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Changes Made to the Study Design or Formulation to Achieve Successful Pivotal BE Studies of HV Drugs after the Initial BE Studies Failed to Meet the Acceptance Criteria
| Change made | No. of ANDAs | Percent |
|---|---|---|
| Increase in sample size in two-way crossover BE study | 41 | 91 |
| Changed to three-way study design and RSABE | 3 | 7 |
| Reformulated | 1 | 2 |
| Total | 45 | 100 |
