Vitalea Science, Inc., a privately held company that specializes in microdosing and micro-tracing studies using AMS, announced today that it has formed an alliance with the Division of Neonatology of Loma Linda University to support clinical research studies on neonatal pharmacology.
"Approximately two thirds of all drugs prescribed to children have not been studied carefully enough for adequate pediatric-specific information to be included on the label. Adult
pharmacokinetic studies are routine in the pharmaceutical industry, but performing them in children poses many challenges," explained Dr. Arlin Blood, Director of Research for the
Neonatal Intensive Care Unit of Loma Linda University Children's Hospital. "Pharmacokinetic studies typically require collection of 8-20 samples of blood per patient totaling 100-500 mL
of blood to enable adequate detection of the drug in each sample. Thus, the amount of blood required makes most conventional pharmacokinetic studies technically impossible in premature or
even term infants," said, Dr. Blood.
"The extreme sensitivity of Accelerator Mass Spectrometry (AMS) offers a potential solution to the problem of pediatric clinical research. At Vitalea, we are validating an assay to
quantify the incorporation of an anti-HIV drug in DNA that would require only a few drops of blood", Dr. Le Vuong, VP of Global R&D of Vitalea Science added. "This foremost
collaboration will establish the utility of AMS as a tool for studying the pharmacokinetics of drugs in children. We hope that the success of this alliance will lead to future
investigation of many other pediatric medications by both academia and industry worldwide," said Dr. Blood.
About Vitalea Science (http://www.llu.edu/lluch/):
Loma Linda is a comprehensive, state-of-the-art medical facility designed especially for children's unique health-care needs. The Children's Hospital Neonatal Intensive Care Unit (NICU)
is one of the largest and most advanced neonatal centers in the world, with 22,000 square feet and 84 beds dedicated to caring for some of the tiniest babies ever born.