BA/BE Studies
- Single dose BA/BE studies:
- Multiple doses of BA/BE studies
- Steady-state studies
- Partial/full replicate/switch-ability design studies
- Parallel BA/BE studies
- Truncated BA/BE studies
- BA/BE studies for controlled psychotropic substances
- Long housing studies
- Comparative BA studies for different dosage forms/505(b)(2) submission types
- Food-effect study
Non-oral dosage form BA/BE studies:
- Injectables
- Topical products (semisolids, patch)
- Inhalation (oral/nasal) products: With & without charcoal
- Suppositories/Enema
- Vaginal route-specific dosage forms
- Lozenges
- Patient population BA/BE studies
- Post-menopausal female subjects
- Geriatric subjects