TY - GEN AU - Pourvasei,Ramak AU - Lee,Ed AU - Eschenberg,Michael AU - Patel,Vimal AU - Macaraeg,Chris AU - Pandya,Kinnari AU - Shih,Judy AU - Ma,Mark AU - Lee,Jean W AU - DeSilva,Binodh TI - Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes SN - 1550-7416 PY - 2013///0802 KW - Antibodies, Monoclonal, Humanized KW - analysis KW - Denosumab KW - Enzyme-Linked Immunosorbent Assay KW - methods KW - Humans KW - RANK Ligand KW - antagonists & inhibitors KW - Reagent Kits, Diagnostic N1 - Publication Type: Journal Article; Validation Study UR - https://doi.org/10.1208/s12248-012-9414-x ER -