Growing public interest in animal welfare issues in recent decades has prompted increased attention to the efforts to develop alternative, nonanimal methods for use in biomedical research and product testing. In A History of the Development of Alternatives to Animals in Research and Testing, the first book-length study of the subject, John Parascandola traces the history of the concept of alternatives to the use of animals in research and testing in Britain and the United States from its beginnings until it had become firmly established in the scientific and animal protection communities by the end of the 1980s. This account of the history of alternatives is set within the context of developments within science, animal welfare, and politics. The book covers the key role played by animal welfare advocates in promoting alternatives, the initial resistance to alternatives on the part of many in the scientific community, the opportunity provided by alternatives for compromise and cooperation between these two groups, and the dominance of the “Three Rs”—reduction, refinement, and replacement.

The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.

Opinion leaders in science and politics examine findings and legislation in alternatives to animal testing! Refine, reduce, replace - These are the three demands that scientists have placed upon themselves in their search for alternatives to animal testing. Indeed much interdisciplinary research is being carried on today, and new fields have emerged, such as in-vitro toxicology. The three R's call for new scientific insights. Moreover, validation and acceptance strategies have to be adapted, a process of much ongoing interest and vital concern to the pharmaceutical and cosmetic industries. Researchers need to know exactly what has been achieved and accepted in alternatives to animal testing in science and politics. In this book they have the opportunity to benefit from the knowledge and expertise of leading researchers and influential representatives of national and international regulatory authorities.

Software and Programming Tools in Pharmaceutical Research is a detailed primer on the use for computer programs in the design and development of new drugs. Chapters offer information about different programs and computational techniques in pharmacology. The book will help readers to harness computer technologies in pharmaceutical investigations. Readers will also appreciate the pivotal role that software applications and programming tools play in revolutionizing the pharmaceutical industry. The book includes nine structured chapters, each addressing a critical aspect of pharmaceutical research and software utilization. From an introduction to pharmaceutical informatics and computational chemistry to advanced topics like molecular modeling, data mining, and high-throughput screening, this book covers a wide range of topics. Key Features: · Practical Insights: Presents practical knowledge on how to effectively utilize software tools in pharmaceutical research. · Interdisciplinary Approach: Bridges the gap between pharmaceutical science and computer science · Cutting-Edge Topics: Covers the latest advancements in computational drug development, including data analysis and visualization techniques, drug repurposing, pharmacokinetic modelling and screening. · Recommendations for Tools: Includes informative tables for software tools · Referenced content: Includes scientific references for advanced readers The book is an ideal primer for students and educators in pharmaceutical science and computational biology, providing a comprehensive foundation for this rapidly evolving field. It is also an essential resource for pharmaceutical researchers, scientists, and professionals looking to enhance their understanding of software tools and programming in drug development.

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.

The Ethics of Psychological Research contains expanded versions of original presentations reported in a two-day symposium on Ethics in Psychological Research held at Atkinson College, York University, near Toronto in September 1980. The book is organized into three major sections, wherein the first deals with ethical principles and regulations, the second with ethics of research with special populations, and the third with problems associated with applications of scientific knowledge. A concluding section then details the results of a psychological research method applied to the question of a psychological ethic.

Too much emotion and insufficient fact. This paradox has long characterized the controversy surrounding animal research. Of Mice, Models, and Men is the first exhaustive treatment of all areas—empirical and conceptual—relevant to the use of animals in research. It is also the first study to combine regard for the welfare of laboratory animals with a knowledgeable acceptance of the continuing need for research involving animals. The book has another rare quality. It is virtually devoid of any of the emotional and exaggerated attacks that have characterized many of the other publications in this area. Instead, it presents, in a manner accessible to both sides, all the relevant historical, social, and scientific information required to form an opinion on the subject. The book thus achieves a most difficult goal—that of bridging the gap between researchers using animals and animal welfare advocates, while pointing out the need for a more active program to promote laboratory animal welfare.