Bioequivalence Studies & Biowaivers
Demonstrating bioequivalence is a critical step in the approval of generic medicines. Equinox provides independent, expert guidance at every stage:
Review of bioequivalence study protocols and results (AUC, Cmax, pharmacokinetic parameters). Advice on study design to ensure global regulatory acceptance. Biowaiver assessments, including BCS-based evaluations and multi-strength considerations. In-vivo and in-vitro data comparisons to support dossier submissions. High quality cost effective bioequivalence trials carried out With our insight, clients can reduce development risks, save costs, and accelerate time to market.
