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Development of a Content Uniformity Test Suitable for Sample Sizes between 30 and 100

  • Biostatistics
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Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

Spectroscopic methods such as near infrared (NIR) for content uniformity (CU) allow the measurement of significantly more dosage units per batch than required by traditional pharmacopoeial testing of 10 to 30 units. Sandell et al. proposed a nonparametric counting test for sample sizes greater than 100. There are manufacturing situations such as small batch sizes or restrictions due to sampling equipment that will yield medium sample sizes between 30 and 100 units per batch. This work provides alternative CU tests for medium sample sizes.

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Author information

Authors and Affiliations

  1. PhRMA CM&C Statistics Expert Team, sanofi-aventis, 10236 Marion Park Drive, Kansas City, Missouri, 64134-0708, USA

    Myron Diener

  2. PhRMA CM&C Statistics Expert Team, Pfizer, Kalamazoo, Michigan, USA

    Greg Larner

  3. PhRMA CM&C Statistics Expert Team, Novartis, East Hanover, New Jersey, USA

    Jim Pazdan

  4. PhRMA CM&C Statistics Expert Team, Merck, West Point, Pennsylvania, USA

    Lori Pfahler

  5. PhRMA CM&C Statistics Expert Team, GlaxoSmithKline, Zebulon, North Carolina, USA

    Helen Strickland

  6. PhRMA CM&C Statistics Expert Team, Pfizer, Groton, Connecticut, USA

    Kim Erland Vukovinsky

  7. Novo Nordisk, Bagsvaerd, Denmark

    Soren Andersen

Authors
  1. Myron Diener
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  2. Greg Larner
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  3. Jim Pazdan
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  4. Lori Pfahler
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  5. Helen Strickland
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  6. Kim Erland Vukovinsky
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  7. Soren Andersen
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Corresponding author

Correspondence to Myron Diener.

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Diener, M., Larner, G., Pazdan, J. et al. Development of a Content Uniformity Test Suitable for Sample Sizes between 30 and 100. Ther Innov Regul Sci 43, 287–298 (2009). https://doi.org/10.1177/009286150904300306

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  • DOI: https://doi.org/10.1177/009286150904300306

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