Zdrowie i gospodarka · 24/06/2026

FDA Releases Draft Guidance on QSP-Based Dose Selection for MABEL in FIH Trials

The FDA has released a draft guidance for industry on using quantitative systems pharmacology (QSP) modeling to select doses for drugs and biological products in first-in-human (FIH) trials, focusing on those that may cause potent reactions.

Source: Federal Register — Health and Human ServicesOpen original release →

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