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W 8 October 2014 Tablets & Capsules clinical trial materials Automated ink-removal system for blinding clinical trial materials Linda A. Felton and Cody J. Wiley University of New Mexico Bruce C. Cathcart Race Rock Associates Among the methods used to blind clinical trial materials, removal of identifying ink from the surface of dosage forms is not com- monly employed because it is very laborious. Recently, however, an automated system for de-inking was developed. This article describes the results of a study that evaluated how this automated system compares to a manual process in terms of the extent of ink removal and the effects on the drug product surface. ell-controlled clinical trials are a critical regulatory element in gaining approval of new chemical entities and in supporting label claim changes [1]. Generally, such tri- als are double-blinded, meaning neither the study partici- pants nor the clinical investigators know which therapy is given. This reduces the introduction of bias into the study results. Blinding of drug products, however, often poses a challenge to the pharmaceutical scientist because manipulating the product to conceal its identity should