Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 10

CHAPTER 1 The Theory and Definitions of Drug Safety — Pharmacovigilance

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W hat is an adverse event (AE)? A serious AE (SAE)? An adverse drug reaction (ADR)? A suspected, unexpected, serious adverse reaction (SUSAR)? A suspected, expected, serious adverse reaction? What do expected, unexpected, listed and unlisted mean?

Note: Unless otherwise noted, the words “drug” or “drug product” or “medicinal product” should be taken in this book to include “biologics” and “vaccines”, too.

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

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