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- Published online June 1, 2022.
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- previous version (February 15, 2022 - 08:07).
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© PDA, Inc. 2022
Author Information
- Christopher T. Houston1,*,
- Andrea Desantis Rodrigues2,
- Brenda Birkestrand Smith3,
- Tao Wang4 and
- Mary Richardson5
- 1Bausch & Lomb, 1400 North Goodman St., Rochester, NY 14609;
- 2PYC Therapeutics, 3210 Merryfield Row, San Diego, CA 92121;
- 3Vir Biotechnology, 499 Illinois St., San Francisco, CA 94158;
- 4AbbVie, 2525 Dupont Drive, Irvine, CA 92612; and
- 5iuvo BioScience, 7500 West Henrietta Rd, Rush, NY 14543
- ↵*Corresponding Author: Bausch & Lomb, 1400 North Goodman St., Rochester, NY 14609; Telephone: (585) 338-6764; E-mail: christopher.houston{at}bausch.com
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In This Issue
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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
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