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Article CommentaryCommentary

Principles for Management of Extractables and Leachables in Ophthalmic Drug Products

Christopher T. Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang and Mary Richardson
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 278-294; DOI: https://doi.org/10.5731/pdajpst.2022.012744
Christopher T. Houston
1Bausch & Lomb, 1400 North Goodman St., Rochester, NY 14609;
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  • For correspondence: christopher.houston@bausch.com
Andrea Desantis Rodrigues
2PYC Therapeutics, 3210 Merryfield Row, San Diego, CA 92121;
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Brenda Birkestrand Smith
3Vir Biotechnology, 499 Illinois St., San Francisco, CA 94158;
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Tao Wang
4AbbVie, 2525 Dupont Drive, Irvine, CA 92612; and
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Mary Richardson
5iuvo BioScience, 7500 West Henrietta Rd, Rush, NY 14543
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PDA Journal of Pharmaceutical Science and Technology: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
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Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
Christopher T. Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang, Mary Richardson
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 278-294; DOI: 10.5731/pdajpst.2022.012744

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Principles for Management of Extractables and Leachables in Ophthalmic Drug Products
Christopher T. Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang, Mary Richardson
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 278-294; DOI: 10.5731/pdajpst.2022.012744
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  • Article
    • Abstract
    • Background
    • Importance of Assessing Leachables in ODPs
    • Current Regulatory Approaches
    • Specific Considerations for Managing Leachables in ODPs
    • Potential Sources and Common Classes of Leachables for ODPs
    • False Negatives Observed during Extractable Testing of Secondary Packaging Components and Leachable Testing of Drug Products for Which Secondary Packaging Components Are Critical
    • Experimental Design Considerations: Extraction/Simulation Studies for ODPs
    • Experimental Design Considerations: Leachable Studies for ODPs
    • Analytical Evaluation Threshold
    • Summary of Analytical Challenges for Extractables and Leachables in ODPs
    • Toxicological Considerations for Leachables in ODPs
    • Safety Qualification for Leachables in ODPs
    • Conclusion: Toxicological Considerations for Leachables in ODPs
    • Case Study on the Safety Qualification of Leachables in an ODP
    • General Sample Evaluation (with Examples of Assessment Tables)
    • Conclusion: Case Study
    • Conflict of Interest Declaration
    • Acknowledgment
    • Footnotes
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
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Keywords

  • Extractables
  • Leachables
  • Ophthalmics
  • Toxicity
  • Endpoints
  • Migrant
  • Simulation

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