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What is Bioequivalence Regulatory Requirements about?

The document discusses regulatory requirements for bioequivalence (BE) evaluations set by various organizations. It provides an overview of BE guidelines from the EU, FDA, WHO, and China for immediate and modified release dosage forms. It also discusses specific BE study requirements and considerations for different drug products and dosage forms, including fixed combination products, transdermal systems, topical forms, and inhalation products. Exemptions and alternative study approaches are described for c

Author

Virag Gophane

Language

EN