Overview
Written by leading investigators from academia and the pharmaceutical industry, this volume is a comprehensive, practical guide for all researchers involved in anticancer drug development. The book covers the entire field from preclinical research, through clinical trials, to licensure requirements in the United States and in the European Union.
Chapters address drug discovery, preclinical models, drug measurement, delivery systems, Phase I trial design, and Phase II-III testing. The book provides state-of-the-art coverage of contemporary drug design concepts, in vitro models, new assay methodologies, good manufacturing practice criteria in the US and EU, and new methods for testing anticancer agents in humans.
Synopsis
Written by leading investigators from academia and the pharmaceutical industry, this volume is a comprehensive, practical guide for all researchers involved in anticancer drug development. The book covers the entire field from preclinical research, through clinical trials, to licensure requirements in the United States and in the European Union.
Chapters address drug discovery, preclinical models, drug measurement, delivery systems, Phase I trial design, and Phase II-III testing. The book provides state-of-the-art coverage of contemporary drug design concepts, in vitro models, new assay methodologies, good manufacturing practice criteria in the US and EU, and new methods for testing anticancer agents in humans.
Doody Review Services
Reviewer:Bruce F. Kimler, PhD(University of Kansas Medical Center)
Description:This book provides an overview of the process of development of anticancer drugs. It addresses the various steps along the pathway to a commercially viable drug: lead discovery, target validation, preclinical testing, clinical trials, and regulatory approval.
Purpose:The purpose is to suggest strategies and technologies that will improve the efficiency of the drug development process. Given the ever-increasing number of potential targets and agents, the enormous cost and low success rate of bringing a drug to market, and the long timeline for development, this is a worthy goal. While a collection of individual contributions will naturally provide more guidance in a few specific areas, the overall scope and content of the book provides a valuable blueprint for the drug development process.
Audience:The book targets individuals actively engaged in or contemplating entry into the field of drug development and is therefore useful to specialists who wish to gain insight into the steps before and after those in which they have their expertise. But it is also useful to the executive or program director who requires a broad picture of the entire process and ways to optimize it. The three editors are well known and well published in the area of oncologic drug development. Similarly, the list of contributors contains qualified representatives from academia, industry, and government.
Features:The book adequately covers certain necessary subjects (the drug discovery process, preclinical testing, clinical trial design, regulatory issues) but devotes the majority of the chapters to new advances and technologies (e.g., combinatorial chemistry, genomics and proteomics, bioinformatics) or concepts (e.g., delivery systems, special populations, pharmacogenetics) that will serve to increase the flow of potential agents through the drug development pipeline. The chapters on new methodologies generally provide concise and understandable summaries of the technology, from rationale to "how to" primers to application to drug development. While the focus on specific drugs or drug classes may make certain chapters dated within a few years, the use of recognized agents as examples of a strategy is valid. It is somewhat disappointing that certain of the illustrations are not in color. This is especially true for illustrations that were originally in color and are now presented as grayscale figures. These are the ones that the expert will appreciate and "fill in" the missing information that color can provide but which may well be meaningless to individuals who are reading the book for an introduction to drug development or to the specialists who wish to broaden their understanding of areas outside their personal expertise.
Assessment:This is a very worthwhile book for anyone wishing an overview of the drug development process. The book covers the history of the drug development process as well as how this process operates today. More importantly, it provides an introduction to novel technologies and strategies that have the potential to change the way in which new anticancer agents are discovered and brought into clinical practice.
Editorials
From The Critics
Reviewer: Bruce F. Kimler, PhD(University of Kansas Medical Center)Description: This book provides an overview of the process of development of anticancer drugs. It addresses the various steps along the pathway to a commercially viable drug: lead discovery, target validation, preclinical testing, clinical trials, and regulatory approval.
Purpose: "The purpose is to suggest strategies and technologies that will improve the efficiency of the drug development process. Given the ever-increasing number of potential targets and agents, the enormous cost and low success rate of bringing a drug to market, and the long timeline for development, this is a worthy goal. While a collection of individual contributions will naturally provide more guidance in a few specific areas, the overall scope and content of the book provides a valuable blueprint for the drug development process. "
Audience: The book targets individuals actively engaged in or contemplating entry into the field of drug development and is therefore useful to specialists who wish to gain insight into the steps before and after those in which they have their expertise. But it is also useful to the executive or program director who requires a broad picture of the entire process and ways to optimize it. The three editors are well known and well published in the area of oncologic drug development. Similarly, the list of contributors contains qualified representatives from academia, industry, and government.
Features: "The book adequately covers certain necessary subjects (the drug discovery process, preclinical testing, clinical trial design, regulatory issues) but devotes the majority of the chapters to new advances and technologies (e.g., combinatorial chemistry, genomics and proteomics, bioinformatics) or concepts (e.g., delivery systems, special populations, pharmacogenetics) that will serve to increase the flow of potential agents through the drug development pipeline. The chapters on new methodologies generally provide concise and understandable summaries of the technology, from rationale to "how to" primers to application to drug development. While the focus on specific drugs or drug classes may make certain chapters dated within a few years, the use of recognized agents as examples of a strategy is valid. It is somewhat disappointing that certain of the illustrations are not in color. This is especially true for illustrations that were originally in color and are now presented as grayscale figures. These are the ones that the expert will appreciate and "fill in" the missing information that color can provide but which may well be meaningless to individuals who are reading the book for an introduction to drug development or to the specialists who wish to broaden their understanding of areas outside their personal expertise. "
Assessment: This is a very worthwhile book for anyone wishing an overview of the drug development process. The book covers the history of the drug development process as well as how this process operates today. More importantly, it provides an introduction to novel technologies and strategies that have the potential to change the way in which new anticancer agents are discovered and brought into clinical practice.
3 Stars from Doody