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Case ReportCase Studies

Evaluation of PDA Technical Report No 33. Statistical Testing Recommendations for a Rapid Microbiological Method Case Study

Thomas Murphy, Julie Schwedock, Kham Nguyen, Anna Mills and David Jones
PDA Journal of Pharmaceutical Science and Technology July 2015, 69 (4) 526-539; DOI: https://doi.org/10.5731/pdajpst.2015.01062
Thomas Murphy
Rapid Micro Biosystems, Inc., Lowell, MA, USA
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Julie Schwedock
Rapid Micro Biosystems, Inc., Lowell, MA, USA
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Kham Nguyen
Rapid Micro Biosystems, Inc., Lowell, MA, USA
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Anna Mills
Rapid Micro Biosystems, Inc., Lowell, MA, USA
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David Jones
Rapid Micro Biosystems, Inc., Lowell, MA, USA
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References

  1. 1.↵
    PDA Technical Report 33 (Revised). Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods; Parenteral Drug Association: Bethesda, MD, 2013; 30–33.
  2. 2.
    1. Schwedock J.
    Microbiology and statistics. Would the compendia method pass validation? Pharm. Technol. 2012, 35 (11), 75–79.
    OpenUrl
  3. 3.
    General Chapter <1227> Validation of microbial recovery from pharmacopeial articles. USP 32-NF27; U.S. Pharmacopeial Convention: Rockville, MD, 2009.
  4. 4.
    1. Montgomery D. C.
    Introduction to Statistical Quality Control, 3rd ed.; Wiley: Hoboken, NJ, 1996, pp 70–71.
  5. 5.↵
    1. Anderson T. W.,
    2. Darling D. A.
    A test of goodness of fit. J. Am. Stats. Assoc. 1954, 49 (268), 765–769.
    OpenUrlCrossRefWeb of Science
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PDA Journal of Pharmaceutical Science and Technology: 69 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 4
July/August 2015
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Evaluation of PDA Technical Report No 33. Statistical Testing Recommendations for a Rapid Microbiological Method Case Study
Thomas Murphy, Julie Schwedock, Kham Nguyen, Anna Mills, David Jones
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 526-539; DOI: 10.5731/pdajpst.2015.01062

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Evaluation of PDA Technical Report No 33. Statistical Testing Recommendations for a Rapid Microbiological Method Case Study
Thomas Murphy, Julie Schwedock, Kham Nguyen, Anna Mills, David Jones
PDA Journal of Pharmaceutical Science and Technology Jul 2015, 69 (4) 526-539; DOI: 10.5731/pdajpst.2015.01062
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  • Article
    • Abstract
    • Introduction
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Keywords

  • TR33
  • Rapid microbiological methods
  • Statistics
  • Method Validation
  • Growth Direct

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