Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

Read More
Topics:

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 […]

Read More
Topics: PBPK Modeling & Simulation

Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations

Prediction accuracy of pharmacokinetic parameters is often assessed using prediction fold error, i.e., being within 2-, 3-, or n-fold of observed values. However, published studies disagree on which fold error represents an accurate prediction. In addition, “observed data” from only one clinical study are often used as the gold standard for in vitro to in vivo extrapolation (IVIVE) studies, despite data being subject to significant […]

Read More
Topics:
Learn More LinkedIn Twitter Facebook Email