[Emergo, UL] Determining External Critical Design Attributes when Conducting Threshold Analyses for Combination Product

Overview of Threshold Analyses for Combination Products

Threshold analyses help determine if differences related to external critical design attributes lead to additional use-related risks to the end user when comparing a proposed generic product to a reference product. The methodology for threshold analyses is described by the U.S. Food and Drug Administration (FDA) draft guidance document released in 2017.

In a previous article, my colleague and I discussed how to conduct Threshold Analyses to meet FDA expectations. This article will explain how to best determine external critical design attributes when conducting Threshold Analyses for combination products.

 

Importance of External Critical Design Attributes

In the 2017 draft guidance, the FDA outlines three types of threshold analyses to conduct in order to determine design differences between a proposed and reference product: labeling comparison, comparative task analysis and physical comparison. Once these comparisons have been completed, a manufacturer should begin categorizing the design differences.

Threshold analysis findings should be categorized based on whether or not a design difference impacts an external critical design attribute. The FDA defines a critical design attribute as a “feature that directly affects how users perform a critical task necessary to use or administer the drug product.” Design differences can be categorized as having no difference, being a minor difference or being an “other” difference. It can sometimes be challenging to differentiate minor attributes from critical attributes when conducting threshold analyses. External critical attributes are defined most easily by first determining a proposed product’s critical tasks.

 

 

Determining External Critical Design Attributes for Threshold Analyses | Emergo by UL

Determining External Critical Design Attributes when Conducting Threshold Analyses for Combination Product

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