Analyzing in vitro experiments can be challenging and time consuming. Yet, crucial decisions depend on accurate data analysis and interpretation early in development. Unfortunately, most lab-based scientists lack access to state-of-the-art models for analyzing in vitro data. A new tool enables the analysis of data generated from complex in vitro studies. These studies include assays using whole cells, tissue samples and solid dosage forms.Read More
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 not been any withdrawal of drugs for causing the potentially life-threatening ventricular arrhythmia, “torsades de pointes” (TdP) since the pharmaceutical industry has adopted these guidelines.
Measuring drug-induced alterations to the electrocardiogram (ECG) QT interval is central to current guidelines. QT interval prolongation can result from pharmacological inhibition of the hERG ion channel. By being “hERGcentric” (or some might even say “hERGphobic”), this approach is overly conservative and can result in false positives. Moreover, the clinical approach to evaluating drug-induced cardiotoxicity— the thorough QT (TQT) study— is expensive and has a low positive predictive value. In this blog post, I’ll discuss the coming shift from using TQT studies towards leveraging early drug discovery data for in silico models to predict cardiotoxicity.Read More
As the end of the year draws near, I want to thank all of our customers for letting us be your biosimulation and model based drug development solution provider. We feel honored to be able to play a small, but crucial role in your success in bringing safe and effective drugs to patients. 2014 has […]Read More
Nearly half of drug candidates fail because of inadequate safety in pre-clinical testing, representing an expensive loss of investment and lost opportunity. Often, drugs are found to cause toxicity through off-target activity. Therefore, understanding how drugs interact with their target receptors, and minimizing off-target activity is crucial to developing effective medications. Over my career, I’ve […]Read More
Welcome! We’re excited to launch Certara’s blog. This gives us a chance to comment on important news and topics in the rapidly changing world of drug development. Our blog will offer more than one contributor to ensure you get multiple perspectives on the issues impacting us all. We hope that you’ll share your comments about our solutions […]Read More
Cassette dosing is a technique primarily used in drug discovery efforts in non-clinical studies to collect pharmacokinetic data from multiple drug candidates in a single experiment. A typical cassette dosing pharmacokinetic study involves simultaneous administration of 5-10 compounds to a set of animals. Serial blood samples are obtained and LC/MS/MS techniques are used to measure […]Read More