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th Together with the 6 Amendment - Council Directive 93/35 EEC - to the Cosmetic Directive 76/768 EEC it was the first time that, according to Article 7b, special claims of efficacy could be legally attributed to cosmetic products but under the obligation to make evidence of the claimed effects; also an entirely new "controller" was introduced - the independent "safety assessor", This indeed means not only progress in reliable and honest marketing arguments but above all transparency as to the respective proof and thus protection of consumer's health. Such claims demand high standards in scientifi cally based methodology and their results in order to prove such demands evidently. There are also within the 6" Amendment to the Cosmetic Directive in Article 4a strict restrictions as to the further use of conventional animal testing for cosmetic pro ducts and their ingredients and especially for finished products. Without doubt there is a competition between the necessity and expectations on consumer health on the one hand and the requirements of acknowledged protection of animals as done in Council Directive 86/609 EEC on the other. But at least, based on the present state of knowledge, tests in human beings cannot replace animal testing in all instances. Not only ethical reasons alone prohibit or impede testing in humans but also very often the lack of knowledge on functional and/or biological processes underlaying observed effects with the consequence that suitable experimental methodologies are missing.
Skin physiology assessment is moving rapidly from a descriptive approach to a deeper understanding of biophysical and biochemical processes in the stratum corneum, e.g. on stratum corneum barrier function as well on stratum corneum hydration. The research with bioengineering methods offers now reliable and reproducible approaches for product testing in the pharmaceutical and cosmetic industry as well as in basic research. This cookbook is intended to give basic information regarding skin physiology, the assessment of skin functions in controlled studies using non-invasive biophysical instruments. It provides basic knowledge on how to plan, perform and evaluate scientific studies. The authors are recognized expert in the field and provide comprehensive chapters with specific emphasis on the practical aspects of non-invasive measurements.
Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.
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.
Presents up-to-date concepts and approaches to the theory and practice of alternatives to animal testing and promotes technology transfer. The text addresses some of the ramifications of the National Institutes of Health Revitalization Act of 1993 which instructs the NIH to fund replacement, reduction and refinement alternatives. It also describes the likely impact of the European Union's Cosmetic Directive, which bans marketing of animal tested cosmetics in Europe after 1997 if alternatives are available. Contributions are grouped into five categories including: dermal toxicity; immunotoxicity; neurotoxicity; and oral/dermal/ocular validation.
This volume of Current Problems in Dermatology presents the reader with a portrait of the scientific background of the complex process of safety assessment of cosmetics as well as information on European cosmetic legislation. A practical approach to the search for toxicity data on cosmetic ingredients and a compilation of the legally required technical dossier of a finished cosmetic product as well as an in-depth analysis of the safety assessment of cosmetic ingredients performed at the EU level by the Scientific Committee on Consumer Products (SCCP) are available. The current status of 3R alternatives to animal testing and the extent to which they are implemented by the cosmetic industry and considered by the SCCP in the risk assessment process is discussed. As such, guidance is provided in relation to the manifold challenges cosmetic safety assessors are faced with in the current EU regulatory setting.In this valuable handbook, qualified cosmetic safety assessors, suppliers of raw materials, dermatologists and pharmacists, toxicologists as well as EU officials and administrators dealing with cosmetics will find relevant information on the European cosmetic legislation, the compilation of cosmetic technical dossiers, toxicological database searches, and the availability and use of alternative methods in the field of cosmetics.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.