PRINCETON, N.J.— 10월 12, 2022 – Certara, Inc., a global leader in drug development software, today announced the release of the PK Submit™ 2.0. The software allows scientists to automatically create a complete electronic pharmacokinetic (PK) regulatory submission-ready data package within minutes during the normal process of setting up and executing a non-compartmental analysis (NCA). PK Submit™ is part of Phoenix™, Certara’s pharmacokinetic and pharmacodynamic (PK/PD) platform, which includes the gold standard WinNonlin software.
PK Submit automates the time consuming, error-prone and complex task of creating pre-clinical and clinical CDISC domains as part of the PK deliverable for regulatory submissions. This latest version incorporates additional features designed to increase efficiency in NCA workflows through automation.
“Lean workflows, where experts do not have to deal with tedious data handling, save time and allow scientists to focus on their core competencies. With the new feature sets, PK Submit™ 2.0 enables even higher R&D productivity,” said Leif Pedersen, president of Software at Certara. “With the integration of the industry-leading CDISC software, Pinnacle 21, into PK Submit™, we are taking an important step toward our goal of providing a seamless experience for users of Certara’s various software products. This integration now helps to make regulatory submission processes even more efficient.”
New capabilities in PK Submit™ include:
- Intuitive user interface to implement complex data transformations
- 현재의 모든 SEND(Standard for Exchange of Nonclinical Data)및 SDTM(Study Data Tabulation Model)구현 가이드에 대한 규정 준수 기능 추가
- 유효성 검사, 연구 데이터에 대한 검토자 가이드 및 Define.xml 생성을 위한 Pinnacle 21과의 통합 기능
Learn more about PK Submit at https://www.certara.com/software/pk-submit-cdisc-technology-solution/.
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Certara 소개
Certara는 독점적인 바이오시뮬레이션 소프트웨어, 기술 그리고 서비스를 통해 전통적인 물질발견과 약물개발을 혁신하여 의학발전을 가속화하도록 지원한다. 2,00062 Certara의 고객으로는 전 세계 62개국에 걸쳐 2,000개 이상의 글로벌 바이오 제약 회사, 선도적인 학술 기관 및 주요 규제기관들이 있다.
