Lee-Na M. Gao

Most-cited papers

1. Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

   T. Broschard, S. Glowienke, Uma Bruen, Lee-Na M. Gao +7 more

   2016Regulatory toxicology and pharmacology : RTP64 citations

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2. Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studies.

   P. Parris, Elizabeth A. Martin, B. Stanard, S. Glowienke +14 more

   2020Regulatory toxicology and pharmacology : RTP22 citations

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3. Aspects of Particle Science and Regulation in Pharmaceutical Inhalation Drug Products

   Lee-Na M. Gao, S. Lyapustina, Melinda K. Munos, M. Capizzi

   200512 citations

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4. Application of modern analytical technologies to the identification of extractables and leachables

   D. Norwood, Lee-Na M. Gao, S. Lyapustina, Melinda K. Munos

   200511 citations

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5. Inhalation Drug Products for ''Safety Thresholds and Best Practices'' Recommendations Perspectives on the PQRI Extractables and Leachables

   D. Norwood, Lee-Na M. Gao, C. L. Stults

   20168 citations

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6. Recommendations to the Food and Drug Administration: Metered Dose Inhaler Tests and Methods in the Chemistry, Manufacturing, and Controls Draft Guidances for Metered Dose Inhalers and Dry Powder Inhalers

   Lee-Na M. Gao, Inhalation Technology Focus GroupInternational Pharmaceutical Team

   20026 citations

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7. Overview of Leachables and Extractables in Orally Inhaled and Nasal Drug Products

   D. J. Ball, D. Norwood, Lee-Na M. Gao

   20124 citations

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8. Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products

   D. Norwood, C. L. Stults, Lee-Na M. Gao

   20121 citations

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9. A perspective on the challenges of extractables, leachables and materials supply for orally inhaled and nasal drug products

   J. O. Mullis, C. L. Stults, B. Falco, Melinda K. Munos +1 more

   20071 citations

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10. Appendix 3: Protocol Addition, Phase 2 Studies: Quantitative Controlled Extraction Studies on the Sulfur - Cured Elastomer

    D. J. Ball, D. Norwood, C. L. Stults, Lee-Na M. Gao

    20120 citations Open access

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11. Appendix 1: Experimental Protocol for Controlled Extraction Studies on Elastomeric Test Articles

    D. J. Ball, D. Norwood, C. L. Stults, Lee-Na M. Gao

    20120 citations

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12. Appendix 4: Protocol Addition, Phase 2 Studies: Quantitative Extractables Studies on Sulfur - Cured Elastomer and Polypropylene

    D. J. Ball, D. Norwood, C. L. Stults, Lee-Na M. Gao

    20120 citations

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