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Bringing Compliance to your Statistical Computing Environment

A statistical analysis includes input datasets from various sources, mature reusable code, bespoke programming, intermediate results, and final output. It is the collection of these various assets that represent an analysis that is attributable, traceable, and reproducible. For this reason, it is important to version entire statistical analyses, and not just versions of files. Furthermore, … Continued

PK Submit CDISC Technology

PK Submit automates the time consuming, error-prone and complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. It allows you to automatically create a complete electronic regulatory submission-ready package within minutes during the normal process of setting up and executing a non-compartmental analysis (NCA).

Scientific Computing World: Connecting Science

Interconnection is an imperative for the modern laboratory, and seamless integration is mandatory from the perspective of the end user, who is generally a scientist. That’s the view of Leif Pedersen, president of software at Certara (…)

Upcoming 2021 Certara University Express Webinars

Certara University is pleased to announce our complimentary 30-minute Express webinar series: Simplify Your Submission Review Process With an Anywhere, Anytime eCTD Viewer Date/Time: Tuesday, August 24, 2021 at 11:00AM EST Description: Your organization has numerous stakeholders responsible for reviewing the content of your drug submissions which requires approving eCTD submission content quickly, fielding agency … Continued

Certara’s Phoenix software supports training of the next generation of the pharmacometricians in China

The Pharmacy department of the Shanghai Chest Hospital is dedicated to developing and applying model-informed precision dosing (MIPD) and model-informed drug development (MIDD) models to optimize dosing for patients in China.  Certara has partnered with Professor Jiao for 20 years to provide academic training to graduate students and researchers on using its pharmacometric software, including … Continued

Phoenix IVIVC – Averaging Data and Scaling Between Studies

November 19, 10:00 am EST In this webinar, Dr. Cardot will discuss two main aspects linked with inter subject variabilities: averaging of data and scaling between studies. When two steps IVIVC are set up, authorities propose to mean the absorption for establishing IVIVC. For averaging, the following points will be discussed: The influence of averaging … Continued

Application of PK/PD Modeling and Simulation in Drug Discovery and Development in China

By Yuancheng Chen, Research Associate of Phase 1 Unit, Huashan Hospital, Fudan University, and visiting scholar of Uppsala University Certara recently held its first virtual Phoenix User Group meeting in China. Over this three-day meeting, attendees learned from Certara’s experts on specific Phoenix workflow examples, updates to the Phoenix product roadmap, an overview the latest … Continued

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