Similar articles for PMID: 32675308

Year	Number of Results
1978	1
1997	1
1998	1
2004	1
2005	3
2006	2
2007	5
2008	2
2009	3
2010	3
2011	5
2012	4
2013	4
2014	11
2015	11
2016	6
2017	9
2018	14
2019	13
2020	16
2021	17
2022	11

1

Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products.

Ronk M, Liu J, Gallegos A, Luo Y, Fujimori K, Li K, Lee H, Nashed-Samuel Y. Ronk M, et al. PDA J Pharm Sci Technol. 2020 Nov-Dec;74(6):627-643. doi: 10.5731/pdajpst.2019.011379. Epub 2020 Jul 16. PDA J Pharm Sci Technol. 2020. PMID: 32675308

2

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

3

A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.

Qi L, Liu J, Ronk M, Gallegos A, Fujimori K, Luo Y, Li K, Lee H, Nashed-Samuel Y. Qi L, et al. J Pharm Sci. 2021 Nov;110(11):3580-3593. doi: 10.1016/j.xphs.2021.07.015. Epub 2021 Jul 27. J Pharm Sci. 2021. PMID: 34324943

4

Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.

Gallegos A, Liu J, Ronk M, Qi L, Li K, Semin D, Nashed-Samuel Y. Gallegos A, et al. J Pharm Sci. 2022 Jun;111(6):1599-1604. doi: 10.1016/j.xphs.2022.03.001. Epub 2022 Mar 5. J Pharm Sci. 2022. PMID: 35257694

5

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.

6

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.

7

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

8

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

9

A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing systems.

Jenke D, Carlson T. Jenke D, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):407-55. doi: 10.5731/pdajpst.2014.00995. PDA J Pharm Sci Technol. 2014. PMID: 25336416

10

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

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