GLP - Control Article is defined as which of the following?

GLP - Control Article is defined as which of the following?

• A. A novel compound under development
• B. Article administered to a test system for the purpose of establishing a basis for comparison with the test article
• C. A placebo medication
• D. A regulatory standard used for compliance

Answer: (B)

In GLP, a control article is any material given to the test system specifically to provide a baseline for comparison with the test article. This lets you distinguish effects caused by the test article from those due to the procedure, vehicle, or other factors. The best choice defines the control article by this purpose: it is administered to establish a basis for comparison with the test article. That’s why a novel compound under development isn’t the control article—it’s usually the test article. A placebo is a type of control, but the term control article covers more than just placebo, since it encompasses any reference material used for comparison. A regulatory standard used for compliance isn’t an article administered to the test system.

In GLP, a control article is any material given to the test system specifically to provide a baseline for comparison with the test article. This lets you distinguish effects caused by the test article from those due to the procedure, vehicle, or other factors. The best choice defines the control article by this purpose: it is administered to establish a basis for comparison with the test article.

That’s why a novel compound under development isn’t the control article—it’s usually the test article. A placebo is a type of control, but the term control article covers more than just placebo, since it encompasses any reference material used for comparison. A regulatory standard used for compliance isn’t an article administered to the test system.