.754 , pp. 527-531
    • Al-Rawithi, S.1    Al-Gazlan, S.2    Al-Ahmadi, W.3    Alshowaier, I.A.4    Yusuf, A.5    Raines, D.A.6
  • 15
    • 20044395069 scopus 로고    scopus 로고
    • An automated method for the determination of Montelukast in human plasma using dual-column HPLC analysis and peak height summation of the parent compound and its photodegradation product
    • Smith GA, Rawls CM, Kunka RL. An automated method for the determination of Montelukast in human plasma using dual-column HPLC analysis and peak height summation of the parent compound and its photodegradation product. Pharm Res. 2004;21:1539-44. http://dx.doi.org/10.1023/B:PHAM.0000041445.76931.27
    • (2004) Pharm Res , vol.21 , pp. 1539-1544
    • Smith, G.A.1    Rawls, C.M.2    Kunka, R.L.3
  • 16
    • 9244265470 scopus 로고    scopus 로고
    • Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy malesand females
    • Cheng H, Leff JA, Amin R, Gertz BJ, De Smet M, Noonan N, et al. Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy malesand females. Pharm Res. 1996;13:445-8. http://dx.doi.org/10.1023/A:1016056912698
    • (1996) Pharm Res , vol.13 , pp. 445-448
    • Cheng, H.1    Leff, J.A.2    Amin, R.3    Gertz, B.J.4    De Smet, M.5    Noonan, N.6
  • 17
    • 18044374457 scopus 로고    scopus 로고
    • A population pharmacokinetic model for montelukast disposition in adults and children
    • Ramakrishnan R, Migoya E, Knorr B. A population pharmacokinetic model for montelukast disposition in adults and children. Pharm Res. 2005;22:532-40. http://dx.doi.org/10.1007/s11095-005-2493-y
    • (2005) Pharm Res , vol.22 , pp. 532-540
    • Ramakrishnan, R.1    Migoya, E.2    Knorr, B.3
  • 18
    • 35348865449 scopus 로고    scopus 로고
    • Effect of light and heat on the stability of Montelukast in solution and in its solid state
    • Al Omari MM, Zoubi RM, Hasan EI, Khader TZ, Badwan AA. Effect of light and heat on the stability of Montelukast in solution and in its solid state. J Pharm Biomed Anal. 2007;45:465-71. http://dx.doi.org/10.1016/j.jpba.2007.07.014
    • (2007) J Pharm Biomed Anal , vol.45 , pp. 465-471
    • Al Omari, M.M.1    Zoubi, R.M.2    Hasan, E.I.3    Khader, T.Z.4    Badwan, A.A.5
  • 19
    • 21744442419 scopus 로고    scopus 로고
    • Voltammetric determination of montelukast sodium in dosage forms and human plasma
    • Alsarra I, Al-Omar M, Gadkariem EA, Belal F. Voltammetric determination of montelukast sodium in dosage forms and human plasma. Farmaco. 2005;60:563-7. http://dx.doi.org/10.1016/j.farmac.2005.04.004
    • (2005) Farmaco , vol.60 , pp. 563-567
    • Alsarra, I.1    Al-Omar, M.2    Gadkariem, E.A.3    Belal, F.4
  • 20
    • 0037466986 scopus 로고    scopus 로고
    • Simultaneous determination of montelukast and loratadine by HPLC and derivative spectrophotometric methods
    • Radhakrishna T, Narasaraju A, Ramakrishna M, Satyanarayana A. Simultaneous determination of montelukast and loratadine by HPLC and derivative spectrophotometric methods. J Pharm Biomed Anal 2003;31:359-68.http://dx.doi.org/10.1016/S0731-7085(02)00650-7
    • (2003) J Pharm Biomed Anal , vol.31 , pp. 359-368
    • Radhakrishna, T.1    Narasaraju, A.2    Ramakrishna, M.3    Satyanarayana, A.4
  • 21
    • 11144284585 scopus 로고    scopus 로고
    • Development of a stability-indicating HPLC method for the determination of Montelukast in tablets and human plasma and its applications to pharmacokinetic and stability studies
    • Alsarra IA. Development of a stability-indicating HPLC method for the determination of Montelukast in tablets and human plasma and its applications to pharmacokinetic and stability studies. Saudi Pharmaceutical Journal. 2004;12:136-43.
    • (2004) Saudi Pharmaceutical Journal , vol.12 , pp. 136-143
    • Alsarra, I.A.1
  • 22
    • 34848921473 scopus 로고    scopus 로고
    • A rapid and sensitive method for the quantitation of montelukast in sheep plasma using liquid chromatography/tandem mass spectrometry
    • Papp R, Luk P, Mullett WM, Kwong E. A rapid and sensitive method for the quantitation of montelukast in sheep plasma using liquid chromatography/tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;858:282-6. http://dx.doi.org/10.1016/j.jchromb.2007.08.003
    • (2007) J Chromatogr B Analyt Technol Biomed Life Sci , vol.858 , pp. 282-286
    • Papp, R.1    Luk, P.2    Mullett, W.M.3    Kwong, E.4
  • 24
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15:657-80. http://dx.doi.org/10.1007/BF01068419
    • (1987) J Pharmacokinet Biopharm , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 26
    • 0033576360 scopus 로고    scopus 로고
    • Bioequivalencia y genéricos Los estudios de bioequivalencia I. Una aproximación a sus bases teóricas, diseño y realización
    • Zapater P, Horga JF. Bioequivalencia y genéricos. Los estudios de bioequivalencia I. Una aproximación a sus bases teóricas, diseño y realización. Rev Neurol. 1999;29:1235-46.
    • (1999) Rev Neurol , vol.29 , pp. 1235-1246
    • Zapater, P.1    Horga, J.F.2
  • 27
    • 84877052107 scopus 로고    scopus 로고
    • Guidance for Industry
    • Food and Drug Administration, Silver Spring: Food and Drug Administration
    • Food and Drug Administration. Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug. Silver Spring: Food and Drug Administration; 2006. p. 1-26.
    • (2006) Bioavailability and bioequivalence studies for orally administered drug , pp. 1-26


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.