Article CommentaryPQRI Special Section
Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults
PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934
Daniel L. Norwood
International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) 1500 K Street, NW, Suite 1100 Washington, DC 20005-1209
Lee M. Nagao
International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) 1500 K Street, NW, Suite 1100 Washington, DC 20005-1209
Cheryl L. M. Stults
International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) 1500 K Street, NW, Suite 1100 Washington, DC 20005-1209

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Daniel L. Norwood, Lee M. Nagao, Cheryl L. M. Stults
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 413-429; DOI: 10.5731/pdajpst.2013.00934
Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
Daniel L. Norwood, Lee M. Nagao, Cheryl L. M. Stults
PDA Journal of Pharmaceutical Science and Technology Sep 2013, 67 (5) 413-429; DOI: 10.5731/pdajpst.2013.00934
Jump to section
- Article
- Abstract
- Introduction
- Industry Consortia—IPAC and IPAC-RS
- The Product Quality Research Insitiute (PQRI)
- Content of the PQRI OINDP Recommendations
- Acceptance of the PQRI OINDP Recommendations
- Scientific and Regulatory Initiatives Since 2006
- Specific Questions and Uncertainty
- Concluding Summary
- Conflict of Interest Declaration
- Acknowledgments
- References
- Figures & Data
- References
- Info & Metrics
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