13 December 2012
Vitalea Science in Pediatric Research
The recent article "Applications of accelerator MS in pediatric drug evaluation," details the challenges, clinical successes and future perspectives on making drugs safer and more available to children. The full article -
Vuong L, Blood A, Vogel J, Anderson M, Goldstein B. (2012). Applications of accelerator MS in pediatric drug evaluation. Bioanalysis 4(15):1871-82.- is available by emailing Ann Hoffman at firstname.lastname@example.org.
The extreme sensitivity of Accelerator Mass Spectrometry (AMS) opens up new avenues of quantitative pediatric research using ambient levels of 14C-drug and single-drop blood volumes to address the PK and PD of drugs and endogenous compounds in children of all age groups in ways not previously possible. In the U.S. and Europe only 20% of all drugs prescribed for children have been tested for safety or efficacy on a pediatric population. Most medicines are prescribed "off-label", with dosages extrapolated from adult data through bodyweight and body-surface area, often without pharmacokinetics (PK) and pharmacodynamics (PD) to support the treatment. Barriers in obtaining accurate PK and PD data in pediatric research involve ethical and regulatory considerations, as well as technical and procedural limitations, with risks often outweighing the benefits to the patient population.
The example from an on-going collaboration with Loma Linda University Children's Hospital shows the utility of AMS for determining 14C-ursodiol in blood samples from neonates after trace administration. Ursodiol is an endogenously occurring compound and an approved treatment for primary biliary cirrhosis in adults that is commonly administered to infants off-label for the treatment of cholestasis. Prior to this landmark study, PK data for ursodiol in infants had not been published. These data demonstrate an extended plasma half-life of more than 60 hours, significantly greater than that reported in previous adult studies. AMS is an effective, safe, and non-invasive approach to studying drugs and nutrients in pediatric subjects allowing drug developers and physicians to make better decisions based on appropriate PK and PD information.
Related Vitalea Publications:
Eckert & Ziegler Vitalea Science delivers the fastest turnaround times in the industry and can assist from study design to data interpretation. We have a great deal of experience in many indications and as part of all contracts offer pre-study consultation to ensure successful study outcome and, that expectations are fully understood and met. If you have questions or concerns pertaining to the analytical capacity of AMS and associated methods, please contact us. We look forward to speaking with you at an upcoming event in the coming months.
For a comprehensive list of publications and presentations please visit the Vitalea website http://www.vitaleascience.com or contact Ann Hoffman: email@example.com or firstname.lastname@example.org or call 801-706-2237.
Eckert & Ziegler Vitalea Science is an integrated provider of isotopes and isotope measurement and calibration services with the Vitalea facility dedicated to GLP level bioanalysis. We are the first U.S.-based bioanalytical contract research organization dedicated to providing services for exploring the pharmacokinetics and metabolism of drug candidates directly in humans and non-clinical species using AMS, both prior to and as part of phase I clinical trials. In our Davis, CA facility, we utilize the BioMICADAS, the only AMS instrument purpose-built to address the specific needs of the pharmaceutical industry.
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