Abstract

THE DRUG LIFECYCLE: AN IN-DEPTH ANALYSIS OF DISCOVERY, DEVELOPMENT, AND POST-MARKETING SAFETY MONITORING

Rutuja M. Rokade, Akash P. Dhoke* and Dr. M. D. Kitukale

Abstract

This systematic review, titled "The Drug Lifecycle: An In-Depth Analysis of Discovery, Development, and Post-Marketing Safety Monitoring," explores the comprehensive process of drug development from initial discovery through clinical development, regulatory approval, and post-marketing surveillance. The study aims to provide a detailed understanding of each phase of the drug lifecycle, examining the methodologies, challenges, and innovations that influence the creation and monitoring of new pharmaceutical products. The drug discovery phase is analyzed, focusing on target identification, lead compound discovery, and preclinical testing, followed by an in-depth discussion of clinical trial phases and regulatory hurdles in approval processes. Post-marketing surveillance is also examined, emphasizing the importance of pharmacovigilance in ensuring ongoing drug safety after a product reaches the market. The review highlights the integration of real-world evidence, AI, and digital tools in optimizing drug development and safety monitoring practices. Furthermore, it addresses the challenges encountered in managing drug lifecycles, including regulatory delays, recruitment issues, and the increasing complexity of biologics and personalized medicines. Future trends, such as the increasing use of genomic data and AI technologies, are explored, offering insights into the next generation of drug development and surveillance strategies. This review provides valuable insights for pharmaceutical professionals, researchers, and regulators in understanding the complexities and future directions of drug lifecycle management.

Keywords: Drug discovery, clinical development, pharmacovigilance, post-marketing surveillance, regulatory approval, AI in drug development, drug safety, real-world evidence.