Zebrafish. Methods for Assessing Drug Safety and Toxicity

This book is a compilation of summarized analytical methods designed to serve the needs of pharmacologists, toxicologists, and other allied health professionals involved the development, use, or monitoring of pharmaceuticals. The summaries are structured monographs on 511 different drug entities detailing 964 different analytical methods, providing the reader with a thorough description of method validation. These analytical methods include not only high performance liquid chromatography (HPLC), but also gas chromatography (GC), immunoassay, electrophoresis, ultra performance liquid chromatography (UPLC) coupled with UV (UPLC-UV) detection and mass spectrometry (UPLC-MS/MS). With more detailed and complete summaries than sketchy and abbreviated formats used in the other books, this book provides a thorough description of method validation and results, as well as the operating parameters.

This book covers system safety methods related to occupational health and safety. It argues for anticipating hazards, risk reduction strategies for hazards processes, and making sure workers' tasks correspond to human capabilities. To this end, the text provides pro-active methods for identifying hazards, assessing risk, analyzing hazards, using tools from system safety, conducting post-incident investigations, considering human errors, applying risk reduction strategies, and managing process safety. While emphasizing methods suitable for all countries, it includes references to U.S. military and Department of Energy documents, as well as a discussion of fault-tree construction.

Explores the benefits and limitations of the latest high-throughput screening methods With its expert coverage of high-throughput in vitro screening methods for toxicity testing, this book makes it possible for researchers to accelerate and streamline the evaluation and risk assessment of chemicals and drugs for toxicity. Moreover, it enables them to comply with the latest standards set forth by the U.S. National Research Council's «Toxicity Testing in the 21st Century: A Vision and Strategy» and the E.U.'s REACH legislation. Readers will discover a variety of state-of-the-science, high-throughput screening methods presented by a group of leading authorities in toxicology and toxicity testing. High-Throughput Screening Methods in Toxicity Testing is divided into five parts: General aspects, including predicting the toxicity potential of chemicals and drugs via high-throughput bioactivity profiling Assessing different cytotoxicity endpoints Assessing DNA damage and carcinogenesis Assessing reproductive toxicity, cardiotoxicity, and haematotoxicity Assessing drug metabolism and receptor-related toxicity Each chapter describes method principles and includes detailed information about data generation, data analysis, and applications in risk assessment. The authors not only enumerate the advantages of each high-throughput method over comparable conventional methods, but also point out the high-throughput method's limitations and potential pitfalls. In addition, the authors describe current research efforts to make high-throughput toxicity screening even more cost effective and streamlined. Throughout the book, readers will find plenty of figures and illustrations to help them understand and perform the latest high-throughput toxicity screening methods. This book is ideal for toxicologists and other researchers who need to implement high-throughput screening methods for toxicity testing in their laboratories as well as for researchers who need to evaluate the data generated by these methods.

Facilitates the discovery and development of new, effective therapeutics With coverage of the latest mass spectrometry technology, this book explains how mass spectrometry can be used to enhance almost all phases of drug discovery and drug development, including new and emerging applications. The book's fifteen chapters have been written by leading pharmaceutical and analytical scientists. Their contributions are based on a thorough review of the current literature as well as their own experience developing new mass spectrometry techniques to improve the ability to discover and develop new and effective therapeutics. Mass Spectrometry for Drug Discovery and Drug Development begins with an overview of the types of mass spectrometers that facilitate drug discovery and development. Next it covers: HPLC–high-resolution mass spectrometry for quantitative assays Mass spectrometry for siRNA Quantitative analysis of peptides Mass spectrometry analysis of biological drugs Applications that support medicinal chemistry investigations Mass spectrometry imaging and profiling Throughout the book, detailed examples underscore the growing role of mass spectrometry throughout the drug discovery and development process. In addition, images of mass spectra are provided to explain how results are interpreted. Extensive references at the end of each chapter guide readers to the primary literature in the field. Mass Spectrometry for Drug Discovery and Drug Development is recommended for readers in pharmaceutics, including medicinal chemists, analytical chemists, and drug metabolism scientists. All readers will discover how mass spectrometry can streamline and advance new drug discovery and development efforts.

Drug Efficacy, Safety, and Biologics Discovery: Emerging Technologies and Tools covers key emerging technologies in pharmaceutical R & D and how they have substantially impacted (or are currently impacting) drug discovery. The cross-disciplinary collaborations implicit in integrating these technologies with drug discovery operations will fuel the engine for future innovations. This book cuts across the multiple areas of drug discovery, each chapter authored by pioneers in that field, making for a broad appeal to the chemical and biological scientists and technologists involved in drug discovery and development.

Provides comprehensive coverage of microneedles for delivering and monitoring patient drugs and vaccines Microneedles are an incredibly active research area and have the potential to revolutionize the way many medicines and vaccines are delivered. This comprehensive research book covers the major aspects relating to the use of microneedle arrays in enhancing both transdermal and intradermal drug delivery and provides a sound background to the use of microneedle arrays in enhanced delivery applications. Beginning with a history of the field and the various methods employed to produce microneedles from different materials, Microneedles for Drug and Vaccine Delivery and Patient Monitoring discusses the penetration of the stratum corneum by microneedles and the importance of application method and force and microneedle geometry (height, shape, inter-needle spacing). Transdermal and intradermal delivery research using microneedles is comprehensively and critically reviewed, focusing on the outcomes of in vivo animal and human studies. The book describes the important topics of safety and patient acceptability studies carried out to date. It also covers in detail the growing area for microneedle use in the monitoring of interstitial fluid contents. Finally, it reviews translational and regulatory developments in the microneedles field and describes the work ongoing in industry. The only book currently available on microneedles Filled with tables, graphs, and black and white images (photographs, micrographs) Authored by four experts in pharmaceutics Microneedles for Drug and Vaccine Delivery and Patient Monitoring is an ideal source for researchers in industry and academia working on drug delivery and transdermal delivery in particular, as well as for advanced students in pharmacy and pharmaceutical sciences.

Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.

The first edition of this book was based upon the recommendations of the Quality Assurance in the Treatment of Drug Dependence Project, and provided a step-by-step-guide for therapists working with clients with alcohol or other drug dependency or misuse. Since publication in 1995 it has become well known for its easy-to-read style and wealth of practical resource materials. However, the evidence in the field has moved forward in the last eight years, creating a need for an updated edition. Retaining the trademark easy-to-use, up-to-date style, the Second Edition offers new chapters on pharmacotherapies, case management, young people, and dual diagnosis. Other chapters have been updated to reflect the latest research findings and current practice, and the practice sheets and client handouts are made available online for downloading and customization by therapists.

Safety and Health for Engineers, 3rd Edition, addresses the fundamentals of safety, legal aspects, hazard recognition and control, and techniques for managing safety decisions, as well as: Completely revises and updates all 38 chapters in the book New edition adds more than 110 stories and cases from practice to illustrate various topics or issues New topics on adapting to new safety concerns that arise from technology innovations; convergence of safety, health and environmental departments in many organizations; the concept of prevention through design; and emphasis on safety management systems and risk management and analysis Includes learning exercises and computational examples based on real world situations along with in-depth references for each chapter Includes a detailed solutions manual for academic adopters Covers the primary topics included in certification exams for professional safety, such as CSP/ASP