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Volumn 101, Issue 1, 2012, Pages 333-341

Reliability evaluation of nonlinear design space in pharmaceutical product development

Author keywords

Dissolution rate; Excipients; Formulation; Multivariate analysis; Nonlinear regression; Simulations; Solid dosage form; Stability

Indexed keywords

INDOMETACIN; LACTOSE; MICROCRYSTALLINE CELLULOSE; STARCH;

EID: 82255162804     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22734     Document Type: Article
Times cited : (16)

References (24)
  • 1
    • 85030490632 scopus 로고    scopus 로고
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Development Q8 (R2). Accessed August 2009, at.
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Development Q8 (R2). Accessed August 2009, at.
  • 2
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design product and process development, understanding and control
    • Yu LX. 2008. Pharmaceutical quality by design product and process development, understanding and control. Pharm Res 25:781-791.
    • (2008) Pharm Res , vol.25 , pp. 781-791
    • Yu, L.X.1
  • 3
    • 70350208809 scopus 로고    scopus 로고
    • Quality by design case study: An integrated multivariate approach to drug product and process development
    • Huang J, Kaul G, Cai CS, Chatlapalli R, Hernendez-Abad P, Ghosh K, Nagi A. 2009. Quality by design case study: An integrated multivariate approach to drug product and process development. Int J Pharm 382:23-32.
    • (2009) Int J Pharm , vol.382 , pp. 23-32
    • Huang, J.1    Kaul, G.2    Cai, C.S.3    Chatlapalli, R.4    Hernendez-Abad, P.5    Ghosh, K.6    Nagi, A.7
  • 5
    • 77956395858 scopus 로고    scopus 로고
    • Surface responses and desirability functions to determine optimal granulation domains
    • Giry K, Viana M, Genty M, Wüthrich P, Chulia D. 2010. Surface responses and desirability functions to determine optimal granulation domains. Drug Dev Ind Pharm 36:1016-1026.
    • (2010) Drug Dev Ind Pharm , vol.36 , pp. 1016-1026
    • Giry, K.1    Viana, M.2    Genty, M.3    Wüthrich, P.4    Chulia, D.5
  • 6
    • 11844291470 scopus 로고    scopus 로고
    • Optimization of sustained-release propranolol dosage form using factorial design and response surface methodology
    • Huang YB, Tasai YH, Yang WC, Chang JS, Wu PC. 2004. Optimization of sustained-release propranolol dosage form using factorial design and response surface methodology. Biol Pharm Bull 27:1626-1629.
    • (2004) Biol Pharm Bull , vol.27 , pp. 1626-1629
    • Huang, Y.B.1    Tasai, Y.H.2    Yang, W.C.3    Chang, J.S.4    Wu, P.C.5
  • 7
    • 0021090437 scopus 로고
    • Computer optimization of formulation of flufenamic acid/polyvinylpolypyrrolidone/methyl cellulose solid dispersions
    • Takayama K, Nambu N, Nagai T. 1983. Computer optimization of formulation of flufenamic acid/polyvinylpolypyrrolidone/methyl cellulose solid dispersions. Chem Pharm Bull 31:4496-4507.
    • (1983) Chem Pharm Bull , vol.31 , pp. 4496-4507
    • Takayama, K.1    Nambu, N.2    Nagai, T.3
  • 8
    • 0025807867 scopus 로고
    • Simultaneous optimization for several characteristics concerning percutaneous absorption and skin damage of ketoprofen hydrogels containing D-limonene
    • Takayama K, Nagai T. 1991. Simultaneous optimization for several characteristics concerning percutaneous absorption and skin damage of ketoprofen hydrogels containing D-limonene. Int J Pharm 74:115-126.
    • (1991) Int J Pharm , vol.74 , pp. 115-126
    • Takayama, K.1    Nagai, T.2
  • 9
    • 0034632938 scopus 로고    scopus 로고
    • Formula optimization of theophylline controlled-release tablet based on artificial neural networks
    • Takayama K, Morva A, Fujikawa M, Hattori Y, Obata Y, Nagai T. 2000. Formula optimization of theophylline controlled-release tablet based on artificial neural networks. J Control Release 68:175-186.
    • (2000) J Control Release , vol.68 , pp. 175-186
    • Takayama, K.1    Morva, A.2    Fujikawa, M.3    Hattori, Y.4    Obata, Y.5    Nagai, T.6
  • 10
    • 0034883684 scopus 로고    scopus 로고
    • Simultaneous optimization based on artificial neural networks in ketoprofen hydrogel formula containing O-ethyl-3-butylcyclohexanol as percutaneous absorption enhancer
    • Wu PC, Obata Y, Fujikawa M, Li CJ, Higashiyama K, Takayama K. 2001. Simultaneous optimization based on artificial neural networks in ketoprofen hydrogel formula containing O-ethyl-3-butylcyclohexanol as percutaneous absorption enhancer. J Pharm Sci 90:1004-1014.
    • (2001) J Pharm Sci , vol.90 , pp. 1004-1014
    • Wu, P.C.1    Obata, Y.2    Fujikawa, M.3    Li, C.J.4    Higashiyama, K.5    Takayama, K.6
  • 11
    • 0023470157 scopus 로고
    • Biharmonic spline interpolation of GEOS-3 and Seasat altimeter data
    • Sandwell DT. 1987. Biharmonic spline interpolation of GEOS-3 and Seasat altimeter data. Geophys Res Lett 14:139-142.
    • (1987) Geophys Res Lett , vol.14 , pp. 139-142
    • Sandwell, D.T.1
  • 12
    • 57149131810 scopus 로고    scopus 로고
    • Formulation optimization of an indomethacin-containing photocrosslinked polyacrylic acid hydrogel as an anti-inflammatory patch
    • Nishikawa M, Onuki Y, Isowa K, Takayama K. 2008. Formulation optimization of an indomethacin-containing photocrosslinked polyacrylic acid hydrogel as an anti-inflammatory patch. AAPS PharmSciTech 9:1038-1045.
    • (2008) AAPS PharmSciTech , vol.9 , pp. 1038-1045
    • Nishikawa, M.1    Onuki, Y.2    Isowa, K.3    Takayama, K.4
  • 13
    • 77956875252 scopus 로고    scopus 로고
    • A statistical approach to the development of a transdermal delivery system for ondansetron
    • Obata Y, Ashitaka Y, Kikuchi S, Isowa K, Takayama K. 2010. A statistical approach to the development of a transdermal delivery system for ondansetron. Int J Pharm 399:87-93.
    • (2010) Int J Pharm , vol.399 , pp. 87-93
    • Obata, Y.1    Ashitaka, Y.2    Kikuchi, S.3    Isowa, K.4    Takayama, K.5
  • 14
    • 2442421920 scopus 로고    scopus 로고
    • Formulation optimization of water-in-oil-water multiple emulsion for intestinal insulin delivery
    • Onuki Y, Morishita M, Takayama K. 2004. Formulation optimization of water-in-oil-water multiple emulsion for intestinal insulin delivery. J Control Release 97:91-99.
    • (2004) J Control Release , vol.97 , pp. 91-99
    • Onuki, Y.1    Morishita, M.2    Takayama, K.3
  • 15
    • 27744536387 scopus 로고    scopus 로고
    • Formulation optimization of photocrosslinked polyacrylic acid modified with 2-hydroxyethyl methacrylate hydrogel as an adhesive for a dermatological patch
    • Onuki Y, Hoshi M, Okabe H, Fujikawa M, Morishita M, Takayama K. 2005. Formulation optimization of photocrosslinked polyacrylic acid modified with 2-hydroxyethyl methacrylate hydrogel as an adhesive for a dermatological patch. J Control Release 108:331-340.
    • (2005) J Control Release , vol.108 , pp. 331-340
    • Onuki, Y.1    Hoshi, M.2    Okabe, H.3    Fujikawa, M.4    Morishita, M.5    Takayama, K.6
  • 16
    • 34147112689 scopus 로고    scopus 로고
    • Bootstrap re-sampling technique to evaluate the optimal formulation of theophylline tablets predicted by non-linear response surface method incorporating multivariate spline interpolation
    • Arai H, Suzuki T, Kaseda C, Ohyama K, Takayama K. 2007. Bootstrap re-sampling technique to evaluate the optimal formulation of theophylline tablets predicted by non-linear response surface method incorporating multivariate spline interpolation. Chem Pharm Bull 55:586-593.
    • (2007) Chem Pharm Bull , vol.55 , pp. 586-593
    • Arai, H.1    Suzuki, T.2    Kaseda, C.3    Ohyama, K.4    Takayama, K.5
  • 17
    • 66949158013 scopus 로고    scopus 로고
    • Effect of an experimental design for evaluating the nonlinear optimal formulation of theophylline tablets using a bootstrap resampling technique
    • Arai H, Suzuki T, Kaseda C, Takayama K. 2009. Effect of an experimental design for evaluating the nonlinear optimal formulation of theophylline tablets using a bootstrap resampling technique. Chem Pharm Bull 57:572-579.
    • (2009) Chem Pharm Bull , vol.57 , pp. 572-579
    • Arai, H.1    Suzuki, T.2    Kaseda, C.3    Takayama, K.4
  • 18
    • 38349141055 scopus 로고    scopus 로고
    • Evaluation of the reliability of nonlinear optimal solutions in pharmaceuticals using a bootstrap resampling technique in combination with Kohonen's self-organizing maps
    • Onuki Y, Ohyama K, Kaseda C, Arai H, Suzuki T, Takayama K. 2008. Evaluation of the reliability of nonlinear optimal solutions in pharmaceuticals using a bootstrap resampling technique in combination with Kohonen's self-organizing maps. J Pharm Sci 97:331-339.
    • (2008) J Pharm Sci , vol.97 , pp. 331-339
    • Onuki, Y.1    Ohyama, K.2    Kaseda, C.3    Arai, H.4    Suzuki, T.5    Takayama, K.6
  • 19
    • 0026530006 scopus 로고
    • Formulation optimization of sustained-release tablet of chlorpheniramine maleate by means of extreme vertices design and simultaneous optimization technique
    • Hirata M, Takayama K, Nagai T. 1992. Formulation optimization of sustained-release tablet of chlorpheniramine maleate by means of extreme vertices design and simultaneous optimization technique. Chem Pharm Bull 40:741-746.
    • (1992) Chem Pharm Bull , vol.40 , pp. 741-746
    • Hirata, M.1    Takayama, K.2    Nagai, T.3
  • 20
    • 77955056488 scopus 로고    scopus 로고
    • Role of individual test samples in optimal solutions in pharmaceuticals predicted using a nonlinear response surface method
    • Onuki Y, Kikuchi S, Yasuda A, Takayama K. 2010. Role of individual test samples in optimal solutions in pharmaceuticals predicted using a nonlinear response surface method. Int J Pharm 396:75-82.
    • (2010) Int J Pharm , vol.396 , pp. 75-82
    • Onuki, Y.1    Kikuchi, S.2    Yasuda, A.3    Takayama, K.4
  • 21
    • 67349238185 scopus 로고    scopus 로고
    • Reliability assessment for the optimal formulations of pharmaceutical products predicted by a nonlinear response surface method
    • Kikuchi S, Takayama K. 2009. Reliability assessment for the optimal formulations of pharmaceutical products predicted by a nonlinear response surface method. Int J Pharm 374:5-11.
    • (2009) Int J Pharm , vol.374 , pp. 5-11
    • Kikuchi, S.1    Takayama, K.2
  • 22
    • 15244345961 scopus 로고    scopus 로고
    • An introduction to modern nonparametric statistics
    • Boston: Duxbury Press.
    • Higgins JJ. 2003. An introduction to modern nonparametric statistics. Boston: Duxbury Press.
    • (2003)
    • Higgins, J.J.1
  • 24
    • 74849087722 scopus 로고    scopus 로고
    • A comparison of methods for the construction of confidence interval for relative risk in stratified matched-pair designs
    • Tang NS, Li HQ, Tang ML. 2010. A comparison of methods for the construction of confidence interval for relative risk in stratified matched-pair designs. Stat Med 29:46-62.
    • (2010) Stat Med , vol.29 , pp. 46-62
    • Tang, N.S.1    Li, H.Q.2    Tang, M.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.