References
- Patel S, Dahiya S, Calvin Sun C, Bansal AK. Understanding size enlargement and hardening of granules on tabletability of unlubricated granules prepared by dry granulation. J Pharm Sci 2011;100:758–6
- Horisawa E, Komura A, Danjo K, Otsuka A. Effect of granule strength on compressed tablet strength. Chem Pharm Bull 1995;43:2261–3
- Limin S, Yushi F, Changquan CS. Massing in high shear wet granulation can simultaneously improve powder flow and deteriorate powder compaction: a double-edged sword. Eur J Pharm Sci 2011;43:50–6
- Steven HC, Steve SYW, Chiajen L, John G. A new perspective on the mechanical evaluation of granular material. Drug Dev Ind Pharm 2013;39:1126–32
- Gena D, Ewa N, Feng Z, et al. Assessment of granulation technologies for an API with poor physical properties. Drug Dev Ind Pharm 2013;39:985–95
- Joe MV, Jan HS, Andries FM, Awie FK. Effect of moisture content, temperature and exposure time on the physical stability of chitosan powder and tablets. Drug Dev Ind Pharm 2014;40:730–42
- Logan R, Briens L. Investigation of the effect of impeller speed on granules formed using a PMA-1 high shear granulator. Drug Dev Ind Pharm 2012;38:1394–404
- Ogawa T, Uchino T, Takahashi D, et al. Pharmaceutical production of tableting granules in an ultra-small-scale high-shear granulator as a pre-formulation study. Drug Dev Ind Pharm 2012;38:1390–3
- Rutesh HD, Stephen HW, Labdhi DC. To determine the end point of wet granulation by measuring powder energies and thermal properties. Drug Dev Ind Pharm 2012;38:439–46
- ICH Guideline. (2009). Pharmaceutical Development Q8 (R2)
- ICH Guideline. (2005). Quality Risk Management Q9
- ICH Guideline. (2008). Pharmaceutical Quality System Q10
- Huang J, Kaul G, Cai CS, et al. Quality by design case study: an integrated multivariate approach to drug product and process development. Int J Pharm 2009;382:23–32
- Hayashi Y, Kikuchi S, Onuki Y, Takayama K. Reliability evaluation of nonlinear design space in pharmaceutical product development. J Pharm Sci 2012;101:333–41
- Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 2008;25:781–91
- Maeda J, Suzuki T, Takayama K. Novel method to construct large-scale design space in lubrication process utilizing Bayesian estimation based on a small-scale design-of-experiment and small sets of large-scale manufacturing data. Drug Dev Ind Pharm 2012;38:1451–9
- Kishore R, Krishna S, Praveen KV, et al. Optimization and characterization of gastroretentive floating drug delivery system using Box-Behnken design. Drug Dev Ind Pharm 2013;39:1928–35
- Anna VC, Francisco FC, Alfonso DP, Ana CCC. Pharmaceutical design of a new lactose-free coprocessed excipient: application of hydrochlorothiazide as a low solubility drug model. Drug Dev Ind Pharm 2013;39:961–9
- Erin MH, Lauren B, Amyn S, Joe ABM. The effect of process parameters on audible acoustic emissions from high-shear granulation. Drug Dev Ind Pharm 2013;39:331–41
- Amélie D, Bruno P, Joël B, et al. Extruder scale-up assessment in the process of extrusion spheronization: comparison of radial and axial systems by a design of experiments approach. Drug Dev Ind Pharm 2013;39:176–85
- Obata Y, Ashitaka Y, Kikuchi S, et al. A statistical approach to the development of a transdermal delivery system for ondansetron. Int J Pharm 2010;399:87–93
- Onuki Y, Morishita M, Takayama K. Formulation optimization of water-in-oil-water multiple emulsion for intestinal insulin delivery. J Control Release 2004;97:91–9
- Kikuchi S, Takayama K. Reliability assessment for the optimal formulations of pharmaceutical products predicted by a nonlinear response surface method. Int J Pharm 2009;374:5–11
- Onuki Y, Ohyama K, Kaseda C, et al. 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 2008;97:331–9
- Arai H, Suzuki T, Tada S, et al. Reliability evaluation of the design space of the granulation process of mefenamic acid tablets using a bootstrap resampling technique. Chem Pharm Bull 2011;59:608–17
- Cooper GF, Herskovits E. A Bayesian method for the induction of probabilistic networks from data. Mach Learn 1992;9:309–47
- Kikuchi S, Onuki Y, Yasuda A, et al. Latent structure analysis in pharmaceutical formulations using Kohonen's self-organizing map and a Bayesian network. J Pharm Sci 2011;100:964–75
- Wilson WI, Peng Y, Augsburger LL. Comparison of statistical analysis and Bayesian networks in the evaluation of dissolution performance of BCS Class II model drugs. J Pharm Sci 2005;94:2764–76
- Hayashi Y, Kikuchi S, Takayama K. Modeling of latent structure of indomethacin solid dispersion tablet using Bayesian networks. Drug Dev Ind Pharm 2011;37:1290–7
- Jansen R, Yu H, Greenbaum D, et al. A Bayesian networks approach for predicting protein–protein interactions from genomic data. Science 2003;302:449–53
- Hayashi Y, Oshima E, Takayama K. Latent structure analysis of the process variables and pharmaceutical responses of an orally disintegrating tablet. Chem Pharm Bull 2012;60:1419–25
- Hirata M, Takayama K, Nagai T. Formulation optimization of sustained-release tablet of chlorpheniramine maleate by means of extreme vertices design and simultaneous optimization technique. Chem Pharm Bull 1992;40:741–6
- Motomura Y. Predictive modeling of everyday behavior from large-scale data. Synthesiology 2009;2:1–11
- Bothtner U, Milne SE, Kenny GN, et al. Bayesian probabilistic network modeling of remifentanil and propofol interaction on wakeup time after closed-loop controlled anesthesia. J Clin Monit Comput 2002;17:31–6