The MAH has committed to provide data from a population PK analysis of paediatric and adult clofarabine concentrations, as well as additional data, which will support a recommendation of dose adjustments in patients with moderate renal impairment, by 31 March 2009.
MAH har forpligtet sig til at udarbejde data fra en farmakokinetisk populationsanalyse af clofarabin- koncentrationer til børn og voksne samt andre data, der vil understøtte en anbefaling om dosisjusteringer til patienter med moderat nyreinsufficiens, inden den 31. marts 2009.