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Pharsight Capabilities in Special Populations: Pediatrics
The challenges and complexities of conducting clinical studies in children are well recognized, with nearly half of pediatric trials for drugs used in adults failing to provide evidence of effectiveness. Pediatric patients are not just small adults: they are a truly unique sub-population in which body weight composition and immaturity of certain physiologic factors may result in PK/PD profiles that differ dramatically from those found in adults.
As the advantages and benefits of pharmacometric analysis for improved drug development and regulatory decision-making have become increasingly well documented, FDA has challenged industry to more rigorously apply modeling and simulation to double the success rate of pediatric trials.
Pharsight has expertise in quantitative pharmacology and population PK/PD modeling to reduce risk in pediatric drug development.
- Study design optimization: dosing recommendations, optimal PK and PD sampling strategy, clinical trial simulations.
- Protocol development: protocol writing and review; scientific rationale for sample size, power calculation, and trial success.
- Scientific and technical writing: regulatory-compliant PK/PD analysis; technical and regulatory population PK reports; manuscript development.
- Small molecules and biologics in neonates, infants, children and adolescents.
Our team has more than 45 conference abstracts and peer reviewed publications in pediatrics, with experience in multiple therapeutic domains and indications, including: anti-infectives, CNS, GI, immunomodulation, endocrine, pain, and rare genetic diseases.