Designing simple PK-PD studies in children.

Conducting clinical pharmacology research studies in pediatric patients is challenging because of ethical and practical constraints but necessary to ensure that drugs are used safely and effectively in this population. Developments in laboratory analytical techniques, such as improved assay sensitivity and the use of alternative sample matrices, can reduce blood loss and offer less invasive blood sampling, causing less trauma to the patient and fewer ethical concerns. Recent advances in data analysis techniques, which aim to extract the maximum amount of useful information from small sample numbers, should be considered when planning a clinical trial and incorporated into the study design. Using 'population' methodology allows a more flexible sampling strategy that enables valuable data to be collected in the course of routine clinical practice, rather than in a rigid, and potentially artificial, setting. Integration of pharmacokinetics and pharmacodynamics and the application of physiological approaches and simulation techniques to the analysis and interpretation of drug concentration and effect data offer new opportunities that have particular relevance to pharmacological research in the field of pediatric anesthetics.