Model-Informed Drug Development (MIDD) – EMA’s Advancement Press Coverage Model-Informed Drug Development (MIDD) – EMA’s Advancement Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from…CertaraMarch 29, 2023
Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling White Paper Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic DrugsCertaraMarch 22, 2023
Data-Backed Trial Design– Applying AI to Clinical Outcome Analysis On-Demand Webinar Data-Backed Trial Design– Applying AI to Clinical Outcome Analysis Global spending on clinical trials is expected to reach $68.9 billion per year by 2025…CertaraMarch 17, 2023
eCTD Templates – A Springboard to Submission Success Fact Sheet eCTD Templates – A Springboard to Submission Success CertaraMarch 17, 2023
Leveraging AI to Accelerate Drug Discovery: Vyasa Joins Certara Blog Leveraging AI to Accelerate Drug Discovery: Vyasa Joins Certara Applying Vyasa’s deep learning expertise to Certara products will enable our clients to expand how…CertaraMarch 10, 2023
What you should know about FDA Project Optimus for your oncology drug approval On-Demand Webinar What you should know about FDA Project Optimus for your oncology drug approval Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…CertaraMarch 10, 2023
RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes On-Demand Webinar RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes Oops, I made a mistake! Everyone has made or seen one, and sometimes it is…CertaraMarch 9, 2023
Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types Press Release Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types Simcyp Simulator has been utilized to inform more than 300 label claims for 90+ novel…CertaraMarch 7, 2023
GlobalSubmit™ eCTD Platform Fact Sheet GlobalSubmit™ eCTD Platform GlobalSubmit enables teams to simplify the eCTD submission process to successfully publish, validate, and review…CertaraMarch 3, 2023
Drug Development Considerations for Live Biotherapeutic Products Blog Drug Development Considerations for Live Biotherapeutic Products A new class of complex biologics has emerged in recent years. These are classified in…CertaraMarch 3, 2023