At a time when the field of cardiac safety is going through important changes, this unique book provides the rationale for, and cutting-edge explanations of, new regulatory landscapes that will likely govern cardiac safety assessments globally for the foreseeable future. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitro Proarrhythmia Assay initiative is well under way.

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new mate...

With the remarkable expansion in the use of antipsychotics, concerns about their immediate, intermediate, and long-term adverse effects have intensified. Despite this, studies consistently show that monitoring of patients taking antipsychotics can be inadequate, haphazard, or worse. This book provides a comprehensive review of the adverse effects of this pharmacologically complex therapeutic class, covering all commonly used conventional and atypical agents. In the first section, each chap...

Therapeutic Drug Monitoring: Newer Drugs and Biomarkers features timely topics such as the monitoring of classical and newer drugs, pharmacogenomics and the application of biomarkers in therapeutic drug monitoring. This reference also discusses the limitations of current commercially available immunoassays for therapeutic monitoring. It presents new and sophisticated techniques used for proper determination of blood levels and the clinical utility of therapeutic drug monitoring of contempo...

The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceu...

Opioids have been used as analgesics for many years, and their use in the management of acute pain related to trauma and surgery is well established. However, patients with persisting pain need a pain management plan that brings relief of symptoms without adverse effects in both the short and longer terms. The prescribing of opioids for chronic non-cancer pain has increased substantially since the first edition of this pocketbook was published, prompting considerable debate regarding the a...

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•...

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. Thi...

The Year Book of Oncology brings you abstracts of the articles that reported the year's breakthrough developments in oncology, carefully selected from more than 500 journals worldwide. Expert commentaries evaluate the clinical importance of each article and discuss its application to your practice. There's no faster or easier way to stay informed! Topics include Supportive Care, Breast Cancer, Gynecologic Cancers, Genitourinary Cancers, Hematologic Malignancies, Thoracic Cancer, Gastrointe...

A state-of-the-art, multidisciplinary approach to cancer and agingWith the majority of cancers occurring in individuals over the age of 65 against a backdrop of an expanding aging population, there is an urgent need to integrate the areas of clinical oncology and geriatric care. This timely work tackles these issues head-on, presenting a truly multidisciplinary and international perspective on cancer and aging from world-renowned experts in geriatrics, oncology, be...

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions.Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.This new edition covers the legal and ethical issues of consent and assent, the additional legal and ...

This revised second edition covers the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development, focusing on the fundamentals that underlie the clinical use and contemporary development of pharmaceuticals. Authors drawn from academia, the pharmaceutical industry and government agencies cover the spectrum of material, including pharmacokinetic practice questions, covered by the basic science section of the certifying examination offered ...