Label Comprehension Studies

Drug Facts Labeling, Consumer Leaflets, Educational Materials or Medication Guides

Concentrics has designed and conducted hundreds of label comprehension studies.  These studies are based on best practices in consumer research and on the FDA’s “Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products” (August 2010).  Studies are often conducted in an iterative fashion by testing various label versions in rounds of testing.

Each program is customized to the sponsor’s goals and needs.  Often the testing begins with pre-testing and proceeds to pilot testing and finally to quantitative testing.

Concentrics has also developed a novel and accelerated approach to initiate the testing.  Ask about our ACE© (Accelerated and Compressed Evaluation) Testing.

Targeted label comprehension studies are sometimes required after data has been analyzed from pilot and quantitative testing and prior to NDA submission.  Concentrics is very experienced in recruiting special populations for targeted testing.  This may include pediatric, adolescent or geriatric populations, various literacy levels, or populations with special medical conditions.

Proprietary Name and Umbrella Brand Label Testing

If you have proprietary name and umbrella brand needs, have specialized testing that we have developed, Discernment Testing, which will assist you identifying potential areas of consumer confusion so that the labeling for your new product can be clear to consumers of normal and low literacy.