BA/BE Studies
BA/BE Studies
Our clinical team at Noah Therapeutics comprises experienced and trained professionals, including doctors, pharmacologists, pharmacists, science post-graduates and graduates who collectively bring extensive experience in conducting Bioavailability/Bioequivalence (BA/BE) studies. With a proven track record in study design, protocol development, data management and regulatory compliance, our team provides expert guidance and oversight to ensure successful study outcomes.
BA & BE Studies in Healthy Volunteers:
- Single dose BA/BE studies: Fast/Fed/Sprinkled applesauce
- Multiple doses BA/BE studies: Fast/Fed
- 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 studies
- PK/PD Studies
- Drug-Drug Interaction Studies
BA/BE in patients/ Patient PK studies
BA/BE studies for Various dosage forms:
- Enteral route: Oral, Sublingual, Rectal
- Parenteral route: Intravascular, Intramuscular, Subcutaneous, Inhalation
- Inhalation (oral/nasal)
- Local/Topical Route: Creams, Lotions, Gels, Patch
- Vaginal route specific dosage forms
- Suppositories/Enema
Special population BA/BE studies
- Post-menopausal female subjects
- Geriatric subjects
- Hypo gonadal male subjects
