QBD

 

 

QBD

 

Title	Year	Author(s)	Link
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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