Article

Artificial Intelligence-Augmented Analytical Method Development and Validation in Pharmaceutical Manufacturing: Current Applications, Regulatory Landscape, and Future Directions

2026-02-19

Abstract excerpt

The pharmaceutical, biotechnology, and medical device industries are undergoing a paradigm shift as artificial intelligence (AI) and machine learning (ML) technologies are increasingly integrated into analytical method development, validation, and lifecycle management. Traditional approaches to method development, while well-established under regulatory frameworks such as ICH Q2(R2) and the recently adopted ICH Q1...

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Statistical Methods in Clinical Trials

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Literature Corpus work: f76e1971-55a3-5988-aa0f-3864356f97bf
DOI: 10.14293/pr2199.003002.v1

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