State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.
The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation.
Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
Описание: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.
Автор: Decker, Michael Название: Design of Hybrid Molecules for Drug Development ISBN: 0081010117 ISBN-13(EAN): 9780081010112 Издательство: Elsevier Science Рейтинг: Цена: 24423.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Design of Hybrid Molecules for Drug Development reviews the principles, advantages, and limitations involved with designing these groundbreaking compounds. Beginning with an introduction to hybrid molecule design and background as to their need, the book goes on to explore a range of important hybrids, with hybrids containing natural products, molecules containing NO- and H2S-donors, dual-acting compounds acting as receptor ligands and enzyme inhibitors, and the design of photoresponsive drugs all discussed.
Drawing on practical case studies, the hybridization of molecules for development as treatments for a number of key diseases is then outlined, including the design of hybrids for Alzheimer's, cancer, and malaria.
With its cutting-edge reviews of breaking developments in this exciting field, the book offers a novel approach for all those working in the design, development, and administration of drugs for a range of debilitating disorders.
Highlights an approach unimpaired by the limitations of the classical search for lead structures - one of the core problems in modern drug development processes, making the content of high relevance for both academic and non-academic drug development processes
Pulls together research and design techniques in a novel way to give researchers the best possible platform from which to review the approaches and techniques applied
Compares the advantages and disadvantages of these compounds
Includes the very latest developments, such as photoactivatable and photo-responsive drugs
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