pre-update Archives

Publication

A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy

This comprehensive review exposes gaps in current knowledge of phase II enzyme and drug transporter…

Jim Gallagher2024 年 1 月 3 日

Publication

Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy

For drugs highly bound to plasma proteins, changes in concentrations of free drug may have…

Jim Gallagher2024 年 1 月 3 日

On-Demand Webinar

填补空白：将药代动力学与定量系统药理学（QSP）相结合，以实现更顺畅的临床阶段过渡

借助行业领导者的真知灼见，掌握临床阶段的转换！Join Piet van der Graaf, SVP…

Danielle Pillsbury2024 年 1 月 2 日

Publication

Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials

A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…

Jim Gallagher2023 年 12 月 19 日

On-Demand Webinar

药物脱靶安全性：Replacing Educated Guesswork with Evidence-Based Risk Assessment

Secondary pharmacology profiling involves the screening of small molecule compounds against a broad range of…

Danielle Pillsbury2023 年 12 月 19 日

On-Demand Webinar

Survival of the Fittest: Evolving Pharmacokinetic Modeling with Pirana

As regulatory acceptance of models for decision-making grows, so too does the need for optimally…

Danielle Pillsbury2023 年 12 月 19 日

On-Demand Webinar

更快的首次人体试验（FIH）：基于生理的药代动力学（PBPK）模型的核心价值

Advanced Strategies and Best Practices for Predictive Pharmacokinetics using Simcyp™ Discovery Refine your approach…

Danielle Pillsbury2023 年 12 月 13 日

Blog

药物开发人员常见电子通用技术文件问题解答

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…

Rob Connelly2023 年 12 月 12 日

Fact Sheet

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator

Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies…

Certara2023 年 12 月 6 日

Article

Pharma Focus Europe – Issue03 – 利用人工智能加速药物开发

Authors: Professor Amin Rostami-Hodjegan, Professor Piet van der Graaf This Pharma Focus EU article, co-authored…

Jim Gallagher2023 年 12 月 5 日

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pre-update

A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy

Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy

填补空白：将药代动力学与定量系统药理学（QSP）相结合，以实现更顺畅的临床阶段过渡

Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials

药物脱靶安全性：Replacing Educated Guesswork with Evidence-Based Risk Assessment

Survival of the Fittest: Evolving Pharmacokinetic Modeling with Pirana

更快的首次人体试验（FIH）：基于生理的药代动力学（PBPK）模型的核心价值

药物开发人员常见电子通用技术文件问题解答

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator

Pharma Focus Europe – Issue03 – 利用人工智能加速药物开发

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