Sökning: "Simulation-estimation study"

Hittade 1 uppsats innehållade orden Simulation-estimation study.

  1. 1. Critical evaluation of methods for estimation of increase in systemic drug exposure for renally impaired patients

    Master-uppsats, Uppsala universitet/Institutionen för farmaceutisk biovetenskap

    Författare :Robin Svensson; [2013]
    Nyckelord :Simulation-estimation study; drug development; renal function; marketing authorisation review;

    Sammanfattning : Introduction: The effect of renal impairment (RI) on systemic exposure is assessed in phase I with RI studies and/or in phase III with population pharmacokinetic analysis. Regulatory review has indicated that the estimated effect of RI from the two methods may differ. LÄS MER