Research ArticleResearch
Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 4-27; DOI: https://doi.org/10.5731/pdajpst.2024.012964
Steven A. Zdravkovic
1Baxter;
Qiang Fu
2Hikma;
Aaron Flick
3American Regent;
Bhargava Jana
1Baxter;
Elizabeth Looney
4Pfizer;
Samuel Kikandi
5Sanofi; and
Tim Verdonck
1Baxter;
Lee Nagao
6Faegre, Drinker, Biddle and Reath
Mary Kate Bielinski
6Faegre, Drinker, Biddle and Reath

References
- 1.↵U.S. Pharmacopeial Convention, <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. Pharmacopeial Forum 2013, 39(5), 270–290.
- 2.↵Product Quality Research Institute. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI, 2006.
- 3.↵Product Quality Research Institute. Safety Thresholds and Best Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular). PQRI, 2021.
- 4.↵International Organization for Standardization, ISO 10993-18 Biological Evaluation of Medical Devices—Part 18 Chemical Characterization of Medical Device Materials within a Risk Management Process. ISO: Geneva, 2020.
- 5.↵
- 6.↵
- Jenke D.
- 7.↵
- Johnson C.,
- Bassan A.,
- Kiehl D.,
- Paskiet D.,
- Pavan M.,
- Parris P.,
- Whelan G.,
- Burild A.,
- Myatt G. J.
- 8.↵
- Jenke D.,
- Beusen J. M.,
- Verlinde P.,
- Baeten J.,
- Christiaens P.,
- Hunt D.,
- Gruddanti P.
- 9.↵
- Zdravkovic S.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 4-27; DOI: 10.5731/pdajpst.2024.012964
Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski
PDA Journal of Pharmaceutical Science and Technology Jan 2025, 79 (1) 4-27; DOI: 10.5731/pdajpst.2024.012964
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