Exploring AI’s Impact on Drug Development and Regulatory Affairs

Abstract

In recent years, Artificial Intelligence (AI) has significantly reshaped various industries, including healthcare and pharmaceutical sectors. This paper explores AI’s role in drug development and regulatory affairs, emphasizing how AI-driven technologies enhance efficiency, precision, and decision-making processes. We will examine the various AI applications in the drug development pipeline, including drug discovery, preclinical and clinical trials, and post-marketing surveillance. Additionally, the paper addresses the evolving regulatory landscape and how AI is influencing regulatory frameworks for drug approval. The challenges and future directions of AI in this space are also discussed.