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Application of Pharmacometrics Methods in Pediatric Drug Development

Application of Pharmacometrics Methods in Pediatric Drug Development

Date: Tuesday, January 26, 2021
Time: 12:30 PM EST
Length: 90 minutes

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Pediatric drug development has come under greater research and regulatory focus in recent years. Several challenges remain as impediments to conducting pediatric clinical trials. Among these challenges are recruitment and enrollment, ethical constraints, and unsuitable study designs. These challenges often lead to lack of statistically robust data on the PK/PD, its variability and the factors which play a role in the variability. To address some of these challenges, pharmacometrics have been increasingly recognized to aid and guide pediatric drug development. The application of pharmacometrics in drug development was first introduced in adult drug development.

More recently, regulatory agencies such as the FDA and EMA have advocated for greater utilization of pharmacometrics in pediatric drug development and have their guidance’s in place (PSP and PIP). Pharmacometrics approaches such as population pharmacokinetics and physiologically based pharmacokinetics have seen greater implementation in pediatrics drug development. Population PK helps in leveraging prior information including from adults as well as integrate sparsely sampled data to generate knowledge and make inferences about pediatric trials. PBPK methods have proven useful in integrating knowledge about the drug, the human body and study design to generate PK knowledge in pediatrics.

The objective of this webinar is to give an overview of the methodological basis of population PK and PBPK and how it relates to pediatric drug development. A few published examples of the utilization of these platforms will be presented. Finally, the regulatory perspective of the use of pharmacometrics in pediatric drug development will be briefly discussed.

Speakers:

  • Aneesh Argikar, Ph.D., Synteract
  • Ayman Akil, Ph.D., Synteract


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