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...

The definitive book on the neutralization of recombinant biopharmaceuticalsRecombinant biopharmaceuticals are an important tool for treating a range of illnesses; however, their efficacy can be severely impaired by their immunogenicity. When introduced into the body, these pharmaceuticals can cause the immune system to produce anti-drug antibodies (ADAs) that neutralize their effects.The first and only book to cover neutralization in connection with biopharmaceuticals and t...

Oncology Book of 2011, British Medical Association's Medical Book AwardsAwarded first prize in the Oncology category at the 2011 BMA Medical Book Awards, Monoclonal Antibody and Peptide-Targeted Radiotherapy of Cancer helps readers understand this hot pharmaceutical field with up-to-date developments. Expert discussion covers a range of diverse topics associated with this field, including the optimization of design of biomolecules and radiochemistry, cell ...

The microenvironment in which a tumor originates plays a critical role in its initiation and progression. Tumor Microenvironment reviews the importance of tumor microenvironment in cancer management. Particular emphasis is placed on discussing how the unique characteristics of the tumor microenvironment not only impact disease progression and response to conventional anticancer therapies, but have also led to the identification of potential new therapeutic targets and treatment po...

The purpose of the book is to introduce platelets, and their functional role in thrombotic and cardiovascular disease, justifying the relevance of platelet proteomics research. Focus then shifts to the recent developments on mass spectrometry (MS)-based proteomics. This chapter shows potential applications for platelet proteomics not yet carried out. It includes examples of post-translational modifications (PTMs) analysis in platelets.The second part of the book focuses on the main...

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...

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•...

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...

An essential outline of the main facets of polypharmacology in drug discovery researchExtending drug discovery opportunities beyond the "one drug, one target" philosophy, a polypharmacological approach to the treatment of complex diseases is emerging as a hot topic in both industry and academic research. Polypharmacology in Drug Discovery presents an overview of the various facets of polypharmacology and how it can be applied as an innovative concept for developing medicines for tr...