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Application of Pharmacometrics Methods in Pediatric Drug Development

Description

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.

Learning Objectives:

  • Provide an overview of the methodological basis of population PK and PBPK and how it relates to pediatric drug development
  • How Population PK can help by leveraging prior information including from adults as well as integrate sparsely sampled data to generate knowledge and make inferences about pediatric trials
  • Explore the regulatory perspective of the use of pharmacometrics in pediatric drug development.

Contributors

  • Aneesh Argikar, Ph.D., Synteract

    Dr. Aneesh Argikar, Ph.D. is an associate Director of Pharmacokinetics with an expertise in pharmacokinetics and drug metabolism. He received his Master of Science degree from Northeastern University, Boston in 2009 followed by a Doctor of Philosophy degree from Temple University, Philadelphia in 2016. At Synteract, Dr. Argikar is involved in population PK modeling and PK/PD analyses, first-in-humans dose predictions in pediatrics and adults, PK analyses for various clinical studies including SAD, MAD, BE, organ impairment, DDI, POC etc. Dr. Argikar’s also serves as a steering committee member for membrane transporter focus group at ASCPT and an ad hoc reviewer for several prestigious scientific journals.

  • Ayman Akil, Ph.D., Synteract

    Dr. Akil is an associate pharmacokinetics director at Synteract. He has experience working in pharmacokinetics modeling as well as predictive modeling using machine learning. He has worked in several therapeutic including infectious diseases, pediatric hepatology, and psychiatry. Dr. Akil has a Ph.D. in pharmaceutical sciences from the University of Pittsburgh and completed a postdoctoral fellowship at Indiana University in modeling and simulation. Prior to joining Synteract he worked as an assistant professor at Mercer University College of Pharmacy in Atlanta, GA.

January 26, 2021
Tue 12:30 PM EST

Duration 1H 30M

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