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A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

New therapeutics discovery and development for ocular diseases have been traditionally associated with a low probability of technical and regulatory success. The significant unmet medical needs for ocular diseases include but aren’t limited to glaucoma, age-related macular degeneration, and retinopathy. Recently, there has also been considerable focus on thyroid eye disease (TED). This research gained … 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.

Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling and Simulation

Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.

Making Sense of 6MWT Variability: Developing a Disease Progression Model for DMD

Duchenne Muscular Dystrophy (DMD) is a life-threatening, sex-linked, pediatric rare disease, primarily affecting boys. It is characterized by progressive muscle degeneration, weakness, and eventually functional loss. DMD is caused by a mutation in the dystrophin gene, a protein needed to maintain muscle integrity, and for improving signaling and growth in differentiation of the muscle tissue. … Continued

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