Simcyp Pediatric

Model Pharmacokinetics in Virtual Children

Simcyp® Pediatric is a module within the Simcyp Population-based Simulator, which is licensed to members of the Simcyp Consortium of leading pharmaceutical and biotechnology companies. It allows pharmacokinetic behavior to be modeled in neonates, infants and children. This provides valuable information relevant to first-time dosing decisions and the design of pediatric clinical studies. The Simulator includes a full physiologically-based pharmacokinetic (PBPK) model together with extensive libraries on demographics, developmental physiology and the ontogeny of drug elimination pathways. It links in vitro data to in vivo ADME and pharmacokinetic/pharmacodynamic (PK/PD) outcomes to help explore potential clinical scenarios and support decision-making in drug development. With Simcyp Pediatric, researchers can:

  • Predict pharmacokinetics based on in vitro drug data or from adult in vivo data by retrograde modeling
  • Quantify potential drug-drug interactions (DDIs) for any age range
  • Simulate pharmacokinetic variability over any pediatric age range, including infants and neonates

Benefits

  • Support strategic decision making: It provides valuable information that might be difficult or impossible to attain through clinical trials.
  • Save time and money: The automated prediction of in vivo outcomes accelerates the assessment of large numbers of compounds.
  • Optimize drug labels: The pattern of CYP metabolic enzymes that contribute to the elimination of a drug may not necessarily be the same in children compared to adults. Thus, it is difficult to use information about DDIs in adults to inform the likelihood of pediatric DDIs. Simcyp Pediatric can help quantify potential DDIs.
  • Easy to use: Simcyp Pediatric has an intuitive user interface. Users gain proficiency quickly through attending training workshops.

Functionality

  • Automated in vitro extrapolation to predict in vivo outcomes supports assessing a of large numbers of compounds metabolized by multiple enzymes
  • High speed, user friendly desk-top application
  • Batch processing facility
  • Transparent algorithms and methodology and easily understood visual outputs through a variety of graphical interfaces
  • Incorporates leading edge science with continually updated databases

By using Simcyp Pediatric, sponsors can gain insight into drug mechanisms while minimizing the exposure of children to experimental therapies.

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