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Quality by design case study: An integrated multivariate approach to drug product and process development

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References

1996Response Surface Methodology: Process and Product Optimization Using Designed Experiments9,540 cited
1997Response surface methodology: Process and product optimization using designed experiments1,344 cited
1998Experimental design and optimization1,177 cited
2005RSM simplified : optimizing processes using response surface methods for design of experiments589 cited
2002Multivariate methods in pharmaceutical applications221 cited

Cited by

2011Developing oral drug delivery systems using formulation by design: vital precepts, retrospect and prospects153 cited
2012Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets118 cited
2017Model-Based Methods in the Biopharmaceutical Process Lifecycle76 cited
2023Examining the effect of logistics service quality on customer satisfaction and re-use intention71 cited
2010A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods54 cited
2019An Optimization-Based Framework to Define the Probabilistic Design Space of Pharmaceutical Processes with Model Uncertainty54 cited
2017Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation47 cited

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