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Dose-Limiting Toxicities

Meaning

Dose-Limiting Toxicities, or DLTs, are defined as adverse effects of a therapeutic agent, such as a peptide or hormonal compound, that are sufficiently severe or unacceptable to require a reduction in the administered dose or the cessation of treatment during a clinical trial. These toxicities are the primary determinant for establishing the maximum tolerated dose (MTD), which is a crucial step in early-phase drug development. Identification of the DLT is paramount for designing a safe, tolerable, and effective dosing schedule for subsequent larger clinical studies.