Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The … Continued
Month: January 2020
This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.
PRINCETON, NJ – Jan. 23, 2020 – Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or services.
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing
A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.
ASCPT is a meeting for clinical pharmacologists, translational scientists, and other scientists in the early phase drug discovery, development, regulatory, and utilization space to collaborate and help improve patient care.
SOT is dedicated to Creating a Safer and Healthier World by Advancing the Science and Increasing the Impact of Toxicology.
ACoP is the annual scientific meeting of the International Society of Pharmacometrics (ISoP).