doseselection

Doseselection is the process of determining the appropriate dose of a drug or other therapeutic agent for clinical use or research, with the aim of achieving therapeutic benefit while minimizing safety risks. It encompasses the selection of a dose level or range to be studied or prescribed, informed by pharmacology, prior data, and clinical judgment.

In drug development, dose selection typically follows early-phase studies that test multiple dose levels to characterize exposure, efficacy signals, and safety. This work often yields a recommended dose for subsequent trials, such as the recommended phase 2 dose or the maximum tolerated dose. Methods include traditional dose-escalation designs (for example, 3+3 cohorts), model-based approaches like continual reassessment methods, and Bayesian or other adaptive designs. Pharmacokinetic and pharmacodynamic modeling, as well as exposure–response analyses, support dose prioritization and tuning.

In clinical practice, approved dosing regimens are specified in product labeling, with adjustments for factors such as age, body weight, organ function, drug interactions, and comorbidities. Postmarketing data and real-world evidence may influence label updates and individual dose optimization.

Key considerations include interindividual variability in drug metabolism, safety thresholds, therapeutic window, and the balance of efficacy versus toxicity. Challenges involve avoiding underdosing that reduces effectiveness and overdosing that increases adverse events, as well as addressing special populations and comedications.

See also: dose-ranging study, dose-escalation, maximum tolerated dose, recommended phase 2 dose, pharmacokinetics.