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3.Pharmacokinetics: Bioequivalence: General Pharmacology Lectures -
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Bioequivalence refers to the comparison of two drug products that are pharmaceutically equivalent, ensuring that they release the same amount of active ingredient into the bloodstream over the same period. This concept is crucial for generic drugs, which must demonstrate bioequivalence to the branded drug before being approved for use.
The parameters used to assess bioequivalence include the rate and extent of absorption, typically measured by the area under the concentration-time curve (AUC) and the peak plasma concentration (Cmax). Any significant difference in these values may indicate variations in the drug’s performance in the body. Regulatory bodies like the FDA and EMA require rigorous testing to ensure that generics perform similarly to their branded counterparts, ensuring patient safety and efficacy.
Bioequivalence testing is performed under highly controlled conditions to assess not just the physical form of the drug but its therapeutic performance in a clinical setting.
This process helps maintain drug quality and promotes access to cost-effective treatments, making essential medications more affordable for patients worldwide.
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