The FDA released a draft guidance on the use of population pharmacokinetic analysis by sponsors of new drugs and biologics.

Population PK analyses can help in selecting dosing regimens, sampling schemes, exposure metrics and in pediatric study designs, the agency says.

Population PK analysis is “especially appropriate in children” because it allows the use of sparse sampling compared to the rich sampling associated with traditional PK analyses, minimizing the total volume of blood sampled, the agency said.