000			03027nam a22004575i 4500
001			978-1-4419-7449-5
003			DE-He213
005			20140220083723.0
007			cr nn 008mamaa
008			101029s2011 xxu| s |||| 0|eng d
020			_a9781441974495 _9978-1-4419-7449-5
024	7		_a10.1007/978-1-4419-7449-5 _2doi
050		4	_aRM1-950
072		7	_aMMG _2bicssc
072		7	_aMED071000 _2bisacsh
082	0	4	_a615 _223
100	1		_aGad, Shayne C. _eauthor.
245	1	0	_aSafety Evaluation of Pharmaceuticals and Medical Devices _h[electronic resource] : _bInternational Regulatory Guidelines / _cby Shayne C. Gad.
264		1	_aBoston, MA : _bSpringer US, _c2011.
300			_aXII, 128p. 2 illus. in color. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
505	0		_aPreface -- Introduction to Safety Assessment in Drug and Medical Device Development -- Drugs: The General Case -- Ind Enabling Toxicology Programs -- Nonclinical Safety Evaluation Studies Conducted To Support Continued Clinical Development -- Supporting Marketing Applications -- Special Therapeutic Category And Route Of Administration Cases -- Device Safety Evaluation -- Appendix A -- INDEX.
520			_aSafety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, and combination products into a single, concise guide for the process in all the major world market countries. The approach of this volume is to first address the broadest scope “general case” for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parentheral, dermal and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences.
650		0	_aMedicine.
650		0	_aToxicology.
650		0	_aPharmaceutical technology.
650		0	_aPharmacy.
650	1	4	_aBiomedicine.
650	2	4	_aPharmacology/Toxicology.
650	2	4	_aPharmaceutical Sciences/Technology.
650	2	4	_aPharmacy.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9781441974488
856	4	0	_uhttp://dx.doi.org/10.1007/978-1-4419-7449-5
912			_aZDB-2-SBL
999			_c105769 _d105769