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Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Relative bioavailability is one of the measures used to assess bioequivalence (BE) between two drug products. For FDA approval, a generic manufacturer must demonstrate that the 90% confidence interval for the ratio of the mean responses (usually of AUC and the maximum concentration, C max ) of its product to that of the "brand name drug" [OB ...
Therefore, if a drug has a bioavailability of 0.8 (or 80%) and it is administered in a dose of 100 mg, the equation will demonstrate the following: De = 0.8 × 100 mg = 80 mg That is the 100 mg administered represents a blood plasma concentration of 80 mg that has the capacity to have a pharmaceutical effect.
The Act facilitates the filing of ANDAs by generic companies by preventing the FDA from asking a generic company to provide anything other than information on how it is going to manufacture the drug, quality assurance, and a study showing that the drug acts the same in a human as the innovator drug; this is called bioequivalence.
Absolute bioavailability refers to the bioavailability of a drug when administered via an extravascular dosage form (i.e. oral tablet, suppository, subcutaneous, etc.) compared with the bioavailability of the same drug administered intravenously (IV). This is done by comparing the AUC of the non-intravenous dosage form with the AUC for the drug ...
The C max is often measured in an effort to show bioequivalence (BE) between a generic and innovator drug product. [4] According to the FDA, drug quality bioavailability (BA) and BE rely on pharmacokinetic measurements such as AUC and C max that are reflective of systemic exposure. [5]
The bioavailability of those products is limited by their solvation rate. A correlation between the in vivo bioavailability and the in vitro solvation can be found. Class III – low permeability, high solubility . Example: cimetidine; The absorption is limited by the permeation rate but the drug is solvated very fast.
Indian generics companies exported US$17.3 billion worth of drugs in the 2017–18 (April–March) year. In 1945–2017, bioequivalence studies were only required for generics of drugs that are less than four years old. Since 2017, all generic drugs of certain classes, irrespective of age, require bioequivalence to be approved. [78]