Maximizing Reusability for Drug Submissions to Different Health Authorities
Many drug developers have products that they want to submit for marketing approval in several…
Certara2023年9月21日
FDA Trends for Accelerated Drug Approvals in Oncology Indications
The FDA has modified and increased expectations around data needed to support accelerated approvals in…
Certara2023年9月20日
Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities
Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…
Certara2023年9月20日
PBPK Application in Drug Discovery and Development
Real-World Application of Physiologically Based Pharmacokinetic Modeling (PBPK) in Support of Decision-Making During Drug Discovery;…
Certara2023年9月20日
Top Lessons Learned from 300 Regulatory Submissions
Who would have thought when we completed work on the first submission for which we…
Certara2023年9月20日
Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software
Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software PRINCETON, N.J.— 2023年9月19日…
Certara2023年9月19日
Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software
Dedicated team of global regulatory experts delivers submissions in increasingly shorter timelines. PRINCETON, NJ –…
Certara2023年9月19日
What is ICER & How Does it Impact the Pharmaceutical Industry?
The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization.…
Certara2023年9月15日
