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Everything You Need to Know About SDTM

Find out all you need to know about CDISC SDTM, from the SDTM implementation guide to a step-by-step process for SDTM dataset creation.

https://www.certara.com/blog/everything-you-need-to-know-about-sdtm/

A Quantitative Systems Pharmacology Model to Study the Efficacy of Therapies for the Treatment of Autoimmune Disease

This webinar is hosted by the International Society of Pharmacometrics (ISoP) Speakers:  Abstract: The development of therapeutic antagonists that target BAFF and APRIL to treat autoimmune disease is still in its infancy, and many questions remain about their mechanisms of action and pharmacodynamic (PD) profiles, and how to optimize their efficacy. We developed a quantitative systems … Continued

https://www.certara.com/on-demand-webinar/a-quantitative-systems-pharmacology-model-to-study-the-efficacy-of-therapies-for-the-treatment-of-autoimmune-disease/

AI-powered QSP Modeling

会場:MassBioHub, 700 Technology Square, 5th Floor, Cambridge, MA 02139 The proliferation of powerful AI models has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. For example: One area where AI can provide immense value is in combination with QSP modeling to significantly accelerate the creation, expansion and validation … Continued

https://www.certara.com/live-events/ai-powered-qsp-modeling/

SDTM Mapping & SDTM Conversion

Make earlier safety & efficacy decisions with rapid trial insights   It takes a load of time and effort to convert source data into Study Data Tabulation Model, or SDTM format. Costly programming resources are typically needed to get the job done. And when it’s left until the end of a trial, you risk costly … Continued

https://www.certara.com/pinnacle-21-enterprise-software/sdtm-mapping-sdtm-conversion/

Best Practices for a Successful eCTD Submission

Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best practices for addressing them.

https://www.certara.com/blog/best-practices-for-a-successful-ectd-submission/

What’s New in the Simcyp™ Simulator – from Regulatory Advances to New Modalities

Already the most sophisticated technology for physiologically based pharmacokinetic modeling (PBPK), the Simcyp Simulator has added a range of new advances in its recently release (version 23).  This webinar, hosted by the subject matter expert scientists at Simcyp, will share these new capabilities and review the features that have enabled the Simulator to be leveraged … Continued

https://www.certara.com/on-demand-webinar/whats-new-in-the-simcyp-simulator-from-regulatory-advances-to-new-modalities/

Waiving clinical studies & accelerating drug development for kinase inhibitor drugs eBook

キナーゼ阻害薬の開発スピードアップ:Free eBook  Unlock the key to faster drug development with our eBook, “Waiving Clinical Studies & Accelerating Drug Development for Kinase Inhibitor (KI) Drugs.” Whether you’re in pre, early, or late clinical stages to post-marketing, this essential resource offers real-world case studies and insights into the power of … Continued

https://www.certara.com/waiving-clinical-studies-accelerating-drug-development-for-kinase-inhibitor-drugs-ebook/

Thank You – Content Download – Simcyp

How about a free demo of the Simcyp™ PBPK Simulator? Complete the form to book your no-obligation demo of the standard software for Population-based Physiologically Based Modeling and Simulation… and see how better off you could be with Simcyp!

https://www.certara.com/thank-you-content-download-simcyp/

CERTAINTY by Certara 2024

Transcript: The Certara community and interdisciplinary industry experts and scientists from model and form drug development bio simulation, clinical pharmacology, regulatory science, and software development come together for Certainty. Certara’s first annual client summit. This coming May fourteenth through sixteenth in Philadelphia at Convene. We will unite to share future visions, strategies, industry trends, and … Continued

https://www.certara.com/video/certainty-by-certara-2024/
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