000			05277cam a2200565 i 4500
005			20250919005553.0
008			151007t20152015flua b 001 0 eng
020			_a9781439874202 (hardback : acid-free paper) _cRM601.92
020			_a1439874204 (hardback : acid-free paper)
039		9	_a201510201236 _bzainol _y10-07-2015 _zfida
040			_aDLC _beng _erda _cDLC _dYDX _dBTCTA _dYDXCP _dUKMGB _dIXA _dNLM _dZWZ _dOCLCF _dCDX _dBDX _dCRCPR
040			_dUKM _erda
090			_aQU550.5.M8P536 2015 9
090			_aQU550.5.M8 _bP536 2015 9
245	0	0	_aPharmaceutical industry practices on genotoxic impurities / _cedited by Heewon Lee, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
264		1	_aBoca Raton : _bCRC Press, Taylor & Francis Group, _c2015
300			_axviii, 517 pages : _billustrations ; _c24 cm.
336			_atext _2rdacontent
337			_aunmediated _2rdamedia
338			_avolume _2rdacarrier
490	1		_aChromatographic science series ; _v107
504			_aIncludes bibliographical references and index.
520			_a'A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text:Explores the safety, quality, and regulatory aspects of GTIsProvides an overview of the latest FDA and EMEA guidelinesExplains the how and why of various GTI control tactics and practicesDescribes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testingIncludes real-life examples of GTI control in drug substance and drug product development processesContaining case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of and a current framework for GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines'-- _cProvided by publisher.
520			_a'Preface According to the World Health Organization's International Agency for Research on Cancer (IARC) (Technical Publication No. 24, 1994), genotoxicity is defined as structural changes at the level of a gene. It is also defined as a broad term that refers to any deleterious change in the genetic material regardless of the mechanism by which the change is induced, as stated by ICH S2(R1),'Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.' Genotoxic compounds have the theoretical potential to damage DNA at any level of exposure, leading to tumor development. This makes the toxicological assessment and determination of acceptable limits of genotoxic impurities (GTIs) difficult. GTIs have become an intensely debated topic in the pharmaceutical industry in recent years. My experiences in the internal and external discussions in meetings and conferences indicate that there is a great deal of confusion and uncertainty over identification, assessment, and control of GTIs. GTIs require different rationale and strategies from'regular' or'ordinary' impurities. Proper management of GTIs entails appropriate guidance and strategies, effective communication between various disciplines, sharing information and results, and understanding of the overall implications. The goal of this book is to present the rationale, strategies, methods, interpretation, practices, and case studies in the pharmaceutical industry in order to facilitate scientific and systematic consensus establishment on GTIs'-- _cProvided by publisher.
650		7	_aMEDICAL / Pharmacology. _2bisacsh
650		7	_aSCIENCE / Chemistry / Analytic. _2bisacsh
650		7	_aSCIENCE / Research & Methodology. _2bisacsh
650		2	_aMutagenicity Tests _xmethods.
650		2	_aMutagens _xadverse effects.
650		2	_aMutagens _xtoxicity.
650		7	_aToxicologie g{u296E}ique. _2ram
650		7	_aMicaments _xToxicologie. _2ram
650		7	_aMutag{u196E}es. _2ram
650	1	7	_aMutagenicity Tests _xmethods. _2mesh
650	2	7	_aMutagens _xadverse effects. _2mesh
650	2	7	_aMutagens _xtoxicity. _2mesh
650		7	_aDrugs _xToxicology. _2fast _0(OCoLC)fst00898958
650		7	_aGenetic toxicology. _2fast _0(OCoLC)fst00940097
700	1		_aLee, Heewon, _eeditor.
830		0	_aChromatographic science ; _vv. 107.
856	4	2	_3Cover image _uhttp://images.tandf.co.uk/common/jackets/websmall/978143987/9781439874202.jpg
907			_a.b16215011 _b2019-11-12 _c2019-11-12
942			_c01 _n0 _kQU550.5.M8P536 2015 9
914			_avtls003594122
990			_azr
991			_aFakulti Farmasi, KKL
998			_ad _b2015-07-10 _cm _da _feng _gflu _y0 _z.b16215011
999			_c599207 _d599207