Skip to main content

AI Safety 2026: The New Pharma Standard

AI Safety 2026: The New Pharma Standard - Regulated AI & Model Drift Monitoring AI Safety 2026: The New Pharma Standard - A comprehensive guide to regulated AI systems, model drift monitoring, and pharmaceutical compliance The pharmaceutical and medical device industries have officially moved past the "experimentation phase" of Artificial Intelligence. In boardrooms from Basel to Boston, the conversation has shifted from "Can AI help us?" to the more pressing question: "Is our AI safe, regulated, and ready for a clinical audit?" By end of 2025, the FDA had approved or cleared 1,016 medical devices using AI/ML technologies- nearly double the number from 2022. Yet regulatory scrutiny has intensified proportionally. The FDA and EMA jointly issued guiding principles in early 2026 establishing that AI governance in drug safety must be explainable, traceable, and inspection-ready -  no different from any other GxP-regulated system. This deep dive...
Post a Comment

Researchers target ocular drug delivery market

Researchers target ocular drug delivery market


Researchers have developed a drug delivery device which attaches to the eye and could negate the need for repeat injections. The team from the University of Southern California has created a simple polymer device which is inserted under the conjunctiva and delivers a therapeutic to the affected area.


In time the device could come to replace the intravitreal injections which patients suffering from glaucoma and related eye diseases currently have to be administered with. 

Ellis Meng, researcher on the project, was keen to emphasise further refinements are in the pipeline. She said: "This prototype isn't optimally sized; it's our first go at proving the concept. We're now building a next-generation device." 

The one centimetre long prototype consists of a refillable reservoir sutured to the sclera which contains the therapeutic. Leading off this is a flexible tube which is inserted into the side of the eye and through which the drug is delivered.

Labels:

Comments

Post a Comment

Popular posts from this blog

Solubility Formulas, Solubility Charts, and Drug Delivery

The Science Behind Solubility: Solubility Formula, Solubility Chart, and Drug Delivery system In the intricate world of pharmaceuticals, understanding solubility is crucial for effective drug development and delivery. Solubility, the ability of a substance to dissolve in a solvent, plays a pivotal role in determining a drug's bioavailability, efficacy, and even its safety profile.  In this article, we will delve into the science behind solubility, exploring solubility formulas, solubility charts, and their significance in drug delivery. The Basics of Solubility: Solubility forms the foundation of drug formulation. It is governed by various factors, including the drug's molecular structure, the solvent's properties, and temperature. When a drug's solubility is low, its absorption into the bloodstream can be compromised, resulting in suboptimal therapeutic effects. To overcome this, scientists employ solubility-enhancing techniques, making solubility formulas and charts i...
Post a Comment
Read this Article »

EU MedTech Innovation Pressure: What Professionals Need to Know in 2026

The EU MedTech Innovation Pressure: Navigating 2026 "Crunch" and EY-DG SANTE Findings For years, the European Union was the global launchpad for EU MedTech Innovation, but recent data suggests a pivotal identity crisis is looming. A "CE Mark" was often the first major milestone for a startup before tackling the FDA. However, the tide has turned. As we move deeper into the mid-2020s, the medical technology landscape is facing a pivotal identity crisis.  The recent EY-DG SANTE study , commissioned by the European Commission, has provided the data to back up what many MedTech professionals have been whispering in boardrooms: the regulatory burden of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is creating an "innovation drain." The Data Speaks: Key Findings from the EY-DG SANTE Study The study was designed to monitor the availability of medical devices on the EU market. The results are a wake-up call. According to the ...
Post a Comment
Read this Article »

​AI Solubility Prediction & 2026 Formulation Trends

If you are a pharmacy student or a researcher in 2026, the old textbooks aren't telling you the whole story. For decades, we learned that solubility was simple: "Like dissolves like." We memorized the Noyes-Whitney equation, looked at a solubility chart , and mixed powders in a beaker. But today, that approach is obsolete. With 90% of new drug candidates classified as "poorly soluble" (BCS Class II and IV), the industry faces an "insolubility crisis." The modern lab doesn't just "dissolve" drugs; it engineers them. We use Artificial Intelligence to predict solubility limits before a molecule is even synthesized. We use lasers and supercomputers to force "brick dust" molecules into the bloodstream. This article is your guide to the New Science of Solubility . We will decode the modern math, the AI tools like FastSolv , and the breakthrough technologies like Lipid Nanoparticles (LNPs) that are redefining drug delivery in ...
Post a Comment
Read this Article »