Understanding Pharmaceutical Quality by Design 2014 Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, Janet Woodcock http://www.ncbi.nlm.nih.gov/pubmed/24854893
A quality by design study applied to an industrial pharmaceutical fluid bed granulation 2012 Vera Lourenço, Dirk Lochmann, Gabriele Reich, José C. Menezesa, Thorsten Herdling, Jens Schewitz http://www.ncbi.nlm.nih.gov/pubmed/22446063
Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space. 2012 Eon-duval A, Valax P, Solacroup T, Broly H, Gleixner R, Strat CL, Sutter J. http://www.ncbi.nlm.nih.gov/pubmed/22821774
Instrumented roll technology for the design space development of roller compaction process 2012 Vishwas V. Nesarikar, Nipa Vatsaraj, Chandrakant Patel, William Early, Preetanshu Pandey, Omar Sprockel, Zhihui Gao, Robert Jerzewski, Ronald Miller, Michael Levin http://www.sciencedirect.com/science/article/pii/S037851731200066X
Rapid exploration of curing process design space for production of controlled-release pellets 2012 Katja Kristan andMatej Horvat http://onlinelibrary.wiley.com/doi/10.1002/jps.23277/abstract
Automating push-through force testing of blister packs 2011 Jha, Salil http://www.tabletscapsules.com/Content/getArticle.aspx?ItemID=0c90dc21-5939-4a8d-ab0b-10cee0940398
Quality by Design for ANDAs: An Example for Modified Release Dosage Forms 2011 http://qbdworks.com/wp-content/uploads/2014/06/QbD-Modified-Release-Dosage.pdf
QbD Status Update Generic Drugs 2011 Susan Rosencrance http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM292666.pdf
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework 2011 Junker B, Kosinski M, Geer D, Mahajan R, Chartrain M, Meyer B, Dephillips P, Wang Y, Henrickson R, Ezis K, Waskiewicz M. http://www.ncbi.nlm.nih.gov/pubmed/22293236
Quality by design and process analytical technology for sterile products–where are we now? 2010 Riley BS, Li X. http://www.ncbi.nlm.nih.gov/pubmed/21181513
Development of quality-by-design analytical methods 2010 Frederick G. Vogt andAlireza S. Kord http://onlinelibrary.wiley.com/doi/10.1002/jps.22325/full
Roadmap for implementation of quality by design (QbD) for biotechnology products. 2009 Rathore AS http://www.ncbi.nlm.nih.gov/pubmed/19647883
Quality by Design for Biopharmaceuticals: Principles and Case Studies 2009 Anurag S. Rathore (Editor), Rohin Mhatre (Editor) http://astore.amazon.com/qbdworks-20/detail/0470282339
Quality by design for biopharmaceuticals 2009 Anurag S Rathore & Helen Winkle http://www.nature.com/nbt/journal/v27/n1/abs/nbt0109-26.html
Formulation optimization of long-acting depot injection of aripiprazole by using D-optimal mixture design 2009 Nahata T, Saini TR. http://www.ncbi.nlm.nih.gov/pubmed/19634350
Quality by Design: Get to the production scale quickly and successfully with Design of Experiments 2009 Norbert Pöllinger, Stefanie Feiler, Philippe Solot, http://www.aicos.com/upload/downloads/Artikel/Stavex_QualityByDesign-e.pdf
Pharmaceutical quality by design: product and process development, understanding, and control. 2008 Yu LX http://www.ncbi.nlm.nih.gov/pubmed/18185986
Quality by design for biopharmaceuticals 2009 Anurag S Rathore1 & Helen Winkle2 http://www.nature.com/nbt/journal/v27/n1/full/nbt0109-26.html
Why quality-by-design should be on the executive team’s agenda 2009 Ted Fuhr, Michele Holcomb, Paul Rutten http://qbdworks.com/wp-content/uploads/2014/06/QbD_McKinsey.pdf
BioProcess Control: What the Next 15 Years Will Bring 2008 Michael Boudreau, Emerson Process Management, Inc. and Trish Benton, Broadley-James Corp. http://www.pharmamanufacturing.com/articles/2008/062/?page=full
QbD for Better Method Validation and Transfer 2010 Phil Nethercote, Phil Borman, Tony Bennett, GSK; Gregory Martin, Complectors Consulting LLC, and Pauline McGregor, PMcG Consulting http://www.pharmamanufacturing.com/articles/2010/060/
A Quality-by-Design Methodology for Rapid LC Method Development (Parts I, II and III) 2008 Ira Krull, Michael Swartz, Joseph Turpin, Patrick H. Lukulay, Richard Verseput http://academy.chromatographyonline.com/lcgc/article/articleDetail.jsp?id=570537; http://academy.chromatographyonline.com/lcgc//article/articleDetail.jsp?id=579016;http://academy.chromatographyonline.com/lcgc//article/articleDetail.jsp?id=593247
What Your ICH Q8 Design Space Needs: A Multivariate Predictive Distribution 2010 John J. Peterson, GlaxoSmithKline Pharmaceuticals http://www.pharmamanufacturing.com/articles/2010/097/?page=full
Quality-by-Design Using a Gaussian Mixture
Density Approximation of Biological Uncertainties
2010 N. Rossner, Th. Heine, R. King http://www.nt.ntnu.no/users/skoge/prost/proceedings/dycops-2010/Papers_CAB2010_common/WeMT1-02.pdf
An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design 2010 Daniel M. Hallow, Boguslaw M. Mudryk, Alan D. Braem, Jose E. Tabora, Olav K. Lyngberg, James S. Bergum, Lucius T. Rossano, Srinivas Tummala http://rd.springer.com/article/10.1007%2Fs12247-010-9094-y
Process modeling and control in drug development and manufacturing 2010 Edited by Cynthia Oksanen and Salvador García-Muñoz http://www.sciencedirect.com/science/article/pii/S0098135410001523
Bioprocesses: Modeling needs for process evaluation and sustainability assessment 2010 Concepción Jiménez-González, John M. Woodley http://www.sciencedirect.com/science/article/pii/S0098135410001018
Computer-aided molecular design using the Signature molecular descriptor: Application to solvent selection 2009 Derick C. Weis , Donald P. Visco http://www.sciencedirect.com/science/article/pii/S0098135409002683
Process modeling and optimization of batch fractional distillation to increase throughput and yield in manufacture of active pharmaceutical ingredient (API) 2010 Yubo Yang, , Rosalin Tjia http://www.sciencedirect.com/science/article/pii/S0098135410001304
The use of modeling in spray drying of emulsions and suspensions accelerates formulation and process development 2009 James W. Ivey, Reinhard Vehring http://www.sciencedirect.com/science/article/pii/S0098135410000748
Pharmaceutical process/equipment design methodology case study: Cyclone design to optimize spray-dried-particle collection efficiency 2010 Lisa J. Graham, Rebecca Taillon, Jim Mullina, Trevor Wigle http://www.sciencedirect.com/science/article/pii/S0098135410001365
Practical application of roller compaction process modeling 2010 Gavin Reynolds, Rohit Ingale, Ron Roberts, Sanjeev Kothari, Bindhu Gururajan http://www.sciencedirect.com/science/article/pii/S0098135410000955
Understanding variation in roller compaction through finite element-based process modeling 2010 John C. Cunninghama, Denita Winstead, Antonios Zavaliangos http://www.sciencedirect.com/science/article/pii/S0098135410001407
Optimizing the design of eccentric feed hoppers for tablet presses using DEM 2010 William R. Ketterhagen, Bruno C. Hancock http://www.sciencedirect.com/science/article/pii/S0098135410001560
Temperature and density evolution during compaction of a capsule shaped tablet 2010 Gerard R. Klinzing, Antonios Zavaliangos, John Cunningham, Tracey Mascaro, Denita Winstead http://www.sciencedirect.com/science/article/pii/S0098135410001511
Drug product modeling predictions for scale-up of tablet film coating—A quality by design approach 2010 Andrew Prpich, Mary T. am Ende, Thomas Katzschner, Veronika Lubczyk, Holger Weyhers, Georg Bernhard http://www.sciencedirect.com/science/article/pii/S0098135410000979
Handling uncertainty in the establishment of a design space for the manufacture of a pharmaceutical product 2010 Salvador García-Muñoz, , Stephanie Dolph, Howard W. Ward II http://www.sciencedirect.com/science/article/pii/S0098135410000700
ICAS-PAT: A software for design, analysis and validation of PAT systems 2009 Ravendra Singh, Krist V. Gernaey, Rafiqul Gania, http://www.sciencedirect.com/science/article/pii/S0098135409001732
An ontological knowledge-based system for the selection of process monitoring and analysis tools 2010 Ravendra Singh, Krist V. Gernaey, Rafiqul Gani http://www.sciencedirect.com/science/article/pii/S009813541000150X
An ontological framework for automated regulatory compliance in pharmaceutical manufacturing 2009 M. Berkan Sesen, Pradeep Suresh, René Banares-Alcantara, Venkat Venkatasubramanian http://www.sciencedirect.com/science/article/pii/S0098

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