The article, authored by Caroline Sychterz, Hong Shen, Yueping Zhang, Michael Sinz, Amin Rostami-Hodjegan, Brian J. Schmidt, Lu Gaohua, and Aleksandra Galetin, explores the role of the breast cancer resistance…
Preclinical research on the trispecific antibody, ISB 2001, published in Nature Cancer leveraged virtual trials to select a higher starting dose that would lower costs and reduce cycle times RADNOR, PA…
Model Informed Drug Development (MIDD) is a critical component in the drug development process and regulatory review. It is frequently utilized as part of a Clinical Pharmacology strategy to inform…
With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical stage, the market for bispecific antibodies is projected to grow to >$30B by 2028. The…
Our Early Phase Clinical Development solutions provide expert support at every stage, from Candidate Selection through Phase 1.
Certara client forums in China, Korea, and Japan support collaboration and networking among drug developers using model-informed drug development approaches to bring new treatments to patients faster. RADNOR, PA –…
The article from the European Journal of Pharmaceutical Sciences reviews the role of Physiologically Based Pharmacokinetic (PBPK) modeling in the FDA’s approval of novel drugs from 2019 to 2023. It…
Every year, the Consortium—comprising over 30 leading biopharmaceutical companies—convenes to discuss Physiologically Based Pharmacokinetic (PBPK) initiatives in drug development and their regulatory impacts. Consortium members collaborate closely with Simcyp scientists,…
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