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Raising the Bar: How NAMs and In Silico Testing Are Reshaping Drug Development (Shaastra, IIT Madras)

How NAMs and In Silico Testing Are Reshaping Drug Development

InSilicoMinds is featured in Shaastra Magazine, IIT Madras. In her article ‘Raising the Bars’, Gauri Kamath explores how New Approach Methodologies (NAMs) are reshaping drug development, moving beyond traditional testing toward smarter, more human-relevant methods:

• In vitro cell cultures, spheroids and organoids: 3D human cell models that mimic tissue responses for toxicology and safety testing.

• Organs-on-Chip (OOCs): microfluidic devices that simulate real organ function, from liver and skin to the human placenta.

• In silico modelling and simulation: AI and computational tools to predict drug behaviour, support QSAR analysis, and provide robust regulatory evidence for generic and biosimilar approvals.

• Human microdosing and advanced safety methods: bridging the gap where conventional animal models fall short.

As the article notes, human bioequivalence studies required for generic drug approvals can be reduced, or even replaced, by advanced in silico modelling and simulation tools that provide robust evidence for regulatory decision-making.

India’s pharma industry is at an inflection point. NAMs, including AI-powered computational tools, are no longer just alternatives. They are the future of smarter, faster, more human-relevant drug development. The full article by Gauri Kamath appears in Shaastra (April 2026), IIT Madras’ science and technology magazine.

Link to Article: https://www.linkedin.com/feed/update/urn:li:activity:7455552748533641216

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