Spontaneous Postmarketing Adverse Events
3 Spontaneous Postmarketing Adverse Events Their pivotal and irreplaceable role in providing safety information when a wider population is exposed to a new product. Before a drug comes to…
The Theory of Drug Safety (Pharmacovigilance)
4 The Theory of Drug Safety (Pharmacovigilance) Why a company needs a drug safety group and how it is constituted. The mission of a drug safety group within a pharmaceutical…
Children, Elderly, and Other Special (Vulnerable) Groups
10 Children, Elderly, and Other Special (Vulnerable) Groups Background Similar to the testing of new drugs in pregnant women, the testing of drugs in special (“vulnerable”) groups poses issues. Special…
The Theory and Definitions of Drug Safety (Pharmacoviligance)
1 The Theory and Definitions of Drug Safety (Pharmacovigilance) What is an adverse event (AE)? A serious AE? An adverse drug reaction (ADR)? A suspected adverse drug reaction (SADR)? A…
