Tag: CTD Submissions

Match Stability Study Container-Closure Systems to Final Market Packaging

Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life. If the container-closure system used during testing doesn’t match the one used in the market, the results may not reflect real-world conditions. Packaging directly impacts exposure to moisture, oxygen, and light—all of which influence chemical…

Stability Study Tips

Use Bracketing and Matrixing Effectively in Stability Studies for Product Variants

Understanding the Tip: What are bracketing and matrixing: Bracketing and matrixing are scientifically justified designs used to reduce the number of stability tests required when dealing with multiple strengths, fill volumes, or packaging sizes of a single product line. Bracketing tests only the extremes (e.g., lowest and highest strengths), while matrixing staggers time point testing…

Stability Study Tips

Follow ICH-Compliant Sampling Intervals for Accurate Stability Assessment

Understanding the Tip: Why structured sampling intervals matter: Stability testing isn’t just about storing products—it’s about analyzing them at critical intervals to track changes over time. Structured sampling intervals are essential to detect degradation trends and determine shelf life accurately. Missing key time points can lead to incomplete datasets, failed regulatory audits, or inaccurate product…

Stability Study Tips