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Streamlining Your NCA Workflow

PK analysis intended for submission contends with many data and compliance challenges. To work efficiently, analysts need a method and toolset that: Join us to explore a workflow that offers these benefits in a secure, cloud-hosted environment. We’ll follow a non-compartmental analysis from end-to-end to highlight best practices for data preparation, modeling, and submission readiness. … Continued

Webinar Spotlight: “Bridging the Gap: Integrating Pharmacometrics with Quantitative Systems Pharmacology (QSP) for Smoother Clinical Phase Transitions”

Master clinical phase transitions with insights from industry leaders! Join Piet van der Graaf, SVP and Head of QSP, Hugo Geerts, Head of Neuroscience Modeling QSP, Mirjam Trame, VP of Certara Drug Development Solutions, and Julie M. Bullock, PharmD, SVP of Drug Development Services at Certara. We are thrilled to welcome keynote speaker and panelist … Continued

Off-Target Drug Safety: Replacing Educated Guesswork with Evidence-Based Risk Assessment

Secondary pharmacology profiling involves the screening of small molecule compounds against a broad range of targets in order to try to predict off-target interactions leading to safety issues in humans. To date, this has generally required an opinion-based approach, but opinions vary and are inherently unreliable. To evaluate this quantitatively requires the use of surrogate … Continued

First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic (PBPK) Modeling

Advanced Strategies and Best Practices for Predictive Pharmacokinetics using Simcyp™ Discovery Refine your approach to early drug development with insights from industry experts in our upcoming webinar, “First-In-Human (FIH) Faster: The Power of Physiologically Based Pharmacokinetic Modeling (PBPK).” If you’re seeking strategies to identify and advance your small molecule drug candidates, expedite product profiling, formulation, … Continued

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

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

Strategy to overcome clinical pharmacology challenges for regulatory approvals [KoreaWebinar]

This webinar is only for Korea: 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 … Continued

Can’t ChatGPT Do That? Practical Applications for AI in Drug Development

While the popularity of tools like ChatGPT have brought AI to the forefront of tech investments, nearly 73% of life science companies still struggle to adopt an appropriate AI technology. Some of the biggest challenges to successful adoption are clearly defined use cases, appropriately trained AI that understands scientific concepts and approachable applications for leveraging … Continued

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