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 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. Project Optimus was initiated by … Continued

Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA)

Certara is proud to partner with Fierce Pharma to bring you this live webinar on October 11, 2022. Register now! Properly understanding the probability of successful drug development requires utilization of all available information. Critical drug development decisions cannot be made with internal data alone. Model-based meta-analysis (MBMA) extracts important insights contained within both proprietary … Continued

Join us for the Phoenix User Group Meeting 2023!

Location: Echo Starhotel Milano, Viale Andrea Doria, 4, 20124 Milan, Italy Join the worldwide Phoenix user community and the Certara Phoenix team to learn about how Phoenix is leveraged to accelerate drug development. The meeting will include presentations from Phoenix users, and updates on the Phoenix vision and roadmap. In addition, Phoenix User Group Meeting … Continued

Understanding Key Components of a Medical Device Clinical Evaluation

Join us on November 15th for this webcast being held in partnership with TOPRA. In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting … Continued

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