412
B. Igne and E. W. Ciurczak
52. M. Fonteyne, J. Vercruysse, F. De Leersnyder, R. Besseling, A. Gerich, W. Oostra, J.P. Remon,
C. Vervaet, T. De Beer, Blend uniformity evaluation during continuous mixing in a twin screw
granulator by in-line NIR using a moving F-test. Anal. Chim. Acta 935, 213–223 (2016)
53. J.M. Vargas, S. Nielsen, V. Cárdenas, A. Gonzalez, E.Y. Aymat, E. Almodovar, G. Classe, Y.
Colón, E. Sanchez, R.J. Romañach, Process analytical technology in continuous manufacturing
of a commercial pharmaceutical product. Int. J. Pharm. 538(1), 167–178 (2018)
54. Y.M. Colón, M.A. Florian, D. Acevedo, R. Méndez, R.J. Romañach, Near infrared method
development for a continuous manufacturing blending process. J. Pharm. Innov. 9(4), 291–301
(2014)
55. Y. Liu, D. Blackwood, Sample presentation in rotary tablet press feed frame monitoring by
near infrared spectroscopy. Am. Pharm. Rev. (2012)
56. P. Frake, D. Greenhalgh, S.M. Grierson, J.M. Hempenstall, D.R. Rudd, Process control and
end-point determination of a fluid bed granulation by application of near infra-red spectroscopy.
Int. J. Pharm. 151(1), 75–80 (1997)
57. W. Li, J. Cunningham, H. Rasmussen, D. Winstead, A qualitative method for monitoring
of nucleation and granule growth in fluid bed wet granulation by reflectance near-infrared
spectroscopy. J. Pharm. Sci. 96(12), 3470–3477 (2007)
58. A.C. Jorgensen, P. Luukkonen, J. Rantanen, T. Schaefer, A.M. Juppo, J. Yliruusi, Comparison
of torque measurements and near-infrared spectroscopy in characterization of a wet granulation
process. J. Pharm. Sci. 93(9), 2232–2243 (2004)
59. A. Peinado, J. Hammond, A. Scott, Development, validation and transfer of a Near Infrared
method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product. J. Pharm. Biomed. Anal.
54(1), 13–20 (2011)
60. M. Alcalà, M. Blanco, M. Bautista, J.M. González, On-line monitoring of a granulation process
by NIR spectroscopy. J. Pharm. Sci. 99(1), 336–345 (2010)
61. J. Vercruysse, M. Toiviainen, M. Fonteyne, N. Helkimo, J. Ketolainen, M. Juuti, U. Delaet,
I. Van Assche, J.P. Remon, C. Vervaet, T. De Beer, Visualization and understanding of the
granulation liquid mixing and distribution during continuous twin screw granulation using
NIR chemical imaging. Eur. J. Pharm. Biopharm. 86(3), 383–392 (2014)
62. R.W. Miller, K.R. Morris, A.G., Roller compaction scale-up, in Pharmaceutical Process ScaleUp, 2nd Ed., ed. by M.Levin (Taylor and Francis, Boca Raton, 2006), pp. 237–266
63. B. Smith-Goettler, C.M. Gendron, R.F. Meyer, Understanding hot melt extrusion via near
infrared spectroscopy. NIR News 25(7), 10–12 (2014)
64. D.J. Goodwin, S. van den Ban, M. Denham, I. Barylski, Real time release testing of tablet
content and content uniformity. Int. J. Pharm. 537(1–2), 183–192 (2018)
65. M. Boiret, F. Chauchard, Use of near-infrared spectroscopy and multipoint measurements for
quality control of pharmaceutical drug products. Anal. Bioanal. Chem. 409(3), 683–691 (2017)
66. J. Luypaert, D.L. Massart, Y. Vander Heyden, Near-infrared spectroscopy applications in
pharmaceutical analysis. Talanta 72(3), 865–883 (2007)
67. M. Blanco, M.A. Romero, Near-infrared libraries in the pharmaceutical industry: a solution
for identity confirmation. Analyst 126(12), 2212–2217 (2001)
68. A.O. Kirdar, G. Chen, J. Weidner, A.S. Rathore, Application of near-infrared (NIR) spectroscopy for screening of raw materials used in the cell culture medium for the production of
a recombinant therapeutic protein. Biotechnol. Prog. 26(2), 527–531 (2010)
69. B. Krakowska, D. Custers, E. Deconinck, M. Daszykowski, Chemometrics and the identification of counterfeit medicines—a review. J. Pharm. Biomed. Anal. 127, 112–122 (2016)
B. Igne and E. W. Ciurczak
52. M. Fonteyne, J. Vercruysse, F. De Leersnyder, R. Besseling, A. Gerich, W. Oostra, J.P. Remon,
C. Vervaet, T. De Beer, Blend uniformity evaluation during continuous mixing in a twin screw
granulator by in-line NIR using a moving F-test. Anal. Chim. Acta 935, 213–223 (2016)
53. J.M. Vargas, S. Nielsen, V. Cárdenas, A. Gonzalez, E.Y. Aymat, E. Almodovar, G. Classe, Y.
Colón, E. Sanchez, R.J. Romañach, Process analytical technology in continuous manufacturing
of a commercial pharmaceutical product. Int. J. Pharm. 538(1), 167–178 (2018)
54. Y.M. Colón, M.A. Florian, D. Acevedo, R. Méndez, R.J. Romañach, Near infrared method
development for a continuous manufacturing blending process. J. Pharm. Innov. 9(4), 291–301
(2014)
55. Y. Liu, D. Blackwood, Sample presentation in rotary tablet press feed frame monitoring by
near infrared spectroscopy. Am. Pharm. Rev. (2012)
56. P. Frake, D. Greenhalgh, S.M. Grierson, J.M. Hempenstall, D.R. Rudd, Process control and
end-point determination of a fluid bed granulation by application of near infra-red spectroscopy.
Int. J. Pharm. 151(1), 75–80 (1997)
57. W. Li, J. Cunningham, H. Rasmussen, D. Winstead, A qualitative method for monitoring
of nucleation and granule growth in fluid bed wet granulation by reflectance near-infrared
spectroscopy. J. Pharm. Sci. 96(12), 3470–3477 (2007)
58. A.C. Jorgensen, P. Luukkonen, J. Rantanen, T. Schaefer, A.M. Juppo, J. Yliruusi, Comparison
of torque measurements and near-infrared spectroscopy in characterization of a wet granulation
process. J. Pharm. Sci. 93(9), 2232–2243 (2004)
59. A. Peinado, J. Hammond, A. Scott, Development, validation and transfer of a Near Infrared
method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product. J. Pharm. Biomed. Anal.
54(1), 13–20 (2011)
60. M. Alcalà, M. Blanco, M. Bautista, J.M. González, On-line monitoring of a granulation process
by NIR spectroscopy. J. Pharm. Sci. 99(1), 336–345 (2010)
61. J. Vercruysse, M. Toiviainen, M. Fonteyne, N. Helkimo, J. Ketolainen, M. Juuti, U. Delaet,
I. Van Assche, J.P. Remon, C. Vervaet, T. De Beer, Visualization and understanding of the
granulation liquid mixing and distribution during continuous twin screw granulation using
NIR chemical imaging. Eur. J. Pharm. Biopharm. 86(3), 383–392 (2014)
62. R.W. Miller, K.R. Morris, A.G., Roller compaction scale-up, in Pharmaceutical Process ScaleUp, 2nd Ed., ed. by M.Levin (Taylor and Francis, Boca Raton, 2006), pp. 237–266
63. B. Smith-Goettler, C.M. Gendron, R.F. Meyer, Understanding hot melt extrusion via near
infrared spectroscopy. NIR News 25(7), 10–12 (2014)
64. D.J. Goodwin, S. van den Ban, M. Denham, I. Barylski, Real time release testing of tablet
content and content uniformity. Int. J. Pharm. 537(1–2), 183–192 (2018)
65. M. Boiret, F. Chauchard, Use of near-infrared spectroscopy and multipoint measurements for
quality control of pharmaceutical drug products. Anal. Bioanal. Chem. 409(3), 683–691 (2017)
66. J. Luypaert, D.L. Massart, Y. Vander Heyden, Near-infrared spectroscopy applications in
pharmaceutical analysis. Talanta 72(3), 865–883 (2007)
67. M. Blanco, M.A. Romero, Near-infrared libraries in the pharmaceutical industry: a solution
for identity confirmation. Analyst 126(12), 2212–2217 (2001)
68. A.O. Kirdar, G. Chen, J. Weidner, A.S. Rathore, Application of near-infrared (NIR) spectroscopy for screening of raw materials used in the cell culture medium for the production of
a recombinant therapeutic protein. Biotechnol. Prog. 26(2), 527–531 (2010)
69. B. Krakowska, D. Custers, E. Deconinck, M. Daszykowski, Chemometrics and the identification of counterfeit medicines—a review. J. Pharm. Biomed. Anal. 127, 112–122 (2016)