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Updated: Feb 3, 2026

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超越MABEL的FIH剂量选择:优化第一阶段临床试验 开始剂量,同时保护患者安全

Mineo Matsumoto1, J Ryan Polli2, Suresh Swaminathan3

  • 1Review Division, Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda- ku, Tokyo, Japan.

Regulatory toxicology and pharmacology : RTP
|February 1, 2026
PubMed
概括

选择免疫调节剂的最佳首次人体 (FIH) 剂量是具有挑战性的. 这种精细的框架通过整合药理动力学/药理动力学建模和案例研究来提高安全性和疗效,从而提高剂量选择.

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