Clinical pharmacology information for pediatric medications - An overview from a global perspective

抄録

Clinical pharmacology information, which is tailored specifically for pediatrics, serves as an essential foundation to ensure its effectiveness and safety in pediatric populations. This encompasses a comprehensive understanding of a product's pharmacokinetics and pharmacodynamics in children. Furthermore, it plays a pivotal role in assisting healthcare professionals in determining appropriate dosages for pediatric patients. The limited availability of such data in the field of pediatric pharmacotherapy has given rise to challenges, often intertwined with the off-label use of medications in pediatric populations. Through the constant/continuous commitment of dedicated individuals, remarkable progress has been made in addressing these challenges and expediting the mitigation of off-label medication use for children over the past decades. Notably, these endeavors have been well recognized in the US and the EU as well as in Japan, although varying strategies have been applied among these regions.

During my presentation, I will share insights into the following key topics based on my experience in pediatric clinical pharmacology, primarily in the US, spanning both academia and industry:

1. Pediatric clinical pharmacology information assists healthcare professionals in pediatric clinical practice.

2. US legislation BPCA/PREA expects industries, government, and academia to play their respective roles.

3. Pediatric CP Information could be obtained at any stage of clinical studies to enhance it, per FDA CP Guidance for Pediatrics (2022)

4. Pediatric clinical studies require well-balanced decisions.

5. Pediatric ethical concepts impact on pediatric study strategy: Safeguards for Children in Clinical Investigations

6. ICH-E11A - Pediatric exploration - focuses more on overall pediatric drug development in relation to its statistical-methodological advancement.

7. Contents required in US-PSP/EMA-PIP matter.

8. Pediatric Clinical Pharmacologists need to be trained.