Essays about: "marketing authorisation review"
Found 1 essay containing the words marketing authorisation review.
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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 biovetenskapAbstract : 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
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