Dissolution Safe Space
The Sponsor intended to have a “dissolution safe space” based on the bio batch dissolution specifications. The Sponsor had performed a BA BE study and 90% CI is within the range of 80% – 125%.
The Sponsor intended to have a “dissolution safe space” based on the bio batch dissolution specifications. The Sponsor had performed a BA BE study and 90% CI is within the range of 80% – 125%.
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.
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FDA released two new chapters to its draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food. The draft guidance is intended to help industry comply with certain requirements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
New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.
InSilicoTrials and InSilicoMinds (Ikiminds Pvt Ltd.) had a discussion with DCGI on AI, Modeling and Simulation advancements in India.
Connect with our in silico team of experts to discuss AI solutions and advanced modeling and simulation for the Pharma and Life Science industries and hyper accelerate your success
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