Article CommentaryCommentary
A General Strategy for the Chemical Aspects of the Safety Assessment of Extractables and Leachables in Pharmaceutical Drug Products: The Chemical Assessment Triad
Dennis Jenke
PDA Journal of Pharmaceutical Science and Technology March 2012, 66 (2) 168-183; DOI: https://doi.org/10.5731/pdajpst.2012.00855

References
- 1.↵
Guidance for Industry. Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, May, 1999.
- 2.↵
Guideline on Plastic Immediate Packaging Materials. European Medicines Agency. CPMP/QWWP/4359/03. EMEA/CVMP/205/04. May 19, 2005.
- 3.↵
Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. QRI Leachables and Extractables Working Group, September 9, 2006, available at http://www.pqri.org/pdfs/LE-Recommendations-to-FDA-09-29-06.pdf.
- 4.↵
- Martin J.,
- Fitzgerald R.,
- Pothier N.,
- Ding W.
- 5.↵
- Jenke D.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 2
March/April 2012
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