Similar articles for PMID: 25188347

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1

The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete.

Jenke D, Couch TR, Robinson SJ, Volz TJ, Colton RH. Jenke D, et al. PDA J Pharm Sci Technol. 2014 May-Jun;68(3):256-70. doi: 10.5731/pdajpst.2014.00977. PDA J Pharm Sci Technol. 2014. PMID: 25188347

2

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

3

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

4

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

5

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

6

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

7

A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study.

Zdravkovic SA, Bruss MD, Piccoli RF, Wood DM. Zdravkovic SA, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):504-26. doi: 10.5731/pdajpst.2014.00992. PDA J Pharm Sci Technol. 2014. PMID: 25336421

8

Extractables analysis of single-use flexible plastic biocontainers.

Marghitoiu L, Liu J, Lee H, Perez L, Fujimori K, Ronk M, Hammond MR, Nunn H, Lower A, Rogers G, Nashed-Samuel Y. Marghitoiu L, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):49-58. doi: 10.5731/pdajpst.2015.01001. PDA J Pharm Sci Technol. 2015. PMID: 25691714

9

Analysis and evaluation of single-use bag extractables for validation in biopharmaceutical applications.

Pahl I, Dorey S, Barbaroux M, Lagrange B, Frankl H. Pahl I, et al. PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):456-71. doi: 10.5731/pdajpst.2014.00996. PDA J Pharm Sci Technol. 2014. PMID: 25336417

10

Safety risk categorization of organic extractables associated with polymers used in packaging, delivery and manufacturing systems for parenteral drug products.

Jenke D. Jenke D. Pharm Res. 2015 Mar;32(3):1105-27. doi: 10.1007/s11095-014-1523-z. Epub 2014 Oct 4. Pharm Res. 2015. PMID: 25277279

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