The Goldilocks Challenge—Controlling Uncertainty When Setting Product Specifications

References

1. 1.↵
   U.S. Food and Drug Administration, Advancing Health Through Innovation: 2017 New Drug Therapy Approvals. Center for Drug Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, January 2018.
2. 2.↵
   International Conference for Harmonisation, Quality Guideline Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. ICH: Geneva, 1999.
3. 3.↵
   International Conference for Harmonisation, Quality Guideline Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH: Geneva, 1999.
4. 4.↵
   International Conference for Harmonisation, Quality Guideline Q8(R2) Annex. ICH: Geneva, 2009.
5. 5.↵
   International Conference for Harmonisation, Quality Guideline Q10: Pharmaceutical Quality System. ICH: Geneva, 2008.
6. 6.↵
   International Conference for Harmonisation, Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH: Geneva, 2012.
7. 7.↵
   1. Woodcock J.

   The Concept of Pharmaceutical Quality. Am. Pharm. Rev. 2004, 7 (6), 10–15.

   OpenUrl
8. 8.↵
   European Biopharmaceutical Enterprises. Considerations in Setting Specifications. EBE Web site, 2013. https://www.ebe-biopharma.eu/ (accessed June 25, 2020).
9. 9.↵
   1. Bercu J.,
   2. Berlam S. C.,
   3. Berridge J.,
   4. Cherney B.,
   5. Cowley D.,
   6. Laughton H. W.,
   7. McLoughlin D.,
   8. McMahon M.,
   9. Moore C. M. V.,
   10. Murti C.,
   11. O'Neill J.,
   12. Parsons R.,
   13. Peng D. Y.,
   14. Quan R. W.,
   15. Subashi A. K.,
   16. Teasdale A.,
   17. Tyler S. M.,
   18. Watson T. J.

   Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities. J. Pharm. Innovation 2019, 14 (1), 76–89.

   OpenUrl
10. 10.↵
    1. Burdick R. K.,
    2. LeBlond D. J.,
    3. Pfahler L. B.,
    4. Quiroz J.,
    5. Sidor L.,
    6. Vukovinsky K.,
    7. Zhang L.

    Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry; Springer: Cham, Switzerland, 2017. p 231.
11. 11.↵
    1. Montgomery D. C.

    Introduction to Statistical Quality Control, 7th ed.; John Wiley & Sons, Inc: Hoboken, NJ, 2013.
12. 12.↵
    1. Woodall W. H.

    Controversies and Contradictions in Statistical Process Control. J. Qual. Technol. 2000, 32 (4), 341–350.

    OpenUrl
13. 13.↵
    1. Howe W. G.

    Two-Sided Tolerance Limits for Normal Populations—Some Improvements. J. Am. Stat. Assoc. 1969, 64 (326), 610–620.

    OpenUrl
14. 14.↵
    1. Meeker W. Q.,
    2. Hahn G. J.,
    3. Escobar L. A.

    Statistical Intervals: A Guide for Practitioners and Researchers, 2nd ed.; John Wiley & Sons, Inc: Hoboken, NJ, 2017, Section 5.3.