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| By: Rick Ng ISBN: 0471601500 Publisher: Wiley-Liss Release Date: 02 January, 2004 Bioscience book rank: 163897 | 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.
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<br />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.
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<br />The book includes chapters on:
<br />Drug discovery
<br />Drug development and preclinical studies
<br />Clinical trials
<br />Good Manufacturing Practice
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<br />You'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.
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<br />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. 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. 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. | |
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| By: Robert A. Copeland ISBN: 0471686964 Publisher: Wiley-Interscience Release Date: 28 March, 2005 Bioscience book rank: 461624 | I have found this book very useful. If you have to use enzyme kinetics, and analyze the data, then you really should have this book. That it is recommended by Prof Cornish-Bowden attests to its accuracy.
<br />Personally I find this topic difficult, but this book is well written, and I have a much better understanding of kinetics after getting this book. Books and reviews on drug design are often disappointing, but Evaluation of Enzyme Inhibitors in Drug Discovery is excellent; it is a book that should be on the shelves of anyone involved in rational drug development, and available to anyone interested in understanding how successful drugs work. It starts by explaining why enzymes are appropriate targets for a drug design in the first place, and goes on to emphasize that inhibiting an enzyme and producing the intended effect on the whole organism is not a trivial matter. As the author remarks, "dogmatic arguments that lead to a priori predictions of what will work best in a biological context more often than not reflect an incomplete understanding". <br /> <br />If rational drug design is ever to become a reality it will involve knowledge of much more than three-dimensional structure, though this sometimes seems to be the only aspect considered. It requires, of course, knowledge of the different kinds of inhibition and how the inhibitor affects enzyme activity at different concentrations of substrates and products. In addition, it requires some knowledge of the metabolic context in which the inhibited enzyme is embedded: if it has almost no flux control then inhibiting it -- even to a high degree -- may have almost no effect on the flux through it (though it may still have large effects on the metabolite concentrations around it). finally it requires understanding of what makes some molecules "drug-like", and others not: it is no use identifying a superb inhibitor of the ideal enzyme if there is no way of delivering it to the target. Copeland deals with all of these points, and others, in an appropriately elementary way. Apart from giving much more information about inhibition than he did in Enzymes (Wiley-Interscience, 2000), here he takes a more leisurely pace and the book should not offer any serious difficulty to anyone wanting to master the subject. <br /> <br />As the author explains, there is much more to enzyme inhibition than just competitive inhibition: some successful drugs are indeed competitive inhibitors, Methotrexate and Viagra among them, but others are not; Finasteride, for example, used for treating benign hypertrophy of the prostate, is an uncompetitive inhibitor of steroid 5alpha-reductase. Classifying inhibitors thus needs more than crude measures of IC50 values, and if these are used at all they need to be used in conjunction with knowledge of how they relate to inhibition constants. <br /> <br />Analysis of the kind set out in the book is essential for understanding why enzyme inhibitors work as drugs, but the sceptical reader may wonder how much of it is post hoc rationalization, and how much was actually used for discovering the drugs. Let us consider the 26 enzyme inhibitors that have become successful drugs that are listed in Chapter 1, from Acetazolamide, an inhibitor of carbonic anhydrase used to treat glaucoma, to Viagra, an inhibitor of phosphodiesterase that is now familiar to everyone. Modern Drug Discovery claimed in 1998 that "Viagra was discovered using a rational drug design approach", but was it? It was not originally conceived as a drug for treating erectile dysfunction, and its usefulness for this discovered almost by chance when it was noticed that some men who participated in clinical trials as a treatment for angina pectoris reported unexpected effects. Even as an inhibitor for phosphodiesterase, Viagra was found by making variations on the structure of Zaprinast, a weak inhibitor that had failed to become a useful anti-allergy treatment. There is little in this history to suggest rational drug design. <br /> <br />There are many good points about this book, but it is often difficult to find them, because the index is very poor. For example, there is a discussion of the characteristics of "drug-like" molecules (Lipinski's rules, etc.), but don't expect to learn this from the index; the only way to find it is to leaf through the pages. Fortunately it comes early in the book, but there are other equally important and equally secret topics later on. In other respects this is a fine achievement, a book that can be enthusiastically recommended. | |
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| By: Lisa K. Minor ISBN: 1574444719 Publisher: CRC Release Date: 20 January, 2006 Bioscience book rank: 560304 | This authors of this book represent a who's who of the industry. To be as advanced as possible, Dr. Minor has had individual chapters written by experts from equipment vendors (GE, PerkinElmer); pharmaceutical companies (J&J, Merck, Lilly), government (NIH) and more. These individual chapters describe in practical terms what these organizations have developed. <br /> <br />The book is meant as a general guidebook that one will take to the workbench. It includes descriptions of methods, exact protocols used to perform such methods, and troubleshooting tools. These techniques have been led by the need to screen targets more rapidly and with more efficiency than in previous years and by advances in chemistry allowing parallel or multiplex chemical synthesis to provide more compounds for screening. <br /> <br />The book should be of interest to those in discovery research as well as those in the academic world who wish to know what has become available in recent years. | |
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| By: Beverly A. Teicher, Paul A. Andrews ISBN: 1588292282 Publisher: Humana Press Release Date: 01 February, 2004 Bioscience book rank: 550506 | ||
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| By: Daniel Lednicer ISBN: 0470007508 Publisher: Wiley-Interscience Release Date: 20 October, 2006 Bioscience book rank: 654270 | ||
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| By: Leslie A. Pray, Sally Robinson ISBN: 0309109868 Publisher: National Academies Press Release Date: 02 October, 2007 Bioscience book rank: 604294 | This is a well-composed and engaging summary of the IOM Forum on Drug Discovery, Development and Translation's workshop on the future of drug safety. Definitely worth a read. You'll feel like you were there! Also one of the authors is a total fox. | |
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| By: Walter Sneader ISBN: 0471899801 Publisher: Wiley-Interscience Release Date: 17 June, 2005 Bioscience book rank: 635644 | ||
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| By: Sachdev S. Sidhu ISBN: 0824754662 Publisher: CRC Release Date: 27 July, 2005 Bioscience book rank: 718998 | This puts everything in one place. This book should be the first reference for anyone interested in phage display. It will save the reader countless hours. I highly recommend. | |
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| By: Charles G. Smith, James T. O'Donnell ISBN: 0849327792 Publisher: Informa Healthcare Release Date: 23 June, 2006 Bioscience book rank: 398417 | Having recently entered the business of analyzing drug discovery and drug development opportunities, and seeking an exposé of the overall process to serve as a checklist, I did some searching on Amazon.com and purchased this book. The content was very disappoining, as what I learned was little more than a series of platitudes and definitions of words. I can forgive this, and attribute it to my failure to assess the target audience of the book. The content likely would be informative to a person who knows nothing about the drug discovery process. <p>What motivates me to write this review is that this book contains the worse pros I have ever seen in print. The abuse of the English language is so severe that the text is painful to read. The editing is atrocious. Every third clause is redundant, and the author never hesitates to use ten words where three would do. Whole paragraphs could be removed without diminishing the information content. Randomly chosen example: "Another function that specialized computer experts handle, in conjunction with their colleagues in the chemistry department, is the computational chemistry operation for the design of new molecules." How about: "Computer experts also work with chemists to design new molecules by computation." The author or his editor appeared to be consciously trying to make the book longer. Technical writing is rarely elegant, but there is no excuse for such writing. | |
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| By: Zhengyin Yan, Gary W. Caldwell ISBN: 1588293327 Publisher: Humana Press Release Date: 01 September, 2004 Bioscience book rank: 844093 | ||
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