行业洞察美国 FDAT1064
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
🤖 AI 摘要
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials." The guidance is intended to provide recommendations in the application of quantitative systems pharmacology (QSP) modeling when a minimum anticipated biological effect level (MABEL) in first-in- human (FIH), phas
分析模型：rule-based-v3 · 07-09 06:59
评分详情
综合分 64/100
信源权威
95
影响范围
70
时效性
50
合规紧急
40
行业关注
35
Federal Register: FDA Notices (官方通知)
操作：