Table V.
Similarities and Differences in Determination of the Last Time Point for an f 2 Calculation
| Country | Last time point/Measurement to include in an f 2 analysis |
|---|---|
| Japan (6,23,24) | The reference drug has reached 85% dissolution. Drug substance: percent dissolved at final time point (or first point of plateau is acceptable) |
| South Korea (29), Mexico (21) | The reference drug reached 85% dissolution |
| Europe (5), Australia (28), Russia (5), Turkey (27) | Any one of the reference or test product has reached 85% dissolution (or asymptote is reached) |
| Thailand (26), Brazil (18), United States (14), South Africa (28) | For both test and reference drugs, no more than one mean value >85% |
| Canada (19) | Drug product reach the dissolution mean of 85% |
| India (21) | Achieve virtually complete dissolution |
| China (20) | Drug dissolution is allowed to reach more than 90% only in one time point |