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Basics on Clinical Safety Testing

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Dermatopharmacology of Topical Preparations

Abstract

Safety testing of topically applied products is now a necessity. Not only do legislative bodies have recommended procedures and legal requirements for the safety testing of topically applied pharmaceuticals, but such bodies have also identified the need for legislation of cosmetics and toiletries. Thus, the European Community (EC) Directive clearly states that “Cosmetic products put on the market within the European Community must not cause damage to human health when they are applied under normal or reasonably foreseeable conditions of use”. There are now also a range of topical products that fall between conventional topical pharmaceuticals and cosmetic products. This was recognised some 20 years ago by Albert Kligman, who introduced the term ‘cosmeceuticals’ to a meeting of the Society of Cosmetic Chemists. This third category has led to some debate concerning the safety testing requirements of the different product categories. The situation is further complicated by the classifications used by different governments. Sunscreens, for example, are currently classified as drugs in the USA, quasi-drugs in Japan and cosmetic products in Europe.

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Authors
  1. Peter J. Dykes
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  2. Anthony D. Pearse
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Editor information

Editors and Affiliations

  1. Abteilung Biopharmazie Spirig AG, Pharmazeutische Präparate, 4622, Egerkingen, Switzerland

    Bernard Gabard

  2. Institut für Spital-Pharmazie, Universitätskliniken/Kantonspital Basel, Spitalstraße 26, 4031, Basel, Switzerland

    Christian Surber

  3. Klinik für Hautkrankheiten, Klinikum der Friedrich Schiller-Universität Jena, Erfurter Straße 35, 07740, Jena, Germany

    Peter Elsner

  4. Laboratoires Spirig SA, 109, Boulevard d’Haussonville, 5400, Nancy, France

    Pierre Treffel

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© 2000 Springer-Verlag Berlin Heidelberg

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Dykes, P.J., Pearse, A.D. (2000). Basics on Clinical Safety Testing. In: Gabard, B., Surber, C., Elsner, P., Treffel, P. (eds) Dermatopharmacology of Topical Preparations. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-57145-9_6

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  • DOI: https://doi.org/10.1007/978-3-642-57145-9_6

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-62960-0

  • Online ISBN: 978-3-642-57145-9

  • eBook Packages: Springer Book Archive

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