第一章
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第二章
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第三章
[1] ICH Expert Working Group, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8, Revision 2, 2009.
[2] U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry, PAT – A framework for innovative pharmaceutical development, manufacturing, and quality assurance, 2004.
[3] M. Fujiwara, W. Momose, K. Kuroda, T. Inatani, K. Yamashita, K. Sako, Proportional control of moisture content of granules by adjusting inlet air temperature in fluidized bed granulation using near-infrared spectroscopy, Adv. Powder Technol. 25 (2014) 704–709.
[4] H. Nakagawa, Y. Kikkawa, K. Matsuura, S. Tanabe, T. Watanabe, Implementation of enhanced QbD to drug product development, J. Jpn. Soc. Pharm. Mach. Eng. 24 (2015) 469–475.
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[16] P.A. Wauters, B. Scarlett, L.X. Liu, J.D. Litster, G.M. Meesters, A population balance model for high shear granulation, Chem. Eng. Commun. 190 (2003) 1309–1334.
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第四章
[1] ICH Expert Working Group, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8, Revision 2, 2009.
[2] K. Hayashi, S. Watano, Novel population balance model for granule aggregation and breakage in fluidized bed granulation and drying, Powder Technol. 342 (2019) 664–675.
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第五章
[1] D. Barrasso, A. El Hagrasy, J.D. Litster, R. Ramachandran, Multi-dimensional population balance model development and validation for a twin screw granulation process, Powder Technol. 270 (2015) 612–621.
[2] N. Metta, M. Verstraeten, M. Ghijs, A. Kumar, E. Schafer, R. Singh, T.D. Beer, I. Nopens, P. Cappuyns, I.V. Assche, M. Ierapetritou, R. Ramachandran, Model development and prediction of particle size distribution, density and friability of a comilling operation in a continuous pharmaceutical manufacturing process., Int. J. Pharmaceutics, 549 (2018) 271–282.
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[12] N. Ouchiyama, T. Tanaka, The probability of coalescence in granulation kinetics, Ind. Eng. Chem. Process Des. Develop. 14 (1975) 286–289.
[13] N. Ouchiyama, T. Tanaka, Kinetic analysis of continuous pan granulation. Possible explanations for conflicting experiments and several indications for practice, Ind. Eng. Chem. Process Des. Develop. 20 (1981) 340–348.
[14] S. Watano, T. Morikawa, K. Miyanami, Mathematical model in the kinetics of agitation fluidized bed granulation. Effects of moisture content, damping speed and operation time on granule growth rate, Chem. Pharm. Bull. 44 (1996) 409–415.
[15] A.A. Adetayo, J.D. Litster, S.E. Pratsinis, B. J. Ennis, Population balance modelling of drum granulation of materials with wide size distribution, Powder Technol. 82 (1995) 37–49.
[16] C. Biggs, R. Boerefijin, M. Buscan, A. Salman, M. Holunslow, Fluidised bed granulation: modelling the growth and breakage kinetics using population balances, Proc. World Congress on Particle Technol., Sydney (2002) 629–636.
[17] H. Liu, T. O’Connor, S. Lee, S. Yoon, A process optimization strategy of a pulsed-spray fluidized bed granulation process based on predictive three-stage population balance model, Powder Technol. 327 (2018) 188–200.
[18] H. Liu, S.C. Galbraith, S.-Y. Park, B. Cha, Z. Huang, R.F. Meyer, M.H. Flamm, T. O’Connor, S. Lee, S. Yoon, Development of a three-compartmental population balance model for a continuous twin screw wet granulation process, Pharm. Dev. Technol. 7450 (2018) 1–39.
[19] D. Barrasso, A. El Hagrasy, J.D. Litster, R. Ramachandran, Multi-dimensional population balance model development and validation for a twin screw granulation process, Powder Technol. 270 (2015) 612–621.
[20] J.A. Gantt, I.T. Cameron, J.D. Litster, E.P. Gatzke, Determination of coalescence kernels for highshear granulation using DEM simulations, Powder Technol. 170 (2006) 53–63.
[21] M. Sen, D. Barrasso, R. Singh, R. Ramachandran, A multi-scale hybrid CFD-DEM-PBM description of a fluid-bed granulation process, Processes 2 (2014) 89–111.
[22] D. Barrasso, T. Eppinger, F.E. Pereira, R. Aglave, K. Debus, S.K. Bermingham, R. Ramachandran, A multi-scale, mechanistic model of a wet granulation process using a novel bi-directional PBMDEM coupling algorithm, Chem. Eng. Sci. 123 (2015) 500–513.
[23] K. Hayashi, S. Watano, Novel population balance model for granule aggregation and breakage in fluidized bed granulation and drying, Powder Technol. 342 (2019) 664–675.
[24] K. Hayashi, S. Watano, Investigation of fluidized bed granulation mechanism by using an online particle size monitoring device, J. Soc. Powder Technol. Jpn. 55 (2018) 316–323.
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[28] M.J. Hounslow, J.M.K. Pearson, T. Instone, Tracer studies of high ‐ shear granulation: II. Population balance modeling, AIChE J. 47 (2001) 1984–1999.
[29] P.C. Kapur, D.W. Fuerstenau, Coalescence model for granulation, Ind. Eng. Chem. Proc. Design Dev. 8 (1969) 56–62.
[30] D. Eyre, R.C. Everson, Q.P. Campbell. New parameterization for a discrete batch grinding equation, Powder Technol. 98 (1998) 265–272.
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