FDA's New Population Pharmacokinetics Guidance — What Drug/Biologic/Device Makers Need To Know

Pharmaceutical Online

Guidehouse's Scott Thiel and Liisa Eisenlohr wrote for Pharmaceutical Online regarding the Food and Drug Administration's (FDA's) recently published new “Population Pharmacokinetics Guidance for Industry” to help set the safety and efficacy of pharmaceutical products. The guidance signals an increased focus on effects of drug dosing for subpopulations based on sex, age, body, weight, and other factors, and asks for applicable drugs to be studied on pediatric patients.

For some medical device companies and digital health companies, the increased parsing out of pharmacokinetics (PK) in these subpopulations may impact the design assumptions for algorithms used in companion diagnostics and drug-dosing calculators. These types of devices tend to have incorporated a specific PK from the drug labeling, usually deep within the product design and often hardcoded. If the pharma company modifies or adds PK information to the drug label, then the device manufacturer will need to update their device design to match that. These types of updates often require a new pre-market submission to FDA prior to placing the updated device on the market.

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