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
