Similar articles for PMID: 35169039

Year	Number of Results
1997	1
2004	1
2005	1
2006	2
2007	7
2008	3
2009	3
2010	4
2011	3
2012	2
2013	5
2014	10
2015	10
2016	5
2017	11
2018	13
2019	13
2020	16
2021	13
2022	13
2023	5
2024	0

1

Principles for Management of Extractables and Leachables in Ophthalmic Drug Products.

Houston CT, Rodrigues AD, Smith BB, Wang T, Richardson M. Houston CT, et al. PDA J Pharm Sci Technol. 2022 May-Jun;76(3):278-294. doi: 10.5731/pdajpst.2022.012744. Epub 2022 Feb 15. PDA J Pharm Sci Technol. 2022. PMID: 35169039

2

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.

3

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

4

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

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

Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.

Jenke D, Egert T, Hendricker A, Castner J, Feinberg T, Houston C, Hunt DG, Lynch M, Nicholas K, Norwood DL, Paskiet D, Ruberto M, Smith EJ, Holcomb F, Markovic I. Jenke D, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):68-87. doi: 10.5731/pdajpst.2016.007229. Epub 2016 Dec 14. PDA J Pharm Sci Technol. 2017. PMID: 27974627

7

Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products.

Jenke D, Castner J, Egert T, Feinberg T, Hendricker A, Houston C, Hunt DG, Lynch M, Shaw A, Nicholas K, Norwood DL, Paskiet D, Ruberto M, Smith EJ, Holcomb F. Jenke D, et al. PDA J Pharm Sci Technol. 2013 Sep-Oct;67(5):448-511. doi: 10.5731/pdajpst.2013.00933. PDA J Pharm Sci Technol. 2013. PMID: 24084660

8

Best practices for extractables and leachables in orally inhaled and nasal drug products: an overview of the PQRI recommendations.

Norwood DL, Paskiet D, Ruberto M, Feinberg T, Schroeder A, Poochikian G, Wang Q, Deng TJ, DeGrazio F, Munos MK, Nagao LM. Norwood DL, et al. Pharm Res. 2008 Apr;25(4):727-39. doi: 10.1007/s11095-007-9521-z. Epub 2008 Jan 9. Pharm Res. 2008. PMID: 18183477 Review.

9

Framework for sensitization assessment of extractables and leachables in pharmaceuticals.

Parris P, Whelan G, Burild A, Whritenour J, Bruen U, Bercu J, Callis C, Graham J, Johann E, Griffin T, Kohan M, Martin EA, Masuda-Herrera M, Stanard B, Tien E, Cruz M, Nagao L. Parris P, et al. Crit Rev Toxicol. 2022 Feb;52(2):125-138. doi: 10.1080/10408444.2022.2065966. Epub 2022 Jun 15. Crit Rev Toxicol. 2022. PMID: 35703156 Review.

10

Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.

Parris P, Martin EA, Stanard B, Glowienke S, Dolan DG, Li K, Binazon O, Giddings A, Whelan G, Masuda-Herrera M, Bercu J, Broschard T, Bruen U, Callis CM, Stults CLM, Erexson GL, Cruz MT, Nagao LM. Parris P, et al. Regul Toxicol Pharmacol. 2020 Dec;118:104802. doi: 10.1016/j.yrtph.2020.104802. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33038429

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