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"This book examines genotoxic impurities and their impact on the pharmaceutical industry.Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed byasection on safety aspects, including safety tests in vivo and vitro, and data interpretation.The second section addresses the risk posed by genotoxic impurities fromoutside sources and from mutagenswithin DNA.In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities."

"Immunotoxicology is a highly specialized discipline that addresses potential adverse effects on the immune system, including immunosuppression, immunogenicity, hypersensitivity and other immune system functional disorders. A broad spectrum of xenobiotics, including agents present in our environment as well as pharmaceutical molecules may adversely affect the immune system."

"This is the definitive, one-stop resource on preclinical drug evaluation for potential mitochondrial toxicity, addressing the issue upfront in the drug development process. It discusses mitochondrial impairment to organs, skeletal muscle, and nervous systems and details methodologies used to assess mitochondria function. It covers both in vitro and in vivo methods for analysis and includes the latest models. "

"This book addresses all the current, up-to-date developments in this scientific discipline. Liver is the chief metabolizing site in the body, and thus, it is a major target organ for drug and chemical toxicity. Therefore, hepatotoxicity is an important endpoint in the safety evaluation of drugs and chemicals.Contributions from leading investigators in hepatotoxicity research address current developments in this scientific discipline and discuss use of current cutting edge technology such as microarrays in hepatotoxicity thus providing a better understanding of hepatotoxins, their interactions and mechanisms of action."

"Drug Safety Evaluation has been written with the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, health care providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated."

"Human interaction with the environment remains one of the most pervasive facets of modern society. In a world characterized by rapid population growth, unprecedented global trade and digital communications, energy security, natural resource scarcities, climatic changes and environmental quality, emerging diseases and public health, biodiversity and habitat modifications are routinely touted by the popular press as they canvas global political agendas and scholarly endeavors."

"Toxicogenomics : principles and applications fills the need for a single, thorough text on the key breakthrough technologies in genomics, proteomics, metabolomics, and bioinformatics, and their applications to toxicology research. The first section following a general introduction is on genomics and toxicogenomics, and qPCR. The next sections are toxicoproteomics and metabolomics. The final section covers bioinformatics aspects, from databases to data integration strategies. A practical resource for specialists and non-specialists alike, this book includes numerous illustrations that support the textual explanations."

"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 testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: In vitro mammalian cytogenetics tests Phototoxicity Carcinogenicity studies The pharmacogenomics of personalized medicine Bridging studies Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin."

"In Quantitative Modeling in Toxicology leading experts outline the current state of knowledge on the modeling of dose, tissue interactions and tissue responses. Each chapter describes the mathematical foundation, parameter estimation, challenges and perspectives for development, along with the presentation of a modeling template. Additionally, tools and approaches for conducting uncertainty, sensitivity and variability analyses in these models are described."

"This volume comprises a collection of contributions by leading experts in system identification, time-series analysis, environmetric modelling and control system design."