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William Gregory
Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
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Вернуться на страницу книги Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
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Thank You
Contents
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Contributors
Notice
CHAPTER 1 The Theory and Definitions of Drug Safety — Pharmacovigilance
The Theory
Adverse Event (AE) — ICH
Adverse Event (AE) — EMA
Adverse Event/Experience (AE) — FDA
Adverse Reaction (AR)
Serious Adverse Event and Serious Adverse Reaction (SAE/SAR)
Non-serious Adverse Event and Non-serious Adverse Reaction (NSAE/NSAR)
Suspected Adverse (Drug) Reaction (SAR/SADR) — FDA
Serious, Unexpected, Suspected Adverse Reaction (SUSAR)
Serious, Expected, Suspected Adverse Reaction
Unexpected Adverse Event — FDA
Unexpected Adverse Reaction — EMA
Unlisted Adverse Reaction — EMA
Expected (Listed versus Labeled)
The Practice
CHAPTER 2 Clinical Trials, Clinical Research Organizations, Phases I–IV, and Investigator-Initiated Trials
Introduction
Phase I
Phase II
Phase III
Phase IV
Late Phase Studies
Investigator-Initiated Research
Other Study-Related Issues
Frequently Asked Questions
CHAPTER 3 Spontaneous Post-marketing Adverse Events
Introduction
United States Regulations
European Union Requirements
Other Regions
Process Issues
Frequently Asked Questions
CHAPTER 4 The Theory of Drug Safety — Pharmacovigilance
A Brief History of the FDA
Regulations, Laws, and Guidances
The United States Regulations and Guidances
The European Union Legislation (including Directives and Regulations), and Guidance
Frequently Asked Questions
CHAPTER 5 The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology
Introduction
Case Report or Individual Case Safety Report
Aggregate Reports
Reporting Rates versus Risk
Why We Can’t Calculate Good Rates
Quantitative Signal Detection Methods
Other Data Mining Methods
CHAPTER 6 Epidemiology and Pharmacoepidemiology: What Are They? What Are Their Limitations and Advantages?
Introduction
Randomized Controlled Trial
Adaptive Clinical Trials
Cohort Study
Case-Control Study
Nested Case-Control Study
Confidence Intervals
Frequently Asked Questions
CHAPTER
7
Regulations, Directives, Guidance, Laws and Consensus Documents
United States
European Union
Consensus Documents
The Practice
Over-the-Counter Drugs
United States
European Union
Staying Up to Date
Scientific/Medical Literature
Meetings and Conferences
The Internet
CHAPTER
8
The United States Food and Drug Administration
Introduction
Center for Drug Evaluation and Research
The Safety Reporting Portal
Risk Management
MedWatch
Safety Databases
Other Useful FDA Web Pages
Center for Biologics Evaluation and Research
Center for Devices and Radiologic Health
Over-the-Counter Products
Drug Safety Oversight Board
Prescription Drug User Fee Act
Prescription Drug User Fee Act: Five-Year Plan
Food and Drug Administration Act (FDAAA) of 2007
21st Century Cures Act
FDA Reauthorization Act of 2017
The Sentinel System and ARIA
What is Expected from Drug Companies by the FDA?
What is Expected from Consumers and Healthcare Professionals by the FDA?
FDA Publications and Updates
Drug Safety Inspections
Frequently Asked Questions
CHAPTER
9
The European Medicines Agency
Introduction
Registration Procedures in the EU
European Medicines Agency
Organization and Structure
Risk Management
EudraVigilance — The EU Safety Database
What Is Not in the Scope of EMA?
The Pharmacovigilance Risk Assessment Committee
Post-marketing PV EU Regulation
Volume 10 Clinical Trial PV
The EMA Website
European Network of Centers for Pharmacoepidemiology and Pharmacovigilance
Newsletters and RSS Feeds
Comments
Agence Nationale de Sécurité des Médicaments et Produits de santé
Missions
Scope
Organization
Frequently Asked Questions
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