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Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc.
Covering the latest advances in CNS drug development, this bookwill guide all those involved in pre-clinical to early clinicaltrials. The authors describe how recent innovations can acceleratethe development of novel CNS compounds, improve early detection ofefficacy and toxicity signals, and increase the safety oflater-stage clinical trials. The current crisis in the drug development industry iscritically reviewed, as well as the steps needed to correct theproblems, including new government-backed regulations andindustry-based innovations designed to accelerate CNS drugdevelopment in the future. Animal-based models of major CNS disorders are described indetail, and the ability of the latest in vitro and computer-basedmodels to simulate CNS disease states and predict drug efficacy andside-effects are examined. Particular attention is given tothe growing use of biomarkers and how they can be used effectivelyin early human trials as signals of potential drug efficacy, aswell as the increasingly important role of imaging studies to guidedose selection. Cognitive assessments that can be useful indicatorsof effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drugtrials for over 20 years, and based on a wealth of drug developmentand clinical trial experience, Critical Pathways to Success inCNS Drug Developmentis full of practical advice forsuccessfully designing and executing CNS drug trials, avoidingpotential pitfalls, and complying with government regulations
Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.
The history of the M. D. Anderson Cancer Center vividly reveals how cancer treatment in America -- and our attitudes toward the disease -- has changed since the middle of the twentieth century. One of the preeminent cancer centers in the world, M. D. Anderson is also one of the first medical institutions devoted exclusively to caring for people with cancer and researching treatments and cures for the disease. Historian James S. Olson's narrative relates the story of the center's founding and of the surgeons, radiologists, radiotherapists, nurses, medical oncologists, scientists, administrators, and patients who built M. D. Anderson into the world-class institution it is today. Through interviews with M. D. Anderson's leaders and patients, Olson brings to life the struggle to understand and treat cancer in America. A cancer survivor who has himself been treated at the center, Olson imbues this history with humor, passion, and humanity. -- Helen Valier
Access to medicine is a topic of widespread interest. However, some issues that impact such access are presently inadequately understood. In particular, international laws require most nations to provide patents on drugs, resulting in premium prices that limit access. In Access to Medicine in the Global Economy, Professor Cynthia Ho explains such laws and their impact for a diverse group of readers, from scholars and policy makers to students in a variety of disciplines. This book explains and interprets important international agreements, beginning with the landmark Agreement on Trade Related Aspects of Intellectual Property (TRIPS), but also including more recent free trade agreements and the pending Anti-Counterfeiting Trade Agreement (ACTA). Professor Ho addresses controversial topics, such as when a nation can provide a compulsory license, as well as whether a nation may suspend in-transit generic goods. The book also discusses how patent-like rights (such as "data exclusivity") prevent lower-cost generic medicines from entering into the marketplace and provides strategies for minimizing the harm of such rights. Clear explanations and diagrams, frequently asked questions, and case studies make these topics accessible to any reader. The case studies also provide a theory of patent perspectives that helps explain why access to medicine, though a universal goal, remains elusive in practice. The book aims to provide an important first step toward eventual workable solutions by promoting a better understanding of existing and future laws that impact access to medicine.
'... a unique book... I highly recommendthis book to process chemists not only in the pharmaceutical industry but in the fine chemical, agrochemical, and colour chemical industries, too ... It is refreshing to see the book in paperback at a low cost. Highly recommended- I will certainly use it as a teaching aid' Chemistry in BritainWho wins the race to turn molecules into medicines? How much does it cost? What factors influence the choice of synthetic routes and reaction mechanisms? How can pharmaceutical companies protect their discoveries? In From Bench to Market, Walter Cabri and Romano Di Fabio chart the process of industrial chemical synthesis, from the first discovery of a molecule to its entry in the marketplace as a drug. Using real case histories of drug development from several therapeutic areas, they discuss all aspects related to the process research for bulk production, including comparison between different synthetic routes, key methodologies and reaction mechanisms, costs, patent competition, and crystalline forms.

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