ABSTRACT

This chapter reviews some key contributions of artificial intelligence and machine learning methods in medical research and drug development. It investigates applications of AI/ML methods in different stages of the drug development from drug discovery up to manufacturing and fault detection. In the current highly competitive landscape of drug development, big pharmaceutical companies are utilizing AI-related methods more than any time before in different stages of drug development. Subgroup analysis, subgroup identification, and personalized medicine are closely related, and they can be considered as three generations of methods for personalized medicine, although their objectives could be slightly different. The subgroup analysis is often referred to as to evaluate treatment effects on a predefined subgroup of patients based on their baseline covariate values. Manufacturing and packaging in pharmaceutical industry is a crucial step, where investments on research and development during clinical trials of an approved drug will be paid off by making it available to the public.