- #Phoenix winnonlin tutorial professional#
- #Phoenix winnonlin tutorial download#
Create a figure that can display key PK parameters vs Study Cohort. Concentration should be presented on a linear and log y-axis. Create a separate plot for each of the Study Cohorts. Create a plot with individual concentration vs time profiles, each subject should have its own line on the plot. Create two figures one with a linear concentration y-axis and one with a log concentration y-axis. Create a mean + SD concentration vs time figure grouped by Study Cohort. Present individual and summary statistics of PK parameters to 3 significant figures. Create a table which presents PK parameter data and summary statistics. Present individual concentration data to the same precision as provided in the bioanalytical data and summary statistics to 3 significant figures. Create a table which presents individual concentration data and summary statistics by timepoint. Use Phoenix WinNonlin to conduct a noncompartmental analysis including the following tables and figures:. Read the study design, analysis plan above. TIME and TIMEU columns represent actual time of the PK sample and the units of time respectively. Pharmacokinetic data are contained within the PK merge file. Ensure that you include page numbers in the footer at the bottom of each page. Do refer to regulatory guidances as appropriate for this study and as have been discussed in class. Do not include generalizations on what is pharmacokinetics or the benefits of pharmacokinetics in drug development, the FDA already knows this. Write clearly, concisely and in context of this particular study. #Phoenix winnonlin tutorial professional#
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.
#Phoenix winnonlin tutorial download#
Read the study design, analysis plan below and conduct a noncompartmental analysis in Phoenix WinNonlin using the PK merge file Download PK merge filereceived. Note: Ensure that you include page numbers in the footer at the bottom of each page.You are a clinical pharmacokineticist working for Company Y, you are responsible for analyzing and reporting pharmacokinetic data from this renal impairment study. Write your final report to include the following components:.
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