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- 615.37 19
- Biological Products -- Periodicals 19
- Biological Products -- standards -- Periodicals 19
- Biological products -- Standards 19
- Biological products -- Standards -- Periodicals 19
- Periodicals 19
- Produits biologiques -- Normes -- Périodiques 19
- ADA anti-drug antibodies -- AUC0-t area under the concentration‒time curve from time 0 to last sampling time point -- AUC∞ area under the plasma concentration‒time curve from time 0 to infinity -- Cmax observed maximum concentration -- IV intravenous -- NOCD new onset of chronic disease -- NONMEM non-linear mixed-effects modeling -- PK pharmacokinetics -- t1/2 terminal elimination half-life -- TEAE treatment-emergent adverse event -- TEAESI treatment-emergent adverse event of special interest -- TESAE treatment-emergent serious adverse event 1
- ADCP antibody dependent cellular phagocytosis -- CQA critical quality attribute -- FcγRIIa Fc gamma receptor IIa -- FcRn neonatal Fc-receptor -- H histidine -- M methionine -- R arginine -- mAb monoclonal antibody -- QbD quality by design -- SPR surface plasmon resonance 1
- ATT abnormal toxicity test -- HAv influenza hemagglutinin split vaccine -- JMR the Minimum Requirements for Biological Products guidelines of Japan -- LTT leukopenic toxicity test -- QGP QuantiGene Plex -- RE national reference influenza vaccine -- SA saline -- WBC white blood cell -- WPV whole virion inactivated influenza vaccine 1