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Year Number of Results
1997 1
1999 1
2003 1
2005 1
2006 1
2007 4
2008 2
2009 3
2010 5
2011 4
2012 5
2013 6
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2015 12
2016 8
2017 12
2018 15
2019 14
2020 20
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Similar Articles for PMID: 32675308

110 results
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Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products.
Ronk M, Nashed-Samuel Y, Liu J, Gallegos A, Luo Y, Fujimori K, Li K, Lee H. Ronk M, et al. PDA J Pharm Sci Technol. 2020 Jul 16:pdajpst.2019.011379. doi: 10.5731/pdajpst.2019.011379. Online ahead of print. PDA J Pharm Sci Technol. 2020. PMID: 32675308
Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products.
Li K, Rogers G, Nashed-Samuel Y, Lee H, Mire-Sluis A, Cherney B, Forster R, Yeh P, Markovic I. Li K, et al. PDA J Pharm Sci Technol. 2015 Sep-Oct;69(5):590-619. doi: 10.5731/pdajpst.2015.01073. PDA J Pharm Sci Technol. 2015. PMID: 26429108
Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper.
Kiminami H, Takeuchi K, Nakamura K, Abe Y, Lauwers P, Dierick W, Yoshino K, Suzuki S. Kiminami H, et al. PDA J Pharm Sci Technol. 2015 Nov-Dec;69(6):713-24. doi: 10.5731/pdajpst.2015.01080. PDA J Pharm Sci Technol. 2015. PMID: 26659102
Extractables and leachables considerations for prefilled syringes.
Jenke DR. Jenke DR. Expert Opin Drug Deliv. 2014 Oct;11(10):1591-600. doi: 10.1517/17425247.2014.928281. Epub 2014 Jun 23. Expert Opin Drug Deliv. 2014. PMID: 24955780 Review.
Identification of leachables observed in the size exclusion chromatograms of a low concentration product stored in prefilled syringes.
Valente JJ, Peddicord MB, Rinaldi FA, Kelly KA, Bolgar MS. Valente JJ, et al. J Pharm Biomed Anal. 2017 May 30;139:133-142. doi: 10.1016/j.jpba.2017.02.039. Epub 2017 Feb 22. J Pharm Biomed Anal. 2017. PMID: 28279928
On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals.
Wakankar AA, Wang YJ, Canova-Davis E, Ma S, Schmalzing D, Grieco J, Milby T, Reynolds T, Mazzarella K, Hoff E, Gomez S, Martin-Moe S. Wakankar AA, et al. J Pharm Sci. 2010 May;99(5):2209-18. doi: 10.1002/jps.22012. J Pharm Sci. 2010. PMID: 20039383 Review.
Perspectives on the PQRI Extractables and Leachables "Safety Thresholds and Best Practices" Recommendations for Inhalation Drug Products.
Norwood DL, Nagao LM, Stults CL. Norwood DL, et al. PDA J Pharm Sci Technol. 2013 Sep-Oct;67(5):413-29. doi: 10.5731/pdajpst.2013.00934. PDA J Pharm Sci Technol. 2013. PMID: 24084658
Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective.
Markovic I. Markovic I. Expert Opin Drug Saf. 2007 Sep;6(5):487-91. doi: 10.1517/14740338.6.5.487. Expert Opin Drug Saf. 2007. PMID: 17877437
The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP).
Paskiet D, Jenke D, Ball D, Houston C, Norwood DL, Markovic I. Paskiet D, et al. PDA J Pharm Sci Technol. 2013 Sep-Oct;67(5):430-47. doi: 10.5731/pdajpst.2013.00936. PDA J Pharm Sci Technol. 2013. PMID: 24084659 Review.
Development of an inductively coupled plasma mass spectrometry method for quantification of extracted tungsten from glass prefilled syringes used as a primary packaging for pharmaceutical and therapeutic protein products.
Fujimori K, Lee H, Phillips J, Nashed-Samuel Y. Fujimori K, et al. PDA J Pharm Sci Technol. 2013 Nov-Dec;67(6):670-9. doi: 10.5731/pdajpst.2013.00941. PDA J Pharm Sci Technol. 2013. PMID: 24265307
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