Systems Pharmacology

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Tom Snowden

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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Topics: Systems Pharmacology

What the FDA Expects from Your Pediatric Drug Program

Barry Mangum

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

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

First-in-human Trials and Going Too FAAH from the Sentry

Graham Scott

Many people in the UK and elsewhere are currently remembering where they were and what they were doing on the day that Diana Princess of Wales died: August 31st marks 20 years since that fateful day. For Clinical Pharmacologists, we may well remember where we were when we heard the news that six volunteers were […]

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Topics: Clinical Pharmacology Strategy

Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

Tom Snowden

Quantitative systems pharmacology (QSP) combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP models predict how drugs modify cellular networks in space and time and how they impact and […]

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Topics: Systems Pharmacology

New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Suzanne Minton

With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]

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Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing
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