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Equipment characterization to mitigate risks during transfers of cell culture manufacturing processes Bằng Christian Sieblist, Marco Jenzsch, Michael Pohlscheidt

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Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation Bằng Hemlata Patil, Roshan V. Tiwari, Michael A. Repka

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Early Implementation of QbD in Biopharmaceutical Development: A Practical Example Bằng Jesús Zurdo, Andreas Arnell, Olga Obrezanova, Noel Smith, Ramón Gómez de la Cuesta, Thomas R. A. Gallagher, Rebecca Michael, Yvette Stallwood, Caroline Ekblad, Lars Abrahmsén, Ingmarie Höidén‐Guthenberg

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Aggregation risk prediction for antibodies and its application to biotherapeutic development Bằng Olga Obrezanova, Andreas Arnell, Ramón Gómez de la Cuesta, Maud E Berthelot, Thomas R. A. Gallagher, Jesús Zurdo, Yvette Stallwood

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Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics Bằng Richard S. Rogers, Nancy S. Nightlinger, Brittney Livingston, Phil C Campbell, Robert W. Bailey, Alain Balland

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Investigation of Design Space for Freeze-Drying: Use of Modeling for Primary Drying Segment of a Freeze-Drying Cycle Bằng Venkat Koganti, Evgenyi Shalaev, Mark Berry, Thomas Osterberg, Maickel Youssef, David Hiebert, Frank Kanka, Martin Nolan, Rosemary Barrett, Gioval Scalzo, Gillian Fitzpatrick, Niall Fitzgibbon, Sumit Luthra, Liling Zhang

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Application of Pharmaceutical QbD for Enhancement of the Solubility and Dissolution of a Class II BCS Drug using Polymeric Surfactants and Crystallization Inhibitors: Development o... Bằng Emad B. Basalious, Wessam El-Sebaie, Omaima N. El‐Gazayerly

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Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm Bằng Glenn A. Van Buskirk, Satish Asotra, Christopher Balducci, Prabir K. Basu, Gerald C. DiDonato, Angelica Dorantes, W. Eickhoff, Tapash K. Ghosh, Mario Ángel-González, Theresa F. Henry, Matthew K. Howard, Jason Kamm, Steven Laurenz, Ryan J. MacKenzie, Russell Mannion, Patrick K. Noonan, Terrance Ocheltree, Umesh Pai, Richard Poska, Michael L. Putnam, Ramani R. Raghavan, Colleen Ruegger, Éric Sanchez, Vinod P. Shah, Zezhi Shao, Russell Somma, Vijay Tammara, Avinash G. Thombre, Bruce Thompson, Robert J. Timko, Satyam Upadrashta, Sivakumar Vaithiyalingam

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Improving biophysical properties of a bispecific antibody scaffold to aid developability Bằng Thomas Spreter von Kreudenstein, Eric Escobar-Carbrera, Paula I. Lario, I. D’Angelo, Karine Brault, John F. Kelly, Yves Durocher, Jason Baardsnes, R. Jeremy Woods, Michael Xie, Pierre‐Alain Girod, M.D.L. Suits, Martin J. Boulanger, David Poon, Gordon Ng, Surjit B. Dixit

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Quality by Design: Concepts for ANDAs Bằng Robert Lionberger, Sau Lawrence Lee, LaiMing Lee, Andre Raw, Lawrence X. Yu

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Understanding Pharmaceutical Quality by Design Bằng Lawrence X. Yu, Gregory E. Amidon, Mansoor A. Khan, Stephen W. Hoag, James E. Polli, G. K. Raju, Janet Woodcock

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QbD-enabled systematic development of gastroretentive multiple-unit microballoons of itopride hydrochloride Bằng Sanjay Bansal, Sarwar Beg, Abhay Asthana, Babita Garg, Gyati Shilakari Asthana, Rishi Kapil, Bhupinder Singh

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Human cell culture process capability: a comparison of manual and automated production Bằng Yang Liu, Paul Hourd, Amit Chandra, David Williams

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Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development Bằng Xinyuan Zhang, Robert Lionberger, Barbara M. Davit, Lawrence X. Yu

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Protein aggregation and its impact on product quality Bằng Christopher J. Roberts

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A Model-Based Methodology for Spray-Drying Process Development Bằng Dan E. Dobry, Dana M. Settell, John M. Baumann, Rod Ray, Lisa Graham, Ron Beyerinck

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Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide Bằng Marcelo Antônio de Oliveira, María Irene Yoshida, Daphne Silva

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Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control i... Bằng Tahisa Marcela Pedroso, Hérida Regina Nunes Salgado

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A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms Bằng Michael Leane, Kendal Pitt, Gavin Reynolds

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A model based approach for identifying robust operating conditions for industrial chromatography with process variability Bằng Edward J. Close, Jeffrey R. Salm, Daniel G. Bracewell, Eva Sørensen

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