References
- ICH guideline. (2009). Pharmaceutical Development Q8 (R2).
- Huang J, Kaul G, Cai C, Chatlapalli R, Hernandez-Abad P, Ghosh K et al. (2009). Quality by design case study: an integrated multivariate approach to drug product and process development. Int J Pharm, 382:23–32.
- Lewis GA, Mathieu D, Phan-Tan-Luu R. (1999). Pharmaceutical Experimental Design. Marcel Dekker, New York.
- Montgomery DC. (1997). Design and Analysis of Experiments. Wiley, New York.
- AlKhatib HS, Sakr A. (2003). Optimization of methacrylic acid ester copolymers blends as controlled release coatings using response surface methodology. Pharm Dev Technol, 8:87–96.
- Huang YB, Tsai 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.
- Marengo E, Cavalli R, Rovero G, Gasco MR. (2003). Scale-up and optimization of an evaporative drying process applied to aqueous dispersions of solid lipid nanoparticles. Pharm Dev Technol, 8:299–309.
- Matsumura M, Nakagami H, Yamao T, Takayama K, Nagai T. (1994). Computer optimization for the formulation of controlled-release theophylline tablet made of micronized low-substituted hydroxypropylcellulose and methylcellulose. Chem Pharm Bull, 42:1902–1908.
- Paterakis PG, Korakianiti ES, Dallas PP, Rekkas DM. (2002). Evaluation and simultaneous optimization of some pellets characteristics using a 3(3) factorial design and the desirability function. Int J Pharm, 248:51–60.
- Rekhi GS, Nellore RV, Hussain AS, Tillman LG, Malinowski HJ, Augsburger LL. (1999). Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets. J Control Release, 59:327–342.
- Vojnovic D, Chicco D, Zenary HE. (1996). Doehlert experimental design applied to optimization and quality control of a granulation process in a high shear mixer. Int J Pharm, 145:203–213.
- Ogawa S, Kamijima T, Miyamoto Y, Miyajima M, Sato H, Takayama K et al. (1994). A new attempt to solve the scale-up problem for granulation using response surface methodology. J Pharm Sci, 83:439–443.
- Takagaki K, Arai H, Takayama K. (2010). Creation of a tablet database containing several active ingredients and prediction of their pharmaceutical characteristics based on ensemble artificial neural networks. J Pharm Sci, 99:4201–4214.
- 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.
- Takayama K, Obata Y, Morishita M, Nagai T. (2004). Multivariate spline interpolation as a novel method to optimize pharmaceutical formulations. Pharmazie, 59:392–395.
- 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.
- 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.
- 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.
- Arai H, Suzuki T, Yada S, Kaseda C, Onuki Y, Takayama K. (2011). Reliability evaluation of the design space of the granulation process of mefenamic acid tablets using a bootstrap resampling technique. Chem Pharm Bull, 59:608–617.
- Brone D, Alexander A, Muzzio FJ. (1988). Quantitative characterization of mixing of dry powders in V-blenders. AIChE J, 44:271–278.
- Horsthuis GJB, van Laarhoven JAH, van Rooij RCBM, Vromans H. (1993). Studies on upscaling parameters of the Gral high shear granulation process. Int J Pharm, 92:143–150.
- Leuenberger H, Luy B, Studer J. (1990). New development in the control of a moist agglomeration and pelletization process. STP Pharm Sci, 6:303–309.
- Peterson JJ. (2008). A Bayesian approach to the ICH Q8 definition of design space. J Biopharm Stat, 18:959–975.
- Lindley DV. (1965). Introduction to probability and statistics from a Bayesian viewpoint, Part 2. Inference. Cambridge University Press, Cambridge.
- ISTM international. (2010). Manual on Presentation of Data and Control Chart Analysis: 8th Edition. America.