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Major Release of Certara GlobalSubmit™ Software Enhances the Regulatory Submission Process Blog Post

Radnor, PA – 2024 年 11 月 25 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development, today announced that a new version of its GlobalSubmit regulatory submissions software…

PK/PD Data Analysis, Concepts and Applications eBook Blog Post

加速您的历程：通过 PK 科学家标准手册学习与成长

Indirect Exposure-Response Modeling for Transthyretin Amyloid Cardiomyopathy Treated with Acoramidis (AG10) Blog Post

De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development Blog Post

Deven Shah, BPharm, PhD David B. Turner, PhD 2024 年 11 月 22 日 In drug development, early strategic planning is crucial to minimizing risks, optimizing formulations, and setting up candidates for success....

A Mechanistic PK/PD Model for First-in-Human Dosing of a Tetraspecific Antibody (MDX2001) for the Treatment of Advanced Solid Tumors Blog Post

MDX2001 is a tetraspecific T cell engager that binds CD3 and CD28 on T cells and binds the tumor associated antigens cMet and Trop2. We developed a quantitative systems pharmacology…

Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies Blog Post

Download PDF You May Also Like AllModeling and Simulation - QSP QSP Modeling in Cancer Therapy | Advancing Tumor-Selective TreatmentsQSP Modeling in Cancer Therapy | Advancing Tumor-Selective TreatmentsPosterQSP Modeling in...

Quantitative Systems Pharmacology model for combined targeting of BAFF and CD40 pathways in systemic lupus erythematosus Blog Post

Download PDF You May Also Like AllModeling and Simulation - QSP QSP Modeling in Cancer Therapy | Advancing Tumor-Selective TreatmentsQSP Modeling in Cancer Therapy | Advancing Tumor-Selective TreatmentsPosterQSP Modeling in...

A Medical Writer’s Guide to Collaborative Authoring Blog Post

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and involved clearly defined roles. The writers wrote all the non-clinical and clinical documentation, and then…

Real-world application of physiologically based pharmacokinetic models in drug discovery Blog Post

Abstract The utility of physiologically based pharmacokinetic (PBPK) models in support of drug development has been well documented. During the discovery stage, PBPK modeling has increasingly been applied for early...

Top Three Insights from Certainty Europe Blog Post

The first European Certainty Conference for the Certara Client Community in Mainz Germany was full of drug development stories that are impacting quality of life and patient experiences across the…