Principles Of Anticancer Drug Development

A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

This book explains how current medicines against cancer work and how we find new ones. It provides an easy-to-understand overview of current options to treat patients with cancer, which includes Surgery, Radiation therapy, Chemotherapy, Targeted therapy and Immunotherapy. The efficiency of all these treatments is limited by the capacity of cancer cells to escape therapy. This book explains the mechanisms of anti-cancer drug resistance and strategies to overcome it. The discovery and development process of a new drug is detailed beginning with the identification and validation of a therapeutic target, the identification of an inhibitor of the target and its subsequent preclinical and clinical development until its approval by regulatory authorities. Particular emphasis has been given to specific aspects of the development process including lead generation and optimization, pharmacokinetics, ADME analysis, pharmacodynamics, toxicity and efficacy assessment, investigational new drug (IND) and new drug application (NDA) and the design of clinical trial and their phases. The book covers many aspects of modern personalized oncology and discusses economic aspects of our current system of developing new medicines and its impact on our societies and on future drug research. The author of this book, Dr. Link counts with more than 20 years of experience in biomedical research reflected in numerous publications, patents and key note and plenary presentations at international conferences. Interested readers, students and teachers should read this book as it provides a unique way to learn/teach about basic concepts in oncology and anti-cancer drug research.

This book explains how current medicines against cancer work and how we find new ones. It provides an easy-to-understand overview of current options to treat patients with cancer, which includes Surgery, Radiation therapy, Chemotherapy, Targeted therapy and Immunotherapy. The efficiency of all these treatments is limited by the capacity of cancer cells to escape therapy. This book explains the mechanisms of anti-cancer drug resistance and strategies to overcome it. The discovery and development process of a new drug is detailed beginning with the identification and validation of a therapeutic target, the identification of an inhibitor of the target and its subsequent preclinical and clinical development until its approval by regulatory authorities. Particular emphasis has been given to specific aspects of the development process including lead generation and optimization, pharmacokinetics, ADME analysis, pharmacodynamics, toxicity and efficacy assessment, investigational new drug (IND) and new drug application (NDA) and the design of clinical trial and their phases. The book covers many aspects of modern personalized oncology and discusses economic aspects of our current system of developing new medicines and its impact on our societies and on future drug research. The author of this book, Dr. Link counts with more than 20 years of experience in biomedical research reflected in numerous publications, patents and key note and plenary presentations at international conferences. Interested readers, students and teachers should read this book as it provides a unique way to learn/teach about basic concepts in oncology and anti-cancer drug research.

The ultimate source of information on the design of new anticancer agents, emphasizing small molecules, this newest work covers recent notable successes resulting from the human genome and cancer genomics projects. These advances have provided information on targets involved in specific cancers that are leading to effective medicines for at least some of the common solid tumors. Unique sections explain the basic underlying principles of cancer drug development and provide a practical introduction to modern methods of drug design. Appealing to a broad audience, this is an excellent reference for translational researchers interested in cancer biology and medicine as well as students in pharmacy, pharmacology, or medicinal and biological chemistry and clinicians taking oncology options. * Covers both currently available drugs as well as those under development * Provides a clinical perspective on trials of new anticancer agents * Presents drug discovery examples through the use of case histories

Reviews the principles of drug development and clinical pharmacology applicable to all classes of anticancer drugs. Covers every aspect of drug development--from drug discovery to approval and routine use. Details how the successful application of pharmacological principles can improve drug delivery, individualized dosing, and the circumvention of drug resistance; elucideates proven strategies for widening the therapeutic margin between antitumor effects and severe toxicity; and more.

This title is directed primarily towards health care professionals outside of the United States. The aim of this book is to provide an introduction to the principles of drug treatment for solid tumours in cancer medicine. Developments in the understanding of tumour biology, molecular biology and genetics - together with the greater understanding of the pharmacology and pharmacokinetics of drugs - have combined to open up the field of medical oncology to rapid advances in the treatment of cancers. The range of drugs that are available is wide and one of the primary aims in drug development is to increase the therapeutic window so that drug toxicity is minimised and tolerable. Drug development of oral formulations of anticancer drugs and the use of drugs that could be given in the day patient setting means that healthcare professionals such as general practitioners - who historically might not have been involved in the drug treatment of the cancer patient - are now going to need to have a greater understanding of the principles of use of anticancer drugs. This book is primarily aimed at this market. Basic principles of drug treatment - develops an understanding of why and when anticancer drugs are used. Covers the purpose of clinical trials in oncology from Phase I to Phase IV trials in drug development. Discusses the organisation of clinical networks in the UK. Case studies in cancer treatment, allowing an understanding of when and why the typical regimes are used. NICE guidelines.

Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval. They focus on using preclinical in vivo and in vitro methods to identify molecules of interest, detailing the targets and criteria for success in each type of testing and defining the value of the information obtained from the various tests. They also define each stage of clinical testing, explain the criteria for success, and outline the requirements for FDA approval. A companion volume by the same editor (Cancer Therapeutics: Experimental and Clinical Agents) reviews existing anticancer drugs and potential anticancer therapies. These two volumes in the Cancer Drug Discovery and Development series reveal how and why molecules become anticancer drugs and thus offer a blueprint for the present and the future of the field.

Updated to include the newest drugs and those currently in development, this Fifth Edition is a comprehensive reference on the preclinical and clinical pharmacology of anticancer agents. Organized by drug class, the book provides the latest information on all drugs and biological agents—their mechanisms of action, interactions with other agents, toxicities, side effects, and mechanisms of resistance. The authors explain the rationale for use of drugs in specific schedules and combinations and offer guidelines for dose adjustment in particular situations. This edition's introduction includes timely information on general strategies for drug usage, the science of drug discovery and development, economic and regulatory aspects of cancer drug development, and principles of pharmacokinetics. Eight new chapters have been added and more than twenty have been significantly revised. A companion website includes the fully searchable text and an image bank.