Comparison Studies & Claims Substantiation Testing Where Standards Are Insufficient

Comparison Studies and Claims Substantiation Testing are categories of testing which typically are not sufficiently covered by standards to develop needed comparisons or claim substantiation. This includes verifying or refuting claims, or other data, on a label.

This presentation will outline comparison and claim types, including a review of what is likely to be a medical claim. Non-medical claims will then be discussed, along with strategies to address such claims, as well as comparisons that may or may not be claims-oriented. These characterization and testing strategies are intended to help develop data that is sufficient for a broad range of uses by the client to include litigation and legal support.

Learning objectives:

1. Determine the difference between medical versus non-medical claims
2. Differentiate between claim types
3. Learn about standardized testing versus scientific testing based on representative use case(s)
4. Discover efficient strategies for testing, including breadth and scale
5. Develop data respective to claim goals

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