Bioequivalent

BIOEQUIVALENT

GASTROBIM^™ is bioequivalent to the pioneer product, GastroGard^®.

Bioequivalence as defined by FDA is the absence of a difference (within pre- defined acceptance criteria) in the bioavailability of the active pharmaceutical ingredient (API) or its metabolite(s) at the site of action when administered at the same molar dose under similar conditions, in an appropriately designed study.

Following this process, the conclusion of bioequivalence was confirmed by the FDA and therefore GastroGard^® and GASTROBIM^™ have been accepted as “interchangeable in a clinical setting”.

READ THE FDA DESCRIPTION OF BIOEQUIVALENCE

Bioequivalence is defined as the absence of a difference (within predefined acceptance criteria) in the bioavailability of the active pharmaceutical ingredient (API) or its metabolite(s) at the site of action when administered at the same molar dose under similar conditions, in an appropriately designed study.
FDA-CVM Guidelines ensure UNIFORMITY.
When using blood drug concentrations as a surrogate for demonstrating product bioequivalence, there is an underlying assumption that two products having an “equivalent” rate and extent of drug absorption, as measured in the blood, will be therapeutically indistinguishable and therefore interchangeable in a clinical setting.
The bioequivalence study report, including blood drug concentrations and other relevant data, was submitted to the FDA-CVM for review and assessment.
Following this process, the conclusion of bioequivalence was confirmed and therefore GastroGard® and Bimeda’s GASTROBIM™ have been accepted as “interchangeable in a clinical setting”.

IMPORTANT SAFETY INFORMATION:
The safety of GASTROBIM^™ paste has not been determined in pregnant or lactating mares.
For use in horses and foals 4 weeks of age and older. Keep out of reach of children. In case of ingestion, contact a physician.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.