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EU to implement BCS-based biowaiver guideline in July

The International Council for Harmonisation's M9 guideline on biopharmaceutics classification system-based biowaivers will take effect July 30, according to the European Medicines Agency. The 18-page guideline covers various topics, including which drugs are eligible for a BCS-based biowaiver and how drug solubility and permeability can be evaluated. Regulatory Focus (2/11)

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