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Therapeutic Equivalence

Therapeutic equivalence requires that drug products be both pharmaceutical equivalents and bioequivalents. To be considered pharmaceutical equivalents, drugs must contain the same active ingredients, be the same dosage form, and be identical in strength. To be bioequivalents, the rate and extent of absorption cannot differ significantly between the test and reference drug when administered at the same molar dose under similar conditions. The FDA classifies drugs as therapeutically equivalent if they are approved as safe and effective, are pharmaceutical equivalents, are bioequivalents or shown to meet an appropriate standard, are adequately labeled, and manufactured according to good practices.

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47 views

Therapeutic Equivalence

Therapeutic equivalence requires that drug products be both pharmaceutical equivalents and bioequivalents. To be considered pharmaceutical equivalents, drugs must contain the same active ingredients, be the same dosage form, and be identical in strength. To be bioequivalents, the rate and extent of absorption cannot differ significantly between the test and reference drug when administered at the same molar dose under similar conditions. The FDA classifies drugs as therapeutically equivalent if they are approved as safe and effective, are pharmaceutical equivalents, are bioequivalents or shown to meet an appropriate standard, are adequately labeled, and manufactured according to good practices.

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Angel De la Victoria
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Therapeutic Equivalence = Bioequivalence + Pharmaceutical Equivalence

Drugs are considered to be therapeutic equivalents and thus suitable for substitution
(generic equivalents) if, among other factors, they are both pharmaceutical equivalents
and bioequivalent.

Therapeutic Equivalents: Drug products are considered to be therapeutic equivalents


only if they are pharmaceutical equivalents and if they can be expected to have the same
clinical effect and safety profile when administered to patients under the conditions
specified in the labeling.
The FDA classifies as therapeutically equivalent those products that meet the following
general criteria:
I. they are approved as safe and effective;
II. they are pharmaceutical equivalents in that they,
(a) contain identical amounts of the same active drug ingredient in the same dosage form
and route of administration, and
(b) meet compendial or other applicable standards of strength, quality, purity, and
identity;
III. they are bioequivalent in that,
(a) they do not present a known or potential bioequivalence problem, and they meet an
acceptable in vitro standard, or
(b) if they do present such a known or potential problem, they are shown to meet an
appropriate bioequivalence standard;
IV. they are adequately labeled; and
V. they are manufactured in compliance with Current Good Manufacturing Practice
regulations.

Bioequivalents: Drugs are deemed bioequivalent if:


"The rate and extent of absorption of the test drug do not show a significant difference
from the rate and extent of absorption of the reference drug when administered at the
same molar dose of the therapeutic ingredient under similar experimental conditions in
either a single dose or multiple doses;" or
"The extent of absorption of the test drug does not show a significant difference from the
extent of absorption of the reference drug when administered at the same molar dose of
the therapeutic ingredient under similar experimental conditions in either a single dose or
multiple doses and the difference from the reference drug in the rate of absorption of the
drug is intentional, is reflected in its proposed labeling, is not essential to the attainment
of effective body drug concentrations on chronic use, and is considered medically
insignificant for the drug."

Pharmaceutical Equivalents : FDA considers drug products to be pharmaceutical


equivalents if they meet these three criteria:
1. they contain the same active ingredient(s)
2. they are of the same dosage form and route of administration
3. they are identical in strength or concentration
Pharmaceutically equivalent drug products may differ in characteristics such as shape,
release mechanism, labeling (to some extent), scoring, and excipients (including colors,
flavors, preservatives).

—Definitions from FDA.gov

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