A pharmaceutical company has contracted with ABC Laboratories to determine drug levels of a new allergy medication after taking it at two different time points (6 hours and 12 hours after ingesting drug) of 25 human subjects. 

In this study, 25 human subjects will be administered the same dosage of the allergy medication: 100 mg.  The pharmaceutical company is looking to see what the average drug level in the subjects is after 6 hours and again after 12 hours; the lab will use gas chromatography/mass spectrometry the analyze the blood samples. 

From the scenario above: 

1. generate a background information and study objectives, the importance of assessing drug levels at different time points, discuss the relevance of the research in evaluating the pharmacokinetics of the allergy medication.

2. Experimental design and methods: 

• Description of test articles--identified by name and CAS number, concentration, purity, and any other distinguishing characteristic. Stability and solubility of test and control articles.
• Description of the test system-- (a) number of animals used, their species and subspecies, where they were procured, age, weight, sex, and means by which the individual animal was identified, or (b) number of humans used.
• Description of methods used, explain the use of GC/MS for drug level analysis.
• Provide details on the methods used for blood sample collection, storage, and preparation for analysis.
• Description of dosage, frequency of dosage, route of administration, etc.

3. Procedural changes:

• Discuss any changes made to the methods described in the original protocol and provide reasons for these modifications.
• Highlight how these changes may have influenced the study outcomes.

4. Storage of records:

• Describe the storage location and conditions for the specimens, raw data, and final data.

Answer rating: 100% (QA)

Answer Background Information and Study Objectives Background The pharmaceutical company has partnered with ABC Laboratories to conduct a study assessing the pharmacokinetics of a new allergy medicati... View the full answer