000			05630cam a2200505 i 4500
005			20250919005553.0
008			151007s2014 flua b 001 0 eng
020			_a9781466593862 _q(hardback : acid-free paper) _cRM352.58
020			_a1466593865 _q(hardback : acid-free paper)
039		9	_a201510201216 _bzainol _y10-07-2015 _zfida
040			_aDLC _beng _erda _cDLC _dYDX _dYDXCP _dNLM _dVET _dCRCPR _dOCLCQ _dBTCTA _dUKMGB _dBDX _dCDX
040			_dUKM _erda
090			_aQV38.5.C641 2014 9
090			_aQV 38.5 _b. C641 2014 9
245	0	0	_aClinical and statistical considerations in personalized medicine / _cedited by Claudio Carini, Pfizer, Cambridge, Massachusetts, USA, Sandeep Menon, Pfizer, Cambridge, Massachusetts, USA, Mark Chang, AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, USA.
264		1	_aBoca Raton : _bCRC Press/Taylor & Francis Group, _c[2014]
264		4	_c@2014
300			_axvi, 344 pages : _billustrations ; _c24 cm.
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
490	1		_aChapman & Hall/CRC biostatistics series
504			_aIncludes bibliographical references and index.
505	0		_a1. Biomarkers for drug development : the time is now! / Claudio Carini and Attila Seyhan -- 2. RNAi screens : triumphs and tribulations / Attila Seyhan and Claudio Carini -- 3. Current advances in epigenetics / Ewan Hunter and Alexandre Akoulitchev -- 4. Biomarkers and precision medicine : the case of rare diseases / Candida Fratazzi and Claudio Carini -- 5. Biomarker-informed adaptive design / Jing Wang, Mark Chang, and Sandeep Menon -- 6. Fitting the dose : adaptive staggered dose design / Joseph Wu, Sandeep Menon, and Mark Chang -- 7. Evidence-based adaptive statistical decision and design strategies for maximizing the efficiency of clinical oncology development programs with predictive biomarkers / Cong Chen and Robert A. Beckman -- 8. Biomarker identification in clinical trials / Ilya Lipkovich and Alex Dmitrienko -- 9. Multiplicity in pharmacogenomics / Lingyun Liu, Fredrick Immermann, and Sandeep Menon -- 10. Patient-reported outcomes in personalized medicine / Demissie Alemayehu and Joseph C. Cappelleri -- 11. Regulatory issues in use of biomarkers in drug development / Aloka G. Chakravarty.
520			_a'Personalized medicine has the potential to change the way we think about, identify, and manage health problems. In the pharmaceutical industry, it is already having an exciting impact on both clinical research and patient care. This impact will continue to grow as our understanding and technologies improve. With contributions from well-known industry leaders in clinical development, this book covers the practical aspects of personalized medicine, focusing on issues that have direct application in the industry. Topics include designs for targeted therapy, adaptive designs, evidence-based adaptive statistical decisions, and design strategies for maximizing the efficiency of clinical oncology'-- _cProvided by publisher.
520			_a'Preface The successful utilization of biomarkers in clinical development and, indeed, realization of personalized medicine require a close collaboration among different stakeholders: clinicians, biostatisticians, regulators, commercial colleagues, and so on. For this reason, we invited experts from different fields of expertise to address the opportunities and challenges, and discuss recent advancements related to biomarkers and their translation into clinical development. The first four chapters discuss biomarker development from a clinical perspective ranging from introduction to biomarkers to recent advances in RNAi screens, epigenetics, and rare disease as targets for personalized medicine approaches. Chapters 5 through 10 are devoted to considerations from a statistical perspective, and the last chapter addresses the regulatory issues in biomarker utilization. A biomarker is a characteristic that can be objectively measured and evaluated as an indicator of a physiological as well as pathological process or response to a therapeutic intervention. Although there is nothing new about biomarkers such as glucose for diabetes and blood pressure for hypertension, the current focus on molecular biomarkers has taken the center stage in the development of molecular medicine. Molecular diagnostic technologies have enabled the discovery of molecular biomarkers and are assisting in the definition of the pathogenic mechanism of diseases. Biomarkers represent the basis of the development of diagnostic assays as well as the target for drug discovery. Biomarkers can help monitoring drugs effect in clinical trials as well as in clinical practice'-- _cProvided by publisher.
650		2	_aPharmacogenetics _xstatistics & numerical data.
650		2	_aBiological Markers.
650		2	_aDrug Discovery _xstatistics & numerical data.
650		7	_aMATHEMATICS _xProbability & Statistics _xGeneral. _2bisacsh
650		7	_aMEDICAL _xInternal Medicine. _2bisacsh
650		7	_aMEDICAL _xPharmacology. _2bisacsh
700	1		_aCarini, Claudio _eeditor
700	1		_aMenon, Sandeep M., _eeditor
700	1		_aChang, Mark, _eeditor
830		0	_aChapman & Hall/CRC biostatistics series (Unnumbered)
907			_a.b16214997 _b2019-11-12 _c2019-11-12
942			_c01 _n0 _kQV38.5.C641 2014 9
914			_avtls003594120
990			_azr
991			_aFakulti Farmasi, KKL
998			_ad _b2015-07-10 _cm _da _feng _gflu _y0 _z.b16214997
999			_c599205 _d599205