Current Issues in Bioavailability and Bioequivalence
When administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses, the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug. Should the rate of absorption varies amongst products, it must be deliberate and stated in the proposed product label, and it must be clearly proved that it is not necessary for achieving effective body drug concentrations on chronic usage or that it is medically irrelevant for the drug. In practise, equivalence is defined as when key pharmacokinetic parameters required to determine the rate and scope of the test, as well as reference products, fall within a predetermined confidence interval. If a drug product is pharmaceutically comparable to the innovator product, meaning it has the same active ingredient, dosage form, strength, and method of administration, and is bioequivalent, the FDA determines it to be therapeutically equivalent. Therapeutically identical products can be used interchangeably. As a result, BE studies are viewed as surrogates for comparative clinical trials in order to determine therapeutic equivalence in terms of safety and efficacy between two pharmacological candidates.
- Biotransformation
- Physico-chemical factors
- Energy dependent efflux transporters
- CYP450 isozymes
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