Clinical Trials Archives

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…

CertaraNovember 4, 2024

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…

CertaraOctober 30, 2024

Press Coverage

Curing Data Collection Woes Could Take a Village

The article "Curing Data Collection Woes Could Take a Village" explores the challenges of clinical…

CertaraOctober 8, 2024

Blog

How Clinical Trial Technology Streamlines the Research Process

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

CertaraSeptember 25, 2024

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…

CertaraSeptember 18, 2024

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…

CertaraSeptember 16, 2024

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…

CertaraAugust 26, 2024

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)…

CertaraAugust 26, 2024

Blog

How does a clinical development plan help drug programs?

How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…

CertaraJuly 26, 2024

Publication

A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator

This collaborative effort by Certara and the Centre for Applied Pharmacokinetic Research (CAPKR) at The…

CertaraJuly 24, 2024

Clinical Trials

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

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

Curing Data Collection Woes Could Take a Village

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)

How does a clinical development plan help drug programs?

A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator

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