Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers - Hardcover

Hardcover

ISBN 10: 1119053331 ISBN 13: 9781119053330

Verlag: Wiley, 2016

Inhaltsangabe

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process.

• Guides researchers as to what drug safety experiments are both practical and useful
• Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools
• Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods
• Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Über diesen Titel

Über die Autorin bzw. den Autor

Yvonne Will, PhD, is a Senior Director and the Head of Science and Technology Strategy, Drug Safety Research and Development at Pfizer, Connecticut, USA. She co-edited the book Drug-Induced Mitochondrial Dysfunction, published by Wiley in 2008.

J. Eric McDuffie, PhD, is the Director of the Discovery / Investigative Toxicology and Laboratory Animal Medicine groups at Janssen Research & Development, California, USA.

Andrew J. Olaharski, PhD, is an Associate Director of Toxicology at Agios Pharmaceuticals, Massachusetts, USA.

Brandon D. Jeffy, PhD, is a Senior Principal Scientist in the Exploratory Toxicology division of Nonclinical Development at Celgene Pharmaceuticals, California, USA.

Von der hinteren Coverseite

Developing novel pharmaceuticals requires nonclinical safety studies on candidate drugs to assess general toxicology (through in vivo experiments), safety pharmacology (effects on major organ systems), and genetic toxicity tests. These data provide risk assessment data that supports progression of candidate drugs from discovery phase through clinical development, to regulatory submission and registration. Traditionally, however, less emphasis was placed on the evaluation of safety issues for projects while still in the drug design phase.

In response to this costly attrition, many pharmaceutical companies invested in “drug discovery toxicology” or “drug discovery safety” to identify hazards and take steps to design out or significantly reduce undesirable safety liabilities earlier; with the ultimate aim of enhancing the probability of success in non-clinical and clinical drug development. Because of this, there is a strong need for personnel involved with toxicology and pharmacology studies need to understand the varied tools and approaches to perform early drug discovery safety analysis.

Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers serves as a valuable tool for those discovery scientists. The authors, writing from firsthand industry experience, give readers insight into the strategy and execution of predictive toxicology practices, including what experiments are possible and useful. In addition, they offer a view into the future, indicating key areas to watch for new predictive methods. Broken into different sections, the book deals with the key topics – Safety Lead Optimization Strategies, In Vitro-In Vivo Pharmacokinetics Translation, Predicting Organ Toxicity In Vitro, False Negative Space, --Omics in Predictive Toxicology, Translational Biomarkers, and Signal Investigation Rationale and Practices.

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods throughout the pre-clinical drug discovery development process.

Aus dem Klappentext

Developing novel pharmaceuticals requires nonclinical safety studies on candidate drugs to assess general toxicology (through in vivo experiments), safety pharmacology (effects on major organ systems), and genetic toxicity tests. These data provide risk assessment data that supports progression of candidate drugs from discovery phase through clinical development, to regulatory submission and registration. Traditionally, however, less emphasis was placed on the evaluation of safety issues for projects while still in the drug design phase.

In response to this costly attrition, many pharmaceutical companies invested in “drug discovery toxicology” or “drug discovery safety” to identify hazards and take steps to design out or significantly reduce undesirable safety liabilities earlier; with the ultimate aim of enhancing the probability of success in non-clinical and clinical drug development. Because of this, there is a strong need for personnel involved with toxicology and pharmacology studies need to understand the varied tools and approaches to perform early drug discovery safety analysis.

Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers serves as a valuable tool for those discovery scientists. The authors, writing from firsthand industry experience, give readers insight into the strategy and execution of predictive toxicology practices, including what experiments are possible and useful. In addition, they offer a view into the future, indicating key areas to watch for new predictive methods. Broken into different sections, the book deals with the key topics – Safety Lead Optimization Strategies, In Vitro-In Vivo Pharmacokinetics Translation, Predicting Organ Toxicity In Vitro, False Negative Space, --Omics in Predictive Toxicology, Translational Biomarkers, and Signal Investigation Rationale and Practices.

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods throughout the pre-clinical drug discovery development process.

Details zur Ausgabe

• Verlag: Wiley
• Erscheinungsdatum: 2016
• Sprache: Englisch
• ISBN 10: 1119053331
• ISBN 13: 9781119053330
• Einband: Gebundene Ausgabe
• Auflage: 1
• Anzahl der Seiten: 584
• Herausgeber: Will Yvonne, McDuffie J. Eric, Olaharski Andrew J., Jeffy Brandon D.
• Kontakt zum Hersteller: Wiley-VCH GmbH; product_safety@wiley.com; ; Boschstrasse 12; Weinheim; 69469; Deutschland