Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally acting generic drugs.
https://www.certara.com/blog/pbpk-modeling-to-support-bioequivalence-generic-product-approvals/Certara’s Phoenix biosimulation software platform is widely used for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and population PK analysis. Recently, we have seen how Certara software helps customers accelerate collaboration across their divisions and groups for better clinical results. Today, we interviewed Sun Hua, Associate Chief Pharmacist at Yijishan Hospital, Drug Evaluation Center, Wannan Medical College, … Continued
https://www.certara.com/article/getting-results-faster-supporting-physicians-and-pharmacists-with-biosimulation-technologies/Reduce time to completion while providing consistency across your batches of patient safety narratives Managing your patient narrative projects with moving timelines is challenging, especially given the complexities that go into preparing your data for use. With the patient narrative building features in Certara’s Synchrogenix™ Writer, you can manage thousands of patient safety narratives to … Continued
https://www.certara.com/video/automate-your-patient-narratives-for-clinical-study-reports-synchrogenix-writer/Are you utilizing a 21 CFR Part 11 compliant repository for your SAS, R, & Python data? Certara Integral data repository is designed to be a 21 CFR Part 11 compliance bolt-on solution to your existing statistical computing environment. This means Integral is compatible with your cloud-based and on-premise computing environments and is agnostic to … Continued
https://www.certara.com/video/integral-data-repository-biostatisticians/Topics: New Trends in the Regulatory Setting Evidence Needs to Enable Uptake Payer & Key Stakeholder Engagement This symposium will be a virtual event with three live presentations featuring Certara’s device specialists in regulatory, real-world evidence generation and scientific communication. It will explore the latest trends transforming the medical technology landscape and how they have … Continued
https://www.certara.com/webinar/how-to-succeed-in-a-transformational-med-tech-landscape-regulatory-evidence-and-communication-strategies-symposium/Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many … Continued
https://www.certara.com/webinar/what-oncology-drug-developers-should-expect-from-the-fdas-project-optimus/As your company moves towards the regulatory submission of a marketing application to a health authority, there are many things to consider in your project planning. Among those is whom your key vendors will be. It’s already challenging enough to figure out which vendors you should be engaging, and it’s even more challenging to know … Continued
https://www.certara.com/blog/when-should-i-select-an-ectd-vendor-for-my-regulatory-submission/Preview of the Pirana Brochure Optimize your pharmacometric workflow Organizing and managing pharmacometric models can be an inefficient and time-consuming process. Pirana’s modeling workbench tools provide modelers with structure to facilitate the iterative processes used to create population PK/PD models and perform simulations resulting in better organization and more efficient analysis of population PK/PD results. … Continued
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