Pharmacovigilance: A Practical Approach - Original PDF

دانلود کتاب Pharmacovigilance: A Practical Approach - Original PDF

Author: Thao Doan

توضیحات کتاب :

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety

سرچ در وردکت | سرچ در گودریدز | سرچ در اب بوکز | سرچ در آمازون | سرچ در گوگل بوک

ضمانت بازگشت

ضمانت بازگشت

فایل های تست شده

فایل های تست شده

پرداخت آنلاین

پرداخت آنلاین

تضمین کیفیت

تضمین کیفیت

دانلود فوری

دانلود فوری

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

 

 

  • Covers the evolving regulatory landscape, as well as current and future use of digital technologies.
  • Uses case studies to ensure content is relevant to everyday practice.
  • Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance.
  • Consolidates today’s available information on this timely topic into one convenient resource.

ادامه ...

Ebook details:
عنوان: Pharmacovigilance A Practical Approach
نویسنده: 9780323581165
ناشر: Elsevier; 1 edition (August 29, 2018)
زبان: English
شابک: 0323581161, 978-0323581165

 

9780323581172 032358117X


حجم: 15 Mb
فرمت: Original PDF

ادامه ...

Front 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. The 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 TEAMS18; FIRST-IN-HUMAN REVIEW COMMITTEE19,20. INTERNAL SAFETY ADVISORY GROUPSSAFETY ASSESSMENT COMMITTEES21; 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. Safety topics of interestEvent 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. Investigator brochureDevelopment 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

ادامه ...
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