ISPE Good Practice Guide: Comparator Management PDF

The ISPE Good Practice Guide: Comparator Management is the pharmaceutical industry’s first-ever resource for comparator processes. It has been developed to use as a central reference source that establishes strategic and tactical considerations related to comparator sourcing. It identifies good practices for making sourcing decisions, including how to set up a good sourcing team. The Guide also discusses good practices for blinding and releasing a comparator for use. The Guide will also explain the risks involved with ineffective comparator methods, and provide companies with strategies for avoiding the costs, delays and potential case study inaccuracies that might result from faulty comparator management.