Formulation Optimization based on Modeling & Simulation for Transdermal Patch
In Silico trial to optimize formulation composition of transdermal patch for achieving bioequivalence
In Silico trial to optimize formulation composition of transdermal patch for achieving bioequivalence
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.
InSilicoMinds was honored to meet with 𝐌𝐫. 𝐌𝐚𝐧𝐨𝐣 𝐉𝐨𝐬𝐡𝐢, 𝐈𝐀𝐒, Department Of Pharmaceuticals (DoP), Ministry Of Chemicals & Fertilizers – Government Of India, to discuss how India can become a
InSilicoMinds was already in the room enabling and helping build and adopt the AI regulatory infrastructure and In Silico first approaches to support the pharmaceutical industry in Uzbekistan. Last month
As we strive for greater efficiency, cost-effectiveness, and patient access to innovative therapies, a groundbreaking concept has emerged – Model Master Files (MMFs).
FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE).
InSilicoMinds’ Chief Scientific Officer, Dr. Pranav Karmwar, will be speaking at an upcoming “AI for Pharma & Biotech” workshop hosted by the Federation of Asian Biotech Associations (FABA).
FDA released two new chapters to its draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food. The draft guidance is intended to help industry comply with certain requirements
U.S. FDA launches a groundbreaking pilot program for the pharmaceutical industry! The program is known as the “General Principles of Model-integrated Evidence (MIE) Industry Meeting Pilot”
The FDA Agency has released a final guidance document that is aimed at drug manufacturers and applicants, offering a framework for assessing the mutagenic and carcinogenic potential of NDSRIs in