reference listed drug

An approved drug product to which new generic versions are compared to show bioequivalence. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application.
By designating a single reference-listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand-name counterpart.

单词	reference listed drug
释义	reference listed drug reference listed drug An approved drug product to which new generic versions are compared to show bioequivalence. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application. By designating a single reference-listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand-name counterpart. AcronymsSeeRLD
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