Abstract
Pharmacoepidemiology is a discipline that investigates the benefits, risks, and uses of medicines, biological agents, medical devices, and other medical interventions in large populations. Pharmacoepidemiology is referred to as a bridge science bringing together epidemiology, clinical pharmacology, and biostatistics. Pharmacoepidemiology studies are mainly based on large healthcare utilization data, relying on epidemiological study designs, analytical methods, and statistical modeling. Pharmacoepidemiology offers unique challenges in terms of controlling for confounders, minimizing selection bias, and addressing the limitations of healthcare databases. Pharmacoepidemiology studies provide “real-world” assessments of the potential benefits and adverse drug events in larger and more diverse populations and a longer follow-up period than premarketing clinical trials, which mostly involve highly selected patient populations. Evidence from pharmacoepidemiological studies is useful for legal, regulatory, and public and clinical decision-making. In this chapter, the definition and application of pharmacoepidemiology, sources of data, and pharmacoepidemiological study designs will be discussed. Furthermore, the main challenges in pharmacoepidemiology and essential skills for pharmacoepidemiology will be explored.
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Beyene, K., Chan, A.H.Y., Man, K.K.C. (2022). Pharmacoepidemiology and Big Data Research. In: Encyclopedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy. Springer, Cham. https://doi.org/10.1007/978-3-030-50247-8_109-1
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