Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes.

Pourvasei, Ramak

Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes. [electronic resource] - The AAPS journal Jan 2013 - 70-7 p. digital

Publication Type: Journal Article; Validation Study

1550-7416

10.1208/s12248-012-9414-x doi


Antibodies, Monoclonal, Humanized--analysis
Denosumab
Enzyme-Linked Immunosorbent Assay--methods
Humans
RANK Ligand--antagonists & inhibitors
Reagent Kits, Diagnostic