Chapter 29 - Clinical Trials and Regulatory considerations of Antiviral agents

Abstract

Antiviral medications are currently an emergent area of study, due to evaluation of several new mutated developing strains. These mutant strains are resistant to currently available regimens. It is well known that development of the new drug requires considerable period of times, and has to be authorized through stringent regulatory bodies for human usage. In this chapter, we discuss the future antiviral drugs currently under process of clinical trials (2015–21) either alone or in combination with other agents. Clinical trials, which form an important component of the drug development process, is a significant instrument for defeating the emerging mass of resistant virus. The chapter clearly focuses on aspects laid by FDA (Food and Drug Administration) for under trial drugs and their combinations. The discussion and recommendations for new molecules approved by the FDA (2015–21) have been included. Various databases including Web of Science and PubMed were examined till January 2022. Our key search terms were, including filters searching limit within “5 Years.” Search for FDA-based guidance documents was restricted by the FDA only.