Equiva Tools · Protocol Studio preview
Biowaiver Decision Tool
Assess whether your generic solid oral product qualifies for a BCS-based biowaiver under ICH M9 and WHO TRS 1003 Annex 6 — before you spend on an in vivo BE study. Free, private, no account required.
- 01Product
- 02BCS
- 03Dissolution
- 04Flags
Product basics
Identify the generic product under assessment.
This tool provides a preliminary decision-support view based on publicly available ICH/WHO criteria. It does not replace regulatory advice or a full quality assessment.