The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)

Diane Paskiet; Dennis Jenke; Douglas Ball; Christopher Houston; Daniel L. Norwood; Ingrid Markovic

doi:10.5731/pdajpst.2013.00936

Review ArticlePQRI Special Section

The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)

Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936

Diane Paskiet

1West Pharmaceutical Services, Exton PA, USA;

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For correspondence: diane.paskiet@westpharma.com

Dennis Jenke

2Baxter Healthcare Corporation, Round Lake, IL, USA;

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Douglas Ball

3Pfizer, Inc., Groton, CT, USA;

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Christopher Houston

4Bausch & Lomb, Rochester, NY, USA;

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Daniel L. Norwood

5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; and

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Ingrid Markovic

6United States Food and Drug Administration, Washington, DC, USA

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Article Information

vol. 67 no. 5 430-447

DOI

https://doi.org/10.5731/pdajpst.2013.00936

PubMed

24084659

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 1, 2013.

Author Information

Diane Paskiet1,*,
Dennis Jenke2,
Douglas Ball3,
Christopher Houston4,
Daniel L. Norwood5 and
Ingrid Markovic6

¹West Pharmaceutical Services, Exton PA, USA;
²Baxter Healthcare Corporation, Round Lake, IL, USA;
³Pfizer, Inc., Groton, CT, USA;
⁴Bausch & Lomb, Rochester, NY, USA;
⁵Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; and
⁶United States Food and Drug Administration, Washington, DC, USA

↵*Corresponding Author: Diane Paskiet, West Pharmaceutical Services, 530 Herman O. West Drive, Exton PA 19341-1147. diane.paskiet{at}westpharma.com

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PDA Journal of Pharmaceutical Science and Technology

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The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)

Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood, Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 430-447; DOI: 10.5731/pdajpst.2013.00936

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The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)

Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood, Ingrid Markovic

PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 430-447; DOI: 10.5731/pdajpst.2013.00936

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Keywords

Extractables
leachables
Safety assessment
Safety qualification thresholds
parenteral and ophthalmic drug products
Best practice recommendations
Biologic concerns
PQRI
Parenteral packaging
Ophthalmic containers

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