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Research ArticleResearch

Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry

Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta and Patrick J. Faustino
PDA Journal of Pharmaceutical Science and Technology November 2016, 70 (6) 523-532; DOI: https://doi.org/10.5731/pdajpst.2015.006411
Anthony B. Ciavarella
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
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Mansoor A. Khan
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
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Abhay Gupta
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
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Patrick J. Faustino
Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
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  • For correspondence: Patrick.Faustino@fda.hhs.gov
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Article Information

vol. 70 no. 6 523-532
DOI 
https://doi.org/10.5731/pdajpst.2015.006411
PubMed 
27974592

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online December 13, 2016.

Article Versions

  • previous version (June 20, 2016 - 13:19).
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Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Anthony B. Ciavarella,
  2. Mansoor A. Khan,
  3. Abhay Gupta and
  4. Patrick J. Faustino*
  1. Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Food and Drug Administration, Life Science Building 64, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
  1. ↵* Address correspondence to Patrick J. Faustino, Ph.D., U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Life Science Building-64, Room 1078, Silver Spring, MD 20993 (Patrick.Faustino{at}fda.hhs.gov, 301-796-0021).
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PDA Journal of Pharmaceutical Science and Technology: 70 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 6
November/December 2016
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Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry
Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta, Patrick J. Faustino
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 523-532; DOI: 10.5731/pdajpst.2015.006411

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Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry
Anthony B. Ciavarella, Mansoor A. Khan, Abhay Gupta, Patrick J. Faustino
PDA Journal of Pharmaceutical Science and Technology Nov 2016, 70 (6) 523-532; DOI: 10.5731/pdajpst.2015.006411
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Keywords

  • Tablet scoring
  • Split tablets
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  • Gabapentin
  • Tablet splitters
  • Dose uniformity

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