Article
Over-Encapsulation: Techniques And Challenges Of Blinding Clinical Trial Material
August 18, 2010
•Article: Over-Encapsulation: Techniques And Challenges Of Blinding Clinical Trial Material
By Capsugel
Over-encapsulation is the most widely used method of blinding supplies in clinicalstudies, which are larger, more complex, and spread through more countries than ever before. This article reviews techniques for successful over-encapsulation and suggests solutions to common problems.
Between 2006 and 2008, the number of registered clinicaltrials increased 156 percent in the USA and 133 percent in Europe, due in part to greater regulatory emphasis on drug safety anda growing demand for comparative effectiveness research. Meanwhile, scientists are seeking more efficient and cost-effective ways to produce high-quality clinical trial materials (CTMs).
Methods of blinding the dosage forms used in CTMs range from deprinting or debossing the comparator or manufacturing an identical placebo to milling the tablets and filling them into capsules. But over-encapsulation is the most common approach. Over-encapsulation places the product or products(e.g.,tablets, caplets, capsules) into an opaque capsule that prevents investigators and subjects from identifying which capsules hold the active medication and which hold the placebo or comparator product. The method removes bias and allows you to perform comparator studies without manufacturing matching placebo samples.
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