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ISPE Issues Guidance for Clinical Trials Comparator Management

Pharmaceutical industry resource for product sourcing and blinding

ISPE
Tue, 03/06/2012 - 13:20
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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a society for professionals involved in the engineering and manufacture of pharmaceuticals and related products, has issued industry guidance to advise clinical trials on comparator management activities. The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s first-ever resource for comparator processes such as product sourcing and blinding. It identifies good practices for making sourcing decisions, including how to set up a good sourcing team. The guide discusses good practices for blinding and releasing a comparator for use. It also explains the risks involved with ineffective comparator methods, and provides companies with strategies for avoiding the costs, delays, and potential case-study inaccuracies that might result from faulty comparator management.

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