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Review article

A quality by design approach to scale-up of high-shear wet granulation process

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Pages 175-189 | Received 28 Apr 2015, Accepted 22 Sep 2015, Published online: 22 Oct 2015

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Preetanshu Pandey, Christopher Levins, Steve Pafiakis, Brian Zacour, Dilbir S. Bindra, Jade Trinh, David Buckley, Shruti Gour, Shasad Sharif & Howard Stamato. (2018) Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process. Pharmaceutical Development and Technology 23:6, pages 587-595.
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S. Badawy & P. Pandey. 2017. Developing Solid Oral Dosage Forms. Developing Solid Oral Dosage Forms 749 776 .
Y. Qiu, X. He, L. Zhu & B. Chen. 2017. Developing Solid Oral Dosage Forms. Developing Solid Oral Dosage Forms 555 591 .
P. Pandey, R. Bharadwaj & X. Chen. 2017. Predictive Modeling of Pharmaceutical Unit Operations. Predictive Modeling of Pharmaceutical Unit Operations 1 13 .
Xianglong Cui, Bing Xu, Xin Wang, Fei Sun, Xinyuan Shi & Yanjiang Qiao. (2016) Using quality by design and quality risk management principles to aid the development of a high shear wet granulation process. Using quality by design and quality risk management principles to aid the development of a high shear wet granulation process.

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