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Table representation of search results timeline featuring number of search results per year.

Year Number of Results
1988 1
1993 1
1996 2
1998 1
1999 1
2000 1
2001 2
2003 2
2004 1
2005 3
2006 2
2008 2
2009 10
2010 6
2011 3
2012 5
2013 7
2014 11
2015 15
2016 5
2017 5
2018 10
2019 6
2020 9
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Similar Articles for PMID: 32179712

104 results
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Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System.
Rolke R, Ramnarine E, Vinther A, Sawant A. Rolke R, et al. PDA J Pharm Sci Technol. 2020 Mar-Apr;74(2):286-288. doi: 10.5731/pdajpst.2019.011239. Epub 2020 Mar 16. PDA J Pharm Sci Technol. 2020. PMID: 32179712
Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9.
Calnan N, O'Donnell K, Greene A. Calnan N, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):581-600. doi: 10.5731/pdajpst.2013.00940. PDA J Pharm Sci Technol. 2013. PMID: 24265300
Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)-through Enhanced Science and Risk-Based Approaches.
Ramnarine E, Vinther A, Bruhin K, Tovar C, Colao M. Ramnarine E, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):456-467. doi: 10.5731/pdajpst.2020.011734. Epub 2020 May 28. PDA J Pharm Sci Technol. 2020. PMID: 32467177
Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management.
Vinther A, Ramnarine E. Vinther A, et al. PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):517-521. doi: 10.5731/pdajpst.2019.010827. Epub 2019 Aug 16. PDA J Pharm Sci Technol. 2019. PMID: 31420505
Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer can help close the Q10 to Q12 Gap.
Lipa MJ, Greene A, Calnan N. Lipa MJ, et al. PDA J Pharm Sci Technol. 2020 Jul 16:pdajpst.2020.011825. doi: 10.5731/pdajpst.2020.011825. Online ahead of print. PDA J Pharm Sci Technol. 2020. PMID: 32675306
International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.
Food and Drug Administration, HHS. Food and Drug Administration, HHS. Fed Regist. 2009 Apr 8;74(66):15990-1. Fed Regist. 2009. PMID: 19507321 Free article.
An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.
Boetzel R, Ceszlak A, Day C, Drumm P, Gil Bejar J, Glennon J, Harris L, Heghes CI, Horga R, Jacobs PL, Keurentjes WJTM, King F, Lee CW, Lewen N, Marchant CA, Maris FA, Nye W, Powell S, Rockstroh H, Rutter L, Schweitzer M, Shannon E, Smallshaw L, Teasdale A, Thompson S, Wilkinson D. Boetzel R, et al. J Pharm Sci. 2018 Sep;107(9):2335-2340. doi: 10.1016/j.xphs.2018.04.009. Epub 2018 Apr 18. J Pharm Sci. 2018. PMID: 29679706 Free article.
Vendor qualification for pharmaceutical excipients--GMP requirements and approach.
Patel KT, Chotal NP. Patel KT, et al. Pharmazie. 2010 Nov;65(11):783-90. Pharmazie. 2010. PMID: 21155382 Review.
QbD implementation and Post Approval Lifecycle Management (PALM).
Ohage E, Iverson R, Krummen L, Taticek R, Vega M. Ohage E, et al. Biologicals. 2016 Sep;44(5):332-40. doi: 10.1016/j.biologicals.2016.06.007. Epub 2016 Jul 21. Biologicals. 2016. PMID: 27449920 Review.
Pharmaceutical excipient development: the need for preclinical guidance.
Baldrick P. Baldrick P. Regul Toxicol Pharmacol. 2000 Oct;32(2):210-8. doi: 10.1006/rtph.2000.1421. Regul Toxicol Pharmacol. 2000. PMID: 11067777 Review.
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