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Z-factor Differentiator

Regulation: FDA allows for ~15% variability (~20% at LLOQ) to pass clinical trials.

Problem: Pharmaceuticals face an accumulation of variability from multiple sources throughout the course of a clinical trial and the higher the variability, the less percent of batches that pass.

Solution: Dr. Rao Marepalli coined the term “Z-Factor” differentiator to hone in on the various sources of variability in a clinical study and how as an analytical partner, Sannova can lower the total variability you are exposed to.

Ask us how we achieve lower variability to increase your chances of approval with regulatory agencies.