A Practical Derivation of the Uncertainty Factor Applied to Adjust the Extractables/Leachables Analytical Evaluation Threshold (AET) for Response Factor Variation

References

1. 1.↵
   Product Quality Research Institute Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. PQRI, 2006.
2. 2.↵
   1. Mullis J. O.,
   2. Granger A.,
   3. Quin C.,
   4. Norwood D. L.

   The Analytical Evaluation Threshold (AET) Concept, Sensitivity and Analytical Uncertainty. Conference Proceedings, Leachables and Extractables. Smithers Rapra, Dublin, Ireland, March 2008.
3. 3.↵
   1. Jenke D.,
   2. Odufu A.

   Utilization of Internal Standard Response Factors to Estimate the Concentration of Organic Compounds Leached from Pharmaceutical Packaging Systems and Application of Such Estimated Concentrations to Safety Assessment. J. Chromatogr. Sci. 2012, 50 (3), 206–212.

   OpenUrlCrossRefPubMed
4. 4.↵
   1. Jenke D.

   Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable’s Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables. PDA J. Pharm. Sci. Technol. 2020, 74 (3), 348–358.

   OpenUrlAbstract/FREE Full Text
5. 5.↵
   1. Jenke D.,
   2. Heise T.

   The Implications of Chromatographically Screening Medical Products for Organic Leachables down to the AET Adjusted for Response Factor Variation. PDA J. Pharm. Sci. Technol. 2021, 75 (3), 273–288.

   OpenUrlAbstract/FREE Full Text
6. 6.↵
   1. Oktem B.

   CDRH Scientific Perspective on Chemical Analysis for Medical Devices. Presented at the PharmaEd Extractables & Leachables Virtual Summit 2020, July 30–31, 2020.
7. 7.↵
   1. Jordi M. A.,
   2. Khera S.,
   3. Roland K.,
   4. Jiang L.,
   5. Solomon P.,
   6. Nelson J.,
   7. Lateef S. S.,
   8. Woods J.,
   9. Martin L.,
   10. Martin S.,
   11. Aiello F.,
   12. Chen N.

   Qualitative Assessment of Extractables from Single-Use Components and the Impact of Reference Standard Selection. J. Pharm. Biomed. Anal. 2018, 150, 368–376.

   OpenUrl
8. 8.↵
   U.S. Pharmacopeial Convention, General Chapter <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. In USP 43—NF 38, USP: Rockville, MD, 2020.
9. 9.↵
   <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. Pharmacopeial Forum 46 (5), 2020.
10. 10.↵
    International Organization for Standardization, ISO 10993-18:2020 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process. ISO: Geneva, 2020.
11. 11.↵
    1. Jordi M. A.,
    2. Rowland K.,
    3. Liu W.,
    4. Cao X.,
    5. Zong J.,
    6. Ren Y.,
    7. Liang Z.,
    8. Zhou X.,
    9. Louis M.,
    10. Lerner K.

    Reducing Relative Response Factor Variation Using a Multidetector System for Extractables and Leachables (E&L) Analysis to Mitigate the Need for Uncertainty Factors. J. Pharm. Biomed. Anal. 2020, 186, 113334

    OpenUrl
12. 12.↵
    1. Zdravkovic S.

    A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials. PDA J. Pharm. Sci. Technol. 2021, 75 (6), 536–552.

    OpenUrlAbstract/FREE Full Text