Similar articles for PMID: 33199517

Year	Number of Results
1997	2
2003	1
2004	1
2006	2
2007	7
2008	2
2009	2
2010	4
2011	4
2012	5
2013	6
2014	11
2015	10
2016	5
2017	12
2018	8
2019	9
2020	13
2021	16

1

An Analytical Strategy Based on Multiple Complementary and Orthogonal Chromatographic and Detection Methods (Multidetector Approach) to Effectively Manage the Analytical Evaluation Threshold (AET).

Jordi M, Heise T. Jordi M, et al. PDA J Pharm Sci Technol. 2021 May-Jun;75(3):289-301. doi: 10.5731/pdajpst.2020.012047. Epub 2020 Nov 16. PDA J Pharm Sci Technol. 2021. PMID: 33199517

2

The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation.

Jenke D, Heise T. Jenke D, et al. PDA J Pharm Sci Technol. 2021 May-Jun;75(3):273-288. doi: 10.5731/pdajpst.2020.012013. Epub 2020 Nov 16. PDA J Pharm Sci Technol. 2021. PMID: 33199516

3

Reducing relative response factor variation using a multidetector approach for extractables and leachables (E&L) analysis to mitigate the need for uncertainty factors.

Jordi MA, Rowland K, Liu W, Cao X, Zong J, Ren Y, Liang Z, Zhou X, Louis M, Lerner K. Jordi MA, et al. J Pharm Biomed Anal. 2020 Jul 15;186:113334. doi: 10.1016/j.jpba.2020.113334. Epub 2020 May 1. J Pharm Biomed Anal. 2020. PMID: 32387747 Free article.

4

Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2020 May-Jun;74(3):348-358. doi: 10.5731/pdajpst.2019.010520. Epub 2020 Apr 15. PDA J Pharm Sci Technol. 2020. PMID: 32295860

5

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

6

Suicidal Ideation.

Harmer B, Lee S, Duong TVH, Saadabadi A. Harmer B, et al. 2021 Apr 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. 2021 Apr 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 33351435 Free Books & Documents. Review.

7

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

8

Qualitative assessment of extractables from single-use components and the impact of reference standard selection.

Jordi MA, Khera S, Roland K, Jiang L, Solomon P, Nelson J, Lateef SS, Woods J, Martin L, Martin S, Aiello F, Chen N. Jordi MA, et al. J Pharm Biomed Anal. 2018 Feb 20;150:368-376. doi: 10.1016/j.jpba.2017.12.029. Epub 2017 Dec 19. J Pharm Biomed Anal. 2018. PMID: 29287264

9

Utilization of internal standard response factors to estimate the concentration of organic compounds leached from pharmaceutical packaging systems and application of such estimated concentrations to safety assessment.

Jenke D, Odufu A. Jenke D, et al. J Chromatogr Sci. 2012 Mar;50(3):206-12. doi: 10.1093/chromsci/bmr048. J Chromatogr Sci. 2012. PMID: 22337797

10

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

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