Innovative Strategies in Pediatric Drug Development

Asghar Mehdi*, Rehan Haider**, Geetha Kumari Das***, Zameer Ahmed****, Sambreen Zameer*****
* Department of Pharmacology, Fazaia Ruth Pfau Medical College Air University, Karachi, Pakistan.
** Department of Pharmacy, University of Karachi, Sindh, Pakistan.
*** OPJS University, Sadulpur, Rajasthan, India.
****-***** Department of Pathology, Dow University of Health Sciences, Karachi, Pakistan.
Periodicity:May - August'2024
DOI : https://doi.org/10.26634/jls.3.2.20962

Abstract

The incidence of pediatric drugs poses unique challenges due to the distinct corporal, pharmacokinetic, and pharmacodynamic characteristics of juveniles. Innovative methods are being developed to address these challenges and ensure the safety and efficacy of pediatric treatments. This paper investigates various approaches to improve pediatric drug handling, including the implementation of age-appropriate formulations, the use of advanced drug delivery systems, and the incorporation of real-world evidence and patient-centric models in clinical trials. Additionally, regulatory frameworks and procedures that support pediatric drug development are examined, emphasizing the roles of initiatives such as the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) in the United States, as well as similar efforts in Europe and other regions. Emphasis is placed on collaborative efforts among key stakeholders: manufacturers, academia, regulatory bodies, and patient advocacy groups, to promote change and address unmet medical needs in pediatric populations. Furthermore, this paper discusses the potential of emerging technologies, particularly artificial intelligence and genomics, to transform pediatric drug development. By leveraging these innovative strategies, the pharmaceutical industry can enhance treatment outcomes for children and advance pediatric healthcare.

Keywords

Pediatric Drug, Age-Appropriate Formulations, Progressive Drug Transmittal Methods, Pedriatric Research Equity Act (PREA), Best Pharmaceuticals for Children Act (BPCA), Machine Intelligence, Genomics, Pediatric Healthcare.

How to Cite this Article?

Mehdi, A., Haider, R., Das, G. K., Ahmed, Z., and Zameer, S. (2024). Innovative Strategies in Pediatric Drug Development. i-manager’s Journal on Life Sciences, 3(2), 8-18. https://doi.org/10.26634/jls.3.2.20962

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