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The goal of an activity-directed isolation process is to isolate bioactive compounds which may provide structural leads of therapeutic importance. Whereas the traditional process of drug development is long and expensive, simple and rapid bioassays can serve as the starting point for drug discovery. This book presents a range of "bench top" bioassa
This comprehensive and useful handbook represents a definitive up-to-date compendium of key in vitro bioassay methods that are employed to quantify and validate the anticancer activity of a drug candidate before it makes its way in to animal or clinical trials. In Vitro Bioassay Techniques for Anticancer Drug Discovery and Development covers the screening and evaluation of potential drug candidates in a wide category of anticancer assays demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules. The major emphasis of the book is to present those bioassays which can be readily set up and practiced in any laboratory with limited funds, facilities or technical know-how.
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Bioassay Methods in Natural Product Research and Drug Development contains the proceedings from the Phytochemical Society of Europe's very successful symposium on this topic, held August 24-27, 1997 in Uppsala, Sweden. In this volume, leading academic and industrial scientists discuss novel methods for assaying natural products to find new structure-activity relationships. Of key importance in this process is the availability and reliability of specific bioassay methods, but chapters also discuss chemical and biological diversity and how to dereplicate natural product extracts to increase efficiency in lead discovery. Anti-tumor, HIV-inhibitory, antiprotozoal, anti-infective and immunomodulatory natural products are discussed. Various industrial projects are presented for the first time. This volume bridges the gap between academic and industrial research and scientists, and should be required reading in drug companies and faculties of pharmacy, as well as serving scientists in pharmacognosy, pharmacology, phytochemistry, natural products and drug discovery.
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source
This detailed book explores protocols for a wide array of preclinical pharmacology and toxicology evaluations to be applied to chemical drugs and their development through in vitro, involving tissues and cell lines, and in vivo models, using animals as experimental systems, utilized to conduct pharmacological research. Written for the Springer Protocols Handbooks series, the methodologies included in this collection have been standardized by the authors through extensive use in the lab so that they are ready to be applied in the labs of readers around the world. Authoritative and practical, Bioassays in Experimental and Preclinical Pharmacology aims to assist undergraduate and postgraduate students, research scholars, scientists, and other academicians performing research in the vital field of drug discovery.
Exploring innovative routes of drug discovery in the postgenomic era, Microbial Genomics and Drug Discovery examines bioinformatic and genomic approaches for the identification, detection, selection, and validation of new antibacterial targets and vaccine candidates. The book discusses potential pathways for effective infection control, inhibition of antibacterial resistance, and acceleration of the drug discovery process. This comprehensive reference describes procedures to recognize common targets in various bacterial species for the design of broad-spectrum antibiotics and clearly illustrates the use of pathway tools in a genomics-based drug discovery project.
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
This book describes the processes that are involved in the development of new drugs. The authors discuss the history, role of natural products and concept of receptor interactions with regard to the initial stages of drug discovery. In a single, highly readable volume, it outlines the basics of pharmacological screening, drug target identification, and genetics involved in early drug discovery. The final chapters introduce readers to stem therapeutics, pharmacokinetics, pharmacovigilance, and toxicological testing. Given its scope, the book will enable research scholars, professionals and young scientists to understand the key fundamentals of drug discovery, including stereochemistry, pharmacokinetics, clinical trials, statistics and toxicology.