Module232025

Lack of Pharmacokinetic (PK) and Pharmacodynamic (PD) Data (1) Limited Understanding :

Age-related effects on PK/PD profiles in children are poorly studied, complicating dosing.

FDA Guidelines :

New guidelines (2022) emphasize pediatric-specific studies to address PK/PD gaps.

ADME Variability :

o Absorption, distribution, metabolism, and excretion (ADME) differ widely across pediatric age groups. o Factors such as gastric pH, organ development, and enzyme levels impact drug efficacy. Challenges in Subpopulation Stratification : Significant heterogeneity in age, weight, and development (e.g., 400 g vs. 70 kg) complicates trials. Genetic Polymorphisms : Genetic variability in enzymes influences drug metabolism and personalized dosing .

Quality (CMC) Development Considerations

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