Drug Safety Archives

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…

Certara2024年10月30日

Blog

がん治療薬開発においてヒトマスバランス試験が必要な理由とは？

Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…

Certara2024年9月23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…

Certara2024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…

Certara2024年9月16日

Conference

ISSX 2025 International Meeting

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Certara2024年9月12日

Blog

Resmetirom: A pioneering NASH clinical program

Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…

Certara2024年8月23日

Blog

Subject Exposure in Aggregate Safety Reports & Common Issues

All new and existing drugs should be safe, effective, and efficacious for the treated populations.…

Certara2024年8月16日

Publication

A literature review of drug transport mechanisms during lactation

The literature review titled "A literature review of drug transport mechanisms during lactation," authored by…

Certara2024年7月7日

Blog

Assessing Drug-Smoking Interactions Using PBPK Modeling

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn't…

Certara2016年7月29日

Blog

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…

Certara2015年12月1日

薬物安全性

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

がん治療薬開発においてヒトマスバランス試験が必要な理由とは？

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

ISSX 2025 International Meeting

Resmetirom: A pioneering NASH clinical program

Subject Exposure in Aggregate Safety Reports & Common Issues

A literature review of drug transport mechanisms during lactation

Assessing Drug-Smoking Interactions Using PBPK Modeling

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

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