Simcyp Consultancy: Bespoke PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry, and genetics. We integrate this information with in vitro drug absorption, metabolism, and transport data to simulate and predict in vivo pharmacokinetics in virtual patient populations.

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

Using Pharmacokinetics to Assure Chemical Food Safety

As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and milk). Therefore, tissue residues are a unique concern in veterinary medicine because indirect exposure to drugs and their metabolites through eating meat or milk could … Continued

Burstable Compute Grid

Certara’s Compute Grid allows you to access up to 1,800 cores in the cloud with just one click, significantly accelerating model runs. Projects that took days can now be completed in hours or even minutes, affordably and without IT support.

Navigating the Path for Pharmacokinetic CDISC Data Preparation

Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the … Continued