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Article CommentaryCommentary

The Goldilocks Challenge—Controlling Uncertainty When Setting Product Specifications

Richard K. Burdick and Julia C. O'Neill
PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 439-445; DOI: https://doi.org/10.5731/pdajpst.2019.010850
Richard K. Burdick
1Burdick Statistical Consulting LLC, 7783 Renegade Hill Drive, Colorado Springs, CO 80923; and
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  • For correspondence: RickBASU@aol.com
Julia C. O'Neill
2Direxa Consulting LLC, 424 Roberts Avenue, Glenside, PA 19038-3605
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Article Information

vol. 74 no. 4 439-445
DOI 
https://doi.org/10.5731/pdajpst.2019.010850
PubMed 
32179710

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 31, 2020.

Article Versions

  • previous version (March 16, 2020 - 09:12).
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© PDA, Inc. 2020

Author Information

  1. Richard K. Burdick1,* and
  2. Julia C. O'Neill2
  1. 1Burdick Statistical Consulting LLC, 7783 Renegade Hill Drive, Colorado Springs, CO 80923; and
  2. 2Direxa Consulting LLC, 424 Roberts Avenue, Glenside, PA 19038-3605
  1. ↵*Corresponding Author: 7783 Renegade Hill Dr., Colorado Springs, CO 80923; Telephone: 719-896-5888; E-mail: RickBASU{at}aol.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 4
July/August 2020
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The Goldilocks Challenge—Controlling Uncertainty When Setting Product Specifications
Richard K. Burdick, Julia C. O'Neill
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 439-445; DOI: 10.5731/pdajpst.2019.010850

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The Goldilocks Challenge—Controlling Uncertainty When Setting Product Specifications
Richard K. Burdick, Julia C. O'Neill
PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 439-445; DOI: 10.5731/pdajpst.2019.010850
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Finding “Goldilocks Specification Limits”
    • 3. Example
    • 4. Summary and Recommendation
    • Conflict of Interest Declaration
    • References
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Keywords

  • Specifications
  • Quality by Design (QbD)
  • Tolerance interval
  • Product life cycle management
  • control strategy
  • Process capability
  • Statistical process control (SPC)

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