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| Available: 0 |
| List Price:$849.00 |
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| Edition: | 2nd |
| Publisher: | Springer Nature |
| ISBN: | 3-642-25241-9 (3642252419) |
| ISBN-13: | 978-3-642-25241-9 (9783642252419) |
| New Edition: | 3-031-35528-8 |
| Binding: | Hardcover |
| Publish Date: | 03/13 |
| Weight: | 0.00 Lbs. |
| Subject Class: | I-M (Internal Medicine) |
| Remarks: | A New Edition of this title is due 05/24 |
| Return Policy: | Returns accepted up to 12 months provided no other recalls or return restrictions apply. |
| Table Of Contents: |
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| Abstract: | Safety aspects have become an outstanding issue in the process of drug discovery and development and there is furthermore a clear tendency of a continuously increasing importance of safety. 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. Today, this former sequential way of working is replaced by simultaneous generation of data including safety, pharmacodynamic and pharmacokinetic aspects. Sometimes, even a bench-to-bedside and bedside-to-bench approach connecting preclinical and clinical data as early as possible is mandatory. This book tries to overcome the separation into toxicology, pharmacokinetics and clinical applications by showing the connectivity between all these disciplines: There is no real safety evaluation possible without combining toxicological, pharmacodynamic and pharmacokinetic data both from a preclinical and from a clinical environment. |
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