Abstract
Adaptation towards digitalization in pharmaceuticals leads to the utilization and development of Artificial Intelligence (AI). Significantly it is reducing human workload with the help of an algorithm. Already AI is acting as a key in clinical trial, health care, quality management, manufacturing, product development, and management. Top pharmaceutical companies have adopted AI in different applications within the pharma sector. Different AI models like Machine learning, Artificial Neural Network, Deep Learning, robotics, and Natural Language Processing are being used in pharmaceuticals and healthcare systems. The Worldwide AI market is growing remarkably with a compound annual growth rate of 49.6% and is expected to reach $18,119 million by 2025. So, for better regulation, concerning safety, privacy regulatory strategy is heading towards a better framework. Different regulatory authorities like China, Europe, and United States (US) have adopted AI for economic and policy aspects. Emerging countries are using these tools for administrative work. US has begun implementing frameworks for AI adaptation, research, and development. The AI policy strategy started in 2016 with a series of workshops conducted under the Obama administration. Federal Food and Drug Administration (FDA) has also published draft guidance for regulatory oversight of AI and Machine Learning. In 2021 FDA published a draft regulation for software as a medical device. This review article provides a snapshot of AI implementation in pharmaceuticals and health care with the regulatory approach in the US.
Highlights
Due to digitalization, Artificial Intelligence (AI) is presently exceptionally famous in various sectors mainly in pharmaceuticals [1]
The main objective of the study is to exhibit the distinctive utilization of AI in both the pharmaceutical and health care sectors by discussing the under fostering regulation identified with AI in the United States (US)
In drug discovery to drug development and each phase of clinical trial AI may lead to a proficient tool for completing task and solving problem in an efficient manner
Summary
Artificial Intelligence (AI) is presently exceptionally famous in various sectors mainly in pharmaceuticals [1]. The main objective of the study is to exhibit the distinctive utilization of AI in both the pharmaceutical and health care sectors by discussing the under fostering regulation identified with AI in the US. In first section we will discuss the broad application of AI in pharmaceuticals and Healthcare and in second section we will give an insight of regulation in USA. Linear Regression, LightBGM, Support Vector Machines (SVMs), Random Forests (RF), and ANNs (Artificial Neural Networks) are instances of Supervised ML models [7]. ANN, KNN, SVM, Decision Tree (DT), Random Forest (RF), Linear Regression LightBGM are common ML methodology in pharmaceuticals. ANNs is the most widely recognized model used in numerous applications such as drug research, design, development, Etc and it consists of processing elements and coefficients. Deep Learning (DL), a recent advance, is becoming another popular method of ML [7]
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