What Are the Challenges in Pediatric Drug Approval?
There are several challenges in getting drugs approved for pediatric use:
Ethical Concerns: Conducting clinical trials in children poses ethical dilemmas and requires parental consent. Small Population: The smaller population makes it difficult to recruit enough participants for trials. Diverse Age Groups: Pediatric trials need to consider different age groups, from neonates to adolescents, each with unique physiological characteristics. Long-Term Safety: Assessing the long-term safety of drugs in children can be challenging and requires extended follow-up studies.
