Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics
单克隆抗体和其他蛋白质疗法的原料药和制剂规格背后的基础监管科学
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doi:10.1016/j.jpha.2023.12.006
Limpikirati, Patanachai K; Mongkoltipparat, Sorrayut; Denchaipradit, Thinnaphat; Siwasophonpong, Nathathai; Pornnopparat, Wudthipong; Ramanandana, Parawan; Pianpaktr, Phumrapee; Tongchusak, Songsak; Tian, Maoxin Tim; Pisitkun, Trairak
