FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces commen...

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of nume...

Nutritional Biochemistry takes a scientific approach to nutrition. It covers not just "whats"--nutritional requirements--but why they are required for human health, by describing their function at the cellular and molecular level. Each case study either leads to a subsequent discovery or enables an understanding of the physiological mechanisms of action of various nutrition-related processes. The text is "picture-oriented" and the commentary is directed towards explaining graphs, figures, ...

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...

There has been major growth in understanding immune suppression mechanisms and its relationship to cancer progression and therapy. This book highlights emerging new principles of immune suppression that drive cancer, and it offers radically new ideas about how therapy can be improved by attacking these principles. Following work that firmly establishes immune escape as an essential trait of cancer, recent studies have now defined specific mechanisms of tumor immune suppression. It also dem...

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...

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...

A COMPLETE INTRODUCTORY TEXT TO THE FIELD OF PHARMACOGENOMICSThe only pharmacogenomics resource to feature a global author team comprised of PharmDs, MDs, PhDs and social scientists, Pharmacogenomics offers an essential, highly accessible survey of this dynamic discipline. You will find thorough coverage of all need-to-know topics, from individual molecules to systemic diseases, plus an examination of the latest technologies that are constantly reshaping the field. P...

Active Surveillance for Localized Prostate Cancer: A New Paradigm for Clinical Management will serve as a useful resource for physicians dealing with, and interested in, this complex and evolving branch of prostate cancer management. The book will also be of interest to scientifically literate patients and their families. The volume provides an introduction to the concept of active surveillance in oncology in general and prostate cancer specifically. The primary focus is to provide a compr...

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of bio...

This book examines in detail the current treatment options for first-line, relapsed, and refractory Hodgkin lymphoma and the management appropriate in special clinical circumstances, including in the elderly, pregnant women, and those with lymphocyte-predominant disease. Careful attention is devoted to the emerging individually tailored treatment strategies that are especially appealing given their potential to reduce early and late treatment side effects in this generally young patient po...