®Pharsight Capabilities in Special Populations: Pediatrics
Body weight composition and immaturity of certain physiologic factors in pediatric populations may result in PK/PD profiles that differ from those found in adults. For example, age-dependent changes in gastric acidity, gastric emptying/motility, as well as maturation in metabolic enzymes (i.e., Phase I and II drug metabolizing enzymes) and kidneys may change the PK and PD of an investigational product in pediatric populations. Other factors affecting drug distribution (e.g., vascular perfusion, body fat composition, the amount and type of plasma proteins) are also subject to maturation during childhood.
Population modeling offer approaches for assessing the PK/PD of drugs in pediatric patients with sparse sampling and to assess the effect of specific covariates on drug disposition.
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Pharsight has the following expertise in population PK/PD modeling in pediatric populations:
- Study design optimization: dose selection, prediction of drug exposure, and optimal sampling strategies to minimize the number of blood samples required in pediatric studies.
- Modeling and simulation of PK/PD in pediatric patients to optimize safety and efficacy of treatments and demonstrate concentration-effect relationships.
- Bridging PK/PD data from adult to pediatric patients.
- Expertise with small molecules and biologics in neonates, infants, children and adolescents.
- Regulatory consultation for study design and submission to FDA and EMEA.