Quality by design (QbD) approaches in current pharmaceutical set-up

References

• Juran JM. Juran on quality by design: the new steps for planning quality into goods and services. New York (NY): Simon and Schuster; 1992.
   Google Scholar
• Woodcock J. The concept of pharmaceutical quality. Am Pharm Rev. 2004;7(6):10–15.
   Google Scholar
• Awotwe-Otoo D, Agarabi C, Wu GK, et al. Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody. Int J Pharm. 2012;438(1):167–175.
   PubMedGoogle Scholar
• Charoo NA, Shamsher AA, Zidan AS, et al. Quality by design approach for formulation development: A case study of dispersible tablets. Int J Pharm. 2012;423(2):167–178.
   PubMedGoogle Scholar
• 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(5):593–601.
   PubMed Web of Science ®Google Scholar
• Verma S, Lan Y, Gokhale R, et al. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm. 2009;377(1):185–198.
   PubMedGoogle Scholar
• Group IEW, editor ICH Harmonized tripartite guideline. Pharmaceutical development Q8 (R2). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2009.
   Google Scholar
• Li Z, Cho BR, Melloy BJ. Quality by design studies on multi-response pharmaceutical formulation modeling and optimization. J Pharm Innov. 2013;8(1):28–44.
   Web of Science ®Google Scholar
• Elder D, Teasdale A. ICH Q9 quality risk management. In: Teasdale A, Elder D, Nims RM, editors. ICH quality guidelines: an implementation guide. Hoboken, NJ, USA: John Wiley & Sons, Inc.; 2017. p. 579–610.
   Google Scholar
• Pogány J. ICH pharmaceutical quality system Q10. WHO Drug Information. 2008;22(3):177–181.
   Google Scholar
• Guideline ICH. Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Q11. London,  United Kingdom: European medicines agency; 2011.
   Google Scholar
• Lowenborg M. Quality-by-design: the good, the bad, the inevitable: drug development & delivery; 2014 [cited 2018 Jan 23] Available from: http://www.drug-dev.com/Main/Back-Issues/QUALITYBYDESIGN-QualitybyDesign-The-Good-The-Bad-T-768.aspx
   Google Scholar
• Sangshetti JN, Deshpande M, Zaheer Z, et al. Quality by design approach: regulatory need. Arab J Chem. 2014;10(Suppl. 2):S3412–S3425.
   Google Scholar
• Plackett RL, Burman JP. The design of optimum multifactorial experiments. Biometrika. 1946;33(4):305–325.
   Web of Science ®Google Scholar
• Zhang L, Mao S. Application of quality by design in the current drug development. Asian J Pharm Sci. 2017;12(1):1–8.
   PubMed Web of Science ®Google Scholar
• Box GEP, Wilson KB. On the experimental attainment of optimum conditions. In: Kotz S, Johnson NL, editors. Breakthroughs in statistics: methodology and distribution. New York, NY: Springer New York; 1992. p. 270–310.
   Google Scholar
• Collins A. Toward a design science of education. New directions in educational technology. NATO ASI series. Vol. 96. Berlin, Heidelberg: Springer Berlin Heidelberg; 1992. p. 15–22.
   Google Scholar
• Yang Y. Multiple criteria third-order response surface design and comparison. Florida: Florida State University; 2008.
   Google Scholar
• Box-Behnken designs: NIST/SEMATECH; 2003 [cited 2018 Jan 23]. Available from: http://www.itl.nist.gov/div898/handbook/pri/section3/pri3362.htm
   Google Scholar
• Box GEP, Hunter WG, Hunter JS. Statistics for experimenters: an introduction to design, data analysis, and model building. Illustrated ed. Vol. 154. US: Wiley (Wiley Series in Probability and Statistics); 1978.
   Google Scholar
• Araujo PW, Brereton RG. Experimental design II. Optimization. TrAC Trends Anal Chem. 1996;15(2):63–70.
   Web of Science ®Google Scholar
• Doornbos DA, De Haan P. Optimization techniques in formulation and processing. In: Swarbrick J, Jc B, editors. Encyclopedia of pharmaceutical technology. Vol. 20. Suppl. 3. New York (NY): Marcel Dekker, Inc.; 2001. p. 77–160.
   Google Scholar
• Pinto J, Podczeck F, Newton J. Investigations of tablets prepared from pellets produced by extrusion and spheronisation. II. Modelling the properties of the tablets produced using regression analysis. Int J Pharm. 1997;152(1):7–16.
   Google Scholar
• Podczeck F. The development and optimization of tablet formulations using mathematical methods. In: Alderborn G, Nyström C, editors. Pharmaceutical powder compaction technology. New York (NY): Informa HealthCare; 1996. p. 561–593.
   Google Scholar
• Chatchawalsaisin J, Podczeck F, Newton JM. The influence of chitosan and sodium alginate and formulation variables on the formation and drug release from pellets prepared by extrusion/spheronisation. Int J Pharm. 2004;275(1):41–60.
   PubMedGoogle Scholar
• Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical experimental design. New York (NY): CRC Press; 1998.
   Google Scholar
• Scheffé H. Experiments with mixtures. J Roy Stat Soc Series B (Methodol). 1958;2(2):344–360.
   Google Scholar
• Taguchi G, Ap O. Introduction to quality engineering: designing quality into products and processes. Unipub/Quality Resources; 1986.
   Google Scholar
• Lewis G. Non classical experimental designs in pharmaceutical formulation. Drug Dev Ind Pharm. 1991;17(12):1551–1570.
   Web of Science ®Google Scholar
• Wehrlé P, Palmieri G, The Taguchi’s SA. performance statistic to optimize theophylline beads production in a high-speed granulator. Drug Dev Ind Pharm. 1994;20(18):2823–2843.
   Web of Science ®Google Scholar
• Chariot M, Lewis G, Mathieu D, et al. Experimental design for pharmaceutical process characterisation and optimisation using an exchange algorithm. Drug Dev Ind Pharm. 1988;14(15–17):2535–2556.
   Web of Science ®Google Scholar
• Nielloud F, Mestres JP, Fortuné R, et al. Formulation of oil in water submicron emulsions in the dermatological field using experimental design. Polym Int. 2003;52(4):610–613.
   Web of Science ®Google Scholar
• Rechtschaffner R. Saturated fractions of 2n and 3n factorial designs. Technometrics. 1967;9(4):569–575.
   Web of Science ®Google Scholar
• Dholariya YN, Bansod YB, Vora RM, et al. Design and optimization of bilayered tablet of Hydrochlorothiazide using the Quality-by-Design approach. Int J Pharm Investig. 2014;4(2):93–101.
   PubMedGoogle Scholar
• Singh B, Garg B, Bhatowa R, et al. Systematic development of a gastroretentive fixed dose combination of lamivudine and zidovudine for increased patient compliance. J Drug Deliv Sci Technol. 2017;37:204–215.
   Web of Science ®Google Scholar
• Stegemann S, Connolly P, Matthews W, et al. Application of QbD principles for the evaluation of empty hard capsules as an input parameter in formulation development and manufacturing. AAPS PharmSciTech. 2014;15(3):542–549.
   PubMed Web of Science ®Google Scholar
• L Bruschi M. Development of drug delivery systems and quality by design. Recent Pat Drug Deliv Formul. 2015;9(2):105.
   PubMedGoogle Scholar
• Atobe K, Ishida T, Ishida E, et al. In vitro efficacy of a sterically stabilized immunoliposomes targeted to membrane type 1 matrix metalloproteinase (MT1-MMP). Biol Pharm Bull. 2007;30(5):972–978.
   PubMed Web of Science ®Google Scholar
• Qin Y, Fan W, Chen H, et al. In vitro and in vivo investigation of glucose-mediated brain-targeting liposomes. J Drug Target. 2010;18(7):536–549.
   PubMed Web of Science ®Google Scholar
• Patel GM, Shelat PK, Lalwani AN. QbD based development of proliposome of lopinavir for improved oral bioavailability. Eur J Pharm Sci. 2016;108:50–61.
   PubMed Web of Science ®Google Scholar
• Pandey AP, Karande KP, Sonawane RO, et al. Applying quality by design (QbD) concept for fabrication of chitosan coated nanoliposomes. J Liposome Res. 2014;24(1):37–52.
   PubMed Web of Science ®Google Scholar
• Yerlikaya F, Ozgen A, Vural I, et al. Development and evaluation of paclitaxel nanoparticles using a quality‐by‐design approach. J Pharm Sci. 2013;102(10):3748–3761.
   PubMed Web of Science ®Google Scholar
• Girotra P, Singh SK, Kumar G. Development of zolmitriptan loaded PLGA/poloxamer nanoparticles for migraine using quality by design approach. Int J Biol Macromol. 2016;85:92–101.
   PubMed Web of Science ®Google Scholar
• Shah B, Khunt D, Bhatt H, et al. Application of quality by design approach for intranasal delivery of rivastigmine loaded solid lipid nanoparticles: effect on formulation and characterization parameters. Eur J Pharm Sci. 2015;78:54–66.
   PubMed Web of Science ®Google Scholar
• Amasya G, Badilli U, Aksu B, et al. Quality by design case study 1: design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion-solvent evaporation method. Eur J Pharm Sci. 2016;84:92–102.
   PubMed Web of Science ®Google Scholar
• Crcarevska MS, Dimitrovska A, Sibinovska N, et al. Implementation of quality by design principles in the development of microsponges as drug delivery carriers: identification and optimization of critical factors using multivariate statistical analyses and design of experiments studies. Int J Pharm. 2015;489(1):58–72.
   PubMedGoogle Scholar
• Prasad PS, Imam SS, Aqil M, et al. QbD-based carbopol transgel formulation: characterization, pharmacokinetic assessment and therapeutic efficacy in diabetes. Drug Deliv. 2016;23(3):1047–1056.
   PubMed Web of Science ®Google Scholar
• Garg NK, Sharma G, Singh B, et al. Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): an improved dermatokinetic profile for inflammatory disorder (s). Int J Pharm. 2017;517(1):413–431.
   PubMedGoogle Scholar
• Kovács A, Berkó S, Csányi E, et al. Development of nanostructured lipid carriers containing salicyclic acid for dermal use based on the Quality by Design method. Eur J Pharm Sci. 2017;99:246–257.
   PubMed Web of Science ®Google Scholar
• Marto J, Gouveia L, Jorge I, et al. Starch-based pickering emulsions for topical drug delivery: a QbD approach. Colloids Surf B Biointerfaces. 2015;135:183–192.
   PubMed Web of Science ®Google Scholar
• Garg B, Katare O, Beg S, et al. Systematic development of solid self-nanoemulsifying oily formulations (S-SNEOFs) for enhancing the oral bioavailability and intestinal lymphatic uptake of lopinavir. Colloids Surf B Biointerfaces. 2016;141:611–622.
   PubMed Web of Science ®Google Scholar
• Marto J, Gouveia L, Gonçalves L, et al. A quality by design (QbD) approach on starch-based nanocapsules: a promising platform for topical drug delivery. Colloids Surf B Biointerfaces. 2016;143:177–185.
   PubMed Web of Science ®Google Scholar
• Pawar J, Tayade A, Gangurde A, et al. Solubility and dissolution enhancement of efavirenz hot melt extruded amorphous solid dispersions using combination of polymeric blends: a QbD approach. Eur J Pharm Sci. 2016;88:37–49.
   PubMed Web of Science ®Google Scholar
• Mercuri A, Pagliari M, Baxevanis F, et al. Understanding and predicting the impact of critical dissolution variables for nifedipine immediate release capsules by multivariate data analysis. Int J Pharm. 2017;518(1):41–49.
   PubMedGoogle Scholar
• Kanojia G, Willems G-J, Frijlink HW, et al. A design of experiment approach to predict product and process parameters for a spray dried influenza vaccine. Int J Pharm. 2016;511(2):1098–1111.
   PubMedGoogle Scholar
• Desai PM, Er PXH, Liew CV, et al. Functionality of disintegrants and their mixtures in enabling fast disintegration of tablets by a quality by design approach. AAPS PharmSciTech. 2014;15(5):1093–1104.
   PubMed Web of Science ®Google Scholar
• Vogt FG, Kord AS. Development of quality‐by‐design analytical methods. J Pharm Sci. 2011;100(3):797–812.
   PubMed Web of Science ®Google Scholar
• Li W, Rasmussen HT. Strategy for developing and optimizing liquid chromatography methods in pharmaceutical development using computer-assisted screening and Plackett-Burman experimental design. J Chromatogr A. 2003;1016(2):165–180.
   PubMed Web of Science ®Google Scholar
• Alden PG, Potts W, Yurach DA QbD with Design-of-experiments approach to the development of a chromatographic method for the separation of impurities in vancomycin: LCGC solutions for separation scientists; 2010 [cited 2018 Jan 23]. Available from: http://www.chromatographyonline.com/qbd-design-experiments-approach-development-chromatographic-method-separation-impurities-vancomycin
   Google Scholar
• Krishna MV, Dash RN, Reddy BJ, et al. Quality by Design (QbD) approach to develop HPLC method for eberconazole nitrate: application oxidative and photolytic degradation kinetics. J Saudi Chem Soc. 2016;20:S313–S322.
   Web of Science ®Google Scholar
• Mallik R, Raman S, Liang X, et al. Development and validation of a rapid ultra-high performance liquid chromatography method for the assay of benzalkonium chloride using a quality-by-design approach. J Chromatogr A. 2015;1413:22–32.
   PubMed Web of Science ®Google Scholar
• Tumpa A, Stajić A, Jančić-Stojanović B, et al. Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. J Pharm Biomed Anal. 2017;134:18–26.
   PubMed Web of Science ®Google Scholar
• Ye C, Terfloth G, Li Y, et al. A systematic stability evaluation of analytical RP-HPLC columns. J Pharm Biomed Anal. 2009;50(3):426–431.
   PubMed Web of Science ®Google Scholar
• Kormány R, Molnár I, Rieger H-J. Exploring better column selectivity choices in ultra-high performance liquid chromatography using Quality by Design principles. J Pharm Biomed Anal. 2013;80:79–88.
   PubMed Web of Science ®Google Scholar
• Monks K, Rieger H-J MI. Expanding the term “Design Space” in high performance liquid chromatography (I). J Pharm Biomed Anal. 2011;56(5):874–879.
   PubMed Web of Science ®Google Scholar
• Awotwe-Otoo D, Agarabi C, Faustino PJ, et al. Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate. J Pharm Biomed Anal. 2012;62:61–67.
   PubMed Web of Science ®Google Scholar
• Haas J, Franklin A, Houser M, et al. Implementation of QbD for the development of a vaccine candidate. Vaccine. 2014;32(24):2927–2930.
   PubMed Web of Science ®Google Scholar
• Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009;27(1):26–34.
   PubMed Web of Science ®Google Scholar
• Zhang L, Yan B, Gong X, et al. Application of quality by design to the process development of botanical drug products: a case study. AAPS PharmSciTech. 2013;14(1):277–286.
   PubMed Web of Science ®Google Scholar
• Singh A, Mangla B, Sethi S, et al. QbD based synthesis and characterization of polyacrylamide grafted corn fibre gum. Carbohydr Polym. 2017;156:45–55.
   PubMed Web of Science ®Google Scholar
• Gupta S, Jhawat V. Quality by design (QbD) approach of pharmacogenomics in drug designing and formulation development for optimization of drug delivery systems. J Control Release. 2017;245:15–26.
   PubMed Web of Science ®Google Scholar
• Verch T. Application of quality by design and statistical quality control concepts in immunoassays. Bioanalysis. 2014;6(23):3251–3260.
   PubMed Web of Science ®Google Scholar
• Puskeiler R, Kreuzmann J, Schuster C, et al. The way to a design space for an animal cell culture process according to Quality by Design (QbD). BMC Proc. 2011;5(8):P12.
   PubMedGoogle Scholar
• Basalious EB, El-Sebaie W, El-Gazayerly O. Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets. AAPS PharmSciTech. 2011;12(3):799–810.
   PubMed Web of Science ®Google Scholar
• Karmarkar S, Garber R, Genchanok Y, et al. Quality by design (QbD) based development of a stability indicating HPLC method for drug and impurities. J Chromatogr Sci. 2011;49(6):439–446.
   PubMed Web of Science ®Google Scholar
• Chatterjee S, editor QbD considerations for analytical methods-FDA perspective. US IFPAC Annual Meeting; 2013 Jan 25.
   Google Scholar
• [cited 2018 Jun 04]. Available from: www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591990.htm
   Google Scholar
• [cited 2018 Jun 04]. Available from: www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591826.htm
   Google Scholar
• [cited 2018 Jun 04]. Available from: www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm585015.htm
   Google Scholar
• [cited 2018 Jun 04]. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM586291.pdf
   Google Scholar
• Elder D, Borman P. Improving analytical method reliability across the entire product lifecycle using QbD approaches. Pharm Outsourcing. 2013;14(4):14–19.
   Google Scholar