Today, the U.S. Food and Drug Administration (FDA) published a revised draft guidance for industry entitled, “Population Pharmacokinetics.” This draft guidance provides recommendations to assist sponsors of new drug applications (NDAs) and biologics license applications (BLAs) in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use.
Population PK analysis is a well-established, quantitative method that can quantify and explain the variability in drug concentrations among individuals. Drug developers frequently use this form of analysis to guide drug development and inform recommendations on therapeutic individualization. Population PK analysis can provide information on the pharmacokinetic properties of a drug and support dosing recommendations in the general patient population or specific populations, including renal impairment, hepatic impairment and pediatrics.
This guidance provides illustrative examples of common applications of population PK analysis to inform drug development and drug use. Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements or postmarketing commitments. The guidance also includes FDA’s current thinking on the data and model requirements needed to support regulatory decisions, recommendations to sponsors on drug labeling based on population PK analysis, and the general expectations regarding the format and content for population PK reports submitted to the Agency.
This guidance revises the February 1999 Population Pharmacokinetics guidance.
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