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Content Uniformity and Dose Uniformity: Current Approaches, Statistical Analyses, and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products

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Abstract

This article reviews current and proposed approaches to content uniformity testing. In addition, the article proposes an approach that allows regulatory agencies and compendia to clearly state allowable consumer risk. Further, the article suggests that producers be allowed to control producer risk through selection of numbers of units and testing tiers. The approach facilitates risk communication to practitioners and patients/consumers, which is impeded with current approaches, and reduces regulatory and compendial burden.

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Authors and Affiliations

  1. U.S. Pharmacopeia, Rockville, Maryland, 20852

    Roger L. Williams

  2. Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, 20857

    Wallace P. Adams

  3. Office of New Drug Chemistry, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, 20857

    Guirag Poochikian

  4. Biostatistics Section, Thomas Jefferson University, Philadelphia, Pennsylvania, 19107

    Walter W. Hauck

Authors
  1. Roger L. Williams
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  2. Wallace P. Adams
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  3. Guirag Poochikian
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  4. Walter W. Hauck
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Correspondence to Walter W. Hauck.

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Williams, R.L., Adams, W.P., Poochikian, G. et al. Content Uniformity and Dose Uniformity: Current Approaches, Statistical Analyses, and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products. Pharm Res 19, 359–366 (2002). https://doi.org/10.1023/A:1015114821387

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