Certara Inc.
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Latest From Certara Inc.
Confirmatory Evidence: FDA Guidance Allowance For Use Of Animal Data Draws Split Views
Industry comments also seek more specificity on the types of real-world data that could supplement a single adequate and well-controlled trial to demonstrate substantial evidence of efficacy, and clarification as to whether confirmatory evidence can come from the same single clinical study.
Project Optimus Is Coming To Cancer Combination Therapy Development
FDA initiative aimed at optimizing cancer drug dosage earlier in development started with single-agent therapies, but moving into combinations is ‘a natural progression,’ Oncology Center of Excellence’s Richard Pazdur says. At a recent workshop, experts discuss considerations for combination product dosage optimization and review case studies that reflect Optimus principles.
Certara Gets Further FDA Grant For Virtual Bioequivalence Studies
The FDA has awarded biosimulation specialist Certara a further grant to verify and expand models for assessing virtual bioequivalence, to help enable safer, faster and more cost-effective generic drug development.
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