000			01579cam a2200385 i 4500
001			18736575
003			OSt
005			20240423153128.0
008			150807s2016 flua b 001 0 eng
010			_a 2015031036
020			_a9781498743471 (hardcover : alk. paper)
035			_a(DNLM)101665454
040			_aDNLM/DLC _cDLC _erda _dDLC
042			_apcc
050	0	0	_aRS 380 .N53 2016 _b2024-7072
060	1	0	_aQV 241
082	0	0	_a _2
100	1		_aNiazi, Sarfaraz, _d1949- , _eauthor.
245	1	0	_aBiosimilars and interchangeable biologics : _bstrategic elements / _cSarfaraz K. Niazi
264		1	_aBoca Raton : _bCRC Press/Taylor & Francis Group, _c2016.
300			_axlv, 599 pages : _billustrations ; _c29 cm.
336			_atext _2rdacontent
337			_aunmediated _2rdamedia
338			_avolume _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0		_aIntroduction to biosimilar and interchangeable products -- Intellectual property issues -- The EMA regulatory guidance -- EMA approved biosimilars -- The FDA regulatory guidance -- The ROW regulatory guidance -- US commercialization -- Global commercialization -- Quality and lifecycle management.
650	1	2	_aBiosimilar Pharmaceuticals _xstandards.
650	2	2	_aDrug Approval.
650	2	2	_aDrug Discovery _xstandards.
650	2	2	_aDrug Evaluation _xstandards.
650	2	2	_aDrug Industry _xstandards.
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2lcc _cBK _n0
999			_c488 _d488