Table II.
Similarities and Differences in Criteria for Exemptions from f 2 Comparisons
| Country | Criteria for f 2 exemptions |
|---|---|
| United States (14), Europe (5), Thailand (26), Russia (5), Turkey (27), South Africa (28), China (20), South Korea (29), Canada (19), Australia (17), Mexico (25) | Where more than 85% of the drug is dissolved for both test and reference products within 15 min, dissolution profiles may be accepted as similar without further mathematical evaluation. |
| Brazil (18) | It is necessary to prove the very rapid dissolution products, by the curve graphic, performing collections at, for example 5, 10, 15, 20, and 30 min. The variation coefficient, at the 15-min point, may not exceed 10%. If the reference comparator drug presents mean dissolution of 85% in 30 min (rapid dissolution), then the test drug must also present rapid dissolution. |
| India (21) | Not provided in the guidance. |
| Japan (6,22,24) | Detail descriptions of the exemptions are provided in the Japanese Guideline for Bioequivalence Studies. |