De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development Blog 医薬品開発のリスク軽減:早期開発における重要な化学、製造、および管理(CMC)および生理学的薬物動態(PBPK)アプローチ 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 Blog 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 Blog 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 Blog 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 Blog PBPKモデル化による生物学的同等性評価およびジェネリック医薬品承認の支援 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 Blog 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 Blog 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 Blog 臨床薬理学と薬物動態学の各チームが協力すべき理由 A symbiosis between a modeler and a trialist is often required to develop a model-informed…Certara2024年11月8日
FAQs on Developing EMA Policy 0070 Submissions Blog FAQs on Developing EMA Policy 0070 Submissions In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…Certara2024年11月1日
Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity Blog 自己免疫の治療に免疫腫瘍薬の使用を拡大するのに数学モデルが役立つ Connecting Cancer and Autoimmunity "The dosing regimens in oncology may not directly inform the optimal…Certara2024年10月31日