Similar articles for PMID: 33199517

Year	Number of Results
1997	1
2002	1
2004	2
2005	1
2006	3
2007	7
2008	2
2009	3
2010	2
2011	2
2012	3
2013	4
2014	8
2015	10
2016	2
2017	11
2018	11
2019	14
2020	15
2021	11
2022	6

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

A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation.

Jenke D, Christiaens P, Beusen JM, Verlinde P, Baeten J. Jenke D, et al. PDA J Pharm Sci Technol. 2022 May-Jun;76(3):178-199. doi: 10.5731/pdajpst.2021.012692. Epub 2021 Nov 15. PDA J Pharm Sci Technol. 2022. PMID: 34782443

5

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

6

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

7

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

8

Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1-Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission.

Christiaens P, Beusen JM, Verlinde P, Baeten J, Jenke D. Christiaens P, et al. PDA J Pharm Sci Technol. 2020 Jan-Feb;74(1):90-107. doi: 10.5731/pdajpst.2018.009761. Epub 2019 Jun 17. PDA J Pharm Sci Technol. 2020. PMID: 31209164

9

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

10

Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?

Jenke D, Christiaens P, Verlinde P, Baeten J, Beusen JM. Jenke D, et al. PDA J Pharm Sci Technol. 2022 May-Jun;76(3):236-247. doi: 10.5731/pdajpst.2021.012673. Epub 2021 Nov 15. PDA J Pharm Sci Technol. 2022. PMID: 34782445

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