USA – FDA releases draft guidance for physiologically based PK analyses

The US Food and Drug Administration (FDA) has issued draft guidance for industry on the use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications.

A PBPK analysis uses models and simulations combining physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic or pharmacodynamic behaviors of a particular drug product, according to the FDA.

The idea behind using this technique is that it helps predict systemic drug exposure from oral drug products.

“When a sponsor submits a drug application, biopharmaceutics modeling could inform drug development of in vivo responses due to formulation alternations, which in turn supports clinically relevant decision making,” the agency advised. “In silico approaches, such as this, would ultimately reduce the long-term burden on both industry and regulators.”…