POWER OF 3™ METHODOLOGY

If you are considering submitting a brand name or two! for regulatory submission - we offer Name Safety Testing methodology called the Power of 3™ that refers to the 3 aspects of a brand name review that should be completed prior to selecting a name for regulatory submission.

Power of 3™ Methodology 

STEP #1

Initial Brand Name Review

(Internal Review) 

  • Database Search for potential conflicts using up to 23 databases based on geographic scope.  This search includes our name safety testing tools such as the FDA POCA system and Word Construction Analysis. 

  • Checklist considering attributes that may contribute to confusion

  • Misbranding / Promotional Review to determine if there is any message or potential claim in the name that may lead to confusion or be misleading about the product. 

STEP #2: 

Name Safety and Commercial Testing

(External Respondent Data)

  • A data collection survey created for healthcare professionals and consumers to evaluate up to 20 name candidates

  • Safety & Commercial Metrics

    • Prescription Interpretation Study​

    • Sound-Alike and Look-Alike Similarity 

    • Promotional Review

    • Overall Impression

    • Ease of Pronunciation

    • Fit to Concept

    • Recall

    • Favorite Choice

  • Patient Harm Analysis (Failure Modes and Effects Analysis (FMEA)

STEP #3

Proactive Risk Assessment (PRA)

(Analysis Stage)

  • After all the data is collected from the Power of 3 Methodology, SafeMark utilizes name safety testing tools to analyze the data and present their findings in the Proactive Risk Assessment on a maximum of 20 name candidates. 

  • The PRA output helps to prioritize the name candidates for regulatory submission.

We use the following Name Safety Tools to prioritize name candidates for regulatory submission... 

  • Degree of Similarity - using FDA POCA's System algorithm but with over 20+ databases for a global project!

  • Word Construction Analysis (SRC-WCA)

  • Percent Derivation (SRC-PD)

  • Name Pair Analysis (SRC-NPA)

  • Handwriting Analysis (SRC-HW)

  • Failure Modes & Effects Analysis (FMEA) Survey - includes Health Canada's LASA assessment required for proprietary name submission reports. 

Power of 3 Methodology applies to the following types of products

Prescription Drug Products

(includes Combination Products)

Nonprescription or OTC Products

Animal Drug Products

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