White Paper Archives

A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit

2023 年 2 月 8 日

By Jim Gallagher

Certara’s combined PBPK/QSP model predicts safety and efficacy biomarker outcomes in Alzheimer’s Disease, as demonstrated in recent lecanemab work with Eisai

2023 年 2 月 2 日

By Jim Gallagher

How Modeling & Simulation is Addressing the Immunogenicity Challenge: An academic nicety is now a drug development and regulatory differentiator

2023 年 1 月 30 日

By Piet van der Graaf and Andrzej Kierzek

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

2023 年 1 月 27 日

By Jim Gallagher

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.