Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group. – Product Quality Research Institute

Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group.

Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group.

Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group.

Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group.

Thresholds and Best Practices for Leachables and Extractables in Parenteral and Ophthalmic Drug Products Working Group
Diane Paskiet, Chair
Doug Ball, Toxicology Co-chair
Dennis Jenke, Chemistry Co-chair

Membership Criteria (PDF)
Proposal (PDF)
Work Plan (PDF)
Study Protocol – Stage 1 (PDF)

The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Opthalmic Drug Product (PODP) by Diane Paskiet, Dennis Jenke, Douglas Ball, et al.

Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products

Meeting Minutes

Chemistry Sub Team – October 3, 2012 (PDF)
Chemistry Sub Team – January 24, 2012 (PDF)
January 12, 2012 (PDF)
December 7, 2011 (PDF)
November 1, 2011 (PDF)
Toxicology Sub Team – August 24, 2011 (PDF)
Chemistry Sub Team – July 26, 2011 (PDF)
Chemistry Sub Team – June 28, 2011 (PDF)
April 7, 2011 (PDF)
December 13, 2010 (PDF)
September 23, 2010 (PDF)
Chemistry Sub Team – August 4, 2010 (PDF)
Chemistry Sub Team – June 28, 2010 (PDF)
April 15, 2010 (PDF)
February 23, 2010 (PDF)
Toxicology Sub Team – January 26, 2010 (PDF)
January 14, 2010 (PDF)
November 20, 2009 (PDF)
October 5, 2009 (PDF)
September 17, 2009 (PDF)
Chemistry Sub Team – September 17, 2009 (PDF)
February 19, 2009 (PDF)
November 4, 2008 (PDF)
October 24, 2008 (PDF)
July 30, 2008 (PDF)
June 24, 2008 (PDF)
Chemistry Sub Team – June 24, 2008 (PDF)
Toxicology Sub Team – June 24, 2008 (PDF)
April 23, 2008 (PDF)
February 7, 2008 (PDF)
January 8, 2008 (PDF)
December 20, 2007 (PDF)
July 9, 2007 (PDF)

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