What is the difference between pharmaceutical equivalents, pharmaceutical alternatives,and therapeutic equivalents?
Question
What is the difference between pharmaceutical equivalents, pharmaceutical alternatives,and therapeutic equivalents?
Solution
Pharmaceutical Equivalents: These are drug products in identical dosage forms and route(s) of administration that contain the same active ingredient(s). They may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.
Pharmaceutical Alternatives: These are drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. Each such drug product individually meets either the identical or its own respective compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates.
Therapeutic Equivalents: These are drug products that are pharmaceutical equivalents and are expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. To be considered therapeutic equivalents, the generic or comparable drug must be pharmaceutically equivalent, meaning they should have the same active ingredient, dosage form, strength and route of administration, and bioequivalent, meaning they release their active ingredient into the bloodstream at the same rate and to the same extent.
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