EMA stability expectations – StabilityStudies.in

Bridging Study Strategies Using Accelerated Stability Data

Bridging Study Strategies Using Accelerated Stability Data How to Use Accelerated Stability Data in Bridging Study Strategies Bridging studies are strategic tools in pharmaceutical development and lifecycle management. They help link stability data from one batch or formulation to another, enabling continued product registration or shelf life extension without repeating full stability programs. This guide…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Defining Long-Term Stability Testing Periods Based on Shelf Life and Regulatory Guidance

Defining Long-Term Stability Testing Periods Based on Shelf Life and Regulatory Guidance Establishing Long-Term Stability Testing Durations Based on Shelf Life and Regulatory Expectations Long-term stability testing is the cornerstone of pharmaceutical shelf life determination. It provides critical evidence that a drug product will remain within specification throughout its marketed storage period. The duration, frequency,…

Intermediate and Long-Term Stability Testing, Stability Testing Types