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Fundamentals of International Regulatory Affairs, Second Edition
Reference book of laws, standards and regulations applicable to healthcare product manufacture on the international market.
Risk Management in Medicine
To err is human, yet nobody wants to accept this fact. This is especially true in medicine! This book focuses on how human failures can be avoided in the medical context. Experts from different disciplines discuss the underlying causes of such failures and explain the techniques required to reduce their frequency. The principles of risk management are clearly described and lessons to be drawn from risk management in other sectors, such as aviation, are identified. Detailed consideration is given to all relevant risk management systems and tools, including Crew Resource Management (CRM), Failure Mode and Effects Analysis (FMEA), Critical Incident Reporting System (CIRS), Team Time Out (TTO) a...
Shi'i Reformation in Iran
In Shi'i Reformation in Iran, Rahnema offers a fresh understanding of Sangelaji’s reformist discourse from a theological standpoint, and takes readers into the heart of the key religious debates in Iran in the 1940s. Drawing on the writings of Sangelaji, as well as interviews with his son, the book provides a comprehensive introduction to the reformist’s ideas. As such it offers scholars of religion and Middle Eastern politics alike a penetrating insight into the impact that these ideas have had on Shi’ism–an impact which is still felt today.
Pharmaceutical Medicine and Translational Clinical Research
Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Shiʿism
This is an anthology of the most significant writing on the doctrinal, intellectual, and spiritual dimensions of Shicism. The works included here foster an interpretive understanding of Shicism in its dogmatic and cognitive aspects. The intent of this book is to balance the attention that has been focused on the political aspect of Shicism. Shicism is often seen, not only as an essentially political phenomenon, but as a creed of violence. Understanding Shicism in its total reality will encourage a more balanced approach to issues which are viewed mostly politically. While not denying the importance of political manifestations, this book offers an understanding of the often neglected religious beliefs and spiritual practices of this world community.
Western Tibet
This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.
Introduction to Statistical Methods for Clinical Trials
Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, pr...
