Category: 백서
Certara’s combined PBPK/QSP model predicts safety and efficacy biomarker outcomes in Alzheimer’s Disease, as demonstrated in recent lecanemab work with Eisai
How Modeling & Simulation is Addressing the Immunogenicity Challenge: An academic nicety is now a drug development and regulatory differentiator
Learn how modeling and simulation can help drug developers overcome the immunogenicity challenge, a major hurdle for biologics development and regulatory approval.
How Drug Developers can Navigate the Inflation Reduction Act of 2022
Learn how the IRA will impact how new drugs are marketed and why negotiating pricing while preparing for lower reimbursements can be challenging for pharmaceutical companies.
Drug interactions with therapeutic proteins, regulatory expectations and modeling and simulation approaches
The eCTD Submission Process: Tips and Tricks for Drug Development Success
Driving Access to Rare Disease Treatments in Europe
Axendia: Improving Healthcare Outcomes by Rewarding Value, NOT Cost
Innovations in Drug and Medical
Device Value Communications:
Optimizing Local Payer Engagement
The Essential Components of a Credible Biomarker Strategy Plan for Your Drug Development Candidate
This white paper will explain why the inclusion and assessment of biomarkers in drug development can also inform many decisions.
