1. In your own words, describe and explain the following with respect to GLP study Test Articles and Control Articles. 1) State clearly what are the Test Articles and Control Articles (TA/CA) in the GLP context? 2) What are the key points (Multiple) for handling and storage of TA/CA? 3) Who is responsible for characterizing the TA and CA and what should be considered in designing such characterization and include sterilization issues to be considered? What is different if the control article is a ‘marketed product’? 4) Clarify the differences in the responsibilities of Test Facility Management and the study Sponsor regarding the TA and CA?
1) Test articles are the object/ substance undergoing safety testing in the GLP setting. Control articles are possibly marketed products that serve as the standard of care. In general, a control article is to represent the basic device or drug that is being possibly improved upon. The control article creates the baseline to which the test article will be…show more content… In your own words, describe in the context of GLP research what is meant when the claim is made that one should never hope to discover anything from a GLP study? If discoveries are not expected to be made during GLP studies, then when would one like to make discoveries? What does it signify and what should the sponsor do if a GLP study in fact generates new and unexpected discoveries?
GLP is a standardized manner for conducting experiments to assess the safety of a device and verifies other results from other experiments. If any new results surface the FDA is more prone to question and delay approval by asking for an explanation of these unexpected results.
In proof of concept, pre-GLP, preliminary and exploratory experiments one would hope to uncover novel ideas or verify that their idea does indeed work in practice. These are the experiments in which the investigator would like to discover and issues with their ideas that may cause pivotal change in their
