Similar articles for PMID: 31843988

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1

Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: An Updated Literature Review.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2020 May-Jun;74(3):324-347. doi: 10.5731/pdajpst.2019.010033. Epub 2019 Dec 16. PDA J Pharm Sci Technol. 2020. PMID: 31843988 Review.

2

Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review.

Jenke DR, Stults CL, Paskiet DM, Ball DJ, Nagao LM. Jenke DR, et al. PDA J Pharm Sci Technol. 2015 1/2;69(1):1-48. doi: 10.5731/pdajpst.2015.01005. PDA J Pharm Sci Technol. 2015. PMID: 25691713 Review.

3

How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):181-190. doi: 10.5731/pdajpst.2018.008938. Epub 2018 Sep 19. PDA J Pharm Sci Technol. 2019. PMID: 30232139

4

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

5

Assessment of Extractable Elements from Elastomers.

Paskiet D, Kraft C, Tullo E, Hunter J, Zurbriggen D. Paskiet D, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):83-91. doi: 10.5731/pdajpst.2017.008193. Epub 2018 Jul 20. PDA J Pharm Sci Technol. 2019. PMID: 30030347

6

Extractables Screening of Polypropylene Resins Used in Pharmaceutical Packaging for Safety Hazards.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):346-367. doi: 10.5731/pdajpst.2016.007401. Epub 2017 May 15. PDA J Pharm Sci Technol. 2017. PMID: 28512176

7

Application of Arrhenius Kinetics to Acceleration of Controlled Extraction Studies.

Jenke D. Jenke D. PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):135-169. doi: 10.5731/pdajpst.2018.009050. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361282

8

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

9

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

10

Identification of leachable impurities in an ophthalmic drug product originating from a polymer additive Irganox 1010 using mass spectroscopy.

Singh G, Gollapalli R, Blinder A, Patel M. Singh G, et al. J Pharm Biomed Anal. 2018 Apr 15;152:197-203. doi: 10.1016/j.jpba.2018.01.053. Epub 2018 Feb 2. J Pharm Biomed Anal. 2018. PMID: 29414013

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