The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline ...
Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and ...
ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...
Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...
Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...
A new guidance document released by the US Food and Drug Administration (FDA) aims to answer some common questions regarding stability testing used to support generic drug applications. The stability ...
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