RNA therapeutics represent one of the most significant shifts in modern medicine. From the rapid development of mRNA COVID-19 vaccines to precision gene silencing and CRISPR-based genome
RNA therapeutics represent one of the most significant shifts in modern medicine. From the rapid development of mRNA COVID-19 vaccines to precision gene silencing and CRISPR-based genome
Model-Integrated Evidence (MIE) is increasingly becoming an important component of science-driven generic drug development. By integrating quantitative modeling and simulation with available in vitro and in vivo evidence, MIE provides a
The Biopharmaceutics Classification System (BCS) allows sponsors to waive in vivo bioequivalence studies for certain oral drug products, replacing them with in vitro dissolution data
For ANDA and 505(b)(2) programs, demonstrating bioequivalence to a reference product is often the single biggest bottleneck in generic drug development, costly clinical studies, long
As mechanistic modeling becomes increasingly integrated into drug development, biologically informed approaches to first-in-human (FIH) dose selection are receiving greater regulatory attention. The FDA‘s newly
As bioequivalence (BE) assessments become increasingly reliant on advanced statistical methodologies, quantitative analysis, and model-informed development strategies, the ability to generate scientifically robust and regulatory-ready
InSilicoMinds was honored to participate in the International Conference on AI in Healthcare 2.0, hosted by Yashoda Hospitals, bringing together leaders from healthcare, pharma, biotech,
InSilicoMinds is featured in the Avicenna Alliance Newsletter for March/April 2026. The AI Task Force Spotlight, written by our Founder and CEO Nirnith Devireddy as
Following its October 2025 biosimilar guidance update and the revised March 2026 draft guidance, the FDA has made its direction increasingly clear: Biosimilar development is
As computational models play an increasingly influential role in drug development, the ability to demonstrate their credibility has become as important as the models themselves.
