Tag: ICH Q1F

Storage Conditions for Real-Time Studies in Climatic Zones

Storage Conditions for Real-Time Studies in Climatic Zones Real-Time Stability Testing: Storage Conditions Across Global Climatic Zones Conducting real-time stability studies requires precise alignment with the storage conditions defined for each ICH climatic zone. These conditions ensure product performance under real-world environmental exposure. This guide explains the specific temperature and humidity requirements for real-time studies…

Real-Time and Accelerated Stability Studies, Stability Testing Types

ICH Guidelines for Accelerated Stability Testing

ICH Guidelines for Accelerated Stability Testing Implementing ICH-Compliant Accelerated Stability Testing Protocols Accelerated stability testing is a crucial component of pharmaceutical development, enabling faster assessment of a product’s stability under stressed conditions. This tutorial explains how to design and execute accelerated stability testing protocols aligned with ICH guidelines, helping pharma professionals estimate shelf life and…

Real-Time and Accelerated Stability Studies, Stability Testing Types