Such evidence may include:* analytical method validation* "in vitro-in vivo" correlation studies(IVIVC)== Regulatory definition ===== Australia ===In Australia, the Therapeutics Goods Administration (TGA) considers preparations to be bioequivalent if the 90% confidence intervals (90% CI) of the rate ratios, between the two preparations, of Cmax and AUC lie in the range 0.80-1.25.
Such evidence may include:* analytical method validation* "in vitro-in vivo" correlation studies== Regulatory definition ===== Australia ===In Australia, the Therapeutics Goods Administration (TGA) considers preparations to be bioequivalent if the 90 % confidence intervals (90 % CI) of the transformed natural log ratios, between the two preparations, of Cmax and AUC lie in the range 0.80-1.25.