approval of drugs

What are the Challenges in Pediatric Drug Trials?

Conducting clinical trials in children presents unique challenges:
Ethical Concerns: Obtaining informed consent from parents or guardians, and assent from older children, can be complex.
Recruitment: Enrolling a sufficient number of pediatric participants is often difficult.
Dosing: Determining the correct dosage for different age groups requires extensive pharmacokinetic and pharmacodynamic studies.
Safety: Children may have different adverse reactions compared to adults, necessitating close monitoring.

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