Performing test systems and test items

Published on July 18, 2013   19 min

A selection of talks on Pharmaceutical Sciences

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"Performing Test Systems and Test Items." This presentation sets forth the key aspects of test items and test systems during the conduct of studies in compliance with the principles of good laboratory practice, in short, GLP. As already said in the first of my three presentations, I am Sergio Caroli. I have been one of the Research Directors of the Istituto Superiore di Sanita that is the National Institute of Health, where I spent a full 42 years. In particular, I was the delegate for Italy at the Institute Working Group on GLP from its new inception in 1988 until I retired in 2010.
Let us start with a few definitions. Do you ever thought what the successful conduct of GLP compliance studies is the proper identification, characterization, and management of test items and test systems. As the principles of GLP say, for each study the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known. But what do tests and reference items in test systems actually mean another approach should be adopted to select a test system.
The test title is added to a test system in a study and is the subject of an application for a marketing permit supported by the study itself. The definition given by the principles of GLP for test item implies that the identity, activities, stability, and bioavailability of the test item are central to the validity of the study.