The Division of Clinical Pharmacology & Therapeutics is directed by Dr. Peter C. Adamson and physically located in the 9th floor of ARC. The Division of Clinical Pharmacology & Therapeutics provides the clinical and laboratory expertise necessary to perform pediatric phase 1 trials and pharmacokinetic studies in a safe, effective and timely manner. The Division can provide guidance to effectively perform trials in pediatric patients from concept proposal, protocol design and conduct, specimen acquisition and analysis, to data analysis and report generation.
Press Release: Dr. Peter C. Adamson To Chair Children's Oncology Group
In designing a pharmacokinetic study for the pediatric population, the general approach is to determine how the dosage regimen in the pediatric population should be adjusted to achieve approximately the same level of systemic exposure that is safe and effective in adults. Based on the intended use of a drug, studies usually are performed in all pediatric age groups. Investigators in the Division of Clinical Pharmacology & Therapeutics can provide the necessary experience in designing a pediatric pharmacokinetic study. Special attention is paid to safety, with carefully planned sampling that minimizes the volume and frequency of blood withdrawal.
The Division of Clinical Pharmacology & Therapeutics can also guide investigators in determining which of the two primary methods for performing a pharmacokinetic evaluation in children (standard versus population PK) is most appropriate for a given drug. In the standard PK approach, either single or multiple doses of a drug are administered to a small group of children with relatively frequent blood sample collection. Specimens are collected, based on absorption and disposition half-lives, over specified intervals. Both model-independent and model-dependent approaches are used to establish pharmacokinetic measures. A population PK study relies on sparse sampling of blood from a larger population than would be used in a standard PK study. One advantage of the population PK approach in pediatric populations is that it allows for infrequent sampling, sometimes as few as 2-4 samples per subject, with sample collection potentially carried out with other blood sampling. Because a relatively large number of patients are studied and samples can be collected at various times of day and repeatedly over time in a given subject, estimates of both population and individual means, as well as estimates of intra- and inter-subject variability are obtained if the population PK study is properly designed.
The Laboratory of the Division of Clinical Pharmacology & Therapeutics is a 2200 square foot state-of-the-art facility located in the Abramson Research Center of the Children's Hospital of Philadelphia. Analytical equipment includes Waters HPLC Alliance Systems with photo diode array, ultraviolet dual-wavelength, fluorescent, electrochemical and LC/MS detectors, giving the laboratory an ability to analyze a broad spectrum of therapeutic agents in biologic matrices. Modern assay techniques utilizing micro-volumes allow for pharmacokinetic study of new therapeutics to be performed in infants and young children. Analyses are performed in accordance with the FDA's GLP standards. The laboratory is capable of serving as the core facility for multi-institutional pediatric pharmacokinetic studies, using a flexible database which tracks specimens from receipt to final analytic results. In addition to hard copy output, data generated can be exported in a variety of electronic formats.
The Division of Clinical Pharmacology & Therapeutics employs Pediatric Clinical Pharmacology Study Coordinators who are specifically educated regarding the scientific and regulatory rigor necessary to perform phase 1 trials and pharmacokinetic studies in children. The Division works closely with sub-specialists throughout The Children's Hospital of Philadelphia to provide the expert care necessary when evaluating new agents in pediatric patients.
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