Post-Authorization Safety Studies of Medicinal Products: The PASS
Book bridges the gap in the literature by providing a complete look
at post-authorization safety studies and important
pharmacoepidemiology and pharmacovigilance aspects. It covers
various types and limitations of active surveillance programs,
including the use of large databases and disparate data sources for
rapid signal detection, as well as novel and advanced design and
analysis approaches for causal interference from observational
data. This book serves as an important reference for
pharmacovigilance scientists and pharmacoepidemiologists who are
searching for the appropriate study design to answer safety
research questions. Readers will be able to effectively and
efficiently design and interpret findings from post-authorization
safety studies with the goal of improving the benefit-risk balance
of a drug in order to optimize patient safety.
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