Obtaining regulatory approval for an invented pharmaceutical brand name continues to be a significant hurdle for the industry. Your team can significantly improve approval results and mitigate risks by incorporating comprehensive safety review methods into the naming process. Brandsymbol’s regulatory experts can provide our pharmaceutical clients with a simple, sequenced, transparent, and standardized approach to name safety testing. Solid safety testing processes adhere to the guidelines for proprietary (invented) name reviews of global health authorities, such as the US Food and Drug Administration (FDA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), and European Medicine’s Agency (EMA).
Brandsymbol’s regulatory experts use several name safety testing tools to help prioritize a list of name candidates for regulatory review based on risk level (low, moderate, or high). One such tool is our proprietary method of analyzing Word Construction Analysis (or WCA). Our Word Construction Analysis is a proprietary algorithmic evaluation 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 sum of the individual elements creates the overall point value for WCA. 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 additional resources on our website.
To learn more about how Word Construction Analysis can benefit your next brand naming initiative, get in touch with our team of experts.