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Updated: Feb 5, 2026
Intraventricular Drug Delivery and Sampling for Pharmacokinetics and Pharmacodynamics Study
Published on: March 31, 2022
A feasibility study prior to an international multicentre paediatric study to assess pharmacokinetic/pharmacodynamic
Agnes Maria Ciplea1, Stephanie Laeer1, Bjoern Bengt Burckhardt1
1Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine-University, Dusseldorf, Germany.
Insights
This feasibility study ensured high-quality sample collection for pediatric clinical trials by evaluating pre-analytical procedures. It confirmed the suitability of sampling, preparation, and bioanalysis for reliable pharmacokinetic and humoral parameter data.
Area of Science:
- Clinical Pharmacology
- Bioanalytical Science
- Pediatric Research
Background:
- Pre-analytical variability in blood sampling, sample preparation, and transport can compromise bioanalytical results and clinical trial data reliability.
- Minimizing interventions is crucial for data quality, especially in vulnerable pediatric populations.
Purpose of the Study:
- To evaluate the quality and applicability of logistical and bioanalytical procedures for pediatric clinical trials.
- To assess pre-analytical procedures including sampling, sample preparation, transport, and bioanalysis.
- To ensure high-quality data extraction and minimize repeated interventions in pediatric studies.
Main Methods:
- The EU-funded LENA project conducted a feasibility study prior to first-in-child studies.
- Procedures involved sampling of drugs and humoral parameters, with blood collection tubes pre-spiked to avoid drug administration in adults.
- Five clinical sites evaluated the sampling, preparation, transport, and bioanalysis procedures with 18 volunteers.
Main Results:
- 97% of pharmacokinetic (PK) samples and 93% of humoral parameter samples were collected appropriately.
- Clinical teams demonstrated preparedness, with minor re-training needed for one team.
- The planned procedures were deemed suitable for pediatric trials, confirming applicability.
Conclusions:
- The feasibility study effectively assessed PK/PD sampling, sample preparation, logistics, and bioanalysis, proving valuable for trial preparation.
- Identified process issues and bottlenecks were addressed before trial commencement.
- Facilitated high-quality study conduct from the initiation of pediatric pivotal studies.
Background:
Variability in pre-analytical procedures such as blood sampling, sample preparation and transport can substantially influence bioanalytical results and subsequently impair reliability of data gathered during clinical trials. Especially in vulnerable populations, all efforts should be made to facilitate high-quality data extraction excluding unnecessary or repeated intervention.
Methods:
The EU-funded LENA project (Labeling of Enalapril from Neonates up to Adolescents) included a feasibility study in its preparatory procedures prior to first-in-child studies. Derived from a regular study visit, it encompassed all procedures, from sampling of two study-specific drugs and four sensitive humoral parameters to bioanalysis, to evaluate the quality of obtained samples and applicability of logistical and bioanalytical procedures. Drug administration to healthy adults was circumvented by pre-spiking the blood collection tubes with a drug solution. Five clinical sites were evaluated.
Results:
Clinical teams' preparedness and applicability of required sampling procedures was investigated in 18 volunteers, on-site. 97% of collected pharmacokinetic (PK) samples and 93% of samples for humoral parameters were obtained eligibly. Results met expectations, though one team had to be re-trained and performed a re-run. Planned procedures for sampling, sample preparation, transport and analysis were found to be suitable for being applied within paediatric trials.
Conclusion:
The concept of the presented feasibility study that simultaneously assesses PK/PD sampling, sample preparation, logistics and bioanalysis proved to be a promising tool for trial preparation. It revealed improperly installed processes and bottlenecks that required adjustments prior to start of recruitment. It facilitated high-quality conduct from the first moment of paediatric pivotal studies.
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