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PITTSBURGH — The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...

Stability studies are a cornerstone of pharmaceutical quality. They ensure that a pharmaceutical product will maintain its efficacy and safety for its established shelf life to protect patient safety.

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it. While every drug molecule is unique and brings its own ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...