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Gene Therapy
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Preclinical Safety Evaluation of Biopharmaceuticals
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the fi...
Regulatory Aspects of Gene Therapy and Cell Therapy Products
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Adenoviral Vectors for Gene Therapy
Adenoviral Vectors for Gene Therapy, Second Edition provides detailed, comprehensive coverage of the gene delivery vehicles that are based on the adenovirus that is emerging as an important tool in gene therapy. These exciting new therapeutic agents have great potential for the treatment of disease, making gene therapy a fast-growing field for research. This book presents topics ranging from the basic biology of adenoviruses, through the construction and purification of adenoviral vectors, cutting-edge vectorology, and the use of adenoviral vectors in preclinical animal models, with final consideration of the regulatory issues surrounding human clinical gene therapy trials. This broad scope ...
The Science of Superheroes
The truth about superpowers . . . science fact or science fiction? Superman, Batman, The X-Men, Flash, Spider Man . . . they protect us from evildoers, defend truth and justice, and, occasionally, save our planet from certain doom. Yet, how much do we understand about their powers? In this engaging yet serious work, Lois Gresh and Robert Weinberg attempt to answer that question once and for all. From X-ray vision to psychokinesis, invisibility to lightspeed locomotion, they take a hard, scientific look at the powers possessed by all of our most revered superheroes, and a few of the lesser ones, in an attempt to sort fact from fantasy. In the process, they unearth some shocking truths that will unsettle, alarm, and even terrify all but the most fiendish of supervillains.
Safety Evaluation of Biotechnologically-derived Pharmaceuticals
Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for th...
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.
Resilience in Ecology and Health
This edited book is a collection of essays addressing emerging concerns and pivotal problems about our planet’s environment and ecology. The contributions gathered here highlight the inter-relation of topics and expertise, connecting resilience with ecology, health, biotechnology and generational challenges. The book concludes with an ethical analysis of the multiple and over-lapping challenges that require urgent attention and long-term resolution. The book is written for scholars and students in a variety of disciplines and fields that deal with sustainability.
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”.
