Archive: 2026/02

How to Track Post-Marketing Studies for Drug Safety

February 16, 2026 Alyssa Penford 10 Comments

Learn how to track post-marketing drug safety studies using FAERS, Sentinel, and real-world data. Understand regulatory systems, signal detection, and best practices to prevent hidden risks after a drug launches.

Partial AUC in Bioequivalence: How It Works and Why It Matters for Generic Drugs

February 5, 2026 Alyssa Penford 10 Comments

Partial AUC measures drug exposure in specific time intervals to improve bioequivalence for complex formulations. It overcomes limitations of traditional metrics like Cmax and AUC. FDA and EMA require it for certain drugs. Challenges include higher sample sizes and precise time intervals. Essential for generic drug developers to prevent rejections.

Patent Exclusivity vs Market Exclusivity: Key Differences Explained

February 4, 2026 Alyssa Penford 14 Comments

Patent and market exclusivity are key protections for pharmaceuticals. Patents protect inventions from USPTO; market exclusivity is FDA-granted. They differ in duration, enforcement, and scope. Understanding both helps navigate drug development and generic competition. Real-world examples show their impact on drug pricing and availability.