Role of Artificial Intelligence (AI) Tools and Machine Learning (ML) in Clinical Trials for FDA Approval of Pharmaceutical Drugs: A Comprehensive Review

Abstract

Over the past few decades, India's pharmaceutical sector has seen major technological innovations in drug development. India now holds a major place in the world for pharmaceutical research and development as a result of these developments. The purpose of this abstract is to give a general overview of some significant technological advancements in the Indian pharmaceutical sector, with a focus on drug development. The growing use of artificial intelligence (AI) and machine learning (ML) algorithms in several phases of drug research and development is one noteworthy advance. These technologies make things quicker and more precise. furthermore, the production of drug and development of drug to the unique techniques. Proteomics and genomics developments have also enabled innovative drugs development methods by enabling the production of drug customized or drug combinational to the unique profiles of each subject. India is becoming a major participant in the global pharmaceutical scene thanks to technical developments in drug discovery, which have also fuelled advances in safety, personalized medicine, and therapeutic efficacy. Yet issues like infrastructure development of drugs and Ethical and safety and AI and ML Validation and Government and Regularity authority Guidance and regulatory compliance still exist, underscoring the necessity of ongoing funding and cooperation in the pharmaceutical industry. This research work aims to study the AI and ML approaches in clinical trials for a FDA approval. The objectives are studied by conducting a interview with the participants from the industry personnel. Key findings from the research are that training and awareness are required in the industry about the AI involvement in the clinical trials. there should be a regulatory compliance maintained to achieve smooth and diligent protocol for clinical trials with AI for FDA approvals.