Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance
With the release of the draft ICH M15 guidance, MIDD is no longer optional -…
Certara2025 年 6 月 11 日
Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance
SVP, PBPK Consultancy Services, Certara SVP, Quantitative Science Services, Certara Sr. Director, Clinical Pharmacology, Certara…
Certara2025 年 5 月 23 日
Essentials of Model-informed Drug Development in Oncology
Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…
Certara2025 年 5 月 2 日
Clinical and Physiologically Based Pharmacokinetic Model Evaluations of Adagrasib Drug–Drug Interactions
Director, Clinical Pharmacology, ORIC Pharmaceuticals SVP, Head of Simcyp PBPK Modeling Services, Certara Director, PBPK…
Certara2025 年 4 月 21 日
Enabling Personalized Therapy with PBPK Modeling for Pediatric Epilepsy
GRIN Therapeutics, Inc., an affiliate of Neurvati Neurosciences, focuses on the research and development of…
Certara2025 年 4 月 16 日
FDA to phase out animal testing with AI and lab-based models
FDA aims to replace animal testing in drug development with AI and lab-based models, enhancing…
Certara2025 年 4 月 11 日
Model-informed Formulation Development: Bridging Experimental Data and Mechanistic Modeling
Discover how predictive modeling and model-informed formulation development (MIFD) are accelerating drug development. Learn from…
Certara2025 年 4 月 11 日
Write Quicker PBPK Reports with the Simcyp Report Assistant
2025 年 4 月 11 日 Writing a report for PBPK models can be an onerous process, especially…
Certara2025 年 4 月 11 日
Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic Capabilities
RADNOR, PA — April 1st, 2025 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in…
Certara2025 年 4 月 1 日
