PK Submit™ Overview Fact Sheet PK Submit™ の概要 PK SubmitがNCA解析のワークフローをどのように加速し、規制要件への準拠を確保するかをご紹介します。Certara2022年10月12日
Certara Announces New Release of PK Submit Announcement Certara Announces New Release of PK Submit PRINCETON, N.J.— 2022年10月12日 – Certara, Inc., a global leader in drug development software,…Certara2022年10月12日
How to Define & Measure Clinical Endpoints to Optimize Your Oncology Drug Dosing On-Demand Webinar How to Define & Measure Clinical Endpoints to Optimize Your Oncology Drug Dosing Historically, the dosing strategy for oncology drugs focused on the maximum tolerated dose. This has…Certara2022年10月5日
Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist Blog Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D)…Certara2022年10月4日
5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results Blog 5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results For the first time, the European Medicines Agency (EMA) has passed new regulations to help…Certara2022年9月27日
EU-CTR Challenges Drug Developers Faced in the First 6 Months Blog EU-CTR Challenges Drug Developers Faced in the First 6 Months Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive…Certara2022年9月26日
Certara – Improving Investment in Drug Development through Biosimulation Podcast Certara – Improving Investment in Drug Development through Biosimulation Certara2022年9月23日
Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA) On-Demand Webinar Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA) Properly understanding the probability of successful drug development requires utilization of all available information. Critical…Certara2022年9月23日
3 Takeaways from the FDA Oligo Guidance You Need to Know Blog 3 Takeaways from the FDA Oligo Guidance You Need to Know In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…Certara2022年9月23日
Pinnacle 21 Data Exchange: Transforming External Vendor Data Management On-Demand Webinar Pinnacle 21 Data Exchange: Transforming External Vendor Data Management The volume and complexity of clinical data are growing at a faster pace than the…Certara2022年9月19日