Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator Publication Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation.…CertaraFebruary 23, 2024
Streamlining Your NCA Workflow On-Demand Webinar Streamlining Your NCA Workflow PK analysis intended for submission contends with many data and compliance challenges. To work efficiently,…CertaraJanuary 18, 2024
Higher Standards: Achieving Cleaner Data, Faster, from Protocol to Submission On-Demand Webinar Higher Standards: Achieving Cleaner Data, Faster, from Protocol to Submission Join our webinar to explore best practices for harnessing the power of standards, without a…CertaraJanuary 16, 2024
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…CertaraDecember 12, 2023
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog 10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions In this blog post, we explore the top 10 things you need to know about…CertaraOctober 17, 2023
Accelerating a drug launch with value communication technology and an integrated workflow Case Study Accelerating a drug launch with value communication technology and an integrated workflow With early approvals for a targeted cancer drug in Brazil and Argentina, this global pharmaceutical…CertaraOctober 2, 2023
Medical Device | Medtronic Demonstrating the economic value of minimally invasive spinal surgery on the iPad Case Study Medical Device | Medtronic Demonstrating the economic value of minimally invasive spinal surgery on the iPad This case study describes the use of a web-based platform to demonstrate the value of…CertaraOctober 2, 2023
Using customer engagement technology to create value communication tools for ABILIFY MAINTENA® (aripiprazole) Case Study Using customer engagement technology to create value communication tools for ABILIFY MAINTENA® (aripiprazole) Otsuka identified several weaknesses in their existing workflow for developing value communication tools. In particular,…CertaraOctober 2, 2023
Maximizing Reusability for Drug Submissions to Different Health Authorities Blog Maximizing Reusability for Drug Submissions to Different Health Authorities Many drug developers have products that they want to submit for marketing approval in several…CertaraSeptember 21, 2023
How A Biotech Startup Company Increased Flexibility and Efficiency by Switching to Phoenix Hosted Case Study How A Biotech Startup Company Increased Flexibility and Efficiency by Switching to Phoenix Hosted Discover how a biotech startup enhanced flexibility and efficiency by adopting Phoenix Hosted, streamlining workflows…CertaraSeptember 8, 2023