January 29, 2019 – New features designed to support the delivery of safer, more effective medications include advanced food staggering and tumor models for optimizing trial design and dose selection.
As novel molecular targets are being continuously discovered and new treatments developed, oncology is one of the biggest therapeutic areas in precision medicine. In particular, new targeted anti-cancer medications that are taken orally, such as the protein kinase inhibitors (KIs), are ideal candidates for model-informed precision dosing (MIPD) technologies.1 One of these technologies is called physiologically-based … Continued
Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2018 were supported by Certara software or services.
As a pediatric nephrologist, I help care for some very sick kids. And because our young patients are so ill, it’s a challenge to recruit them into clinical studies. Of course, we want to provide our patients with the best care; getting the dose right on their medications is a big part of that. However, … Continued
The December 22, 2018 partial shutdown of the United States government affected roughly 25% of federal agencies, including the Food and Drug Administration (FDA), which has furloughed about 40% of its overall workforce. The duration of the shutdown is uncertain. In light of this uncertainty, it is important to understand the impact of the government … Continued
