The International Council for Harmonisation (ICH) is a unique project that brings together regulatory authorities and pharmaceutical industry representatives to discuss scientific and technical aspects of pharmaceutical product development and
We recently attended, A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs Webinar and are excited to share the details with you.
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 and, increasingly, PBPK absorption modeling.
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 timelines, and in some cases,
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 The FDA‘s newly released draft guidance on Quantitative
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 evidence is becoming more important
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, technology, academia, and regulatory agencies
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 Co-Chair of the Avicenna Alliance
Following its October 2025 biosimilar guidance update and the revised March 2026 draft guidance, the FDA has made its direction increasingly clear: Biosimilar development is no longer just about generating
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. With the FDA‘s adoption of
For years, FDA has been progressively accepting in silico evidence. PBPK models, MIDD frameworks, virtual bioequivalence, and computational approaches have been finding their place in regulatory submissions across drug development.
In its 2025 draft guidance on AI-supported regulatory decision-making, followed by the joint FDA–EMA Guiding Principles of Good AI Practice in early 2026, regulators made their direction clear: AI in
