000			03281nam a22003258i 4500
001			CR9780511977640
003			UkCbUP
005			20200124160309.0
006			m|||||o||d||||||||
007			cr||||||||||||
008			101013s2012||||enk o ||1 0|eng|d
020			_a9780511977640 (ebook)
020			_z9780521766067 (hardback)
040			_aUkCbUP _beng _erda _cUkCbUP
050	0	0	_aRM301.25 _b.E82 2012
082	0	0	_a615.1/9 _223
245	0	0	_aEssential CNS drug development / _cedited by Amir Kalali [and others].
264		1	_aCambridge : _bCambridge University Press, _c2012.
300			_a1 online resource (x, 207 pages) : _bdigital, PDF file(s).
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
500			_aTitle from publisher's bibliographic system (viewed on 05 Oct 2015).
505	0	0	_tHistory of CNS drug development / _rSheldon H. Preskorn -- _tRegulatory issues / _rGwen L. Zornberg -- _tEssential CNS drug development : pre-clinical development / _rAlan J. Cross and Frank D. Yocca -- _tPhase I trials : from traditional to newer approaches / _rMatthew Macaluso, Michael Krams and Sheldon H. Preskorn -- _tPhase II development and the path to personalized medicine in CNS disease / _rDouglas E. Feltner and Kenneth R. Evans -- _tCNS drug development : Phase III / _rJudith Dunn, Penny Randall and Amir Kalali -- _tStatistics issues relevant to CNS drug development / _rCraig H. Mallinckrodt, William R. Prucka and Geert Molenberghs -- _tClinical trials management at company level / _rNuala Murphy -- _tClinical trials management at the site level / _rJoseph Kwentus -- _tMedical writing for CNS indications / _rGinette Nachman -- _tDissemination of clinical trial information : multiple audiences, multiple formats / _rLeslie Citrome -- _tThe importance of treating cognition in schizophrenia and other severe mental illnesses : background, strategies, and findings to date / _rPhilip D. Harvey and Richard S.E. Keefe -- _tLeveraging disruptive technologies to drive innovation in CNS clinical drug development / _rPenny Randall, Judith Dunn and Amir Kalali.
520			_aCentral Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.
650		0	_aCentral nervous system stimulants _xDevelopment.
700	1		_aKalali, Amir, _eeditor.
776	0	8	_iPrint version: _z9780521766067
856	4	0	_uhttps://doi.org/10.1017/CBO9780511977640
999			_c520930 _d520928