February 15, 2011 -- In collaboration with Vitalea Science, Inc., Rosa & Co will present a poster at the 2011 American Society for Clinical Pharmacology and Therapeutics in Dallas, TX entitled “Compartmental Analysis of Urosodiol PK in Neonates using AMS " at 8:00 am on March 4, 2011.
One of the reasons for the dearth of clinical drug testing in newborns is a lack of sensitive and non-invasive tools to support clinical trials. Most medicines prescribed to children are done off-label, with dosages extrapolated from adult data through body weight and surface-area calculations. Ursodiol (UDCA), while not approved by the FDA for use in newborns, is used to treat pediatric cholestasis. Measurement of UDCA PK requires differentiating between endogenous and exogenous compound by using a labeled tracer. This is the first clinical study of UDCA pharmacokinetics in a pediatric population. The PK model uses Accelerated Mass Spectrometry (AMS) data in a first of kind study in neonatal ICU patients.
About Rosa & Co
Rosa informs our customer’s most critical decisions -- from preclinical through clinical development -- with the creation and use of mathematical models that simulate disease physiology, drug action, patient variability, and trial outcomes. To address the full spectrum of related issues, Rosa offers two customized approaches: classic pharmacokinetic/ pharmacodynamic (PK/PD) models and Rosa’s innovative PhysioPDa” models. With these approaches, Rosa’s clients collaborate in model creation and testing, retain the final model, and acquire the ability to use and interpret it. Rosa’s staff have unparalleled experience in drug-disease modeling and simulation (M&S), spanning hundreds of applications and dozens of clients over close to two decades of professional experience. Rosa is unique in their breadth and depth of disease area experience, including metabolic and cardiovascular diseases, oncology, gastro-intestinal disease, inflammatory diseases, immune dysfunction (including rheumatoid arthritis), pain, skin conditions, respiratory, and antibacterials/antivirals. For more information, visit www.rosaandco.com.
About Vitalea Science
Vitalea Science is a technology-driven Contract Research Organization that provides ultralow detection strategies for drugs and drug candidates at microdose levels. Situated in Northern California, the company was formed by chemists and physicists from the University of California at Davis and the Department of Energy’s Lawrence Livermore National Lab in 2003. For more information, visit www.vitaleascience.com
