Certara’s Simcyp MechDermA Model Achieves Regulatory Approval: Demonstrates Virtual Bioequivalence in Dermal Drug Development

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

Certara’s Best of the Blog 2019

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 Annual Meeting

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 Annual Meeting

SOT is dedicated to Creating a Safer and Healthier World by Advancing the Science and Increasing the Impact of Toxicology.

ACoP11

ACoP is the annual scientific meeting of the International Society of Pharmacometrics (ISoP).