Generic drugs scientific basis

Bioequivalence Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions. Some drugs, however, are intended to have a different absorption rate. The FDA may consider a product bioequivalent to a... 

SCIENTIFIC BASIS FOR GENERIC DRUG PRODUCT EQUIVALENCY BIOAVAILABILITY-BIOEQUIVALENCY... 

An interesting scientific question raised by the new regulations was the point at which two drugs should be regarded as identical . The definition affects not only whether a novel drug could be patented as a new molecular entity but also whether an out-of-patent generic drug (see Section IV.D) could be approved on the basis of an AND A. 

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