原文始发于微信公众号(化学音乐文化):S4C2:Biologic Clinical Considerations
JanFourman,PhD, EdD,MBA, MSRA
扫描左侧二维码,获取视频课;扫描右侧二维码,获取音频课 Safety with Biologics Introduction: Gain a better understanding of biologic agents, risk factors and potential Mechanism of Actions (MOAs) as it relates to safety Part 2 – Preclinical Considerations Nonclinical safety evaluation general concepts Biologics approach Supporting First Human Dose (FHD) Species selection Tissue cross-reactivity Repeat-dose toxicity Regulatory filing considerations Immunogenicity and immunotoxicity assessments Developmental and reproductive toxicity testing Carcinogenicity assessment
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