Hans Vogel – Drug Discovery and Evaluation (3 Volume set)

Автор: Hans Vogel
Название книги: Drug Discovery and Evaluation
Формат: PDF
Тема: Фармакология
Страницы: 560 + 1387 + 2118
Качество: Изначально компьютерное, E-book

1. Methods in Clinical Pharmacology
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined.

As these processes can be divided up stepwise we have designed a book series “Drug Discovery and Evaluation” in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series “Pharmacological Assays” comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays”. Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology”.

2. Safety and Pharmacokinetic Assays
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.

3. Pharmacological Assays
Many young pharmacologists have only limited training in traditional methodologies, as these still-relevant methods are simply not available in today’s electronic databases. Drug Discovery and Evaluation: Pharmacological Assays corrects this problem by comprehensively covering the pharmacological methods that have been utilized successfully for more than a hundred years as well as the latest technologies. Thoroughly revised and expanded to two volumes, it offers an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Every chapter has been updated, and numerous assays have been added. Each of the more than 1,000 assays comprises a detailed protocol outlining purpose and rationale, and a critical assessment of the results and their pharmacological and clinical relevance.