医薬品開発における投与量最適化のシフトは、新規化合物の80%以上を開発する小規模バイオテクノロジー企業にとって、どのような意味を持つのでしょうか？また、今後の臨床試験は、どのようなステップを踏むべきでしょうか。
In this webinar, Drs. Julie Bullock, Vincent Duvall, Adekemi Taylor, and Italo Poggesi will explain how clinical pharmacology and pharmacometric approaches can improve dose optimization decision making
Using this case study, we share how we were able to turn their challenges into opportunities, achieving major wins.
This webinar presented the modeling capabilities of the Simcyp Biologics Simulator for ADCs and showed how it can help drug development programs save time and money.
During this webinar, we present a framework for qualification of the Simcyp Simulator with respect to competitive and mechanism-based CYP-mediated DDIs involving inhibition that was published recently
We’ll discuss the immediate implications on Phase 1 dosing and design, as well as the potential implications for products already into Phase 2 and 3 of development, including modeling and simulation.
In this webinar, you will learn why Phoenix is the industry’s gold standard in pharmacokinetic, pharmacodynamic and non-compartmental analysis.
The focus of the presentation was on leveraging PBPK modeling during the development of OLZ/SAM and regulatory interactions.
With Certara’s Phoenix Platform, you can provide your scientists the tools they need to efficiently perform PK/PD modeling and simulation to support your drug research and development.
Industry standards are continually evolving, creating an environment of rapid change. With change comes challenges. This webinar will identify current eCTD submission challenges, provide applicable solutions and take a look ahead at what’s to come.
In this webinar, you will tour the software with our leading experts: Iain Gardner, PhD and Hannah Jones, PhD, followed by a live Q&A.
By watching this webinar, you’ll learn how cell therapies are helping to address unmet medical needs, hear about a typical patient’s cell therapy journey, and understand how clinical pharmacology and pharmacometrics can be used to optimize and accelerate the development of these drugs.
In this webinar, Certara expert, Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented. They’ll share first impressions, talk through some of the biggest challenges to date and share what next steps sponsors should take to continue to prepare for the challenges that still lie ahead.
In this webinar, you will learn how to efficiently bring together all your PK/PD models, study data, and results into a single validated environment.
This virtual event with three live presentations featured Certara’s device specialists in regulatory, real-world evidence generation and scientific communication. It explored the latest trends that are transforming the medical technology landscape and how they have affected regulatory approvals and market access.
In this webinar, Drs. Fran Brown, Tina Morris and Patrick Smith will participate in a panel discussion on:
•Understanding the evolving funding landscape
• Re-evaluating your drug development and regulatory strategy
• Making every dollar count with smart, quality decisions
• Determining what data and insights you need to prove your argument
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 confidence.
This webinar will provide an overview of newly released version 1.1 R speaks NLME (RsNLME), Certara’s collection of R packages that enable scientists to run pharmacometrics models in R using the Certara NLME engine. Highlights of this release will review enhanced workflow capabilities
医薬品開発における投与量最適化のシフトは、新規化合物の80%以上を開発する小規模バイオテクノロジー企業にとって、どのような意味を持つのでしょうか？また、今後の臨床試験は、どのようなステップを踏むべきでしょうか。
This session shows how Synchrogenix Writer™ enables companies to gain productivity and efficiency in the medical writing process. Our experts will go over the product and focus on features designed to automate one of the most laborious documents to write – patient safety narratives.
his presentation will explain how the use of advanced technology and automation allows for the production of clinical documents with future disclosure in mind. The program will cover how “transparency-friendly” presentation standards can be integrated into your process beginning from initial medical writing using patient narratives as a case study.
Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry? Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory).
In this webinar, you will learn how to combine data access, analysis and collaboration for data-driven research with D360. Certara expert Dr. Fabian Rauscher will give an overview of the value of the scientific research software and show a demo of D360’s key features.
In this webinar you’ll learn how Synchrogenix Writer™ enables companies to gain productivity and efficiency in the medical writing process. Our expert Trevor Standish will go over the product and focus on features designed to automate one of the most laborious documents to write – patient safety narratives.
In this webinar you’ll learn how Phoenix Secure can efficiently organize and manage your Pharmacokinetic (PK), SAS, R, and other data sets.
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 PK/PD modeling. With Phoenix Hosted, you make everyday data tasks easier for your team, allowing them to focus on higher value tasks.
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
In this webinar you’ll learn about using PBPK software, Simcyp Discovery Simulator for first-in-human dose prediction to help avoid the valley of death, crossing from preclinical to clinical research.
Learn how this new solution streamlines the process of ingesting clinical trial data from external sources and significantly improves the process of acquiring and managing vendor data.
Our expert Kevin Trimm demonstrates how to wholistically automate NCA workflows with PK Submit. He will provide an overview of the value of PK Submit and will show a demo of the key features. A special focus will be the new integration of Pinnacle 21 into PK Submit.
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 numerous and well-documented, Simcyp Discovery’s functionality and attainability has been tailored to address the needs of discovery and translational scientist during the initial phases of drug discovery and development.
