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AAPS PharmSciTech

Quality by Design: Case Studies and Scientific Foundations

Guest Editor(s): Robin Bogner, James Drennen, Mansoor Khan, Cynthia Oksanen, Gintaras Reklaitis Status: Open

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Investigating Gabapentin Polymorphism Using Solid-State NMR Spectroscopy
Author(s): Kassibla E. Dempah; Dewey H. Barich; Aditya M. Kaushal; Zhixin Zong; Salil D. Desai; Raj Suryanarayanan; Lee Kirsch; Eric J. Munson
Quality 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 Tablets
Author(s): Raafat Fahmy; Ravikanth Kona; Ramesh Dandu; Walter Xie; Gregg Claycamp; Stephen W. Hoag
Improvement of Tablet Coating Uniformity Using a Quality by Design Approach
Author(s): Atul Dubey; Fani Boukouvala; Golshid Keyvan; Richard Hsia; Kostas Saranteas; Dean Brone; Tushar Misra; Marianthi G. Ierapetritou; Fernando J. Muzzio
De-risking Pharmaceutical Tablet Manufacture Through Process Understanding, Latent Variable Modeling, and Optimization Technologies
Author(s): Koji Muteki; Vidya Swaminathan; Sonja S. Sekulic; George L. Reid
Quality-by-Design Case Study: Investigation of the Role of Poloxamer in Immediate-Release Tablets by Experimental Design and Multivariate Data Analysis
Author(s): Goldi Kaul; Jun Huang; Ramarao Chatlapalli; Krishnendu Ghosh; Arwinder Nagi
The Application of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product Stability
Author(s): Kenneth Craig Waterman

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