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Items: 1 to 20 of 102

1.

Quality-by-design: are we there yet?

Cook J, Cruañes MT, Gupta M, Riley S, Crison J.

AAPS PharmSciTech. 2014 Feb;15(1):140-8. doi: 10.1208/s12249-013-0043-1. Epub 2013 Nov 12.

2.

Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm.

Zalai D, Dietzsch C, Herwig C.

PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):569-80. doi: 10.5731/pdajpst.2013.00943.

PMID:
24265299
3.

Pharmaceutical product development: A quality by design approach.

Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J.

Int J Pharm Investig. 2016 Jul-Sep;6(3):129-38. doi: 10.4103/2230-973X.187350. Review.

4.

Understanding pharmaceutical quality by design.

Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J.

AAPS J. 2014 Jul;16(4):771-83. doi: 10.1208/s12248-014-9598-3. Epub 2014 May 23. Review.

5.

Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns.

del Val IJ, Kontoravdi C, Nagy JM.

Biotechnol Prog. 2010 Nov-Dec;26(6):1505-27. doi: 10.1002/btpr.470. Review.

PMID:
20665659
6.

Roadmap for implementation of quality by design (QbD) for biotechnology products.

Rathore AS.

Trends Biotechnol. 2009 Sep;27(9):546-53. doi: 10.1016/j.tibtech.2009.06.006. Epub 2009 Aug 3. Review.

PMID:
19647883
7.

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

Yu LX, Baker J, Berlam SC, Boam A, Brandreth EJ, Buhse L, Cosgrove T, Doleski D, Ensor L, Famulare J, Ganapathy M, Grampp G, Hussong D, Iser R, Johnston G, Kesisoglou F, Khan M, Kozlowski S, Lacana E, Lee SL, Miller S, Miksinski SP, Moore CM, Mullin T, Raju GK, Raw A, Rosencrance S, Rosolowsky M, Stinavage P, Thomas H, Wesdyk R, Windisch J, Vaithiyalingam S.

AAPS J. 2015 Jul;17(4):1011-8. doi: 10.1208/s12248-015-9754-4. Epub 2015 Apr 4.

8.

Quality by design and process analytical technology for sterile products--where are we now?

Riley BS, Li X.

AAPS PharmSciTech. 2011 Mar;12(1):114-8. doi: 10.1208/s12249-010-9566-x. Epub 2010 Dec 23. Review.

9.

Pharmaceutical quality by design: product and process development, understanding, and control.

Yu LX.

Pharm Res. 2008 Apr;25(4):781-91. doi: 10.1007/s11095-007-9511-1. Epub 2008 Jan 10. Erratum in: Pharm Res. 2008 Oct;25(10):2463.

PMID:
18185986
10.

Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework.

Junker B, Kosinski M, Geer D, Mahajan R, Chartrain M, Meyer B, Dephillips P, Wang Y, Henrickson R, Ezis K, Waskiewicz M.

PDA J Pharm Sci Technol. 2011 May-Jun;65(3):254-86. doi: 10.5731/pdajpst.2011.00739.

PMID:
22293236
11.

Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT).

Aksu B, De Beer T, Folestad S, Ketolainen J, Lindén H, Lopes JA, de Matas M, Oostra W, Rantanen J, Weimer M.

Eur J Pharm Sci. 2012 Sep 29;47(2):402-5. doi: 10.1016/j.ejps.2012.06.009. Epub 2012 Jun 26.

PMID:
22749874
12.
13.

Guidelines, editors, pharma and the biological paradigm shift.

Singh AR, Singh SA.

Mens Sana Monogr. 2007 Jan;5(1):27-30. doi: 10.4103/0973-1229.32176.

14.

Summary of the EMA Joint Regulators/Industry QbD workshop (London, UK; 28-29 January 2014).

Cook G, France G, Holte Ø, Lorenti G, Tainsh D.

PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):163-76. doi: 10.5731/pdajpst.2015.006171. Epub 2016 Jan 21.

PMID:
26797977
15.

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. doi: 10.1016/j.ejpb.2012.03.003. Epub 2012 Mar 13.

PMID:
22446063
16.

Quality by design approach for formulation development: a case study of dispersible tablets.

Charoo NA, Shamsher AA, Zidan AS, Rahman Z.

Int J Pharm. 2012 Feb 28;423(2):167-78. doi: 10.1016/j.ijpharm.2011.12.024. Epub 2011 Dec 23.

PMID:
22209997
17.

Implementation of QbD for the development of a vaccine candidate.

Haas J, Franklin A, Houser M, Maraldo D, Mikola M, Ortiz R, Sullivan E, Otero JM.

Vaccine. 2014 May 19;32(24):2927-30. doi: 10.1016/j.vaccine.2014.02.028. Epub 2014 Mar 2.

PMID:
24598725
18.

Procedures and methods of benefit assessments for medicines in Germany.

Bekkering GE, Kleijnen J.

Eur J Health Econ. 2008 Nov;9 Suppl 1:5-29. doi: 10.1007/s10198-008-0122-5.

PMID:
18987905
19.

Hurdles in tissue engineering/regenerative medicine product commercialization: a pilot survey of governmental funding agencies and the financial industry.

Bertram TA, Tentoff E, Johnson PC, Tawil B, Van Dyke M, Hellman KB.

Tissue Eng Part A. 2012 Nov;18(21-22):2187-94. doi: 10.1089/ten.TEA.2012.0186. Epub 2012 Sep 27.

PMID:
22838399
20.

Implementation of quality by design toward processing of food products.

Rathore AS, Kapoor G.

Prep Biochem Biotechnol. 2017 May 28;47(5):435-440. doi: 10.1080/10826068.2017.1315601. Epub 2017 Apr 12.

PMID:
28402220

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