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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
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  • For correspondence: daniel.norwood@boehringer-ingelheim.com
Lee M. Nagao
International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) 1500 K Street, NW, Suite 1100 Washington, DC 20005-1209
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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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PDA Journal of Pharmaceutical Science and Technology: 67 (5)
PDA Journal of Pharmaceutical Science and Technology
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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

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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
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  • Article
    • Abstract
    • Introduction
    • Industry Consortia—IPAC and IPAC-RS
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    • Acceptance of the PQRI OINDP Recommendations
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Keywords

  • Extractables
  • Leachables
  • Inhalation
  • OINDP
  • PQRI
  • Qualification threshold
  • Safety concern threshold
  • Analytical Evaluation Threshold

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