Our goal is to provide our pharmaceutical clients with a simple, sequenced, transparent, and standardized approach to name safety testing. Our safety testing process is designed to adhere to the guidelines for proprietary (invented) name reviews by global health authorities, such as the US Food and Drug Administration (FDA), Health Canada, and European Medicine’s Agency (EMA).
When prioritizing a list of name candidates for regulatory review based on risk level (low, moderate, or high), we analyze data using our name safety testing tools like a process we call Word Construction Analysis (or WCA).
Our Word Construction Analysis is a formula-based approach that goes beyond POCA and evaluates name pair similarities based on the name structure (letters, number of characters, etc.) using a scale of 0 (no similarity) to 10 (highest similarity), with a range of 5-7 as the point of concern threshold.
WCA can be used in the proprietary (invented) name review process to identify potential conflicts in brand name candidates based on an in-depth evaluation of name pair similarity-based elements, including:
Similarity-Based Elements
- Combined POCA Score
- Individual Orthographic and Phonetic Scores
- Starting Letter Comparison
- Prefix Comparison
- Suffix Comparison
- Character Count
- Character Placement – 2nd, 3rd, 4th position, etc.
The WCA Point System attributes more points for higher similarity. The overall point value for WCA is created by the sum of the individual elements. At present, we consider a point range to support similarity between a name pair for the EMA to be 6 to 10 points and for the FDA starting at 4. The further evaluation would include a Name Pair Analysis (NPA) which considers the overlapping characteristics and the setting for use for the name pair.
Our SafeMark team developed the Word Construction Analysis process in 2019 and uses it in abbreviated reviews, such as a GAP Analysis, Risk Assessment, and Regulatory Prescreening, as well as during full name safety testing to ensure our clients get the best and safest name candidates possible.
For more of the latest safety testing insights, check out the following sources:
- Complete materials from the Name Review Group (NRG) Joint Meeting with Interested Parties last month, which includes a presentation from our very own Dyan Rowe Davis, President of SafeMark.
- SafetyPulse Newsletter Winter Issue 2021
To learn more about how Word Construction Analysis can benefit your next brand naming initiative, get in touch with our team of experts.