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

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 ...

Principles of Clinical Pharmacology is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the t...

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...

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...

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 gu...

Immune Biology of Allogeneic Hematopoietic Stem Cell Transplantation provides clinical and scientific researchers with a deep understanding of the current research in this field and the implications for translational practice. By providing an overview of the immune biology of HSCT, an explanation of immune rejection, and detail on antigens and their role in HSCT success, this book embraces biologists and clinicians who need a broad view of the deeply complex processes involved. It then mov...

Breast Cancer:Breast cancer is second only to lung cancer as the leading cancer cause of death in women. In 2010 207,000 women will be diagnosed with breast cancer and over 39,000 are expected to die from breast cancer.Nevertheless, ongoing research and recent advances in both diagnostic and therapeutic modalities continue to make breast cancer management a rapidly evolving area in which the practitioner will want to be fully updated on current developments...

Recombinant Antibodies for Immunotherapy provides a comprehensive overview of the field of monoclonal antibodies (mAbs), a market that has grown tremendously in recent years. Twenty-five articles by experienced and innovative authors cover the isolation of specific human mAbs, humanization, immunogenicity, technologies for improving efficacy, 'arming' mAbs, novel alternative Ab constructs, increasing half-lives, alternative concepts employing non-immunoglobulin scaffolds, novel therapeutic...

“Drs. Butterfield, Kaufman and Marincola on behalf of the SITC have created a comprehensive must-have resource covering the basic and translational science behind approved and investigational immune therapies, and disease-by-disease clinical application of the therapies, written by leaders in the field. The textbook will be highly valuable reading for those just entering the field and for experienced scientists and clinicians looking to expand their knowledge base.”—Mario ...

This book is a comprehensive resource on psychotropic medications, detailing the latest methods for defining their characteristics, their use in different patient populations, and drug-drug interactions; an important collection of information forclinicians, students, researchers, and members of the pharmaceutical industry alike.The first section provides the foundational principles of these drugs. Mathematical modeling of parameters that affect their entryto,and exit from, the cent...

Personalized Immunosuppression in Transplantation: Role of Biomarker Monitoring and Therapeutic Drug Monitoring provides coverage of the various approaches to monitoring immunosuppressants in transplant patients, including the most recently developed biomarker monitoring methods, pharmacogenomics approaches, and traditional therapeutic drug monitoring. The book is written for pathologists, toxicologists, and transplant surgeons who are involved in the management of transplant patients, off...