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
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