SIVA V3: Simcyp in Vitro Analysis Toolkit

The SIVA Toolkit is a user-friendly platform, specifically designed to assist scientists
with the analysis of complex in vitro studies using whole cells, tissue samples, and solid
dosage forms to assess the exposure, metabolism, transport, and dissolution/solubility
of drugs.

Mechanistic Modeling of Genome Scale Molecular Interaction Networks

Upon the completion of the Human Genome Project, the lead investigator, Dr. Francis Collins remarked: Science is a voyage of exploration into the unknown. We are here today to celebrate a milestone along a truly unprecedented voyage, this one into ourselves. Alexander Pope wrote, “Know then thyself. Presume not God to scan. The proper study … Continued

PBPK Modeling of Supersaturating Drug Product Behavior

The problem of supersaturating drug products might loosely be summed up as: “If you’re not part of the solution, you’re part of the precipitate!” Indeed, more than 60% of new drug candidates are poorly soluble1 which can severely limit their bioavailability. To ameliorate this issue, a common approach is formulating to create supersaturated solutions of … Continued

New Tools Support Developing Better TB Drugs

Tuberculosis (TB)—caused by infection with the mycobacterium Mycobacterium tuberculosis—is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015. TB is also the leading cause of death in HIV-infected individuals. TB usually attacks the lungs but can infect any part of the … Continued

Leveraging PBPK Modeling and Simulation for Neonatal and Infant Drug Development

Despite increased regulatory support for pediatric drug development, sponsors still face ethical, economic and practical constraints. Indeed, while children represent about 40% of the world’s population, only 10% of the drugs on the market have been approved for pediatrics. Children are not small adults, and all children are not the same. In particular, children under … Continued

Prediction of Liver Volume; One Size Doesn’t Fit All!

When your physician writes you a prescription, they do so knowing that the dose prescribed will (on average) be safe and beneficial to you, but that it is likely certainly not optimal for you as an individual (as has been the topic of a previous blog post). The balance between absorption, distribution and elimination of … Continued

How PBTK Models Support Toxicological Triage

Did you know that only a small fraction of the tens of thousands of commercially-used chemicals have undergone toxicological assessment? Time and cost constraints, not to mention the ethical impossibility of studying these chemicals in human trials, hamper large-scale toxicological assessment. Physiologically-based toxicokinetic (PBTK) models can be leveraged to predict TK from in vitro measurements … Continued

6 Real-life Lessons About PBPK Modeling

I recently had the pleasure of attending a 1.5 day Certara forum for management on the applications of physiologically-based pharmacokinetic (PBPK) modeling and simulation in Chicago, IL. Our CSO Dr. Amin Rostami and Certara consulting scientist, Dr. Alice Ke aptly led the forum. The highlight of the meeting was discussing the latest challenges and trends … Continued