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Clinical Data Extrapolation

Meaning

Clinical data extrapolation is the scientific and regulatory process of extending the conclusions drawn from a clinical trial in one population or clinical setting to another related population, dosage regimen, or indication. This practice allows for the application of evidence without conducting an entirely new, exhaustive study, provided there is a strong biological rationale and sufficient supporting data. In hormonal health, this is frequently used when adapting pediatric dosing from adult data or applying a drug’s efficacy across different, but biologically similar, hormonal deficiency states. Careful consideration of differences in pharmacokinetics and pharmacodynamics between the populations is paramount.