Model Informed Drug Development 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

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

Application of physiologically based pharmacokinetic modeling of novel drugs approved by the U.S. food and drug administration

The article from the European Journal of Pharmaceutical Sciences reviews the role of Physiologically Based…

CertaraSeptember 1, 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

Video

Certara’s MIDD Oncology Capabilities

Improve Oncology Study Decisions with Certara's MIDD Team Transcript: The pace of oncology drug…

CertaraAugust 7, 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

Publication

New Horizons of Model Informed Drug Development in Rare Diseases Drug Development

Model-informed drug development is revolutionizing the way we approach rare diseases, where traditional large-scale clinical…

CertaraJuly 11, 2024

Model Informed Drug Development

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

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

Application of physiologically based pharmacokinetic modeling of novel drugs approved by the U.S. food and drug administration

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)

Certara’s MIDD Oncology Capabilities

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

New Horizons of Model Informed Drug Development in Rare Diseases Drug Development

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