000			04569cam a2200505 i 4500
001			22132886
003			OSt
005			20250823191646.0
008			210714s2019 mouab b 001 0 eng c
010			_a 2021301538
016	7		_a101738270 _2DNLM
020			_a9780323581165 _qpbk.
020			_a0323581161 _qpbk.
035			_a(OCoLC)on1015855399
040			_aNLM _beng _cNLM _erda _dYDX _dOCLCF _dOCLCO _dOCLCA _dDLC
042			_apcc
050	0	0	_aRM302.5 _b.D63 2019
060	0	0	_a2018 I-615
060	1	0	_aQV 771
100	1		_aDoan, Thao, _eauthor.
245	1	0	_aPharmacovigilance : _ba practical approach / _cThao Doan, Cheryl Renz, Mondira Bhattacharya, Fabio Lievano, Linda Scarazzini.
264		1	_aSt. Louis, Missouri : _bElsevier, _c[2019]
300			_axiv, 213 pages : _bcolor illustrations, color maps ; _c24 cm
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0		_aFront Cover; Pharmacovigilance: A Practical Approach; Pharmacovigilance: A Practical Approach; Copyright; List of Contributors; Acknowledgments; Introduction; Contents; I -- THE REGULATORY ENVIRONMENT; 1 -- Does Regulation Drive Science or Does Science Drive Regulation?; INTRODUCTION; IMPORTANT EVENTS IN PHARMACOVIGILANCE; IMPORTANT PHARMACOVIGILANCE ORGANIZATIONS; IMPORTANT REGULATORY AUTHORITIES AND REGIONS; THE WORLD OF REGULATORY SCIENCE; EMA PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE; NEW WAVE OF GLOBAL PHARMACOVIGILANCE REGULATION; THE EU QPPV; THE RISE OF THE NATIONAL QPPV
505	8		_aThe Pharmacovigilance System Master FileIs Regulatory Guidance Just Guidance?; How can Industry Influence Regulation?; Enforcement of Pharmacovigilance Regulations; CONCLUSIONS; REFERENCES; II -- SAFETY DATA AND REAL WORLD EVIDENCE; 2 -- Signal Management and Methods of Signal Detection; INTRODUCTION; SIGNALS (BOX 2.2); SIGNAL DETECTION; SIGNAL VALIDATION; SIGNAL ASSESSMENT; DETERMINING BENEFIT/RISK (BOX 2.5); SAFETY GOVERNANCE IN PHARMACOVIGILANCE; SAFETY GOVERNANCE FRAMEWORK; SAFETY OVERSIGHT BOARD (BOX 2.8); SAFETY MANAGEMENT TEAMS 18; FIRST-IN-HUMAN REVIEW COMMITTEE 19,20
505	8		_aINTERNAL SAFETY ADVISORY GROUPS SAFETY ASSESSMENT COMMITTEES 21; SAFETY GOVERNANCE SUPPORT; SAFETY GOVERNANCE PROCESS (BOX 2.11); CONCLUSION; LIST OF DEFINITIONS; REFERENCES; FURTHER READING; 3 -- Product Safety Monitoring in Clinical Trials; INTRODUCTION; SAFETY PLANNING; Systemic Approach; Development Risk Management Plan and Development Core Safety Information (Box 3.3); Specific Safety Issues (Box 3.4); DATA COLLECTION AND EVALUATION; Data Collection (Box 3.5); General principles and considerations; Specialized data collection and adjudication; Baseline risk factor documentation
505	8		_aSafety topics of interest Event adjudication; Data monitoring committee (Box 3.6); Safety assessment committees; Data Evaluation; Quantitative analysis; Individual studies (Box 3.8); Individual studies (Box 3.8); Meta-Analysis (Box 3.11); Meta-Analysis (Box 3.11); Qualitative analysis (Box 3.12); Signal evaluation; Safety actions in response to a confirmed signal-risk management (Box 3.13); REPORTING AND COMMUNICATION OF SAFETY INFORMATION; Expedited Reporting; Causality assessment of individual case safety report (Box 3.14); Communicating Safety Information (Box 3.16); Informed consent
505	8		_aInvestigator brochure Development Safety Update Report; CONCLUSION; REFERENCES; 4 -- Causality Assessment and Examples of Adverse Drug Reactions (Drug-Induced Liver Injury, Renal, Skin, and Major ...; INTRODUCTION; THE CIOMS WORKING GROUP CRITERIA; THE BRADFORD-HILL CRITERIA; LIVER: CAUSALITY ASSESSMENT IN DRUG-INDUCED LIVER INJURY IN ADULTS; Step 1: Take History and Perform a Physical Examination; Step 2: Calculate the R-Value; Step 3: Exclude Differential Diagnoses; Step 4: Literature Review; Step 5: Clinical Judgement for Final Drug-Induced Liver Injury Diagnosis
650		0	_aPharmacovigilance.
650	1	2	_aPharmacovigilance.
650	2	2	_aDrug Monitoring.
650	2	2	_aPatient Safety.
650		7	_aPharmacovigilance. _2fast _0(OCoLC)fst02002642
700	1		_aRenz, Cheryl, _eauthor.
700	1		_aBhattacharya, Mondira, _cMD, _eauthor.
700	1		_aLievano, Fabio, _eauthor.
700	1		_aScarazzini, Linda, _eauthor.
906			_a7 _bcbc _cpccadap _d2 _encip _f20 _gy-gencatlg
942			_2lcc _cBK _n0
999			_c1961 _d1961