Generic Drug Products and Therapeutic Equivalence

Authored by: Leon Shargel

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v3-11

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Abstract

Generic drug products are multisource drug products are products marketed by more than one manufacturer that contain the same active pharmaceutical ingredient (API) or drug substance in the same dosage form, given by the same route of administration, and meeting regulatory guidelines for therapeutic equivalence to the corresponding innovator or brand-name drug product. Pharmaceutical equivalents are drug products that contain the same active ingredient(s), are of the same dosage form, are administered by the same route, and are identical in strength or concentration. Even though the multisource drug products may be pharmaceutical equivalents and meet USP-NF monographs 1 or other applicable standards (i.e., strength, quality, purity, and identity), pharmaceutical equivalents may not have the same drug product performance.

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