USA – FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

The US Food and Drug Administration (FDA) on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications.

Since the original population PK guidance was published in 1999, FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of population PK analysis methods have improved.”

Specifically, the revised, 23-page draft guidance includes a description of the types of scientific and regulatory questions appropriate for population PK analysis and outlines FDA’s recommendations for data analysis and modeling. Recommendations on the format and content of population PK reports submitted to FDA as well as any labeling statements informed by the results of these analyses are also included…