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.
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. Our key areas of expertise include:
- 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
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.
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.
Physiologically Based Pharmacokinetics (PBPK) | KinderPharm
If efficacy has not been demonstrated in adults or other pediatric patients the extrapolation of efficacy cannot be justified and adequate and well controlled trials in pediatric patients will be needed. Typically however, there are usually a range of options available based on the availability of existing data that can help support the decision to adopt a “No Extrapolation”, “Partial Extrapolation” or “Full Extrapolation” approach.
KinderPharm’s experienced pediatrician’s and clinical pharmacologist’s can help you assess the available data and determine the best way to approach to minimize the burden of conducting trials in patients and provide the most efficient and cost effective approach to meet the regulatory requirements for pediatric labelling.
Pop PK & Sparse Sampling | KinderPharm
Population PK analysis (PopPK) is a powerful tool that enables pharmacometricians to interrogate complex PK, PD and clinical data-sets and seek correlations between multiple variables (covariates). Typically these analyses can reveal how drug clearance (CL) is influenced by factors such as; age, gender, race, bodyweight, body surface area, hepatic function, renal function, concomitant mediations, performance status, disease progression etc. These data can then be used to identify subsets of patients (special patient populations) that may need excluded from treatment or may require dose modification.
PopPK analysis can also be used to estimate pharmacokinetic parameters from very sparse datasets (e.g. one or two samples) collected at random sampling times through the disposition of the drug. This is a particularly valuable tool in pediatric drug development as it can be used to analyze PK data in children with a minimal number of blood draws. In addition to PopPK strategies, KinderPharm scientists also make used of computer-based algorithms to design optimized blood-draw schedules to minimize the number of samples that need to be taken from children to obtain PK data.