Item description for Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by H. Gerhard Vogel...
Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago, drug discovery and evaluation was a sequential process starting with the selection of the most active compound from a series of newly synthesized compounds by means of special pharmacological assays. Safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails.
This "sequential" strategy has been abandoned for several reasons:
- Some negative effects on organ function, e.g. ventricular tachy-arrhythmia, were detected too late. On the other hand, negative findings in chronic toxicity studies in animals turned out to be irrelevant for human beings.
- New scientific approaches, e.g. combinatorial chemistry, high-throughput screening, in silico models, pharmaco-genomics and pharmaco-proteomics offered new possibilities.
- There are several examples which show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed.
The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. A change of strategy was therefore adopted, involving the following changes:
- Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization).
- The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group. Easily accessible and the most informative tests now have to be selected.
- Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development.
Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics.
The book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs.
The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.
In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.
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Est. Packaging Dimensions: Length: 10.71" Width: 7.87" Height: 1.5" Weight: 4.23 lbs.
Release Date Oct 10, 2006
ISBN 3540256385 ISBN13 9783540256380
Reviews - What do customers think about Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays?
Well constructed and potentially useful Sep 15, 2005
I have the 2nd edition of this reference, obtained in 2003. Springer-Verlag and their printers have done a very nice job of making this large (1400-page) book, and they provide a very readable typeset. The text is laid out in numerous short application notes describing different pharmacological assays, and these include sections on the study's purpose, a paragraph on the procedure, another on the approach to interpreting results, a fourth cursory section discussing modifications of the method by others, and a usually generous list of references after that. A big plus, I think, is the inclusion of a CD-ROM that contains an Adobe PDF of the entire text. This is a better medium in which to do searching, especially since the hardcover's printed lookup is set up in such extensive run-in indexing, with numerous cascades of indented em-dashes on subentries that it is really kind of annoying. The Contents list, grouped by organ systems, is a lot more useful.
It's still a difficult call making a decision to recommend a text like this - if you are actively doing pharmacological research, your sources are probably more current at your bench, or in recent journals and meetings. But, the very readable structure, many references, and a useful CD-ROM, suggests Vogel's text as an appealing and well-assembled package for academic and group reference.
A wonderful book for pharmacological Researchers Jun 29, 2000
The book is a wonderful addition to books on drug evaluation. I feel pharmacologists are getting very few books on this subject. This book can end up the search for such pharmacologists. It will surely boost the research in this field. I hope that this book should reach into hands of every pharmacologists. Whether he/she is a academician or researcher, this book will be a valuable addition to his/her personal library. Each institute conducting research or teaching in pharmacology should also have this book in the library.
Many thanks to the authors and publishers of this books.