April 2019 – Certara

Clinical Pharmacology Strategy

Certara > Blog > 2019 > April

The Role of Quantitative Systems Pharmacology in First-in-Human Trial Design

on Apr 26, 2019 11:11:20 AM

QSP can inform designing First-in-Human clinical trials to help determine the starting dose and subsequent dose escalations to ensure human subject safety.

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Simulating Viral Dynamics in the New Trial Simulator

Posted by Suzanne Minton, Bill Poland

on Apr 10, 2019 11:32:03 AM

Antiviral drug development presents a unique set of challenges. First, viruses are constantly mutating, and drug-resistant viruses emerge easily. Therefore, combination therapies are typically required to maintain a sustained virologic response. In addition, successful treatment requires high medication adherence, which is often a challenge for patients with chronic viral infections such as hepatitis or HIV. […]

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Topics: PK/PD Modeling & Simulation