Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables

References

1. 1.↵
   PQRI Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, 2006. Product Quality Research Institute Web Site. http://pqri.org/wp-content/uploads/2015/08/pdf/LE_Recommendations_to_FDA_09-29-06.pdf (accessed June 16, 2019).
2. 2.↵
   1. Norwood D. L.,
   2. Nagao L. M.

   The Analytical Evaluation Threshold (AET),. 2005. Product Quality Research Institute Web Site. http://pqri.org/wp-content/uploads/2015/08/pdf/PQRI_AET_Poster.pdf (accessed June 14, 2019).
3. 3.↵
   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
4. 4.↵
   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.
5. 5.↵
   1. Christiaens P.,
   2. Beusen J. M.,
   3. Verlinde P.,
   4. Baeten J.,
   5. Jenke D.

   Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation. PDA J. Pharm. Sci. Technol. 2020, 74 (1), 108–133.

   OpenUrlAbstract/FREE Full Text