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How to Modernize Patient Narrative Writing

Medical writing is evolving, and cutting-edge technology is leading the way. Join us for an insightful discussion on how automation is transforming patient narrative writing—saving time, reducing complexity, and enhancing accuracy. This webinar will explore how the appropriate use of technology can streamline the creation of patient narratives. We’ll also showcase real-world applications through an … Continued

Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform

Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics, efficacy, and safety. Predicting immunogenicity is complex because of its multifactorial drivers, including compound properties, subject characteristics, and treatment parameters. To integrate these, the Immunogenicity Simulator was developed using published, predominantly late-stage trial data from 15 therapeutic proteins. This single-blinded … Continued

Standards for All: Controlling Your Metadata for Vendors, Study Sites, and Submission Datasets

Data standardization is the key to faster, more accurate analysis, resulting in successful submissions. By applying standards at the point of collection, you save time and reduce the risk of manual errors as you approach interim analyses, prepare regulatory documents, or simply make “no/no-go decisions” based on early results. But if standardization is the key … Continued

Measuring metabolites in index clinical DDI studies

A key drug development safety consideration is whether the drug candidate will interact with co-medications. Drug-drug interaction (DDI) studies are used to help assess this risk. These studies quantify the impact of the drug candidate on key drug-metabolizing enzymes. The most studied metabolic enzymes are the cytochrome P450 (CYP) enzyme family members. Recommended index substrates … Continued

Exploring the Innovations in Simcyp Simulator Version 24

Join us for an exclusive webinar led by Simcyp’s world-class experts to explore the newest developments in the Simcyp Simulator, the gold standard in physiologically based pharmacokinetic (PBPK) modeling. With the release of Version 24, the Simcyp Simulator introduces cutting-edge enhancements that further elevate its capabilities. The latest features in Version 24 include: Don’t miss … Continued

Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies

This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2 inhibitor, across multiple cancer types, including relapsed and refractory (R/R) myelofibrosis (MF), Merkel cell carcinoma (MCC), and other malignancies. Using a PK model based on 318 subjects, researchers found that tumor type influenced navtemadlin’s absorption, clearance, and exposure, with factors … Continued

Best Practices for International Pharma Content Roll-Out

Pharmaceutical market access, sales, and field teams rely on high-quality, effective content to demonstrate their products’ value globally. As companies expand internationally, effectively rolling out content that meets global and local needs becomes challenging. These materials typically include  These diverse content types are vital in supporting market access strategies, informing reimbursement discussions, and driving sales … Continued

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