Different strengths in BE Study

For different concentrations of oral administration of the same API (or the same combination of drugs), with the same dosage forms of the same manufacturer, is produced in the same location, the report data bioequivalence study of a concentration can be considered acceptable for the rest concentrations (usually the lower concentration except for the case bioequivalence study for higher concentrations is not conducted due to safety reasons) when fully meet the following conditions:
a) The rest concentrations are considered to have the same manufacturing process with concentration used in bioequivalence study;
b) The formula for preparation of the considered concentration are similar (in API and excipient) and the same percentage of coordination between the components or, in the case of drugs account for less than 5% in the formula, the rate of coordination among the remaining ingredients in a formula similar to formula of the concentration used in bioequivalence studies;
c) There was a linear correlation between drug concentration and absorption of drugs into the body in the considered range of dose (or dose of treatment);
d) For a solid oral drugs: In the same experimental conditions of the solubility test, dissolution of the considered concentration should similar to concentration used in the bioequivalence study (based on percentage of drug released over time). Established methods, comparison of dissolution charts and acceptable limit is prescribed in Annex II- Guidance for BE study of bioavailability / bioequivalence of ASEAN.