Essays about: "marketing authorisation review"

Found 1 essay containing the words marketing authorisation review.

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

    University essay from Uppsala universitet/Institutionen för farmaceutisk biovetenskap

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

    Abstract : 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. READ MORE