The purpose and content of bioequivalence research

The purpose of bioequivalence study: to prove that the bioavailability of two preparations of the same drug is exactly the same, and finally to make it have the same effectiveness and safety when replacing two related preparations.

The contents of bioequivalence research: to develop a new dosage form of drugs on the market, whose effectiveness and safety have been proved by clinical trials, and to prove whether the new dosage form is bioequivalent with the original dosage form; After the patent of innovative drugs expires, develop its generic drugs to prove whether generic drugs and innovative drugs are equally effective and safe.

Bioequivalence means that different preparations of the same drug are given the same dose under the same experimental conditions, and there is no obvious difference in absorption speed and degree. Bioequivalence is different from drug equivalent, which means that the same dosage of the same drug is made into the same dosage form, but the inactive ingredients are not necessarily the same, and the content, purity, uniformity, disintegration time limit and dissolution rate meet the same prescribed standards.