PBPK Modeling & Simulation

Why Using In Silico Modeling for Cardiac Safety is the Next Big Thing

Sebastian Polak

The sky high cost of drug development means that late stage drug attrition is especially devastating. Thus, the ability to assess potential drug safety issues early— using in vitro data— would be very beneficial. The current paradigm for cardiac safety pharmacology is rooted in the preclinical ICH S7B and clinical ICH E14 guidelines. There have […]

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Topics: PBPK Modeling & Simulation

Dosing for Two: How Pharmacometrics Supports Drug Safety in Pregnancy

Alice Ke

According to the US Census Bureau, there is a birth every eight seconds in the United States. Women frequently take prescription and over-the-counter drugs during pregnancy. Given the ubiquity of pregnancy and births, you’d think that there would be a robust understanding of the safety and efficacy of drugs in pregnant women. However, the vast […]

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Topics: PBPK Modeling & Simulation

A Clearer Crystal Ball: A Meta-regression Model Predicts TB Relapse

David Hermann

What would you guess is the world’s most neglected disease? I bet that you wouldn’t pick tuberculosis (TB)— a disease that causes an estimated 9 million new cases and 1.3 million deaths annually. This infectious disease is caused by the bacterium Mycobacterium tuberculosis. TB usually attacks the lungs, but can attack any part of the body. […]

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Topics: Uncategorized

1 Size Doesn’t Fit All: PBPK M&S for Individual Risk of Complex DDIs

Helen Humphries

Drug-drug interactions (DDIs) are a primary threat to the safety and efficacy of clinical practice. Clinically relevant drug interactions are primarily due to drug-induced alterations in the activity and quantity of metabolic enzymes and transporters. Indeed, DDIs that cause unmanageable, severe adverse effects have led to restrictions in clinical use and even, drug withdrawals from […]

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Topics: PBPK Modeling & Simulation
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