RAPS sponsored webcast: 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 Clinical Trials Regulation (CTR) for the European Union (EU) took effect on January 31, 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union. Beginning on January 31st, 2023, sponsors are … Continued

De-risk pre-IND stage decisions with Simcyp Discovery PBPK software for discovery and translational scientists

Certara recently announced the launch of the SimcypTM Discovery Simulator, a PBPK platform developed specifically for discovery and translational scientists. Simcyp has been leading the scientific field of PBPK modeling for over twenty years and is used for decision-making throughout all stages of drug development and post-marketing. While the benefits of the Simcyp Simulator are … Continued

Learn how to create CDISC domains in minutes with PK Submit

Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be a time-consuming, error prone and complex task. Certara’s software PK Submit provides a compliant solution that keeps research teams from tedious data handling. With its ability to create a complete electronic PK regulatory submission package in minutes the software saves … Continued

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)

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 data and publicly available clinical trial results, thus enabling critical R&D, financial (e.g., in/out-licensing), and commercial decision-making with the highest … Continued

eChalk Talk: Avoid getting “lost in translation” – Increase confidence in translational research using biosimulation

One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued

TOPRA sponsored webcast: 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

Learn how to leverage the power of cloud computing to streamline your workflow!

Learn how to leverage the power of cloud computing to streamline your workflow! Certara’s Phoenix Hosted package provides your PK scientists with a secured and validated Certara AWS workspace allowing for much quicker transit time from compliant data sources. It enhances productivity and supports compliance requirements by managing complex time-based data, the foundation for all … Continued

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