5Product Validation
5.1 Introduction
Product validation is a key phase of product development. It is when the success criteria of the developed product are tested and evaluated by consumers to ensure expectations and product potential are explored before launching onto the market. This phase requires a combination of different tests to prove product performance involving both technical tests to establish key variables and tests with consumers to ensure it is actually perceived. In general it is key to assess: (i) performance and efficacy of the product against criteria connected to consumer claims and regulation requirements, (ii) consumer reaction to the product, and (iii) stability over time to ensure performance can be maintained. In all three of these key aspects, it is important to understand how response variables relate to each other and that predictions for variables are within the relevant performance range. This is possible using linear or multiple linear regression models.
Three case studies are discussed in this chapter. The first concerns a multicenter randomized pilot study performed to assess the effect of a new pharmaceutical preparation as add‐on therapy in GERD (gastroesophageal reflux disease) patients. Based on data retrieved from a questionnaire designed to measure and evaluate specific GERD symptoms of heartburn, regurgitation, and dyspepsia, three scores were calculated by combining frequency and severity of each symptom. Investigators need to analyze ...
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