Methods to Detect, Predict, and Prevent Adverse Drug Reactions in Pharmacovigilance and Clinical Practice

The fundamental principle in any drug approval process is that the drug’s perceived benefits outweigh the risks at the population level. However, post-marketing authorization, adverse drug reactions (ADRs) abound in clinical practice as individual-level factors vary. Further, the number of subjects on whom a drug is tested during the process of drug development is relatively small and thus continuous monitoring is warranted. This is undertaken through the process of pharmacovigilance, which is defined by the World Health Organization as the science and activities related to detecting, assessing, understanding, and preventing adverse effects and other medicine/vaccine-related problems. This chapter outlines the various study designs of post-authorization safety studies used to identify ADRs and the various challenges in detecting ADRs. This chapter also summarizes the various strategies to predict and prevent ADRs in clinical practice and by other means such as pharmacogenetics, use of omics, and in silico approaches including artificial intelligence.