Rosa & Co and Vitalea Science to Present at ASPCT 2011 Meeting
In collaboration with Vitalea, Inc., Rosa 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.
Online, February 14, 2011 (Newswire.com) - 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.
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Tags: drug-disease modeling, pharmacokinetics, pharmacometrics, physiological modeling