These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
259 related articles for article (PubMed ID: 22821774)
1. 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. Eon-duval A; Valax P; Solacroup T; Broly H; Gleixner R; Strat CL; Sutter J J Pharm Sci; 2012 Oct; 101(10):3604-18. PubMed ID: 22821774 [TBL] [Abstract][Full Text] [Related]
2. Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein. Rouiller Y; Solacroup T; Deparis V; Barbafieri M; Gleixner R; Broly H; Eon-Duval A Eur J Pharm Biopharm; 2012 Jun; 81(2):426-37. PubMed ID: 22426134 [TBL] [Abstract][Full Text] [Related]
3. A quality by design study applied to an industrial pharmaceutical fluid bed granulation. Lourenço V; Lochmann D; Reich G; Menezes JC; Herdling T; Schewitz J Eur J Pharm Biopharm; 2012 Jun; 81(2):438-47. PubMed ID: 22446063 [TBL] [Abstract][Full Text] [Related]
4. Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets. Badawy SI; Narang AS; LaMarche KR; Subramanian GA; Varia SA; Lin J; Stevens T; Shah PA J Pharm Sci; 2016 Jan; 105(1):168-81. PubMed ID: 26852852 [TBL] [Abstract][Full Text] [Related]
5. System-wide hybrid MPC-PID control of a continuous pharmaceutical tablet manufacturing process via direct compaction. Singh R; Ierapetritou M; Ramachandran R Eur J Pharm Biopharm; 2013 Nov; 85(3 Pt B):1164-82. PubMed ID: 23523542 [TBL] [Abstract][Full Text] [Related]
6. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium. Myerson AS; Krumme M; Nasr M; Thomas H; Braatz RD J Pharm Sci; 2015 Mar; 104(3):832-9. PubMed ID: 25546650 [TBL] [Abstract][Full Text] [Related]
7. Quality by design for herbal drugs: a feedforward control strategy and an approach to define the acceptable ranges of critical quality attributes. Yan B; Li Y; Guo Z; Qu H Phytochem Anal; 2014; 25(1):59-65. PubMed ID: 24108478 [TBL] [Abstract][Full Text] [Related]
8. Achieving continuous manufacturing: technologies and approaches for synthesis, workup, and isolation of drug substance. May 20-21, 2014 Continuous Manufacturing Symposium. Baxendale IR; Braatz RD; Hodnett BK; Jensen KF; Johnson MD; Sharratt P; Sherlock JP; Florence AJ J Pharm Sci; 2015 Mar; 104(3):781-91. PubMed ID: 25470351 [TBL] [Abstract][Full Text] [Related]
9. Excipient variability and its impact on dosage form functionality. Dave VS; Saoji SD; Raut NA; Haware RV J Pharm Sci; 2015 Mar; 104(3):906-15. PubMed ID: 25561249 [TBL] [Abstract][Full Text] [Related]
10. Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing. Stauffer F; Vanhoorne V; Pilcer G; Chavez PF; Rome S; Schubert MA; Aerts L; De Beer T Eur J Pharm Biopharm; 2018 Jun; 127():92-103. PubMed ID: 29452241 [TBL] [Abstract][Full Text] [Related]
11. Critical factors in manufacturing multi-layer tablets--assessing material attributes, in-process controls, manufacturing process and product performance. Vaithiyalingam SR; Sayeed VA Int J Pharm; 2010 Oct; 398(1-2):9-13. PubMed ID: 20656000 [TBL] [Abstract][Full Text] [Related]
12. Interdependence of drug substance physical properties and corresponding quality control strategy. Cui Y; Song X; Reynolds M; Chuang K; Xie M J Pharm Sci; 2012 Jan; 101(1):312-21. PubMed ID: 21918985 [TBL] [Abstract][Full Text] [Related]
14. Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products. Boussès C; Ferey L; Vedrines E; Gaudin K J Pharm Biomed Anal; 2015 Nov; 115():114-22. PubMed ID: 26183807 [TBL] [Abstract][Full Text] [Related]
15. Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein. Looby M; Ibarra N; Pierce JJ; Buckley K; O'Donovan E; Heenan M; Moran E; Farid SS; Baganz F Biotechnol Prog; 2011; 27(6):1718-29. PubMed ID: 21948302 [TBL] [Abstract][Full Text] [Related]
16. Applications of process analytical technology to crystallization processes. Yu LX; Lionberger RA; Raw AS; D'Costa R; Wu H; Hussain AS Adv Drug Deliv Rev; 2004 Feb; 56(3):349-69. PubMed ID: 14962586 [TBL] [Abstract][Full Text] [Related]
17. Characterization of a Saccharomyces cerevisiae fermentation process for production of a therapeutic recombinant protein using a multivariate Bayesian approach. Fu Z; Baker D; Cheng A; Leighton J; Appelbaum E; Aon J Biotechnol Prog; 2016 May; 32(3):799-812. PubMed ID: 27095416 [TBL] [Abstract][Full Text] [Related]
18. A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products. Troiano G; Nolan J; Parsons D; Van Geen Hoven C; Zale S AAPS J; 2016 Nov; 18(6):1354-1365. PubMed ID: 27631558 [TBL] [Abstract][Full Text] [Related]
19. Process Analytical Technology for Crystallization of Active Pharmaceutical Ingredients. Malwade CR; Qu H Curr Pharm Des; 2018; 24(21):2456-2472. PubMed ID: 29956616 [TBL] [Abstract][Full Text] [Related]
20. An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation. Adam S; Suzzi D; Radeke C; Khinast JG Eur J Pharm Sci; 2011 Jan; 42(1-2):106-15. PubMed ID: 21056102 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]