Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women
The article "Recent Applications of Pharmacometrics and Systems Pharmacology Approaches to Improve and Optimize Drug…
CertaraNovember 18, 2024
Why Clinical Pharmacology & Pharmacometrics Should Collaborate
A symbiosis between a modeler and a trialist is often required to develop a model-informed…
CertaraNovember 8, 2024
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
FAQs on Developing EMA Policy 0070 Submissions
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…
CertaraNovember 1, 2024
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
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
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
