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.
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.