Simcyp Pediatric is a module within the Simcyp Simulator that allows for the modeling of pharmacokinetic behavior in neonates, infants and children. This provides valuable information relevant to dosing decisions, analysis of drug-drug interactions and other safety issues, design and formulation of drugs for children, and the design of pediatric clinical studies to minimize the number of required subjects.
The Simcyp 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.
While there have been numerous regulatory initiatives to advance pediatric drug development, 40% of all drugs for children and 90% for neonates continue to be prescribed off-label. Underlying this issues are the many challenges inherent in pediatric trials: enrollment difficulties, small number of patients, variability in physiological characteristics, uncertainties in dose selection, and ethical complexities. Simcyp Pediatric addresses that challenge by with its unique Simulator.
With Simcyp Pediatric, researchers can:
- Determine and optimize dose selection for children, from neonates to age 2, 2-6 years, 6-12 years and adolescents;
- 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;
- Inform clinical trial design for pediatrics.
Simcyp Pediatric provides insight into drug mechanisms while minimizing the exposure of children to experimental therapies. Our Simcyp consulting team can use Simcyp Pediatric to advance your program.
Children are not small adults, nor are all children the same. This is especially true for children under the age of two, as many developmental processes are not reflected by simple scalars such as body weight or body surface area and projecting doses based on simple allometric scaling can lead to significant overdoses in certain age groups.
Simcyp Pediatric has been successfully applied:
- Drugs developed specifically for children diseases or children’s conditions as varied from adults;
- Dosing in children. In infants and neonates, PBPK models incorporating pediatric ontogeny can more accurately predict the drug PK as compared to allometry, when there is a sufficient understanding of the ADME process of the drug and the ontogeny is well- characterized for those processes;
- Formulation/bridging for children. Liquid versus oral, extended release, transdermal delivery, topicals and other options have been achieved via PBPK bridging analyses;
- DDI in children. Aligned with organ development, the DDI liability may vary widely from the adult data.
- Pediatric ADAM (Advanced Dissolution, Absorption and Metabolism Model)
- Automated in vitro extrapolation to predict in vivo outcomes supports assessing a of large numbers of compounds metabolized by multiple enzymes
- Transparent algorithms and methodology and easily understood visual outputs through a variety of graphical interfaces
- Intestinal transporter ontogeny
- Pediatric GI tract
- MPML MechDermA™ dermal model for pediatrics