What recent paediatric guidelines mean for drug developers
Justin Hay, Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs…
Certara2023 年 9 月 25 日
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
