References
- Food and Drug Administration. 2003. Final report on pharmaceutical cGMPs for the 21st century—A risk-based approach.
- Yu LX. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharm Res 2008;25:781–791.
- Moreton C. Functionality and performance of excipients in a quality-by-design world part 2: Excipient variability, QbD, and robust formulations. American Pharm Rev 2009;12:40–45.
- Belic A, Skrjanc I, Bozic DZ, Vrecer F. Tableting process optimisation with the application of fuzzy models. Int J Pharm 2010;389:86–93.
- Huang J, Kaul G, Cai C, Chatlapalli R, Hernandez-Abad P, Ghosh K et al. Quality by design case study: An integrated multivariate approach to drug product and process development. Int J Pharm 2009;382:23–32.
- Verma S, Lan Y, Gokhale R, Burgess DJ. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm 2009;377:185–198.
- Wu H, Khan MA. Quality-by-design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point. J Pharm Sci 2009;98:2784–2798.
- Rafati H, Talebpour Z, Adlnasab L, Ebrahimi SN. Quality by design: Optimization of a liquid filled pH-responsive macroparticles using Draper-Lin composite design. J Pharm Sci 2009;98:2401–2411.
- Wu H, Tawakkul M, White M, Khan MA. Quality-by-design (QbD): An integrated multivariate approach for the component quantification in powder blends. Int J Pharm 2009;372:39–48.
- Maltesen MJ, Bjerregaard S, Hovgaard L, Havelund S, van de Weert M. Quality by design - Spray drying of insulin intended for inhalation. Eur J Pharm Biopharm 2008;70:828–838.
- Zidan AS, Sammour OA, Hammad MA, Megrab NA, Habib MJ, Khan MA. Quality by design: Understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function. Int J Pharm 2007;332:55–63.
- Rahman Z, Zidan AS, Habib MJ, Khan MA. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm 2010;389:186–194.
- L’Hote-Gaston J, Schmitt R, Li Y, Karas C. Using polyethylene oxide blends to assess the effect of excipient variability: In formulation development of hydrophilic extended-release matrix tablets. Pharm Tech 2009;33:36–41.
- Doelker E, Mordier D, Iten H, Humbert-Droz P. Comparative tableting properties of sixteen microcrystalline celluloses. Drug Dev Ind Pharm 1987;13:1847–1875.
- Williams RO, Sriwongjanya M, Barron MK. Compaction Properties of microcrystalline cellulose using tableting indices. Drug Dev Ind Pharm 1997;23:695–704.
- Pérez-Marcos B, Martínez-Pacheco R, Gómez-Amoza JL, Suoto C, Concheiro A, Rowe RC. Interlot variability of carbomer 934. Int J Pharm 1993;100:207–212.
- Alvarez-Lorenzo C, Castro E, Gómez-Amoza JL, Martínez-Pacheco R, Souto C, Concheiro A. Intersupplier and interlot variability in hydroxypropyl celluloses: Implications for theophylline release from matrix tablets. Pharma Acta Helv 1998;73:113–120.
- Gabrielsson J, Sjöström M, Lindberg NO, Pihl AC, Lundstedt T. Robustness testing of a tablet formulation using multivariate design. Drug Dev Ind Pharm 2006;32:297–307.
- Kushner J IV, Langdon BA, Hiller JI, Carlson GT. Examining the impact of excipient material property variation on drug product quality attributes: a quality-by-design study for a roller compacted, immediate release tablet. J Pharm Sci 2011;100:2222–2239.
- García-Muñoz S. Establishing multivariate specifications for incoming materials using data from multiple scales. Chemom Intell Las Syst 2009;98:51–57.