PK/PD Modeling & Simulation | KinderPharm
Pediatric PK/PD modeling and simulation is a cornerstone of pediatric drug development As identified by the FDA as part of the “Critical Path Initiative” poor dose and dose regimen selection is a frequent reason for trial failure. PK/PD modeling and simulation approaches are particularly useful when existing data is available to support either a full or partial extrapolation of data from other patient populations.
Impacting the design of pediatric studies
Pediatric PK/PD modeling and simulation is a rapidly evolving science. Application of these strategies can have an enormous impact on the design of pediatric studies, providing insight and guidance on the rational selection of pediatric doses and dose regimens.
The KinderPharm Pharmacokinetic modeling team have deep industry experience with the most cutting edge PK/PD modeling/simulation population PK, sparse sampling and allometric scaling techniques.
Key areas of expertise:
- PK and PK/PD study designs
- Bioavailability/Bioequivalence Studies
- Optimized sparse sampling strategies
- PK/PD Modeling and Simulation
- Allometric scaling
- Physiologically Based PK models (PBPK)
- Pediatric Extrapolation
Building predictive models to guide pediatric dosing
We utilize multiple software platforms (Phoenix-WinNonLin, ADAPT, NonMem) and physiologic PBPK modeling approaches to understand the relationships between drug exposure and response which in turn are used to build predictive models to guide pediatric dosing. We operate under stringent (GLP) data collection and data analysis procedures and build regulatory compliant data sets for submissions within our audit-trailed 21CFR Part 11 PK Database System.
Experienced in the therapeutic area
We have broad therapeutic area experience including oncology, anti-infectives, CNS, GI respiratory, immunology, endocrinology/metabolic diseases with both small molecules and biologics in neonates, infants, children and adolescents.
Contact us with any questions you may have on pediatric PK/PD modeling and simulation.