How do the regulatory authorities evaluate the bioequivalence of generic drugs?
Dr. Kimberly W. Raines, a reviewer for the United States Food and Drug Administration (FDA) Division of Bioequivalence 2, has provided a good primer on generic drugs and bioequivalence at https://www.fda.gov/downloads/forpatients/about/ucm410215.pdf. The details of the evaluation process for bioequivalence can vary between the national regulatory authorities of different countries but most countries adopt the same principles as used by the FDA.
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