Informing Pediatric Drug Development: A Selection from Certara’s Best of Blogs

A selection of short essays by Certara’s pediatric drug development experts. Learn about our technologies and strategies for pediatric drug development to inform dose selection, including PK/PD simulations using sparse data analysis and our Simcyp Pediatric Simulator. Certara’s regulatory writing consultancy, Synchrogenix, also offer regulatory strategy for pediatrics.

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Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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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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