Health Canada Proposes New BE Standards for Highly Variable Drugs
Health Canada is revising its comparative bioavailability requirements for highly variable drug products.
Under the proposal, a drug may be considered a HVDP if the variation for the area under the concentration, or AUC, versus time curve is greater than 30 percent in terms of absorption. Critical dose drugs would not be eligible.
Sponsors submitting HVDPs would need to provide a scientific rationale supporting the claim that the variability is not clinically significant. The submissions would also need to demonstrate that variation estimates are reliable and not subject to outliers.
Comments are due by Aug. 25. Read the proposed policy notice here: www.fdanews.com/6-15-Canada-HVDP.pdf. — Jonathon Shacat