FDA plans to phase out animal testing requirements
Discover how the FDA plans to replace animal testing with AI and organ-on-chip technologies for…
Certara2025 年 4 月 10 日
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach
This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…
Certara2025 年 3 月 4 日
2025 cell and gene challenges: Scalability, supply chain and manufacturing
Explore insights on 2025 challenges in cell and gene therapy, including commercial viability, with expert…
Certara2025 年 2 月 3 日
AI in Life Sciences Finds an Early Success and Will Continue in 2025
Fran Brown highlights how AI in life sciences drives more precise drug development and reduces…
Certara2024 年 12 月 24 日
CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of
2024 年 12 月 13 日 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…
Certara2024 年 12 月 13 日
Advancing pharmacometrics in Africa – Transition from capacity development toward job creation
This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…
Certara2024 年 12 月 9 日
Semi-mechanistic Model of ATG-101, a PD-L1/4-1BB Bispecific Antibody, for Treatment of Solid Tumors
Abstract Trimer formation is key to the pharmacology of the bispecific ATG-101 but is difficult…
Certara2024 年 9 月 16 日
Blinatumomab Trimer Formation
Insights from a Mechanistic PKPD Model on the Implications for Switching from Infusion to Subcutaneous…
Certara2024 年 9 月 16 日
Dose Selection for DuoBody®-PD-L1x4-1BB (GEN1046)
Abstract DuoBody®-PD-L1x4-1BB (GEN1046) is an investigational, first-in-class, bispecific antibody designed to elicit an antitumor immune…
Certara2024 年 9 月 9 日
