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


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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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