Biotech Values

[randychub]

Rock - Have the analyst ask which of these sameness requirements the FDA has verified that TEVA has meet.

Randy


Table 1. Criteria Used for Sameness Determination of Enoxaparin Sodium

1. Equivalence of heparin source material and mode of depolymerization
2. Equivalence of physiochemical properties
3. Equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species
4. Equivalence in biological and biochemical assays
5. Equivalence of in vivo pharmacodynamic profile