Clinical Trials Archives

Publication

妊婦および授乳中の女性のための治療薬を改善および最適化するファーマコメトリクスとシステム薬理学アプローチの直近のアプリケーション

The article "Recent Applications of Pharmacometrics and Systems Pharmacology Approaches to Improve and Optimize Drug…

Danielle Pillsbury2024年11月18日

Blog

臨床薬理学と薬物動態学の各チームが協力すべき理由

A symbiosis between a modeler and a trialist is often required to develop a model-informed…

Certara2024年11月8日

Publication

Informing pregnancy dose via target-mediated drug disposition modeling and simulations for a recombinant human monoclonal antibody

The article titled "Informing pregnancy dose via target-mediated drug disposition modeling and simulations for a…

Danielle Pillsbury2024年11月4日

Blog

FAQs on Developing EMA Policy 0070 Submissions

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…

Certara2024年11月1日

Publication

Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women

The article titled "Using PBPK modeling to supplement clinical data and support the safe and…

Danielle Pillsbury2024年10月30日

Blog

How Clinical Trial Technology Streamlines the Research Process

Learn how innovative clinical trial technology helps to revolutionize research & ensure the swift rollout…

Certara2024年9月25日

Publication

A close examination of BCRP’s role in lactation and methods for predicting drug distribution into milk

The article, authored by Caroline Sychterz, Hong Shen, Yueping Zhang, Michael Sinz, Amin Rostami-Hodjegan, Brian…

Danielle Pillsbury2024年9月18日

Publication

A tutorial on physiologically based pharmacokinetic approaches in lactation research

The tutorial by Amita Pansari, Xian Pan, Lisa M. Almond, and Karen Rowland-Yeo examines the…

Danielle Pillsbury2024年9月16日

Publication

Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

The article "Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system…

Danielle Pillsbury2024年8月26日

Publication

Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)

The article “Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL)…

Danielle Pillsbury2024年8月26日

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臨床試験

妊婦および授乳中の女性のための治療薬を改善および最適化するファーマコメトリクスとシステム薬理学アプローチの直近のアプリケーション

臨床薬理学と薬物動態学の各チームが協力すべき理由

Informing pregnancy dose via target-mediated drug disposition modeling and simulations for a recombinant human monoclonal antibody

FAQs on Developing EMA Policy 0070 Submissions

Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women

How Clinical Trial Technology Streamlines the Research Process

A close examination of BCRP’s role in lactation and methods for predicting drug distribution into milk

A tutorial on physiologically based pharmacokinetic approaches in lactation research

Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)

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