Bioequivalence & BA/BE Studies
Bioequivalence & BA/BE Studies — Accelerating Generic Drug Approvals
Zetalix designs and executes BA/BE studies meeting CDSCO, US FDA, EMA, WHO, and other global standards for generic approvals, ANDA filings, and WHO pre-qualification.
- Fasting and fed state study designs
- Single-dose, multiple-dose, steady-state protocols
- Highly variable drug (HVD) reference-scaled average bioequivalence
- Narrow therapeutic index (NTI) drug protocols
- NABL-accredited bioanalytical laboratory partnerships
- Pharmacokinetic analysis and reporting
- CDSCO and FDA-compliant study reports
