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In Vitro Product Quality Tests and Product Performance Tests for Topical and Transdermal Drug Products

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Topical Drug Bioavailability, Bioequivalence, and Penetration

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Abstract

Two categories of tests are performed: (i) product quality tests and (ii) product performance tests. Product quality tests are intended to assess attributes of the dosage form whereas product performance tests are designed to assess the performance of the dosage form that in many cases is related to the drug release from the dosage form. Quality and performance tests together assure identity, strength, quality, purity, and performance of the drug product. All quality and performance tests for topical dosage forms are described.

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References

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Author information

Authors and Affiliations

  1. DOLE Pharma, LLC, 13 Oak Trail Rd., 07631, Englewood, NJ, USA

    Avraham Yacobi PhD, MPharm

  2. Department of Pharmaceutical Sciences, University of Nebraska Medical Center College of Pharmacy, 986025 Nebraska Medical Center, 68198-6025, Omaha, NE, USA

    Clarence T. Ueda

  3. 11309 Dunleith Place, 20878, North Potomac, MD, USA

    Vinod P. Shah

Authors
  1. Avraham Yacobi PhD, MPharm
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  2. Clarence T. Ueda
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  3. Vinod P. Shah
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Corresponding author

Correspondence to Avraham Yacobi PhD, MPharm .

Editor information

Editors and Affiliations

  1. Pharmaceutical Consultant, North Potomac, Maryland, USA

    Vinod P. Shah

  2. University of California, San Francisco School of Medicine, Department of Dermatology, San Francisco, California, USA

    Howard I. Maibach

  3. The Defence Science and Technology Laboratory, Biomedical Sciences Department, Salisbury, United Kingdom

    John Jenner

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Yacobi, A., Ueda, C., Shah, V. (2014). In Vitro Product Quality Tests and Product Performance Tests for Topical and Transdermal Drug Products. In: Shah, V., Maibach, H., Jenner, J. (eds) Topical Drug Bioavailability, Bioequivalence, and Penetration. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1289-6_6

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