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Connecting hydroxychloroquine in vitro antiviral activity to in vivo concentration for prediction of antiviral effect: a critical step in treating COVID-19 patients
TLDR
In vitro EC50/EC90 values for hydroxy chloroquine should be compared to the in vivo free extracellular tissue concentration, which is similar to the free plasma hydroxychloroquine concentration.
An Analysis of N-Acetylcysteine Treatment for Acetaminophen Overdose Using a Systems Model of Drug-Induced Liver Injury
TLDR
DILIsym predicts that the oral NAC treatment protocol is superior to the 21-h intravenous protocol and ALT is the optimal available biomarker for discontinuation of the therapy.
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical
TLDR
An update on the application of PBPK modeling in submissions received between 2018 and 2019 is provided and a few notable examples are highlighted.
FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis
TLDR
The FDA clinical review and rationale for the approval of midostaurin for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytes with associated hematological neoplasm, and mast cell leukemia is summarized.
In vitro to in vivo extrapolation and species response comparisons for drug-induced liver injury (DILI) using DILIsym™: a mechanistic, mathematical model of DILI
TLDR
This study demonstrates that mechanistic, mathematical modeling offers a method for interpreting and extrapolating results of drug-induced liver injury and illustrated how modeling can aid in selecting the most appropriate pre-clinical species for safety testing results relevant to humans.
Cross-species transcriptomic analysis of mouse and rat lung exposed to chloroprene.
TLDR
Transcriptional BMD values for the pathway were more similar to differences in tumor response than were estimated target tissue dose surrogates based on the total amount of chloroprene metabolized per unit mass of lung tissue per day.
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