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The Pharmacokinetics (PK) of ADC therapeutics typically show a discrepancy between the PK of total antibody and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation, however recent evidence suggests that the underlying mechanisms may be more complex. In this webinar, we will present how quantitative systems &hellip; <a href="https://kr.certara.com/webinar/exploring-adc-pharmacokinetics-using-qsp-apac-webinar/">Continued</a>

The eCTD v4.0 standard introduces several changes to the submission process, including updated granularity, context groups, re-used files, and more. The change will require new habits and new technology, but one upside is better harmonization across regulatory agencies. Join our webinar to discuss some of the nuanced changes in the v4.0 standard and discover how &hellip; <a href="https://kr.certara.com/webinar/ectd-4-0-new-standard-new-technology-new-opportunities/">Continued</a>

Scientists in drug discovery often spend excessive time managing research data instead of concentrating on identifying the most promising compounds for new drugs. The right technology streamlines the drug discovery process, providing a seamless workflow for data-driven design, analysis, and research tracking of small molecules. In this webinar, experts from Certara and Chemaxon will guide &hellip; <a href="https://kr.certara.com/webinar/closing-the-loop-how-to-improve-the-management-of-your-design-make-test-analyze-cycle/">Continued</a>

Iberoamerican Pharmacometrics Network

New therapeutics development in rare diseases presents both opportunities and complexities. Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration. The top 3 critical downfalls in rare diseases development include Poor understanding of … Continued

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Unlocking Efficiency in Drug Development with Simcyp PBPK Modeling  Complex drug-drug interactions (DDIs) are a significant roadblock in drug development. While crucial for safety, traditional methods like extensive clinical trials can be time-consuming, cost millions of dollars, and delay the delivery of potentially life-saving treatments to patients in need.  This white paper introduces Simcyp PBPK … Continued

When you think of clinical data standardization, you might think of forms and datasets, or of CDISC’s CDASH, SDTM and ADaM models. And while these are an excellent and necessary starting point for standardization, it’s important to understand the many other ways you can use standardization to improve the efficiency of your clinical trials.    Clinical … Continued

In the ever-evolving pharmaceutical landscape, advancing drug development requires innovative tools that seamlessly integrate science and regulatory standards. The release of Simcyp™ PBPK Simulator Version 23 provides an even more comprehensive platform for all stages of drug development.  Physiologically Based Pharmacokinetic (PBPK) modeling is a cornerstone in drug development, providing predictive insights into drug behavior … Continued

Learn about biosimilars, their benefits for patients who take biologic drugs, and how pharmaceutical companies demonstrate their bioequivalence to approved biosimilars.