When dissolution profile comparisons is used to waive bioequivalence requirements, the number of test drugs and reference drug in dissolution profile comparison shall be at least 12 dosage units each with sufficient sampling points. The values of similarity factor (f2 value) or other appropriate statistical results should be provided.The percent of variation coefficient of test and reference products at the first sample point should not be more than 20%, and at other time points should not be more than 10%.Only one measurement should be considered after 85% dissolution of both the products in f2 value calculation. If more than 85% of the drug is dissolved within 15 minutes, dissolution profiles may be accepted as similar without further mathematical evaluation.The method to calculate dissolution similarity and result interpretation are provided in the attachment.