000 03419nam a22004095i 4500
001 u371657
003 SIRSI
005 20160812080140.0
007 cr nn 008mamaa
008 100716s2010 xxu| s |||| 0|eng d
020 _a9781441964182
_9978-1-4419-6418-2
040 _cMX-MeUAM
050 4 _aRS380
050 4 _aRS190-210
082 0 4 _a615.19
_223
100 1 _aTurner, J. Rick.
_eauthor.
245 1 0 _aNew Drug Development
_h[recurso electrónico] :
_bAn Introduction to Clinical Trials: Second Edition /
_cby J. Rick Turner.
264 1 _aNew York, NY :
_bSpringer New York :
_bImprint: Springer,
_c2010.
300 _aXXV, 256 p.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aNew Drug Development -- The Regulatory Environment -- Drug Discovery -- Nonclinical Research -- Designing Clinical Trials -- Conducting Clinical Trials I: Experimental Methodology -- Conducting Clinical Trials II: Operational Execution -- Statistical Analysis -- Statistical Significance -- Clinical Significance -- Sample Size Estimation -- General Safety Assessments -- Efficacy Assessment -- Cardiac and Cardiovascular Safety Assessments -- Manufacturing Small Molecule Drugs and Biologicals -- Postmarketing Surveillance -- Main Themes and Concluding Comments.
520 _aNew Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.
650 0 _aMedicine.
650 0 _aPharmaceutical technology.
650 1 4 _aBiomedicine.
650 2 4 _aPharmaceutical Sciences/Technology.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9781441964175
856 4 0 _zLibro electrónico
_uhttp://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-1-4419-6418-2
596 _a19
942 _cLIBRO_ELEC
999 _c199537
_d199537