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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

新薬承認に向けて臨床薬理学的課題を克服するための戦略

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

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

Compliance in the Cloud: What you need to know about computer system validation when moving your application to the cloud

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

Streamlining Pharmacokinetic Data Management with Certara’s Integral

The PK scientist’s data pipeline handles a range of raw data types, including SAS, R, and other formats from multiple partners. This is particularly critical in complex trials with substantial data volumes. Effective data compliance management is vital, involving tailored compliance for exploratory studies and full compliance for clinical studies adhering to FDA’s Title 21 … Continued

RAPS Sponsored Webcast: Leveraging Today’s Technology to Accelerate Submissions: Real Life Examples and Lessons Learned

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

How the cloud version of Phoenix supports reduce total cost of operation and maximize flexibility and efficiency [Korean Webinar]

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

AAPS eChalk Talk: Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program

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

Clinical Pharmacology Issues That Can Lead to Approvability Problems for Your Drug

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

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