Key development considerations for cell therapies
2024 年 12 月 5 日 What is a “cell therapy”? Nearly every recent oncology clinical conference has…
Certara2024 年 12 月 5 日
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know
2024 年 12 月 3 日 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…
Certara2024 年 12 月 3 日
De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development
2024 年 11 月 22 日 In drug development, early strategic planning is crucial to minimizing risks, optimizing…
Certara2024 年 11 月 22 日
A Medical Writer’s Guide to Collaborative Authoring
Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…
Certara2024 年 11 月 22 日
Top Three Insights from Certainty Europe
The first European Certainty Conference for the Certara Client Community in Mainz Germany was full…
Certara2024 年 11 月 21 日
Mastering Value Storytelling with Data-Driven Stories
Unlocking the Power of Storytelling in Healthcare Communication In the realm of healthcare communication, persuasion…
Certara2024 年 11 月 14 日
PBPK Modeling to Support Bioequivalence & Generic Product Approvals
Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally…
Certara2024 年 11 月 12 日
Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting
On 2024 年 10 月 30 日, we hosted our Pinnacle 21 Enterprise (P21E) User Group Meeting (UGM)…
Certara2024 年 11 月 12 日
4 Ways to Optimize Agency Partnerships Using a Platform-Oriented Approach
In the pharmaceutical and medical devices industries, the journey from product development to market introduction…
Certara2024 年 11 月 8 日
Why Clinical Pharmacology & Pharmacometrics Should Collaborate
A symbiosis between a modeler and a trialist is often required to develop a model-informed…
Certara2024 年 11 月 8 日
