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  • Book
    Joachim W. Fluhr, editor.
    Summary: Skin physiology assessment is moving from a descriptive approach to a deeper understanding of biophysical and biochemical processes in the stratum corneum, such as epidermal barrier function and stratum corneum hydration. New, non-invasive approaches offer reliable and reproducible methods for product testing in the pharmaceutical and cosmetic industry, as well as in basic research. While standard instruments focus on functional aspects, innovative devices offer a deeper understanding of underlying mechanisms. This book discusses the assessment of skin physiology and of skin functions in clinical studies using non-invasive biophysical instruments, offering readers a comprehensive guide to planning, performing and evaluating the results of scientific studies in skin measurement and the legal framework for these studies. Written by leading experts in the field, it focuses on practical aspects of non-invasive measurements. After introducing the legal aspects of the current framework for clinical cosmetic studies and basic research in cosmetology, it explores the technical practicalities of organizing a testing lab and the pre-requirements for planning a study. The third and main section addresses specific topics in cosmetic testing e.g. skin hydration, and also includes chapters on sensory aspects and in vivo skin structure vizualization. This new, updated edition of Practical Aspects of Cosmetic Testing is a valuable tool for researchers, students, and medical staff wanting to gain insights into how best to assess skin functions in controlled studies using non-invasive biophysical instruments.

    Contents:
    Intro
    Preface to the Second Edition
    Preface to the First Edition
    Contents
    Part I: Legal Aspects of Cosmetic Testing
    Chapter 1: Regulatory Aspects
    1.1 Comparison Between General Cosmetic Legislation in Europe and Other Countries
    1.2 Recent Changes in European Cosmetic Regulation
    1.3 Important Weblinks
    1.3.1 European Union
    1.3.2 USA
    1.3.3 Canada
    1.3.4 Japan
    1.3.5 Mercosur Countries (Examples)
    1.3.6 ASEAN Countries (Example)
    1.3.7 South Africa
    1.3.8 China
    1.3.9 India
    1.4 Cosmetic Safety Testing 1.5 Responsibility Considerations for Planning and Conduct of a Cosmetic Safety Study
    1.6 Frequent Cosmetic Safety Study Models
    1.7 Cosmetic Efficacy Testing
    1.8 Cosmetic Labeling and Packaging
    References
    Chapter 2: Ethical Aspects of Cosmetic Testing
    2.1 Introduction
    2.2 Brief History of Research Ethics
    2.3 Ethical Aspects of Cosmetic Testing
    2.4 Ethical Aspects of Noninvasive Skin Measurements
    2.5 Essential Ethical Requirements for Performing a Study
    2.6 Other Considerations
    2.7 Conclusion
    References
    Chapter 3: Good Clinical Practice 3.1 Principles of GCP
    3.2 Standard Operating Procedures (SOPs)
    3.3 Study Design and Protocol Standards
    3.4 Conduct Standards
    3.5 Recording and Reporting Standards
    References
    Chapter 4: Guidelines in Skin Testing
    4.1 Introduction
    4.2 Skin Bioengineering Endeavour
    4.3 Validation of Methods and Instrumentations
    4.4 Standardization and Quality Controls
    4.5 Search for "Good Biometrological Practice"
    4.6 Guidelines in Perspective
    4.7 Conclusion
    References
    Chapter 5: Claim Support: How to Create and Substantiate Claims 5.1 Introduction: Cosmetic Claims and Cosmetic Product Testing
    5.1.1 What Is a Cosmetic Claim?
    5.1.2 Borderline Claims
    5.2 The Process of Creating Cosmetic Claims
    5.2.1 Global or Regional
    5.2.2 Communication Style and Medium
    5.2.3 Consumer Factors
    5.3 Deciding How to Support a Claim
    5.3.1 Classifying Claims
    5.3.2 Level of Evidence
    5.3.2.1 Established and Widely Available Evidence
    5.3.2.2 Established Rationale But Requiring Specific Evidence
    5.3.2.3 Evidence Based Upon a Significant Advance in Science or Technology
    5.4 Generating Information to Support Claims 5.5 Presenting Information in Support of a Claim
    5.6 State of the Art
    5.7 Conclusion
    References
    Part II: General Aspects of Cosmetic Testing
    Chapter 6: Testing Laboratory
    6.1 Requirements for Accommodation and Arrangement
    6.1.1 Reception/Volunteer Recruitment Office
    6.1.2 Data Base/Subject File Room
    6.1.3 Waiting Area for Volunteers
    6.1.4 Room for Conducting General Volunteer Information Sessions
    6.1.5 Investigator's Office(s)/Examination Room(s)
    6.1.6 Testing Lab Room(s)
    6.1.7 Staff Office(s)
    6.1.8 Restrooms for Volunteers
    Digital Access Springer 2020