The Roundtable: Our Thoughts About Model Based Drug Development

Author: Alice Ke

Alice Ke obtained her PhD in pharmaceutics from the University of Washington, Seattle, where her research was focused on the assessment of fetal and CNS drug distribution using clinical imaging techniques. She then accepted an ORISE fellowship in the Office of Clinical Pharmacology at the FDA, where she developed and validated PBPK and population PK models to support dose adjustment for pregnant women. After completing her fellowship, Dr. Ke was a research scientist in the Department of Drug Disposition and PK/PD at Lilly Research Laboratories, where she applied population PK and PBPK modeling & simulation techniques to provide model-based advice on the design of clinical pharmacology studies. Currently, Dr. Alice Ke is a Consultant and Scientific Advisor at Simcyp. Her research interests continue to center around the applications of PBPK and PK/PD modeling to predicting complex drug interactions and PK/PD in special populations.

Recent Posts

Leveraging PBPK Modeling and Simulation for Neonatal and Infant Drug Development

Alice Ke

Despite increased regulatory support for pediatric drug development, sponsors still face ethical, economic and practical constraints. Indeed, while children represent about 40% of the world’s population, only 10% of the drugs on the market have been approved for pediatrics. Children are not small adults, and all children are not the same. In particular, children under […]

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Topics: PBPK Modeling and Simulation

Dosing for Two: How Pharmacometrics Supports Drug Safety in Pregnancy

Alice Ke

According to the US Census Bureau, there is a birth every eight seconds in the United States. Women frequently take prescription and over-the-counter drugs during pregnancy. Given the ubiquity of pregnancy and births, you’d think that there would be a robust understanding of the safety and efficacy of drugs in pregnant women. However, the vast majority of drugs are prescribed to pregnant women off-label— often scaling doses from the recommendations set for men or non-pregnant women— because of ethical concerns about performing clinical testing in this vulnerable population.

Physiological and absorption, distribution, metabolism, and excretion (ADME) changes during pregnancy can significantly affect pharmacokinetics (PK). This can lead to under-dosing, with lack of therapeutic effect, or over-dosing, with potential toxicity that endangers both mother and developing fetus. In this blog post, I’ll discuss how pharmacometrics and modeling approaches can be leveraged to identify drugs whose PK may be altered during pregnancy, guide rational study design, and support dosing recommendations for pregnant women.

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Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation
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