ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Double-Dummy Design

A study design that is utilized when two different looking products are being tested against each other. A Placebo to Match (PTM) is made for each of the different products. the patients then take either the active of one product and PTM the other or viceversa. For example, if product X and product Y look different, a double dummy design would call for patient 1 to take product X and PTM product Y and patient 2 to take product Y and PTM product X.

Publication Source: ISPE Good Practice Guide: Comparator Management

Publication Date: 2012

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