Pharmacokinetic Modeling

How can pharmacokinetic modeling assist you in understanding the effects of drugs within the human body?

Exponent uses a variety of dose modeling techniques, including dose response modeling and Physiologically Based Pharmacokinetic (PBPK) modeling to describe the process of drug absorption, distribution, metabolism, and excretion, which together make up the pharmacokinetic profile of a drug. PBPK models can also be modified to account for various life stages, such as children, the elderly, or pregnancy in order to understand how pharmacokinetics are affected.

How is pharmacokinetic modeling used in litigation disputes or issues of regulatory compliance?

Regulatory proceedings and litigations increasingly involve modeling methods to improve chemical exposure and risk assessments concerning occupational and environmental health, pharmaceuticals, food safety, and medical devices. In a regulatory context, PBPK models can aid in registration or re-registration processes (e.g., for agrochemicals). In a litigation context, pharmacokinetic models can be used to understand the levels of a drug in the human body in order to determine if there was intoxication.

Exponent scientists are experienced in developing and applying these methods to reconstruct exposure and dose, as well as to improve dose-response characterizations that play a critical role in risk assessment.

How can pharmacokinetic modeling help you understand the real-life effects of pharmaceutical drugs or environmental toxins?

We use pharmacokinetic models to apply a realistic mathematical description of physiology, anatomy, and biochemistry to simulate exposures by multiple routes and dosing scenarios to environmental toxicants, trace elements, food additives, or pharmaceuticals. These models improve dose-response characterization by allowing an understanding of the relationship between experimental or environmental levels of exposure and internal dose.