Pharmacokinetic Modeling & Efficacy Extrapolation: FDA Takes New Approaches to Drug Approvals

An array of new and expanded indications of therapeutics for rheumatic disease last year relied on pharmacokinetic modeling for intravenous dosing and efficacy extrapolation for pediatric populations.
Source: The Rheumatologist - Category: Rheumatology Authors: Tags: ACR Convergence Drug Updates Approvals Biosimilars U.S. Food and Drug Administration (FDA) Source Type: research