Pediatric patients, whether neonates, children, or adolescents, need access to well-evaluated drugs. Pediatric studies are imperative as the age-specific physiologic changes influence drug pharmacokinetics (PK) and pharmacodynamics (PD). For this reason, dosing and safety are not predictable in children and neonates at different developmental stages, and we cannot extrapolate them from adults and often from other age groups.
Despite worldwide regulatory efforts, there is still a significant need to develop new therapies for pediatric diseases and to establish safety, efficacy, and dosing for products that are used off-label in children.
Accelsiors is an expert CRO in model-based (pharmacometrics) approaches in pediatric drug development, including identifying the dose regimen for different age groups to inform clinical trial design better.
Accelsiors has conducted pediatric clinical research since 2002. We are experts in planning and conducting pediatric clinical trials of all phases and age groups, from first in humans to phase III registration trials, from neonatal to adolescence.
In addition to conducting pediatric trials, we routinely support our clients in finding answers for all complex problems a pediatric drug developer may face.
We consider many other factors when working on study designs considering the most suitable drug formulations and routes of administration. Other factors like drug palatability, ease of administration, and age-appropriate formulations may significantly impact study procedure adherence and compliance.
High-quality pharmacokinetic (PK) and pharmacodynamic (PD) studies are the cornerstone of any pediatric development program. The results of the PK/PD studies are essential in understanding the dose–concentration–response relationship. Without PK data from appropriate populations to support marketing authorizations, clinicians have little choice but to use medications off-label, which can lead to an increased risk of toxicity or subtherapeutic dosing.
PK/PD models can tell the expected effect size during sample size calculations, reducing the burden of unnecessary research and also helping refine dosing strategies relevant to routine clinical practice.
Pediatric clinical trials are more than just ensuring safe treatments for children. They’re about forging a future of holistic, evidence-backed healthcare for all ages. In this mission, Accelsiors shines brightly.
Our Commitment: Accelsiors doesn’t just run trials; we’re shaping the future of pediatric clinical research.