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통계 계산 환경에 대한 규정 준수

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 기술

PK Submit은 규제 문서 제출을 위한 약동학(PK) 결과의 일부로 시간이 오래 걸리며 오류가 발생하기 쉽고 복잡한 CDISC 도메인 생성 작업을 자동화합니다. 비구획분석(non-compartmental analysis, NCA)을 설정하고 실행하는 일반적인 프로세스 도중에 몇 분 안에 완전한 전자 규제 제출 문서 준비 패키지를 자동으로 생성할 수 있습니다.

과학적 컴퓨팅 세계: 과학을 연결하다.

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: 2021년 8월 24일 화요일 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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