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Author: Alice Ke

Leveraging PBPK Modeling and Simulation for Neonatal and Infant Drug Development

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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 … Continued

Dosing for Two: How Pharmacometrics Supports Drug Safety in Pregnancy

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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 … Continued

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