Noncompartmental Analysis in Phoenix- Pharmacokinetics

Description

This assignment is a continuation from Module 4. Following your review of the bioanalytical data, anomalies in the data have been updated and a new data file is provided. Now you need to create tables and figures as discussed in the presentations and conduct the noncompartmental analysis.

Drug X is an antibiotic being developed to treat pneumonia. You receive updated data from a completed first in human clinical study which evaluated the pharmacokinetics of three single oral dose levels (50, 100, and 150 mg) of Drug X. Each dose level enrolled six healthy volunteers. The study evaluated plasma concentration of drug X at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours post dose.

Use Phoenix WinNonlin to analyze the data. Create a report that includes objectives, methods, results and conclusions. Include any discussion on any anomalous data and how this was handled as appropriate. Your Phoenix project should also be submitted.

Instructions

1. Download the new data filePreview the document, and follow single dose administration at three dose levels in a first in human study.

2. Use Phoenix WinNonlin to

– review bioanalytical concentration data
– conduct a noncompartmental analysis
– generate individual concentration and summary tables of concentration and PK parameter data
– mean and individual concentration vs time figures and PK parameter plots
– graphically analyze the concentration vs time data
– review the PK parameters
– interpret concentration and pharmacokinetic parameter data
– provide conclusions of impact of dose on PK parameters.

3. Save your Phoenix project. You will need to submit it as part of this assignment.

4. Create a report (a word document) with your findings that includes:

– table of contents
– details of the study design
– objectives of the PK analysis
– methods
– results
– discussion on any anomalous data and how this was handled as appropriate
– references as needed
– conclusions

5. Write in full sentences and be specific to the study in question.