What is a drug bioequivalence study?
In the early 1970s, the “United States Food and Drug Administration” (FDA) became interested in biological availability of new drugs. During this period, a drug bioequivalence study panel was formed by the Office of Technology Assessment (OTA) to understand the chemical and therapeutic equivalence relationships of drug products.
What are bioequivalence standards?
The U.S. Food and Drug Administration (FDA) sets bioequivalence standards for different drug dosage forms. The manufacturer of the brand-name drug also must prove bioequivalence before a new form of an approved drug can be sold.
Why are bioavailability and bioequivalence important?
The concepts of bioavailability (BA) and bioequivalence have gained considerable importance during the last three decades because of their application to new brand-name drugs, as well as to generic drugs.
Does average bioequivalence imply drug prescribability or drug switchability?
Drug switchability, therefore, is exchangeability within the same subject. As indicated in [ 1 ], in general, average bioequivalence (ABE) cannot imply either drug prescribability or drug switchability. Therefore, it is suggested that the assessment of bioequivalence should take into consideration of drug prescribability and drug switchability.
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