Next Case Study

Pediatric trial

In silico MD clinical trial in children 12-18 years of age


The Sponsor had performed SD and MD PK, tolerability and safety trials in children 12-18 years of age in acute pain indication. The Sponsor intended to develop a pediatric program in chronic pain indication. Massive amount of PK, tolerability and safety data for the acute and chronic conditions were available in adults.

Question of Interest

Could M&S replace the chronic pain SD clinical trial in children 12- 18 years of age and predict the optimal PK sampling scheme for the MD trial?


The compound had a “well behaved” pharmacokinetic profile. PBPK modeling was already successfully applied from adults to children in the acute program. PBPK modeling was applied in chronic pain as well. 


A pediatric PBPK model was developed from the adult model and used to simulate the SD trial.      


  •  The Agency accepted the Sponsor’s Pediatric Investigational Plan including the in silico SD PK study in children 12-18 years of age.
  • Ethical approach
  • The Sponsor reduced costs and timelines of the new generation patch development program 

Related Case Studies

In silico QSTR Model

In silico Quantitative Structure-Toxicity Relationship (QSTR) Model for Predicting Toxicity of Aromatic Aldehydes using Extended Topochemical Atom (ETA) Indices.

Read More »

Fill the details to download the case study

Download your case study by clicking the link below