Winnonlin support1/2/2023 ![]() ![]() Write clearly, concisely and in context of this particular study. Keep in mind that this is a professional report that is intended to be submitted to the FDA in support of filing a new drug application for approval. Interpretation of the results is fundamental to this final project. Your manager will expect you to make study conclusions that are supported by the data and can be used to support patient dosing information. The expectations of your manager are that you accurately conduct the PK analysis based on the analysis plan below, create the tables and figures as planned and write up a high quality PK report that documents all the findings from the clinical study and presents data in a clear and concise manner. Create tables and figures and describe the findings in your report. Read the study design, analysis plan below and conduct a noncompartmental analysis in Phoenix WinNonlin using the PK merge file Download PK merge filereceived. ![]() You are a clinical pharmacokineticist working for Company Y, you are responsible for analyzing and reporting pharmacokinetic data from this renal impairment study. ![]()
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