000 04085nam a22004455i 4500
001 978-3-642-25240-2
003 DE-He213
005 20140220082845.0
007 cr nn 008mamaa
008 130305s2013 gw | s |||| 0|eng d
020 _a9783642252402
_9978-3-642-25240-2
024 7 _a10.1007/978-3-642-25240-2
_2doi
050 4 _aRM1-950
072 7 _aMMG
_2bicssc
072 7 _aMED071000
_2bisacsh
082 0 4 _a615
_223
100 1 _aVogel, H. Gerhard.
_eeditor.
245 1 0 _aDrug Discovery and Evaluation: Safety and Pharmacokinetic Assays
_h[electronic resource] /
_cedited by H. Gerhard Vogel, Jochen Maas, Franz J. Hock, Dieter Mayer.
264 1 _aBerlin, Heidelberg :
_bSpringer Berlin Heidelberg :
_bImprint: Springer,
_c2013.
300 _aXXIV, 1404 p. 243 illus. eReference.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aFrom the contents: General Introduction: Safety Pharmacology -- Safety Pharmacokinetics -- Safety Toxicology.
520 _aSafety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago 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. But 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.
650 0 _aMedicine.
650 0 _aToxicology.
650 1 4 _aBiomedicine.
650 2 4 _aPharmacology/Toxicology.
700 1 _aMaas, Jochen.
_eeditor.
700 1 _aHock, Franz J.
_eeditor.
700 1 _aMayer, Dieter.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9783642252396
856 4 0 _uhttp://dx.doi.org/10.1007/978-3-642-25240-2
912 _aZDB-2-SBL
999 _c96809
_d96809