Establishment of a reference material for standardization of the anti-complementary activity test in intravenous immunoglobulin products used in Japan: A collaborative study - Nojima, Kiyoko; Okuma, Kazu; Ochiai, Masaki; Kuramitsu, Madoka; Tezuka, Kenta; Ishii, Mieko; Ueda, Sadao; Miyamoto, Takashi; Kamimura, Koichiro; Kou, Enki; Uchida, Sanae; Watanabe, Yoshiharu; et al. (Biologicals, 2017)
Keywords: Animals; Anti-complementary activity; bioassays; Biological Assay - methods; Biological Assay - standards; Calibration; complement; Complement Activation - drug effects; Complement Inactivating Agents - pharmacology; Complement Inactivating Agents - standards; Cooperative Behavior; Guinea Pigs; Humans; immunoglobulins; Immunoglobulins, Intravenous - pharmacology; Immunoglobulins, Intravenous - standards; intravenous injection; Japan; Laboratories - standards; Quality Control; Reference material; Reference Standards; Reproducibility of Results; risk; Sheep; Standardization; Japan; Reference material; Anti-complementary activity; Standardization