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According to the Institute of Medicine (IOM) and U.S. Food and Drug Administration (FDA), 'developing new scientific approaches to detecting, understanding, predicting and preventing adverse events' was a critical path to the future of drug safety. This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment and promotes evidence-based toxicology. Each specific area of toxicology relevant for drug discovery is discussed in detail, including theory, experimental approaches and data interpretation supported by comprehensive up-to-date references. Many chapters provide fascinating case studies, which are of general interest for those who have basic science training and are interested in how chemicals interact with the human body.
The first book to focus on comprehensive systems biology as applied to drug discovery and development Drawing on real-life examples, Systems Biology in Drug Discovery and Development presents practical applications of systems biology to the multiple phases of drug discovery and development. This book explains how the integration of knowledge from multiple sources, and the models that best represent that integration, inform the drug research processes that are most relevant to the pharmaceutical and biotechnology industries. The first book to focus on comprehensive systems biology and its applications in drug discovery and development, it offers comprehensive and multidisciplinary coverage of...
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.
The discovery and development of a biological active molecule with therapeutic properties is an ever increasing complex task, highly unpredictable at the early stages and marked, in the end, by high rates of failure. As a consequence, the overall process leading to the production of a successful drug is very costly. The improvement of the net outcome in drug discovery and development would require, amongst other important factors, a good understanding of the molecular events that characterize the disease or pathology in order to better identify likely targets of interest, to optimize the interaction of an active agent (small molecule or macromolecule of natural or synthetic origin) with thos...
A unique, integrative look at information-based medicine The convergence of medical science, biology, pharmacology, biomedical engineering, healthcare, and information technology is revolutionizing medical and scientific practice, and has broader social implications still being understood. The Engines of Hippocrates provides a unique, integrative, and holistic look at the new paradigm of information-based medicine, covering a broad range of topics for a wide readership. The authors take a comprehensive approach, examining the prehistory, history, and future of medicine and medical technology and its relation to information; how history led to such present-day discoveries as the structure of ...
Apply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, ...
Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.
Dieses Buch ist ein wichtiges Referenzwerk für Toxikologen in vielen Bereichen und bietet eine umfassende Analyse molekular Modellansätze und Strategien der Risikobewertung von pharmazeutischen und Umweltchemikalien. - Zeigt, was mit rechnergestützter Toxikologie aktuell erreicht werden kann, und wirft einen Blick auf zukünftige Entwicklungen. - Gibt Antworten zu Themen wie Datenquellen, Datenpflege, Behandlung, Modellierung und Interpretation kritischer Endpunkte im Hinblick auf Gefahrenbewertungen im 21. Jahrhundert. - Bündelt herausragende Konzepte und das Wissen führender Autoren in einem einzigartigen Referenzwerk. - Untersucht detailliert QSAR-Modelle, Eigenschaften physiochemischer Arzneistoffe, strukturbasiertes Drug Targeting, die Bewertung chemischer Mischungen und Umweltmodelle. - Behandelt zusätzlich die Sicherheitsbewertung von Verbraucherprodukten und den Bereich chemische Abwehr und bietet Kapitel zu Open-Source-Toxikologie und Big Data.
Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.
Methods, Processes, and Tools for Collaboration "The time has come to fundamentally rethink how we handle the building of knowledge in biomedical sciences today. This book describes how the computational sciences have transformed into being a key knowledge broker, able to integrate and operate across divergent data types." Bryn Williams-Jones, Associate Research Fellow, Pfizer The pharmaceutical industry utilizes an extended network of partner organizations in order to discover and develop new drugs, however there is currently little guidance for managing information and resources across collaborations. Featuring contributions from the leading experts in a range of industries, Collaborative ...