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 […]Read More
In this webinar, Certara’s Dr. Alice Ke explained how modeling and simulation aligns with the directionality of regulatory, ethical and testability factors. She focused on the rapid advances in the use of physiologically-based pharmacokinetic modeling (PBPK) to support drug development for neonates and infants.Read More
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.Read More
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.Read More
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.Read More