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Preclinical Development Handbook
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and te...
Biological Reactive Intermediates IV
The finding that chemicals can be metabolically activated to yield reactive chemical species capable of covalently binding to cellular macromolecules and the concept that these reactions could initiate toxicological and carcinogenic events stimulated a meeting by a small group of toxicologists at the University of Turku, in Finland, in 1975 (Jollow et al. , 1977). The growing interest in this field of research led to subsequent symposia at the University of Surrey, in England in 1980 (Snyder et al. , 1982), and the University of Maryland in the U. S. A. in 1985 (Kocsis et al. , 1986). The Fourth International Symposium on Biological Reactive Intermediates was hosted by the Center for Toxicol...
Toxicological Testing Handbook
Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance. Every chapter highlights regulatory requirements specific to the United States, Europe, and Japan, and in addition to expanded information on da
Global Approach in Safety Testing
This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.
Immunotoxicology Strategies for Pharmaceutical Safety Assessment
An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates Helps readers understand the significance of the methods and approaches to immunotoxicology testing Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing
Xenotransplantation
Xenotransplantation involves the transplantation of cells, tissues, and whole organs from one species to another. Interest in animal-to-human xenotransplants has been spurred by the continuing shortage of donated human organs and by advances in knowledge concerning the biology of organ and tissue rejection. The scientific advances and promise, however, raise complex questions that must be addressed. This book considers the scientific and medical feasibility of xenotransplantation and explores the ethical and public policy issues surrounding the possibility of renewed clinical trials. The volume focuses on the science base of xenotransplantation, public health risks of infectious disease transmission, and ethical and public policy issues, including the views of patients and their families.
