Manual of Drug Safety And Pharmacovigilance

by Cobert, Barton, M.D.

• ISBN13: 9780763738891
• ISBN10: 0763738891
• Edition: 1st
• Format: Paperback
• Copyright: 2006-12-01
• Publisher: Jones & Bartlett Learning

Summary

Drug Safety 101! A how-to manual for newcomers To The field of drug safety, clinical research, regulatory affairs, law and other domains touching on pharmacology who wish to learn the theory And The practicalities of drug safety (pharmacovigilance) and side effects, this comprehensive and practical guide provides essential information on drug safety and regulations, including recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. Whether you're working in drug safety, clinical research, regulatory affairs, epidemiology, marketing and sales, nursing, pharmacoepidemiology, or another area in the pharmaceutical industry, FDA (or other regulatory agency), academia, hospital (especially pharmacy or formulary committee) are a lawyer, writer, or other professional who needs to know the details of drug safety and side effects,  training nurses, pharmacists and PharmD and PhD pharmacology students or medical students, this is the book for you! This book teaches the ins and outs of drug safety in the industry, a hospital, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done in the industry and FDA when confronted with a drug safety problem. Book includes a free CD-ROM!

Table of Contents

The Theory & Definitions of Drug Safety (Pharmacovigilance)

Clinical Trials, CROs, Phases I-IV, Investigator Initiated Trials

Spontaneous, Post-Marketed AEs

The Theory of Drug Safety (Pharmacovigilance)

AEs with New Chemical Entities, Generics, Excipients and Placebos

Acute and Chronic (Late Ocurring) AEs, AEs that disappear (BendectineTM ), Diethylstilbesterol (DES)

The Mathematics of AEs

Organizations: The Food and Drug Administration (FDA) -MedWatch

Organizations: European Medicines Evaluation Agency

Where Data Resides

Signals and Signaling in the Context of Risk Management

Data Privacy and Sharing

The Roles of Academia, Companies, Government Health Authorities, Non-Governmental Organizations (NGOs), Consumer Groups, and Gadflies in the World of Pharmacovigilance

What is It? Risk Management and Assessment

FDA's Pre-Marketing Risk Assessment Guidance of March 2005

FDA's Development and Use of Risk Minimization Action Plans Guidance of March 2005

FDA's Good Pharmacovigilance Practices and Pharmacoepidemologic Assessment Guidance of March 2005

Epidemiology and Pharmacoepidemiology -What are They? -What are Their Limitations and Advantages?

Product Quality Issues

Pregnancy, Lactation, and AEs -AEs in Pregnant Partners of Males Taking a Drug -Pregnancy Registries -The Swedish Pregnancy Registry

Children, the Elderly, and Other Special Groups

Drug Interactions and Polypharmacy

Drug Labeling, Warnings, etc. -Physicians'

Table of Contents provided by Publisher. All Rights Reserved.