Certara Inc.

The US Food and Drug Administration’s draft guidance on demonstrating substantial evidence of efficacy has drawn split views on the suitability of animal data to serve as confirmatory evidence, while

The US Food and Drug Administration’s Project Optimus, which has changed how sponsors approach dosage optimization for single-agent oncology agents, is coming to combination therapies. During a recent

The US Food and Drug Administration has granted biosimulation specialist Certara further funding to verify and expand its models for assessing virtual bioequivalence, with an ultimate goal of helpin