PDF Ebook Drugs-From Discovery to Approval
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Drugs-From Discovery to Approval
PDF Ebook Drugs-From Discovery to Approval
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Review
"…ideal for researchers who want a basic, unadorned presentation of drug research and development." (Journal of Clinical Research Best Practices, October 2007) "…a concise, no-nonsense overview of drug research and development from target identification to product manufacturing." (Journal of Clinical Research Practices, October 2007) “…an exciting and novel text…excellent and essential text…” (Journal of Chemical Technology and Biotechnology, Vol. 80 (8), August 2005) “…an exciting and novel text …provides a concise, yet comprehensive survey of the entire drug development process.” (Journal of Chemical Technology and Biotechnology, 2005; Vol. 80, 964-965) “…a practical reference source on this important process.” (Journal of the National Medical Association, Vol.97, No.3, March 2005) "…this book is appealing...the information...should provide a greater understanding of social and ethical concerns regarding modern medications in a complex world." (Journal of Pharmacy Technology, November/ December 2004) "...a concise guide to the subject...readable and clearly written...can be recommended for the general reader..." (Pharmaceutical Journal, 24 April 2004)
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From the Back Cover
Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies. Drugs–From Discovery to Approval presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future. Coverage also includes: A helpful listing of current FDA and European guidelines A special section on regulatory authorities and processes in Japan and China Rich illustrations throughout, including more than ninety figures and tables Useful appendices on the history of drug discovery and development Representative examples of drug mechanisms in action Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, Drugs–From Discovery to Approval represents a practical and approachable reference on this important process.
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Product details
Hardcover: 368 pages
Publisher: Wiley-Liss; 1 edition (January 2, 2004)
Language: English
ISBN-10: 0471601500
ISBN-13: 978-0471601500
Product Dimensions:
6.5 x 0.9 x 9.4 inches
Shipping Weight: 1.4 pounds (View shipping rates and policies)
Average Customer Review:
4.2 out of 5 stars
9 customer reviews
Amazon Best Sellers Rank:
#1,841,392 in Books (See Top 100 in Books)
I purchased this as a text for a graduate level class in new drug product development.I have an MS in CRO Management and over a decade career experience across all phases of drug development, and find this text to be among the best overall primers in the drug development process.At the time of its publishing, it very comprehensively and accurately described all phases of drug development with reference to the applicable regulations and ICH guidance, and begins each chapter with a helpful flow chart of the process.I've referenced this text when developing trainings, and for when I need a high level review of areas of development I don't commonly work in.I highly recommend it for students, prospective drug industry employees and current employees looking to expand their overall knowledge of the drug development process.
This book fills a needed hole in the books about the pharma/drug industry. It provides a concise review of the drugs from discovery to approval and details the various steps along the way, including discovery, clinical trials, manfacturing and approval. There is enough science to provide the necessary background but not so much that the non scientist would be overwhelmed. It is well illustrated with plenty of diagrams and outlines. Dr. Ng delivers on a summary which can be read by novice to intermediate who desires to know more about the process. I think this book is a must read for attorneys or business people who are looking to understand the drug approval process and are working in the industry. It is also up to date which is very important in this field, where regulations can change. Finally it covers both US and other countries, although its US coverage is better than its non US coverage. This is the only reason I did not give the book 5 stars.I find this book a good personal reference in a short concise form and therefore recommend it.
I work in an organization that supports advanced gene therapy research that may lead to new therapies for chronic and life threatening diseases, but I am not a scientist. As a communicator, I needed to understand the long and arduous journey from discovery to pre-clinical research, to FDA-approved clinical manufacturing, and to human clinical trials. This book was excellent in helping me understand both the research and the regulatory environment.The author says it best in the introduction, "The intention of this book is to provide an overview about how a drug is discovered, the amount of and types of laboratory tests that are performed, and the conduct of clinical trials before a drug is ready to registered for human use." The author also fully explains the role of regulatory authorities in these processes.The book includes chapters on:Drug discoveryDrug development and preclinical studiesClinical trialsGood Manufacturing PracticeYou'll also learn about things like toxicology studies, pharmacodynamics, and pharmacokinetics, and Investigational New Drug applications. Although the book contains some technical discussions and exhibits, the author has a logical and easy-to-understand way of presenting the information.If, like me, you need to get a better understanding of process of getting basic drug research to the market, this book is for you.
Hard to say you "love" what is essentially a textbook....however, this is a great resource for those in need of understanding of the research and development of drugs...whether you work in the pharmaceutical industry or simply taking college courses.
It's tough to learn quickly about the complexities of pharma R&D. This is a useful guide for those new to the industry and fills in the gaps for those more experienced. Like all books of its type, it will age quite rapidly in an sector undergoing rapid scientific and organizational change.
This is a very clear and concise review of the drug development process as well as the regulatory issues. It is well organized and well written. It is not a "behind the scenes" nitty-gritty book, but will help anyone who wants to understand the process.
This book is written to cover a broad range of topics related to the drug discovery and approval process. Since so many topics are covered, there is very little in-depth coverage on any particular topic. It's suitable people who don't have any serious scientific training or experience in the industry. If you are looking for a high-level overview, this is a good book. If you would like more detailed information about any specific topic, you should probably look elsewhere. Some of the explaintions are over simplied in order for the average reader to understand. Much of the material covered in the book can be found in much greater detail by visiting the fda site or googling for the code of federal regulations. But if you do not what the FDA is or what CFR stands for, this book is probably right for you.
If you are not a specialist in the field of drug discovery but need nevertheless to have a comprehensive knowledge of the process that starts at the discovery of a potential new drug and ends at the registration of the drug with a regulatory agency, this book is for you. The book is full of flowcharts and illustrations that help you to understand the process. It's certainly not a book for specialists, but can be really helpful for lawyers, contracts officers and everyone who works in the drug discovery industry.
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