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USFDA Guidance: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Selecting an appropriate starting dose for first-in-human (FIH) clinical trials is one of the most critical decisions in drug development. An initial dose that is too high may expose participants to unnecessary safety risks, while a dose that is too low may provide limited scientific value and delay clinical development. To support safer and more informed dose selection, the FDA released the draft guidance "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Mini
Sharan Murugan
1 day ago5 min read