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Reports from Medicines and Medical Devices Agency add new data to research in life sciences

Published in Medical Letter on the CDC and FDA, June 28th, 2009

Data detailed in 'An investigation into the importance of "very rapid dissolution" criteria for drug bioequivalence demonstration using gastrointestinal simulation technology' have been presented. According to recent research from Serbia, "The Biopharmaceutics Classification System (BCS) is based on the mechanistic assumptions that the rate and extent of oral drug absorption are governed by drug solubility, intestinal permeability, and dissolution rate from the dosage form administered. One of the goals of BCS is to identify classes of drugs for which bioequivalence may be established based solely on the in vitro dissolution data, i.e., which would be eligible for biowaiver."

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