Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations On-Demand Webinar Applications of PBPK modelling for regulatory submissions: case studies involving DDIs, transporters and special populations Over the past two decades, there have been transformative changes in our approach to using…Danielle Pillsbury2022 年 10 月 20 日
Simultaneous FDA & EMA Submissions for Drug Approvals Article Simultaneous FDA & EMA Submissions for Drug Approvals Is there a better way? The question always breeds critical thinking and often leads to…Certara2022 年 10 月 19 日
RAPS sponsored webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 months On-Demand Webinar RAPS 赞助的网络广播:The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 months Join us on November 10th for this webcast being held in partnership with RAPS. The…Becca Bucci2022 年 10 月 17 日
PBPK Modeling & Simulation of Therapeutic Oligonucleotides from Bench to Bedside Blog PBPK Modeling & Simulation of Therapeutic Oligonucleotides from Bench to Bedside Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage…Certara2022 年 10 月 14 日
PK Submit™ Overview Fact Sheet PK Submit™ 概览 了解 PK Submit™ 如何加速 NCA 工作流并确保符合监管要求Danielle Pillsbury2022 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
The Growing Value of Quantitative Systems Pharmacology (QSP) Blog The Growing Value of Quantitative Systems Pharmacology (QSP) Drug developers are continuously searching for new ways to improve and expedite biopharmaceutical R&D, inform…Certara2022 年 10 月 7 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…Becca Bucci2022 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