Harness the Power of Augmented Intelligence for Streamlined Regulatory CMC Strategies in Drug Development
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Harness the Power of Augmented Intelligence for Streamlined Regulatory CMC Strategies in Drug Development
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This audiocast discusses the impact of Artificial Intelligence (AI) and Augmented Intelligence on regulatory strategies and submissions in drug development. AI methods, such as predictive analytics and machine learning, can aid in quality control decision-making, cost reduction through corrective action plans, and identifying data requirement issues early on. The audiocast presents an example of an emerging biotech company using AI-powered software to generate a CMC submission for a new drug candidate, resulting in time savings and reduced errors. It emphasizes the importance of understanding drug development goals, selecting appropriate AI tools, and assembling a capable team to leverage AI's potential in improving the regulatory CMC process.