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
发布者：药时代，转载请首先联系contact@drugtimes.cn获得授权
为好文打赏 支持药时代 共创新未来！ 