Clinical Operations
Jindal Life Science facility is designed to -
- Single dose BA/BE studies: Fast/Fed/Sprinkled apple-sauce.
- Multiple doses BA/BE studies: Fast/Fed
- Steady-state studies
- Partial/full replicate design studies
- Parallel BA/BE studies
- BA/BE studies for controlled psychotropic substances
- Long housing studies (e.g. depot injections/endogenous substances/diet restricted/teratogenic drugs)
- 505(b)(2) submission types
- Non-oral dosage form BA/BE studies:
• Injectable
• Topical products (semisolids, patch)
• Inhalation (oral/nasal) products: With & without charcoal
• Suppositories/Enema
• Vaginal route specific dosage forms
• Lozenges
• Food-effect studies
• Drug-drug PK interaction studies
• In-vitro bioequivalence studies - Special population BA/BE studies
• Post-menopausal female subjects
• Hypo gonadal male subjects
• Geriatric subjects
Facility
- 2 Clinics with 71 Bed Capacity and 3 Beds of ICU.
- 2 4000 series LC-MS / MS machines.
- 600+ volunteer bank.