References
- Pitt B, Konstam MA. Overview of angiotensin II-receptor antagonists. Am J Cardiol. 1998;82:S47–S49.
- Sekar V, Chellan VR. Immediate release tablets of telmisartan using superdisintegrant-formulation, evaluation and stability studies. Chem Pharm Bull. 2008;56:575–577.
- Tran PHL, Tran HTT, Lee B-J. Modulation of microenvironmental pH and crystallinity of ionizable telmisartan using alkalizers in solid dispersions for controlled release. J Control Release. 2008;129:59–65.
- Cho KH, Choi H-G. Development of novel bepotastine salicylate salt bioequivalent to the commercial bepotastine besilate in beagle dogs. Drug Dev Ind Pharm. 2013;39:901–908.
- Kim J-e, Park Y-J. Paclitaxel-loaded hyaluronan solid nanoemulsions for enhanced treatment efficacy in ovarian cancer. IJN. 2017;12:645.
- Kim J-E, Park Y-J. High paclitaxel-loaded and tumor cell-targeting hyaluronan-coated nanoemulsions. Colloids Surfaces B Biointerf. 2017;150:362–372.
- Kalepu S, Nekkanti V. Insoluble drug delivery strategies: review of recent advances and business prospects. Acta Pharmaceutica Sinica B. 2015;5:442–453.
- Guideline IHT. Pharmaceutical development. Q8 (2R) As revised in August. 2009.
- Visser JC, Dohmen WM, Hinrichs WL, et al. Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films. Int J Pharm. 2015;485:70–76.
- Juran JM. Juran on quality by design: the new steps for planning quality into goods and services. New York, USA: Simon and Schuster; 1992.
- Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009;27:26–34.
- McKenzie P, Kiang S, Tom J, et al. Can pharmaceutical process development become high tech? AIChE J. 2006;52:3990–3994.
- Rahman Z, Zidan AS, Habib MJ, et al. Understanding the quality of protein loaded PLGA nanoparticles variability by Plackett-Burman design. Int J Pharm. 2010;389:186–194.
- Salazar J, Heinzerling O, Müller RH, et al. Process optimization of a novel production method for nanosuspensions using design of experiments (DoE). Int J Pharm. 2011;420:395–403.
- Wu H, White M, Khan MA. Quality-by-Design (QbD): an integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development. Int J Pharm. 2011;405:63–78.
- Lawrence XY. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res. 2008;25:781–791.
- Zidan AS, Sammour OA, Hammad MA, et al. 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.
- Lee Y-L, Kim M-S, Park M-Y, et al. Quality by design: understanding the formulation variables and optimization of metformin hydrochloride 750 mg sustained release tablet by Box–Behnken design. J Pharm Invest. 2012;42:213–220.
- Park S-J, Choo G-H, Hwang S-J, et al. Quality by design: screening of critical variables and formulation optimization of Eudragit E nanoparticles containing dutasteride. Arch Pharm Res. 2013;36:593–601.
- Rausand M. Preliminary hazard analysis. Trondheim, Gjøvik, Ålesund (Norway): Norwegian University of Science and Technology; 2005.
- Stamatis DH. Failure mode and effect analysis: FMEA from theory to execution. Milwaukee (WI): ASQ Quality Press; 2003.
- Guideline IHT. Quality risk management. Q9, Current Step 2005;4:408.
- Hakemeyer C, McKnight N, John RS, et al. Process characterization and design space definition. Biologicals. 2016;44:306–318.
- Kaljević O, Djuriš J, Djurić Z, et al. Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets. J Drug Deliv Sci Technol. 2016;32:56–63.
- Rathore AS. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009;27:546–553.