ABSTRACT
This chapter discusses the wide range of topics, including safety monitoring, data safety monitoring committees, quantitative methods for safety assessment, pragmatics trials, real-world evidence and methods, benefit-risk planning, and quantitative methods for benefit-risk assessment. The data have high variability in measurements and are multidimensional and interrelated in nature. The use of tabular outputs for safety data often results in large volumes of output leading to problems in generation, assessment, validation, assembly, comprehension, and communication of safety findings. In order to obtain maximum gain from using visual analytics, some considerations must be borne in mind. The concept of grammar of graphics in the construction of graphs has become very widely used due to its logical, structured, and highly efficient way in creating graphs and implementation in software tools, in particular ggplot. Safety data needs should be put into the context aligned with concepts of drug safety profiles.
