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  1. 1
    Equipment characterization to mitigate risks during transfers of cell culture manufacturing processes

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

    Udgivet 2015
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  2. 2
    Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation

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

    Udgivet 2015
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  3. 3
    Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

    Early Implementation of QbD in Biopharmaceutical Development: A Practical Example af 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

    Udgivet 2015
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  4. 4
    Aggregation risk prediction for antibodies and its application to biotherapeutic development

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

    Udgivet 2015
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  5. 5
    Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics

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

    Udgivet 2015
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  6. 6
    Investigation of Design Space for Freeze-Drying: Use of Modeling for Primary Drying Segment of a Freeze-Drying Cycle

    Investigation of Design Space for Freeze-Drying: Use of Modeling for Primary Drying Segment of a Freeze-Drying Cycle af 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

    Udgivet 2011
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  7. 7
    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

    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... af Emad B. Basalious, Wessam El-Sebaie, Omaima N. El‐Gazayerly

    Udgivet 2011
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  8. 8
    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

    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 af 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

    Udgivet 2014
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  9. 9
    Improving biophysical properties of a bispecific antibody scaffold to aid developability

    Improving biophysical properties of a bispecific antibody scaffold to aid developability af 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

    Udgivet 2013
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  10. 10
    Quality by Design: Concepts for ANDAs

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

    Udgivet 2008
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  11. 11
    Understanding Pharmaceutical Quality by Design

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

    Udgivet 2014
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  12. 12
    QbD-enabled systematic development of gastroretentive multiple-unit microballoons of itopride hydrochloride

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

    Udgivet 2014
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  13. 13
    Human cell culture process capability: a comparison of manual and automated production

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

    Udgivet 2009
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  14. 14
    Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

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

    Udgivet 2011
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  15. 15
    Protein aggregation and its impact on product quality

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

    Udgivet 2014
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  16. 16
    A Model-Based Methodology for Spray-Drying Process Development

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

    Udgivet 2009
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  17. 17
    Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide

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

    Udgivet 2014
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  18. 18
    Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

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

    Udgivet 2011
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  19. 19
    A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

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

    Udgivet 2014
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  20. 20
    A model based approach for identifying robust operating conditions for industrial chromatography with process variability

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

    Udgivet 2014
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