Category: オンデマンド・ウェビナー

Traditionally, PK Scientists have operated with locally installed applications to resume their PK analysis. In this environment the computer system was under control of the local IT department who would provide all necessary documentation expected by regulatory authorities to provide evidence that their computer system is CFR part 11 compliant. In the new world of … Continued

As the drug development industry strives to accelerate submission timelines and improve patient access to healthcare solutions, regulatory professionals are increasingly pressured to leverage technology to go faster. During this webinar, Heather Graham, vice president of regulatory science and medical affairs at Certara, will facilitate a panel comprising industry experts to discuss the current technology … Continued

The cloud version of Phoenix, Phoenix Hosted, 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. It contributes to reduce the total cost of … Continued

The development of new drugs for rare diseases is a challenging process due to small patient populations and the high cost of clinical trials. One key challenge is identifying optimal dosing regimens. Pharmacokinetics of drugs can vary widely between individuals, and it can be difficult to obtain enough data from clinical trials to make informed decisions about dosing. … Continued

今日、臨床薬理情報は医薬品添付文書の50％以上を占めています。不完全な臨床薬理学開発プログラムは、審査期間中にスポンサーに重大な問題を引き起こしたり、販売申請の承認可否に影響を与える可能性があります。Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of … Continued

In a sector where both competition and stakeholder expectations are high, a comprehensive approach that blends digital stakeholder engagement with effective value communication is crucial for success. This presentation offers a 360-degree view on leveraging digital technologies to revolutionize how pharma companies interact with key stakeholders such as payers, providers, and patients. Simultaneously, the session … Continued

モデルに基づくメタ解析（MBMA）は、ターゲットとする治療領域における開発品と競合医薬品の臨床アウトカムを定量的に比較する最新のファーマコメトリクス手法です。サターラが提供する「CODEx」は学術論文や申請文書等に含まれる公開データから構築した臨床アウトカムデータベースとそれらデータの可視化アプリで構成され、MBMAの効果的な活用を推進します。… Continued

SEND datasets have become an integral part of the review, analysis, and interpretation of nonclinical toxicology studies as per FDA guidance and the needs and trend will only continue to grow. The SEND dataset creation process is challenging and often requires a combination of data integration and manual effort. The quality control process is critically … Continued

Discover Simcyp Biopharmaceutics, our latest addition to the Simcyp suite of technologies. This software empowers drug formulation scientists with advanced model-informed formulation development (MIFD) technology. As a proud member of the Simcyp family, Simcyp Biopharmaceutics provides a robust workbench for formulation development and optimization, maintaining the Simcyp gold standard for unparalleled formulation success. Join us … Continued