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.