IVIVC - In Vitro-In Vivo Correlation

Level A/B/C | FDA/EMA Guidance | Generic Drug Development

Save dissolution evidence in Program OS Full biowaiver eligibility review Formulation optimizer

Level A IVIVC

Point-to-point correlation (Most predictive)

Level B IVIVC

MDT vs MRT correlation

Level C IVIVC

Single point correlation

Deconvolution

Batch Formulation Ranking

Sorts already-computed Level A results by FDA acceptance criteria. This is a sorting convenience, not a validated regulatory model or a biowaiver determination.

About IVIVC

Level A: Most predictive. Point-to-point correlation. FDA preferred for waivers.
Level B: MDT vs MRT. Less predictive.
Level C: Single point correlation. Least predictive.
FDA Acceptance Criteria: R² > 0.9, Prediction Error < 10% for Level A